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Public Health Approaches to Type 2 Diabetes Prevention: the US National Diabetes Prevention Program and Beyond

  • Diabetes Epidemiology (E Selvin and K Foti, Section Editors)
  • Open access
  • Published: 05 August 2019
  • Volume 19 , article number  78 , ( 2019 )

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  • Stephanie M. Gruss 1 ,
  • Kunthea Nhim 1 ,
  • Edward Gregg 2 ,
  • Miriam Bell 1 ,
  • Elizabeth Luman 1 &
  • Ann Albright 1  

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A Correction to this article was published on 27 June 2020

This article has been updated

Purpose of Review

This article highlights foundational evidence, translation studies, and current research behind type 2 diabetes prevention efforts worldwide, with focus on high-risk populations, and whole-population approaches as catalysts to global prevention.

Recent Findings

Continued focus on the goals of foundational lifestyle change program trials and their global translations, and the targeting of those at highest risk through both in-person and virtual modes of program delivery, is critical. Whole-population approaches (e.g., socioeconomic policies, healthy food promotion, environmental/systems changes) and awareness raising are essential complements to efforts aimed at high-risk populations.

Successful type 2 diabetes prevention strategies are being realized in the USA through the National Diabetes Prevention Program and elsewhere in the world. A multi-tiered approach involving appropriate risk targeting and whole-population efforts is essential to curb the global diabetes epidemic.

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Introduction

Worldwide, it is estimated that 425 million adults (20–79 years) have diabetes, projected to reach 629 million by 2045 [ 1 •]. In the USA, about 30 million adults (18 years and older) have diabetes, or 12.2% of the adult population [ 2 ]. Diabetes was estimated to cost $727 billion in 2017 in health expenditures worldwide [ 1 ] and $327 billion in 2017 in total economic costs in the USA [ 3 •]. Increases in diabetes prevalence have led to increases in related complications, such as cardiovascular disease, visual impairment and vision loss, lower extremity amputations, end-stage renal disease, disability, and premature mortality [ 2 ].

The majority of diabetes is type 2, which generally follows a period of prediabetes, a condition where blood glucose levels are higher than normal, but not high enough for a type 2 diabetes diagnosis [ 2 ]. In the USA, risk factors for prediabetes and type 2 diabetes include being overweight or having obesity; having a racial/ethnic background that is African-American, Hispanic/Latino, American Indian, Asian American, or Pacific Islander; having a parent or sibling with diabetes; having hypertension; having a history of gestational diabetes; and living a sedentary lifestyle. An estimated 353 million adults worldwide [ 1 ]—84.1 million in the USA (33.9% of all adults) [ 2 ]—have prediabetes diabetes. Given the magnitude of these numbers, identifying those at risk and preventing or delaying onset of type 2 diabetes are critical to ending the pandemic.

Type 2 diabetes can be prevented or delayed through mitigation of modifiable risk factors, such as healthier eating, weight loss, and increased physical activity. Studies show lifestyle intervention as a sole modality, lifestyle intervention in combination with therapeutics, and whole-population approaches are all promising for type 2 diabetes prevention. Public health interventions using glycemic risk stratification to target individuals at “very high” risk (having obesity and impaired glucose tolerance (IGT)) and “high” risk (being overweight with IGT) have proven to significantly reduce conversion to type 2 diabetes [ 4 ]. Individuals in these categories have a fasting plasma glucose (FPG) > 100 mg/dL, HbA1c levels > 5.7%, and a 10-year diabetes incidence of 20–30% or more [ 5 ]. Individuals in lower risk tiers may be more appropriately targeted via risk counseling and whole-population strategies [ 5 , 6 , 7 ]. Population-level policies, systems, and environmental approaches, along with lifestyle intervention for those at high risk, are likely optimal to achieve the greatest level of impact [ 8 ].

The purpose of this review is to highlight the foundational and current research and translation studies which underlie high-risk population and whole-population strategies for type 2 diabetes prevention worldwide, with particular focus on the U.S. National Diabetes Prevention Program, as catalysts for global prevention efforts.

Worldwide Evidence for Type 2 Diabetes Prevention Through Lifestyle Change

Foundational research.

The scientific evidence for prevention through lifestyle changes is compelling based on a series of randomized control trials (RCTs), which found through intensive, structured, yearlong educational programs focused on moderate weight loss (5–7%), increasing self-efficacy around engagement in one’s health, and moderate increases in physical activity over time, it is possible to prevent or delay type 2 diabetes among those at very high and high risk. RCTs have been conducted in various settings among diverse racial and ethnic populations. Common elements include utilizing a group-based intervention and evaluating effectiveness in terms of increased physical activity and healthy eating, and improved clinical metrics, such as weight, body mass index (BMI), waist circumference, HbA1c, and blood glucose.

The Chinese Da Qing group-based RCT was the first and longest running of such studies. It began in 1986 [ 9 ] with a follow-up study conducted in 1997–2006. The study demonstrated a 43% incidence reduction in the intervention group after 14 years when compared to the control group. Type 2 diabetes was delayed by an average of 3.6 years [ 10 ], and the incidence of severe retinopathy and cardiovascular-related disease and events were reduced [ 10 , 11 ]. After 30 years, 577 adults with IGT were followed from the original trial; the intervention group had a median delay in type 2 diabetes incidence of 3.96 years, an average increase in life expectancy of 1.44 years, and fewer cardiovascular disease and all-cause deaths, reduced incidence of cardiovascular events, and lower incidence of microvascular complications compared to the control group [ 12 ].

The U.S. Diabetes Prevention Program (DPP) was a three-arm RCT, which began in 1996 [ 13 ••]. The study found that a lifestyle change intervention focused on a 5–7% weight loss and a moderate increase in physical activity over one year achieved a 58% relative risk reduction in type 2 diabetes, and that use of metformin achieved a 31% reduction, when compared to a placebo [ 13 ••]. The DPP used intensive one-on-one counseling with a minimum of 50% racially and ethnically diverse individuals across both male and female genders at high risk for type 2 diabetes (elevated plasma glucose of 95 to 125 mmol/L or fasting glucose of 7.8 to 11.0 mmol/L) [ 13 ••]. A follow-up study, the U.S. Diabetes Prevention Program Outcomes Study (DPPOS), reported a 34% reduction in type 2 diabetes incidence 10 years after the completion of the DPP trial for the lifestyle change intervention arm [ 14 ], and a 27% reduction after 15 years (18% for the metformin arm), compared to the placebo group [ 15 ]. Furthermore, the study found that lifestyle change was cost-effective compared to a placebo, and that cumulative quality-adjusted life years (QALYs) gained over a 3-year timeframe were greater for lifestyle (6.81) than either metformin (6.69) or a placebo (6.67) [ 16 ].

The Finnish Diabetes Prevention Study (Finnish DPS), which began in 2001 [ 17 ], tested lifestyle intervention in a community-based primary health care setting, and designed and implemented a high-risk screening assessment for type 2 diabetes that is used worldwide called the Finnish Type 2 Diabetes Risk Score [ 18 ]. The study demonstrated a risk reduction of 58%, as well as a legacy effect of 43% reduction in type 2 diabetes incidence three years after completion of the study. The study has also been successfully translated in Greece with similar results [ 19 ].

The Japanese DPP, conducted in 2005 in male participants with IGT > 140 mg/dL, found a cumulative 4-year incidence of diabetes of 9.3% in the control group, versus 3.0% in the intervention group [ 20 ]. The Indian DPP-1 trial, conducted in 2006, was a community-based RCT involving 531 subjects with IGT across three intervention arms (one was given advice on lifestyle modification (LSM), one was treated with metformin (MET), and another was given LSM plus MET) and one control arm. A relative risk reduction of 26–29% after 30 months was similar in all three intervention arms [ 21 ]. Additional 3-year results suggest that both metformin and lifestyle change were cost-effective in preventing type 2 diabetes [ 22 ].

Translational Research

Translational research, which examines how to best tailor key research findings into policy, program, or practice [ 23 ], further demonstrates that lifestyle interventions are feasible and effective in real-world settings [ 24 ]. A systematic review and meta-analysis of 28 US-based DPP translation studies found a mean weight loss of over 4% across 3797 high-risk participants and demonstrated cost-effectiveness in terms of program, materials, and staff costs [ 24 ].

The European DE-PLAN study (“Diabetes in Europe – Prevention using Lifestyle, Physical Activity, and Nutritional Intervention”), implemented in 17 countries, was a community-based 10-month translation of the Finnish DPS targeting those at high risk for type 2 diabetes [ 19 ]. DE-PLAN began in 2008 and used the Finnish Diabetes Risk Score to determine eligibility [ 19 ]. In 2018, study participants in Poland ( n  = 175) with increased risk for type 2 diabetes received 10 months of lifestyle counseling sessions, physical activity, and self-efficacy sessions [ 25 ••]. Participants with a higher starting BMI and a history of increased glucose were more likely to achieve the goal weight loss of ≥ 5% of initial body weight compared to those with lower risk [ 25 ]. A UK study had similar findings, also determining adults with obesity and higher HbA1c levels (6–6.4%) not only met the weight loss outcomes of the US DPP trial but also gained more QALYs than those with lower risk; the intervention was also determined to be cost-saving [ 26 ].

The Australian Good Ageing in Lahti Region Lifestyle (GOAL) Implementation program, based on the Finnish DPS, found positive associations between changes in self-efficacy and dietary behaviors and improvement in waist circumference, cholesterol levels, triglycerides, diastolic blood pressure, and FPG in the lifestyle intervention arm compared to the control group [ 27 ]. GOAL was further scaled up with over 10,000 participants via the Melbourne DPS with significant improvements in cardiovascular risk factors, waist circumference, BMI, and weight loss [ 28 ].

Alternative modalities of lifestyle change program delivery, such as virtual program delivery and telehealth, have the potential to reach millions of people, even in remote areas. Shortly after publication of the 2002 DPP research study, Tate et al. (2003) conducted the first RCT of a yearlong Internet-based diabetes prevention lifestyle change weight loss program alone vs. one with the addition of e-behavioral counseling [ 29 ]. The group receiving e-behavioral counseling submitted calorie and exercise information and received weekly e-mail behavioral counseling and feedback from a counselor for 12 months and lost 4.8% of original body weight compared to 2.2% among those receiving the Internet program only [ 29 ]. A 2013 text messaging study in India showed that mobile technology can have an impact on clinical outcomes, with cumulative incidence of type 2 diabetes at 2 years of 18% in the text messaging counseling group vs. 27% in the control group [ 30 ], and a sustained reduction in incidence after 5 years [ 31 ]. Similar studies have been conducted (Supplemental Table 1 ) to determine the effectiveness of various forms of virtual delivery, including delivery via television, social networking sites, and online. These published studies on virtual delivery found ~ 4% to 10% weight loss after virtual implementation of a yearlong diabetes prevention lifestyle change program. A summary of results is included in Supplemental Table 1 .

The evidence is clear: lifestyle interventions can prevent or delay type 2 diabetes among various races, ethnicities, genders, and regions. Additionally, type 2 diabetes prevention program interventions continue to demonstrate cost-effectiveness/cost savings in real-world settings over time [ 32 , 33 ].

The US National DPP—a Case Study

Large-scale implementation of the US DPP trial’s lifestyle change program began in 2010, when Congress authorized the US Centers for Disease Control and Prevention (CDC) to establish and lead the National DPP in an effort to make the intervention broadly available to individuals at high risk [ 34 ]. The National DPP is a partnership of public and private organizations working to build a delivery system for the lifestyle intervention. It consists of four core elements: a trained workforce of lifestyle coaches; national quality standards supported by the CDC Diabetes Prevention Recognition Program (DPRP); a network of program delivery organizations sustained through coverage; and participant referral and engagement [ 35 ]. The National DPP lifestyle change program is based on evidence and key features of the US DPP trial that were shown to be successful: realistic weight loss goal after 12 months (minimum 5% of initial body weight), documentation of physical activity minutes (≥ 150 min per week), and attendance throughout the 12-month program, with an emphasis on self-efficacy that focuses on improving problem-solving skills, social supports, the use of built environments, and strategies to adapt to change [ 35 ]. The National DPP is the world’s largest translation of the US DPP study, having reached over 324,000 participants across > 3,000 organizations as of April 12, 2019 [ 36 ]. The DPRP is the quality assurance arm of the National DPP, developing evidence-based standards (DPRP Standards) and monitoring and evaluating participating organizations for fidelity and effectiveness of intervention delivery [ 37 ]. The DPRP Standards are updated every three years based on new dietary, physical activity, self-efficacy, delivery modality, and other type 2 diabetes prevention evidence. Through the DPRP, CDC awards either preliminary (based on participant attendance rather than outcomes) or full (meeting all DPRP Standards) recognition to successful organizations [ 37 ]. CDC recognition is widely accepted in the USA as an assurance of a quality type 2 diabetes prevention program and can result in insurance coverage for participants and reimbursement for program delivery organizations.

Public and private insurance coverage for type 2 diabetes prevention interventions is crucial to widespread adoption and participation in National DPP lifestyle change programs. Insurance coverage expands payment options, thereby reducing the burden of cost for participants. Currently, over 3.8 million public employees and dependents in 20 states have the National DPP lifestyle change program as a covered benefit and over 100 private employers and commercial plans include it as a covered benefit for their employees [ 38 ]. In 2018, the US Centers for Medicare & Medicaid Services (CMS) began coverage for eligible Medicare beneficiaries who participate in CDC-recognized programs and meet performance goals of the National DPP [ 40 ]. CMS provides reimbursement for participants meeting program goals such as 5% weight loss in organizations that have achieved either preliminary or full CDC recognition [ 39 ]. Eight states in the USA also provide Medicaid coverage for eligible beneficiaries [ 38 ].

Based on published translational research, feedback from stakeholder organizations, and gray literature scans (stakeholder materials and policies not found in peer-reviewed journals), CDC concluded that there was sufficient evidence to allow organizations delivering the National DPP lifestyle change program virtually to apply for CDC recognition. Thus, in order to expand availability and increase program participation (especially for those in rural or remote locations), the DPRP Standards were amended in January 2015 to allow online modes of delivery in addition to in-person. The Standards were amended again in February 2018 to also include telehealth and combination (in-person/virtual) delivery and new participant-level variables that include education level, enrollment source, and payer source. All virtual providers are held accountable to the same quality standards as in-person delivery organizations, including the provision of coaching services [ 37 ]. As of April 2019, CDC had 121 recognized virtual providers delivering the yearlong lifestyle change program to over 193,000 people [ 36 ].

Key Findings from In-Person National DPP Delivery in the USA

DPRP data from the first 4 years (February 2012–January 2016) of the National DPP, describing the experience of 14,747 participants who attended 4 or more sessions of the lifestyle change program in 220 organizations, showed an average weight loss of 4.2%, with 35.5% of participants achieving ≥ 5% weight loss [ 40 ]. Participants reported an average 152 min per week of physical activity, with 41.8% meeting the physical activity goal of 150 min per week. Participants with longer retention and greater participation in the program and who were more physically active were more likely to have higher weight loss [ 40 ].

Implementation of the National DPP: New Insights

Analysis sample.

To further assess National DPP implementation success, we examined recent DPRP data and analyzed new variables (education level, enrollment source, and payer source) to assess their relationship with participant outcomes. More than 297,000 participants attended one or more lifestyle change program sessions between February 2012 and January 2019. For the purpose of this new analysis, 143,489 eligible participants across all program modalities (in-person, online, distance learning, and combination) who completed the yearlong lifestyle change program and attended ≥ 3 sessions in the first 6 months (analyzed participants) were included in descriptive analyses. Of those, 29,069 eligible participants who started the program in 2018 and reported new variables (education level, enrollment source, and payer source) were included in the multivariable analysis (Fig.  1 ).

figure 1

Flow chart for analysis sample. CDC = Centers for Disease Control and Prevention; DPRP = Diabetes Prevention Recognition Program; LCP = CDC-recognized lifestyle change program; National DPP = National Diabetes Prevention Program. 1 Participant eligibility was based on BMI (≥ 25 kg/m 2 , or ≥ 23 kg/m 2 if Asian American), a blood test indicating prediabetes, a CDC Prediabetes Screening Test or American Diabetes Association Type 2 Diabetes Risk Test, or a previous diagnosis of gestational diabetes mellitus. 2 Education level, enrollment sources, and payer sources were not collected before February 2018

Measures and Methods

Percent body weight change was the primary outcome of this analysis, calculated among participants with at least 2 documented body weights using the first (baseline) and last recorded weights. Average weight loss and physical activity minutes per week were calculated among participants who attended ≥ 3 sessions in the first 6 months and whose time from first session attended to last session attended was ≥ 9 months. CDC considers this threshold to be the minimum dose to begin seeing lifestyle and weight change that can impact type 2 diabetes [ 40 ].

Mantel-Haenszel chi-square tests of difference were used to assess bivariate associations between participants’ characteristics and duration of participation. Results were stratified by duration of participation (≥ 9 vs. < 9 months). Multiple logistic regression models were used to estimate the association between participants’ attendance and duration of participation and the likelihood of meeting the minimum 5% weight loss goal conditional on other factors. Adjusted odds ratios (AORs) in relation to a reference category were reported with their respective 95% confidence intervals (CIs). Results with p  < 0.05 were considered statistically significant. All analyses were conducted using SAS, version 9.4.

Overall, about 60% of analyzed participants attended the lifestyle change via an online-only modality, 40% via an in-person only modality, and <  1% via distance learning only or combination modality (Table 1 ). About 40% of analyzed participants attended at least 17 lifestyle change sessions; 31% met the minimum 5% weight loss goal, and 45% met the average 150+ min per week of physical activity goal. Three quarters were females; over half were aged 45–64 years; over 60% were non-Hispanic whites; about half reported having 4 years of college or more; and over 70% had obesity (body mass index (BMI) ≥ 30 kg/m 2 ).

Weight loss success was significantly higher among those who attended ≥ 17 sessions (AOR 3.2), those who stayed in the program for ≥ 9 months (AOR 1.3), and those with ≥ 150 min of physical activity per week (AOR 1.7) (Table 2 ). Participants aged 45–64 and ≥ 65 years had 3.2 and 1.6 times, respectively, the odds of meeting the 5% weight loss goal than those aged 18–44. Females, non-Hispanic blacks, and those with obesity were slightly less likely to meet the 5% weight loss goal than males, non-Hispanic whites, and those overweight (BMI between 25 and 29.9 kg/m 2 ).

This analysis is subjected to some limitations. First, biometric data (weight and physical activity minutes) was self-reported either by CDC-recognized organizations or participants themselves. However, lifestyle coaches were provided guidance to use the same scale at each session for recording participants’ body weight to ensure consistency. Second, calculation of percent weight loss was based on first and last recorded weight. Participants who lost more weight might be more likely to stay in the program longer and continue to lose more weight by the end of the program than those who dropped out early. Third, CDC’s DPRP began requiring organizations to submit information on participants’ education level, enrollment source, and payer source in February 2018; thus, our analyses were limited to a small sample of participants who started the program in 2018 (~ 10% of the total National DPP participants), as the remaining participants had not yet had the opportunity to participate in the program for a year prior to our study. Lastly, the analysis only included eligible participants based on CDC’s DPRP Standards, so it may not be generalizable to ineligible participants who may also benefit from this program.

Participation in Lifestyle Change Intervention

Successful expansion of lifestyle change interventions relies on sufficient enrollment and retention. A recent analysis of 2016–2017 U.S. National Health Interview Survey data showed that 73.5% of adults with overweight or obesity with diagnosed prediabetes and 50.6% of adults with overweight or obesity and elevated American Diabetes Association (ADA) risk scores reported receiving risk reduction advice or referrals to risk reduction activities from their health care providers [ 41 •]. Of those referred, only one third reported engagement in risk-reducing activities in the past year, and less than 3% reported participating in a type 2 diabetes prevention program. The key drivers for engagement in risk-reducing activities and programs included receiving advice from a health professional, having higher education, having insurance, being non-white race/ethnicity, and being middle aged. This study underscores the need for research from fields such as behavioral economics, human-centered design, and habit formation, to understand how to best engage people at high risk in type 2 diabetes prevention programs. Other approaches for systems change include the establishment of referral processes from clinical health care providers to community-based implementation programs, and media and marketing strategies to drive traffic to such programs. A recent study found that primary care providers in the USA who were aware of the National DPP lifestyle change program and the Prevent Diabetes STAT: Screen, Test, and Act Today™ Toolkit developed by CDC and the American Medical Association (AMA) were more likely to screen patients for prediabetes and make referrals to CDC-recognized organizations offering the National DPP. Those who used electronic health records were also more likely to screen, test, and refer [ 42 ].

Offering diabetes prevention programs via businesses and worksites could help lower employee health care costs and increase QALYs, and is an important systems approach still in need of broader consideration among employers [ 43 ]. Evidence-based programs within worksite wellness programs and health-based interventions within worksites are increasing in scope in the USA, and seem to be slowly gaining traction elsewhere in the world as well. To assist employers and insurers in determining the feasibility of providing the National DPP lifestyle change program or including it as part of their employees’ insurance benefits, CDC developed the Diabetes Prevention Impact Toolkit [ 43 ]. The toolkit helps estimate the cost per employee and the associated cost savings related to offering the National DPP lifestyle change program, including estimating the employee’s QALYs gained. A summary of recent peer-reviewed literature on employer-based diabetes prevention programs in the USA found that greater weight loss and maintenance of weight loss were achieved among worksites that implemented the National DPP lifestyle change program compared to worksites that implemented other interventions [ 44 ].

Another key approach to increasing participation focuses on raising awareness of both prediabetes as a serious condition and of type 2 diabetes prevention activities. This is a challenge, as many providers are not screening or testing patients for prediabetes when considering its risk factors (obesity, overweight, glycemic range, and cardiovascular risks) In the USA, CDC, ADA, and AMA partnered with the Ad Council to launch the nation’s first national public service campaign about prediabetes [ 45 ] which encourages people to take a short online test at DoIHavePrediabetes.org to learn their prediabetes risk. From the campaign’s launch on January 21, 2016, through March 31, 2019, 2.5 million people have completed the online risk test [ 46 ].

Whole-Population Approaches

Because of the widespread prevalence of type 2 diabetes and its risk factors, lifestyle change programs for the highest-risk people alone cannot sufficiently impact the diabetes pandemic without approaches that support prevention efforts across whole systems and communities. Larger-scale, population-wide prevention strategies, such as environmental, policy, cost reimbursement, and health marketing/awareness efforts, are therefore needed. Several whole-population approaches have been implemented in the USA. Many focus on socioeconomic policy involving nutrition regulation such as menu labeling; subsidies to increase the affordability of fruits and vegetables, particularly in rural or hard-to-reach areas [ 47 , 48 ]; sugar-sweetened beverage tax and decreased added sugars; and increased whole grains, fibers, nuts, and legumes and elimination of trans fats (or trans fatty acids) as recommended by the American Heart Association [ 49 ]. Globally, supported by WHO, clear nutrition “front-of-pack labeling” has been found to improve dietary habits and reduce cardiovascular complications [ 50 ].

A systematic review found strong evidence in Europe for implementing multiple policies simultaneously, including taxes on unhealthy food, subsidies for healthy food, trans fat elimination, and trade agreements with supportive countries who implement similar taxation and food policies [ 51 ••]. A 2014 systematic review of the evidence behind food taxation and food subsidies (government/local investments in healthy food) found that both should be implemented in tandem at a minimum rate of 10 to 15% to ensure the unhealthy foods are less accessible and healthy foods/beverages are more accessible to purchasers [ 52 ]. Similarly, Colchero et al. studied the effect of taxing sugar-sweetened beverages in stores in Mexico and found reductions in purchases of the taxed beverages associated with increases in purchases of untaxed beverages [ 53 ].

Environmental changes such as targeting the built environment and community planning efforts also show promise in reaching large populations. These approaches include the expansion or building of walking, biking, and hiking trials, and other “safe” routes [ 54 ]. A systematic review evaluating the effect of built environment policies on obesity-related outcomes across the USA, Canada, Chile, the UK, and New Zealand found that physical activity-related policies had a stronger impact when they involved improvements to transportation infrastructure. These improvements included creating more structural access such as building cycling lanes and park trails [ 55 ].

A possible limitation of whole-population approaches is that researchers have to rely largely on modeling studies or intermediate outcomes to determine impact. Short-term and longitudinal impact testing involving actual health and economic trends is more difficult, but critical to assessing intervention success. Also critical is understanding the contexts in which whole-population approaches are most effective.

To achieve large-scale type 2 diabetes prevention, interventions directed to both high-risk populations and the general population are necessary. There is strong evidence for the prevention of type 2 diabetes from RCTs and subsequent translation studies in which people at high risk engage in a structured lifestyle intervention that addresses nutrition, physical activity, and behavior change strategies resulting in a weight loss of ≥ 5%. Whole-population strategies also show promise in reaching large numbers of people and include multi-sector and multi-policy approaches, most successfully in combination. These approaches include taxation of unhealthy foods, enhancing the built environment, addressing food accessibility, offering worksite wellness, and raising awareness of prediabetes among health care providers and the general public.

Large-scale implementation of what has been proven to work, including alternate delivery approaches for type 2 diabetes prevention programs to reach disparate and geographically isolated populations, is needed. Continued examination of outcomes and program effectiveness is needed to refine global prevention efforts. Fortunately, there is much evidence worldwide that type 2 diabetes prevention or delay is attainable, and that prevention strategies can be adapted across cultures and environments. Success will require a combination of policy, systems, environmental, and health marketing/awareness approaches with effective interventions for high-risk populations and partnerships across sectors. Based on the data showing the impact of diabetes it warrants being prioritized to protect the public’s health around the world and curb the increasing burden of diabetes.

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Gruss, S.M., Nhim, K., Gregg, E. et al. Public Health Approaches to Type 2 Diabetes Prevention: the US National Diabetes Prevention Program and Beyond. Curr Diab Rep 19 , 78 (2019). https://doi.org/10.1007/s11892-019-1200-z

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  • Department of Medicine, Duke University, Durham, NC, United States

Type 2 Diabetes Mellitus (T2DM) is characterized by chronically elevated blood glucose (hyperglycemia) and elevated blood insulin (hyperinsulinemia). When the blood glucose concentration is 100 milligrams/deciliter the bloodstream of an average adult contains about 5–10 grams of glucose. Carbohydrate-restricted diets have been used effectively to treat obesity and T2DM for over 100 years, and their effectiveness may simply be due to lowering the dietary contribution to glucose and insulin levels, which then leads to improvements in hyperglycemia and hyperinsulinemia. Treatments for T2DM that lead to improvements in glycemic control and reductions in blood insulin levels are sensible based on this pathophysiologic perspective. In this article, a pathophysiological argument for using carbohydrate restriction to treat T2DM will be made.

Introduction

Type 2 Diabetes Mellitus (T2DM) is characterized by a persistently elevated blood glucose, or an elevation of blood glucose after a meal containing carbohydrate ( 1 ) ( Table 1 ). Unlike Type 1 Diabetes which is characterized by a deficiency of insulin, most individuals affected by T2DM have elevated insulin levels (fasting and/or post glucose ingestion), unless there has been beta cell failure ( 2 , 3 ). The term “insulin resistance” (IR) has been used to explain why the glucose levels remain elevated even though there is no deficiency of insulin ( 3 , 4 ). Attempts to determine the etiology of IR have involved detailed examinations of molecular and intracellular pathways, with attribution of cause to fatty acid flux, but the root cause has been elusive to experts ( 5 – 7 ).

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Table 1 . Definition of type 2 diabetes mellitus.

How Much Glucose Is in the Blood?

Keeping in mind that T2DM involves an elevation of blood glucose, it is important to understand how much glucose is in the blood stream to begin with, and then the factors that influence the blood glucose—both exogenous and endogenous factors. The amount of glucose in the bloodstream is carefully controlled—approximately 5–10 grams in the bloodstream at any given moment, depending upon the size of the person. To calculate this, multiply 100 milligrams/deciliter × 1 gram/1,000 milligrams × 10 deciliters/1 liter × 5 liters of blood. The “zeros cancel” and you are left with 5 grams of glucose if the individual has 5 liters of blood. Since red blood cells represent about 40% of the blood volume, and the glucose is in equilibrium, there may be an extra 40% glucose because of the red blood cell reserve ( 8 ). Adding the glucose from the serum and red blood cells totals about 5–10 grams of glucose in the entire bloodstream.

Major Exogenous Factors That Raise the Blood Glucose

Dietary carbohydrate is the major exogenous factor that raises the blood glucose. When one considers that it is common for an American in 2021 to consume 200–300 grams of carbohydrate daily, and most of this carbohydrate is digested and absorbed as glucose, the body absorbs and delivers this glucose via the bloodstream to the cells while attempting to maintain a normal blood glucose level. Thinking of it in this way, if 200–300 grams of carbohydrates is consumed in a day, the bloodstream that holds 5–10 grams of glucose and has a concentration of 100 milligrams/deciliter, is the conduit through which 200,000–300,000 milligrams (200 grams = 200,000 milligrams) passes over the course of a day.

Major Endogenous Factors That Raise the Blood Glucose

There are many endogenous contributors that raise the blood glucose. There are at least 3 different hormones that increase glucose levels: glucagon, epinephrine, and cortisol. These hormones increase glucose levels by increasing glycogenolysis and gluconeogenesis ( 9 ). Without any dietary carbohydrate, the normal human body can generate sufficient glucose though the mechanism of glucagon secretion, gluconeogenesis, glycogen storage and glycogenolysis ( 10 ).

Major Exogenous Factors That Lower the Blood Glucose

A reduction in dietary carbohydrate intake can lower the blood glucose. An increase in activity or exercise usually lowers the blood glucose ( 11 ). There are many different medications, employing many mechanisms to lower the blood glucose. Medications can delay sucrose and starch absorption (alpha-glucosidase inhibitors), slow gastric emptying (GLP-1 agonists, DPP-4 inhibitors) enhance insulin secretion (sulfonylureas, meglitinides, GLP-1 agonists, DPP-4 inhibitors), reduce gluconeogenesis (biguanides), reduce insulin resistance (biguanides, thiazolidinediones), and increase urinary glucose excretion (SGLT-2 inhibitors). The use of medications will also have possible side effects.

Major Endogenous Factors That Lower the Blood Glucose

The major endogenous mechanism to lower the blood glucose is to deliver glucose into the cells (all cells can use glucose). If the blood glucose exceeds about 180 milligrams/deciliter, then loss of glucose into the urine can occur. The blood glucose is reduced by cellular uptake using glut transporters ( 12 ). Some cells have transporters that are responsive to the presence of insulin to activate (glut4), others have transporters that do not require insulin for activation. Insulin-responsive glucose transporters in muscle cells and adipose cells lead to a reduction in glucose levels—especially after carbohydrate-containing meals ( 13 ). Exercise can increase the glucose utilization in muscle, which then increases glucose cellular uptake and reduce the blood glucose levels. During exercise, when the metabolic demands of skeletal muscle can increase more than 100-fold, and during the absorptive period (after a meal), the insulin-responsive glut4 transporters facilitate the rapid entry of glucose into muscle and adipose tissue, thereby preventing large fluctuations in blood glucose levels ( 13 ).

Which Cells Use Glucose?

Glucose can used by all cells. A limited number of cells can only use glucose, and are “glucose-dependent.” It is generally accepted that the glucose-dependent cells include red blood cells, white blood cells, and cells of the renal papilla. Red blood cells have no mitochondria for beta-oxidation, so they are dependent upon glucose and glycolysis. White blood cells require glucose for the respiratory burst when fighting infections. The cells of the inner renal medulla (papilla) are under very low oxygen tension, so therefore must predominantly use glucose and glycolysis. The low oxygen tension is a result of the countercurrent mechanism of urinary concentration ( 14 ). These glucose-dependent cells have glut transporters that do not require insulin for activation—i.e., they do not need insulin to get glucose into the cells. Some cells can use glucose and ketones, but not fatty acids. The central nervous system is believed to be able to use glucose and ketones for fuel ( 15 ). Other cells can use glucose, ketones, and fatty acids for fuel. Muscle, even cardiac muscle, functions well on fatty acids and ketones ( 16 ). Muscle cells have both non-insulin-responsive and insulin-responsive (glut4) transporters ( 12 ).

Possible Dual Role of an Insulin-Dependent Glucose-Transporter (glut4)

A common metaphor is to think of the insulin/glut transporter system as a key/lock mechanism. Common wisdom states that the purpose of insulin-responsive glut4 transporters is to facilitate glucose uptake when blood insulin levels are elevated. But, a lock serves two purposes: to let someone in and/or to keep someone out . So, one of the consequences of the insulin-responsive glut4 transporter is to keep glucose out of the muscle and adipose cells, too, when insulin levels are low. The cells that require glucose (“glucose-dependent”) do not need insulin to facilitate glucose entry into the cell (non-insulin-responsive transporters). In a teleological way, it would “make no sense” for cells that require glucose to have insulin-responsive glut4 transporters. Cells that require glucose have glut1, glut2, glut3, glut5 transporters—none of which are insulin-responsive (Back to the key/lock metaphor, it makes no sense to have a lock on a door that you want people to go through). At basal (low insulin) conditions, most glucose is used by the brain and transported by non-insulin-responsive glut1 and glut3. So, perhaps one of the functions of the insulin-responsive glucose uptake in muscle and adipose to keep glucose OUT of the these cells at basal (low insulin) conditions, so that the glucose supply can be reserved for the tissue that is glucose-dependent (blood cells, renal medulla).

What Causes IR and T2DM?

The current commonly espoused view is that “Type 2 diabetes develops when beta-cells fail to secrete sufficient insulin to keep up with demand, usually in the context of increased insulin resistance.” ( 17 ). Somehow, the beta cells have failed in the face of insulin resistance. But what causes insulin resistance? When including the possibility that the environment may be part of the problem, is it possible that IR is an adaptive (protective) response to excess glucose availability? From the perspective that carbohydrate is not an essential nutrient and the change in foods in recent years has increased the consumption of refined sugar and flour, maybe hyperinsulinemia is the cause of IR and T2DM, as cells protect themselves from excessive glucose and insulin levels.

Insulin Is Already Elevated in IR and T2DM

Clinical experience of most physicians using insulin to treat T2DM over time informs us that an escalation of insulin dose is commonly needed to achieve glycemic control (when carbohydrate is consumed). When more insulin is given to someone with IR, the IR seems to get worse and higher levels of insulin are needed. I have the clinical experience of treating many individuals affected by T2DM and de-prescribing insulin as it is no longer needed after consuming a diet without carbohydrate ( 18 ).

Diets Without Carbohydrate Reverse IR and T2DM

When dietary manipulation was the only therapy for T2DM, before medications were available, a carbohydrate-restricted diet was used to treat T2DM ( 19 – 21 ). Clinical experience of obesity medicine physicians and a growing number of recent studies have demonstrated that carbohydrate-restricted diets reverse IR and T2DM ( 18 , 22 , 23 ). Other methods to achieve caloric restriction also have these effects, like calorie-restricted diets and bariatric surgery ( 24 , 25 ). There may be many mechanisms by which these approaches may work: a reduction in glucose, a reduction in insulin, nutritional ketosis, a reduction in metabolic syndrome, or a reduction in inflammation ( 26 ). Though there may be many possible mechanisms, let's focus on an obvious one: a reduction in blood glucose. Let's assume for a moment that the excessive glucose and insulin leads to hyperinsulinemia and this is the cause of IR. On a carbohydrate-restricted diet, the reduction in blood glucose leads to a reduction in insulin. The reduction in insulin leads to a reduction in insulin resistance. The reduction in insulin leads to lipolysis. The resulting lowering of blood glucose, insulin and body weight reverses IR, T2DM, AND obesity. These clinical observations strongly suggest that hyperinsulinemia is a cause of IR and T2DM—not the other way around.

What Causes Atherosclerosis?

For many years, the metabolic syndrome has been described as a possible cause of atherosclerosis, but there are no RCTs directly targeting metabolic syndrome, and the current drug treatment focuses on LDL reduction, so its importance remains controversial. A recent paper compared the relative importance of many risk factors in the prediction of the first cardiac event in women, and the most powerful predictors were diabetes, metabolic syndrome, smoking, hypertension and BMI ( 27 ). The connection between dietary carbohydrate and fatty liver is well-described ( 28 ). The connection between fatty liver and atherosclerosis is well-described ( 29 ). It is very possible that the transport of excess glucose to the adipose tissue via lipoproteins creates the particles that cause the atherosclerotic damage (small LDL) ( Figure 1 ) ( 30 – 32 ). This entire process of dietary carbohydrate leading to fatty liver, leading to small LDL, is reversed by a diet without carbohydrate ( 26 , 33 , 34 ).

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Figure 1 . Key aspects of the interconnection between glucose and lipoprotein metabolism.

Reducing dietary carbohydrate in the context of a low carbohydrate, ketogenic diet reduces hyperglycemia and hyperinsulinemia, IR and T2DM. In the evaluation of an individual for a glucose abnormality, measure the blood glucose and insulin levels. If the insulin level (fasting or after a glucose-containing meal) is high, do not give MORE insulin—instead, use an intervention to lower the insulin levels. Effective ways to reduce insulin resistance include lifestyle, medication, and surgical therapies ( 23 , 35 ).

The search for a single cause of a complex problem is fraught with difficulty and controversy. I am not hypothesizing that excessive dietary carbohydrate is the only cause of IR and T2DM, but that it is a cause, and quite possibly the major cause. How did such a simple explanation get overlooked? I believe it is very possible that the reductionistic search for intracellular molecular mechanisms of IR and T2DM, the emphasis on finding pharmaceutical (rather than lifestyle) treatments, the emphasis on the treatment of high total and LDL cholesterol, and the fear of eating saturated fat may have misguided a generation of researchers and clinicians from the simple answer that dietary carbohydrate, when consumed chronically in amounts that exceeds an individual's ability to metabolize them, is the most common cause of IR, T2DM and perhaps even atherosclerosis.

While there has historically been a concern about the role of saturated fat in the diet as a cause of heart disease, most nutritional experts now cite the lack of evidence implicating dietary saturated fat as the reason for lack of concern of it in the diet ( 36 ).

The concept of comparing medications that treat IR by insulin-sensitizers or by providing insulin itself was tested in the Bari-2D study ( 37 ). Presumably in the context of consuming a standard American diet, this study found no significant difference in death rates or major cardiovascular events between strategies of insulin sensitization or insulin provision.

While lifestyle modification may be ideal to prevent or cure IR and T2DM, for many people these changes are difficult to learn and/or maintain. Future research should be directed toward improving adherence to all effective lifestyle or medication treatments. Future research is also needed to assess the effect of carbohydrate restriction on primary or secondary prevention of outcomes of cardiovascular disease.

Data Availability Statement

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s.

Author Contributions

The author confirms being the sole contributor of this work and has approved it for publication.

Conflict of Interest

EW receives royalties from popular diet books and is founder of a company based on low-carbohydrate diet principles (Adapt Your Life, Inc.).

Publisher's Note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

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24. Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia. (2011) 54:2506–14. doi: 10.1007/s00125-011-2204-7

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Keywords: type 2 diabetes, insulin resistance, pre-diabetes, carbohydrate-restricted diets, hyperinsulinemia, hyperglycemia

Citation: Westman EC (2021) Type 2 Diabetes Mellitus: A Pathophysiologic Perspective. Front. Nutr. 8:707371. doi: 10.3389/fnut.2021.707371

Received: 09 May 2021; Accepted: 20 July 2021; Published: 10 August 2021.

Reviewed by:

Copyright © 2021 Westman. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Eric C. Westman, ewestman@duke.edu

This article is part of the Research Topic

Carbohydrate-restricted Nutrition and Diabetes Mellitus

  • Research article
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  • Published: 05 June 2018

Diagnosis of diabetes mellitus and living with a chronic condition: participatory study

  • José Adailton da Silva   ORCID: orcid.org/0000-0002-6037-7649 1 ,
  • Elizabethe Cristina Fagundes de Souza 1 ,
  • Ana Gretel Echazú Böschemeier 1 ,
  • Camyla Cristina Maia da Costa 1 ,
  • Héllydade Souza Bezerra 1 &
  • Eva Emanuela Lopes Cavalcante Feitosa 1  

BMC Public Health volume  18 , Article number:  699 ( 2018 ) Cite this article

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Diabetes mellitus is one of the most serious chronic illnesses in the world due to its prevalence, economic and social effects, and negative impact on the quality of life of the affected people. The diagnosis implies changes in life habits especially related to feeding, physical activity, and constant self-care, requiring greater personal autonomy.

This study aims to understand how individuals living with diabetes deal with the recognition of the chronic condition in their health care practices. This is a participatory research with a qualitative approach focusing on reflexivity. Sixteen people with diabetes mellitus were intentionally chosen, and qualified to participate in the study. The selected methodology allowed the constitution of life stories and focused on the multiple ways human beings deal with their illnesses.

The participants attended eight closed group meetings, with an specific methodology which benefited them to retrieve their own history as well as the multiple experiences to deal with the disease, here called Strategic Health Promotion Group (SHPG). The data produced and the dialogue between researcher and researched subjects were related to three major thematic perspectives: I) recognizing diabetes II) living with diabetes III) exercising personal autonomy. This work contains the meanings attributed to the Perspective I from which the following three categories emerged: The impact of the diagnosis, the denial of the illness, and the acceptance of the illness. It was observed that the diagnosis of a chronic illness generates a multiplicity of feelings, moving through narratives of complications and death events shared between generations. The participants expressed feelings related to denial or acceptance of the chronic condition which required an active adaptation exercising. From the current diagnosis, it was observed that new signs were added to the person’s existence, influencing their habits, health care practices and quality of life.

Conclusions

The emotional aspects of subjects diagnosed with diabetes mellitus strongly influence the acceptance or denial of the illness, interfering in their personal adherence to treatment. As a chronic condition, involving life-longing care practices, which intervenes in therapeutic participation, it is indispensable to respect and to encourage the personal autonomy of the subjects.

Peer Review reports

Chronic non-transmissible diseases represent a major problem in the world, being the main cause of death today [ 1 ]. Diabetes mellitu s is one of the most worrying chronic diseases for its major economic and social impact, reported as responsible for 11.6% of the health care expenses worldwide in 2010 [ 2 ]. According to the World Health Organization [ 3 ], in 2014, a total of 422 million adults had diabetes and in 2012 there were 1.5 million deaths caused by this illness.

Diabetes mellitus is defined as a syndrome caused by several etiologies and is characterized by a metabolic dysfunction with a degenerative potential that involves energetic sources resulting from changes in the production, secretion and/or inability of the insulin to adequately exercise its effects. It is a chronic condition that requires the subjects living with the illness to have a continuous self-management of the lifestyle and adaptation to the illness [ 4 ].

Diabetes mellitus is often considered a silent illness and linked to poor health care. In fact, 46.5% of the affected people are unaware of their condition [ 5 ]. Thus, the news of having diabetes is often abrupt and may be accompanied by feelings of denial and/or difficulty in the treatment participation, which involves important changes in lifestyle.

The projections for diabetes mellitus are worrying. Currently, 10% of the world population lives with the illness and it is estimated that, by 2025, 300 million people will be affected. At that time, 75% of people with diabetes will be residents of developing countries, as a 170% increase in new cases is estimated for these countries, while an increase of 42% is expected for in developed countries [ 6 ].

The statistics in Brazil are close to the world average. However, it is estimated that by 2030, the country will occupy the 6th position in the world ranking, with 11.3% of the population affected by the illness [ 2 ].

However, more than preventive actions, the health care system needs health promoting actions that impact on the quality of life of the subjects already affected by the illness. It is necessary to stimulate a greater autonomy for self-care actions and participation into the required treatment, strategies that go beyond the use of medications.

The main interferences into different diabetes types of treatment are caused by the negative emotional reactions that arise before the need for permanent care to control the illness. The subject’s emotional background can set difficulties to the adoption of self-care actions and participation in the treatment [ 7 ].

The treatment of diabetes encompasses a number of factors, some of which are specific, other global. Overall, they all involve a permanent education and the modification of a lifestyle from the very moment that the disease has been diagnosed. For subjects, this includes submitting to rules that are not always well accepted, such as healthy eating, correct and regular use of medication, including oral anti-diabetic drugs and/or insulin, and self-monitoring of blood glucose. Living with a chronic condition can be very threatening because it affects all the signs of the subjects, changing their routine and their relatives’ routine [ 8 ].

The results presented in this article are a part of the research Project “Health Promotion Strategies: Autonomy challenges in subjects living with Diabetes Mellitus”, from the Collective Health Department at the Federal University of Rio Grande do Norte. Its main objective is to “compose health promotion strategies in a direction to stimulate the autonomy and health care of people living with diabetes”. For doing so, it was initiated the creation of a Strategic Health Promotion Group (SHPG). In this article, results are presented around the objective of “sharing the experiences of people living with diabetes as well as how they build and fortify their autonomy, facing the necessity of lifestyle changes and their participation in the therapeutic and health care decisions”. The importance of this study for public and collective health is linked to the need of recognition not only of the subject’s own perceptions and life strategies, but also to the significance of searching new forms of understanding their condition, through dialogue, as well as the discomfort related to the impact of the diagnosis and its daily treatment. This project also intends to elaborate strategies directed to therapeutic participation, proposing innovative ways of dealing and taking care of the health of subjects with a chronic condition.

The working groups of people living with diabetes are generally associated to linked diseases like high blood pressure and are very common at Basic Health Care. However, they are frequently directed only to a biomedical approach consisting of: prevention, control and treatment of diseases [ 9 ], diverging from the emancipatory actions of subjects that are proposed by Health Care Promotion actions. In the Brazilian Health System, groups like the SHPG - that is described here - could help to qualify the processes of Basic Health Care, consolidating its attributes and fortifying Health Care Promotion actions in accordance with the principles and guidelines of the National Health Promotion Policy.

The knowledge about the perception of patients who live with diabetes is important because of the psychosocial discomfort and the continuous treatment hinder the participation of these subjects to their new way of life. The present study aims to understand how subjects with diabetes deal with the fact that they are chronically ill and how being aware of their situation influences the way they take care of their health.

This study is a participatory research with a qualitative and reflexivity-centered approach. It followed the recommendations of the Research Ethics Committee (REC) from the Onofre Lopes University Hospital (HUOL) at the Federal University of Rio Grande do Norte (UFRN).

A participatory research strategy was adopted considering the production of knowledge guided by shared care, where the subject who needs health attention, in this case, people living with a diabetes mellitus condition, are at the center of the stage. An epistemological, clinical and methodological approach based on shared care stimulates the preeminence and autonomy of the subjects, considering the individual, familiar, social and cultural dimensions of the person who is under its view and treatment [ 10 ]. Therefore, a participatory research approach shows its dynamism and capacity of being a strategy for social change, relying on the mutual collaboration among the subjects who take part on the process [ 11 ].

Following this perspective, we adopted the participatory research strategy described by Passos et al. [ 12 ]: in this proposition, knowledge and awareness are first developed in each group,for subsequent collective comprehension, being the responsibility of the researchers to take care of their own intervention by a reflexive approach, characterizing the ethical-political nature of the research.

Subjects with both type 1 and type 2 diabetes were intentionally chosen to participate in the group as long as they agreed with being part of the experience, as long as they were monitored by a health unit located in Santa Cruz, a small town from Rio Grande do Norte – Brazil, which was the research field qualified to participate in the study. The total number of voluntary participants was justified as an intentional sample derived from a specific population of 70 (seventy) people diagnosed with diabetes mellitus belonging to this health unit. The minimal number defined to compose the group was of 12 subjects, being the maximum a number of 25 subjects. To define the minimum and maximum values of the sample there was a specific operational criteria that would allow the participants to feel assisted, to communicate in an effective way, to acknowledge and recognize each other and, finally, to build the particular dynamics of the group identity [ 13 ]. The sample size should also allow the coordinators to feel comfortable during the process of assessing the communication of the group members. We also considered the potential loss of participants during the programmed 8 (eight) sessions, by spontaneous quitting or personal impediments. The eight encounters treated specific topics chosen by the individuals participating in the group. This closed group is in the category of the denominated SHPG – Strategic Health Promotion Group.

The encounters took place between May and August 2017, with a specific methodology oriented to capture the life stories and multiple experiences of the subjects. Those experiences were initially related to the illness, but the narratives moved beyond it to connect this experience with other aspects of their life’s complexity. Each meeting was defined based on a chosen topic coming from the previous one. The role of the researcher in the coordination of a participatory group is to mediate the dialogues between the subjects that are a part of the research, without missing the objective of contributing with the shared management of the participants.

This type of group management has been developed in researches about mental health in Brazil and Canada [ 12 , 14 ]. Those experiences have taught us the importance of dissipating the centrality of the researcher – observer to evidence the collective realm where knowledge construction through shared experiences manifests itself. In such approaches, the shared management brings up the necessary opening for the production of each group’s identity, and, consequently, the production of a shared group autonomy.

In terms of the techniques used to collect the narratives, it is necessary to point out that the meetings were audio recorded and the speeches were transcribed literally and in their complete versions. The produced data has been classified into three main thematic axes composed by the following dialogue stages: I) recognizing diabetes; II) living with diabetes; and III) exercising personal autonomy. The current study contains the analysis of the perspective I “Recognizing diabetes”, which deals with the impact of the diagnosis and the process of acceptance and denial of the chronic condition. For the sake of a better organization, we chose to have the statements that compose the perspective I in categories defined upon the objective of the study and quoted above.

The content of the data was analyzed under Minayo’s perspective [ 15 ], and under the directions of a reflexive approach, which in this study is considered as the ability of the subjects to monitor their own actions and their own desires through traditional principles of promoting the dialogue. For researchers, the reflexive dialogue can be established within themselves and their subjective preferences as well as with the collective experience, pursuing an attitude of continuous anxiety about one’s own actions, the preconceptions involved in each decision, and the methods used to filter, to control, to define, and to guide the social processes [ 16 ].

Written informed consent was obtained from all participants. In order to maintain confidentiality, each participant was identified by the name of an Ancient Greek city. Despite its geographical distance, this country has a particular relevance in the etiology of two central words that guide this research experience: diabetes (διαβαίνειν) and autonomy (αὐτόνομος). In this study, the participants’ names are: Corfu, Fira, Mykonos, Meteora, Veria, Atenas, Heraklion, Creta, Rhodes, Castória, Micenas, Patras, Delfos, Zakynthos, Epidauros and Volos.

All 16 (sixteen) participants live with Type 2 Diabetes Mellitus, of whom 12 (twelve) are females and 4 (four) are males aged from 57 to 90 years.

Based on the perspective I “Recognizing diabetes” and on the objectives of this study, the results were organized into three categories discussed below, namely: the impact of the diagnosis; the denial of the illness and the acceptance of the illness.

The impact of the diagnosis

This category shows how subjects reacted to the discovery of their chronic condition, which was mostly unexpected. The impact of the news caused several reactions, a mix of emotions and feelings, such as despair, preoccupation, unrest and even panic, when the information was disclosed by means of a diagnostic test or a health professional:

“I discovered it at age 42... I was a bit overweight. The doctor said: you are diabetic! What a shock! I almost died!” (Fira).

“I panicked. I thought I was never going to be normal anymore in my life. I panicked! Do you know what panic is?” (Zankythos).

As diabetes sometimes has a silent character, in some cases it can be discovered with important previously installed complications, and this can lead to the feeling of anger and revolt at the moment of diagnosis, as shown in the speech of Patras.

“At first I felt anger, I was angry at the time, because when I discovered I was already harmed, I already had my vision affected, then at the time I felt revolted, angry”. (Patras).

For Heraklion, however, the reaction to the chronic condition was not immediate, perhaps due to the non-correlation of the diagnosis of diabetes with a chronic condition:

“At that time (the diagnosis) I confess that I did not feel anything... only with time I started to feel the difficulties and started to get more... I wouldn’t say unhappy, but worried!” (Heraklion).

Still on the impact of the diagnosis, we also detected a change of attitude of some participants in relation to the recognition of diabetes. Some expressed certain predictability in relation to the illness, especially because of heredity from the histories of complications and deaths shared between generations, as we can see below:

“I did not suspect (of the illness) but I had doubts, because of the family, my father died at 45, most of Dad’s family all died of diabetes... everything is hereditary”. (Mykonos).

Other speeches also drew attention to the recognition of hereditary factors in the diagnosis of the illness. However, there is again concern and fear about the prognosis, when they compared their situation to that of people they had heard of in their life experiences:

“I come from a diabetic family, my brothers and sisters have it. One of them is already dead”. (Meteora).

“I’m also from a diabetic family. Most of my uncles had problems (with diabetes) and died”. (Véria).

“My brother died of diabetes, he lost both legs, so I’m afraid because I remember this when my diabetes (glucose) gets too high...” (Volos).

In this category, it was observed that the dialogues in a group caused important reflections in the way each participant faced the diagnosis, which can influence the different stages of acceptance and denial of the chronic condition and in its ways of carrying out self-care as well as in dealing with institutional health care.

The denial of the illness

We imagine that the way to deal with the diagnosis and the new ways of carrying on with life directly influences the acceptance or denial of the illness. This category is composed by the dialogues concerning the non-acceptance of the chronic condition attributed, mainly, to the limitations of daily life implied by having to live with a long-term illness.

Denial is present in the reactions of dissatisfaction exposed by Castória.

“You feel unhappy by having diabetes. There are days that I meditate a lot, there are times when I am alone, sometimes I cry, then I try to visit someone; I want to get that thought out of my head. I cry because of diabetes and because of the difficulties too”. (Castória).

For Veria, the dissatisfaction, revolt and non-acceptance comes from the lack of the indicators control of the illness caused by many factors:

“I was diagnosed four years ago ... but I cannot control it, I could never control it, I take insulin, but I cannot control it ... I thought it was a simple thing. I thought I was going to control it”. (Veria).

Other participants, in the dialogue in a large group, end up expressing the dissatisfaction with the illness resulting from abrupt changes in lifestyle, not always tolerated, especially when related to food:

“It’s very annoying to live with diabetes, you cannot eat everything, and you have to be on a diet”. (Heraklion).

“I got like this because it is an illness that forbids us to eat everything, I miss it, especially the sweet stuff”. (Epidauros).

On the other hand, the participants also take the group to reflect on stigma towards the illness as well as on the fact that seeking to adapt to the illness, doesn’t always mean accepting it:

“I feel sad because of this diabetes, I tell everyone it was a nickname they gave me, I do not say that I am diabetic, it was a nickname they gave me”. (Micenas).

“No one gets rid of this. Diabetes is forever. But, I control it and I live”. (Volos).

Thus, living with diabetes is complex and non-acceptance can come from multiple factors, all of which permeate the meanings people give to their lifestyle habits.

Acceptance of the illness

Acceptance of the illness, the last category analyzed, may be directly related to the control of the illness and strategies for overcoming and living with the new chronic condition. It is evident that there is an understanding of the importance of self-care for their well-being and on their health-illness process:

“I take the medicine on time, I do not eat food I’m not supposed to eat, we cannot eat them! We need to adapt”. (Corfu).

“You have to try to do those physical activities that are good for diabetes: you have to try to walk, exercise, swim, it’s extremely good for us”. (Rhodes).

Patras’s speech also contributes to the understanding that by controlling the illness, acceptance becomes more feasible, as an intrinsic relationship between accepting-controlling and controlling-accepting.

“Diabetes is an illness that we will live with and we have to try to be happy... under control! We need to try to control every day more... food, physical activity, medicine, taking them correctly, always up to date with the medication”. (Patras).

In this category, reflexivity is also raised about the exchange of experiences of the group. The dialogues with the participants could facilitate the acceptance of the chronic condition, as it’s seen in the speech of Epidauros:

“Today I think I’m more relaxed, I think I’m more optimistic, to know what diabetes is, how we should live together and what to do to have better health”. (Epidauros).

Accepting a chronic illness is a gradual process where the subjects first become aware of their situation, by this means, facilitating their adaptation. This contributes to a better quality of life and decreases the risk of complications related to the illness.

The discourses of the participants regarding the impact of the diagnosis made it possible to perceive that a mixture of feelings emerge. They include preoccupation, panic, and even anger and consequently denial of the condition. This was also observed in another study that identified the existence of a relationship between emotion and diabetes, where one directly influences the other [ 17 ]. It is also known that the emotional impact generated by the diagnosis and its entire burden triggers the complications of diabetes mellitus [ 17 ].

In this same perspective, some studies have pointed out a greater vulnerability of people living with chronic conditions to the emotional instabilities that can vary from mild to serious problems, such as severe depression, and that would be associated with the therapeutic rigour of the illness [ 18 ].

It is important to understand that diabetes has a negative impact on the quality of life of the subjects, especially due to the emotional changes, the limiting situation, and the process of (non-)acceptance of the illness. A study carried out in Brazil that measured the quality of life of patients, identified that among the subjects studied, physical and emotional factors were the most determinant for their quality of life, and the emotional impact occupied the second place, corresponding to a value of 77.2%. The authors explained that diabetes mellitus interferes in the patients’ quality of life in a negative way [ 19 ].

Still on the diagnosis of Diabetes Mellitus, some authors [ 17 ] mention that the diagnosis is made through routine tests or through the suspicion of symptoms of the illness. They also affirm that, as in the present research, the disclosure and confirmation of the diagnosis generates many feelings before the new chronic condition.

In the context of acceptance, denial, and the impact of diagnosis, we can describe the stages of mourning explained by Elisabeth Kubler-Ross [ 20 ] in her book “On Death and Dying”: denial, anger, bargaining, depression and acceptance. Some studies [ 21 , 22 ] have shown that the impact of the diagnosis of a chronic illness resembles the stages of mourning, as it is always very difficult and affects the self-image and self-esteem. People that receive the diagnosis, just as mourning, go through several stages where feelings can go through several phases. The stages of mourning should be used in a flexible way and help a comprehensive understanding of the subjects diagnosed with a chronic illness [ 21 ].

Fear was a common reaction in the dialogues of the participants of this study, especially when they reported traumatic family experiences with complications and deaths caused by diabetes. Some studies pointed out that sometimes the awakening to the illness can cause bad feelings when, for example, the patients are aware of histories with traumatic prognoses such as death or amputations, and because of this, they tend to fear the repetition of those events with risk of tragic ends, such as those observed in relatives or close friends, especially arising from the fear of chronic complications of the illness [ 23 , 24 ].

The acceptance of a chronic condition is a result of a transformation that takes place gradually in the behavior of the subjects, moving in the direction of a greater awareness and adaptation to the illness. These aspects directly contribute to their responsibility towards their overall health state. When patients accept their condition, they find an inner peace, thus favoring acceptance and better adaptation to their chronic condition [ 8 ].

However, the difficulty of accepting a chronic condition brings subjects to a particular dialectic dynamic in their lives. Accepting the chronic condition requires that the person recognizes and learns somehow to live with the discomfort and pain generated by the restrictions imposed by the new habits. It is necessary to reflect on alienated acceptance or adaptation to new habits, always re-evaluating the health practices so as not to stigmatize subjects, because words such as “patients, diabetic person, carrier” reduce the subjects to objects and as they are submitted to passivity. Accepting treatment, in a more minimalist conception, “implies recognizing oneself as having a significant limitation, determined by a chronic illness. It implies, therefore, a loss of autonomy” [ 25 ]. The sense of being stigmatized was exalted in this study. In this sense, autonomy is fundamental even to favor therapeutic participation into the new ways of dealing with life.

During the dialogues with the group, we also noticed how the impact of the diagnosis and new ways of living influence on the emotional state of those subjects. The fact of having to live with a chronic illness causes discomfort and dissatisfaction because the condition requires a complex and long-term treatment which impacts on the whole social network in which the subject is inserted. This demonstrates the importance of the exchange of experiences in the pursuit for greater autonomy.

It is known that exchanging experiences also influences on a better acceptance of chronic conditions, because when it is possible to live with the illness, there is time for a greater acquisition of knowledge, generating greater ease in the management of the treatment [ 18 ]. Thus the experience acquired individually is strengthened when transmitted to others through group dialogues that address individual experiences in search of collective pacts.

Therapeutic participation is a conditional factor for improving the quality of life of subjects with chronic diseases. Studies have indicated that the therapeutic success in patients with diabetes mellitus is linked to the extent to which the subjects act and commit themselves for their well-being, as for example by monitoring their glycemic status, changing their life habits and making correct use of medications. Counseling about the illness and its treatment is very important for therapeutic participation in the care of the subjects, improving their life quality [ 26 , 27 , 28 ].

The group experience can also potentialize changes in lifestyle. However, changes in life habits are complex; it is a difficult and slow process, particularly with regard to food. Eating habits are related to cultural, economic and social factors [ 25 ]. We identified in the speeches of the participants that food is one of the most difficult factors to control the illness. Other studies [ 19 , 29 ] have stated that the negative impact on the quality of life is influenced by the new lifestyle, which should be adopted, and especially because people with diabetes need more food restriction, which has a greater impact on therapeutic participation and health care. Thus, food re-education is one of the greatest challenges faced by some people with diabetes mellitus, where negative feelings related to food control occur, such as the difficulty to meet the goals set by the health team and consequent frustration [ 18 ].

Recognition of diabetes, in its broadest sense, emerges not only through the knowledge of clinical diagnosis, but also through the repositioning of the subjects in their ways of living and taking care of health. It goes through reflexivity, looking and re-signifying the perception of themselves and their social network, identifying their beliefs, values and establishing a relationship of mutual support in the search for autonomy. It is known that recognizing oneself in the condition of living with a chronic illness is fundamental for the good performance of self-care actions and, consequently, for their participation on treatments [ 7 ]. It is also fundamental to guarantee the control of their own lives, so that the person may be able to deal with the limitations that are imposed by the diabetes mellitus, with co-responsibility as a fundamental aspect for the success of the treatment and for the quality of life [ 30 ]. Participation through the exchange of experiences in the SHPM was able to influence this context in a positive way.

Providing autonomy to the subjects means to consider them as owners of conceptions and experiences that directly influence their relationship with both health professionals and their own health-illness process. Thus, the experience of illness and self-care is taken into account [ 21 , 31 ].

Furthermore, it is important to work and encourage the personal autonomy of subjects who live with diabetes because they are full of experiences that influence their ways of living with the chronic condition. Participatory studies are still insufficiently explored in the context of groups of people living with diabetes from the perspective of autonomy. Moreover, further studies are needed to deepen the theme and to make it possible the construction of new propositions. It is also necessary to apply the SHPG in multi-centric studies to improve the analysis related to the subject’s mutual sharing of illness experiences and narratives in therapeutic participation and health care, especially on the stages of acceptance and denial of the illness.

This study allowed us to observe that the emotional aspects involved in the diagnosis of diabetes mellitus can influence whether or not the illness is accepted. The way in which the subjects recognize diabetes and re-evaluate their habits influence their participation into treatment, because this is a chronic condition in which changes are often marked by their duration and by the risk they offer.

The denial of the chronic condition results in a greater difficulty in developing self-care, influencing the lack of participation into the different approaches of treatment.

Denial of the illness seems to be more related to the difficulties in controlling the illness resulting from changes in lifestyle. It is a difficult process for the subjects and requires a slow adaptation because an appropriate treatment needs the understanding of the implications of such changes in the subjects’ lives.

With regard to the acceptance of the chronic condition, we observed that it does not correspond to a static phase, but to a process of transformation that happens gradually. The subjects need to have a greater understanding about their personal recognition and their ways of dealing with health.

Giving voice to the participants as holders of the experiences affect the research process at its core. Participatory research in the light of reflexivity transformed the reality of both participants and researchers, overcoming the dichotomy between subjects and objects investigated. The possibility of a broader participation allowed the subject’s collective repositioning, transcending the automatic collection of data into strategies of knowledge production and practices related to self-care and shared care, based on the exchange of experiences.

In conclusion, we can affirm that the process of accepting-controlling the illness favors a better adherence to treatment, strengthening the personal autonomy inasmuch as life quality. Therefore, it is indispensable to respect and encourage the personal autonomy of the subjects, making them co-responsible for their treatment.

Abbreviations

Strategic Health Promotion Group (SHPG)

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Acknowledgements

We greatly appreciate the collaboration of the sixteen subjects who participated in this study contributing to science and public health.

This study was auto financed by the first author, José Adailton da Silva.

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José Adailton da Silva, Elizabethe Cristina Fagundes de Souza, Ana Gretel Echazú Böschemeier, Camyla Cristina Maia da Costa, Héllydade Souza Bezerra & Eva Emanuela Lopes Cavalcante Feitosa

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JAS, ECFS and CCMC participated in the drafting, design, analysis and interpretation of the results, writing and approval of the version to be published. HSB, EELCF and AGEB participated in data interpretation, writing and critical review. AGEB participated in translation of the article. The final version of this article has been read and approved by all the authors.

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This research is a part of a larger study entitled “Health Promotion Strategies: The Challenge of Autonomy for People Living with diabetes mellitus”. Since it was a research involving human beings, the study followed the criteria and requirements established by the Resolution 466 of December 12, 2012, of the National Health Council, obeying the recommendations of the Research Ethics Committee (REC) of the Onofre Lopes University Hospital (HUOL) of the Federal University of Rio Grande do Norte (UFRN) under Opinion n° 1.868.237 CAAE n° 61,947,616.4.0000.5292. The respondents were also given the opportunity to review and revise the transcripts of their speeches. Informed consent written was obtained from all participants. The ethical approval opinion is available on Brazil Platform http://plataformabrasil.saude.gov.br/visao/publico/indexPublico.jsf

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Silva, J.A., Souza, E.C.F., Echazú Böschemeier, A.G. et al. Diagnosis of diabetes mellitus and living with a chronic condition: participatory study. BMC Public Health 18 , 699 (2018). https://doi.org/10.1186/s12889-018-5637-9

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Research Design and Methods

Article information, using community engagement methods to guide study protocol decisions for school-aged children with type 1 diabetes.

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Fayo Abadula , Lori C. Jordan , Lauren LeStourgeon , Sarah S. Jaser; Using Community Engagement Methods to Guide Study Protocol Decisions for School-Aged Children With Type 1 Diabetes. Diabetes Spectr 15 February 2024; 37 (1): 95–99. https://doi.org/10.2337/ds23-0018

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Many challenges exist in developing multisite protocols for newly diagnosed children with type 1 diabetes. Our research team engaged community members to increase the likelihood of study success during a planning grant for a longitudinal study aimed at understanding risk and protective factors for neurocognitive function in school-aged children newly diagnosed with type 1 diabetes.

Two methods were used to obtain caregiver input into study protocol decisions. The first was a survey given to caregivers of children with diabetes ( n = 21) about which aspects of the study protocol would make families more or less likely to participate. The second was a Community Engagement (CE) Studio to obtain recommendations from a diverse group of caregivers of children with diabetes ( n = 7) on key aspects of recruitment and enrollment.

Results from both the survey and the CE Studio indicated that caregivers were interested and willing to participate in a longitudinal study of this nature. Both methods resulted in similar preferences for the type and amount of compensation, convenient study visits, flexible scheduling options, and receipt of neurocognitive test results. Recommendations from the CE Studio included additional strategies to minimize participant burden and enhance communication around study participation.

Both the feasibility survey and the CE Studio were useful mechanisms to obtain caregiver input during the study’s planning and design phase. Uniquely, the CE Studio approach offers researchers the ability to gain valuable community member input with minimal staff effort.

Researchers increasingly acknowledge the need to involve community members in study design to ensure that research studies are meaningful to the study population and to anticipate and address barriers to participation ( 1 , 2 ). For example, the National Institutes of Health (NIH) All of Us study ( 3 ), which aims to enroll >1 million participants to ensure representative samples in medical research, has a dedicated group “to develop novel approaches to educate communities and support enduring relationships with program participants.” Community engagement in research exists on a continuum, ranging from brief surveys of a patient population to focus groups or Community Engagement (CE) Studios, to including community members as active partners or leaders on the research team ( 4 ).

It is particularly important to seek input from populations who have been historically underrepresented in research in the planning stage to ensure that the study addresses outcomes that are meaningful to them and to identify potential barriers to and facilitators of their participation ( 1 ). Given known disparities in diabetes treatment and outcomes among children with diabetes ( 5 ) and the lack of interventions for type 1 diabetes that involve racially and ethnically minoritized youth ( 6 ), community engagement in pediatric diabetes research is crucial.

Longitudinal cohort studies are needed in new-onset pediatric type 1 diabetes to better understand the risk and protective factors for neurocognitive complications ( 7 ). Yet, enrolling school-aged children with diabetes and their families in research studies may be especially challenging, particularly at the time of diagnosis, given the unexpected nature of the diagnosis and the burden of type 1 diabetes management on caregivers. In addition, differences in approaches for newly diagnosed children across medical centers (i.e., some centers admit all newly diagnosed patients and conduct diabetes education in the hospital, whereas others only admit children in diabetic ketoacidosis and conduct diabetes education in the outpatient setting) create challenges in developing protocols for multisite studies. Youth with type 1 diabetes from racially and ethnically minoritized groups are less likely to participate in research ( 6 ), and it is therefore crucial to engage these communities early in the process.

As part of a planning grant (NIH U34 mechanism), we aimed to explore potential barriers to and facilitators of participation in a longitudinal study of recently diagnosed children with type 1 diabetes. Although even young children assent to research participation, caregivers must consent to research participation as well as associated risks and time commitments. We used more traditional methods to survey caregiver preferences, as well as the innovative CES approach ( 8 ).

These methods were used in preparation for a longitudinal study to understand the risk and protective factors for neurocognitive complications of type 1 diabetes. The longitudinal study protocol is expected to include cognitive testing and MRI studies of the brain in children aged 6–11 years, along with parent questionnaires and review of glucose data. In addition, we anticipate collecting real-time information using ecological momentary assessment (EMA) via a smartphone app to measure children’s outcomes, including sleep quality, physical activity, diet, mood, and behavior.

To identify potential problems with feasibility, we developed a survey for parents/caregivers to understand which aspects of the potential study protocol would make families more or less willing to participate. The feasibility survey consisted of 33 items, including questions about basic demographic information (child age, sex, race/ethnicity, and diabetes duration; parental education; and family income) and parent attitudes about compensation, scheduling, study-related blood work, receipt of information about the child’s MRI and cognitive testing results, and overall likelihood of study participation ( Supplementary Material ).

Families were eligible to participate in the feasibility survey if they had a child aged 6–11 years who had type 1 diabetes and was followed by the Vanderbilt Pediatric Diabetes Program. After obtaining informed e-consent, questions were asked over the phone (by a member of the research team and entered into a REDCap [Research Electronic Data Capture] database) or in person after a clinic appointment (completed by the parent on a digital tablet and entered directly into REDCap). On average, the survey took 5–10 minutes to complete, and parents received a $10 gift card upon completion of the survey.

We also conducted a CE Studio with caregivers of children with type 1 diabetes to obtain diverse perspectives on barriers to and facilitators of participation. Specifically, we sought their input for study outcomes and recruitment and retention strategies. The Studio was conducted by the Community Engaged Research Core, which is part of the Vanderbilt Institute for Clinical and Translational Research. The Studio was implemented by a team that included faculty researchers, a community navigator, and a skilled facilitator.

The CE Studio is an approved model for the NIH All of Us project. In this model, the Studio facilitator creates a neutral environment that allows for open and frank discussion and guides the conversation between the researchers and community experts (i.e., caregivers for children with type 1 diabetes). The Studio facilitator has experience working with diverse populations and possesses the ability to balance the power differential that may naturally occur when researchers and community members come together ( 9 ).

Before the Studio, the community navigator conducted a planning meeting with the research team. The CE Studio team invited individuals from a database of past community engagement experts, in addition to reaching out to community-based organizations working with children with type 1 diabetes and social media groups for parents/caregivers of children with type 1 diabetes. All interested caregivers completed an online form, which collected basic information, including demographics, educational background, and life experience (e.g., age of the child and diabetes duration).

The CE Studio team then selected a group to invite to the Studio to ensure a diverse representation of experiences. The community experts attended an orientation meeting before the Studio, during which they reviewed an orientation guide. The orientation guide included frequently asked questions and a glossary of common research terms. The guide also outlined the purpose of the CE Studio, the roles and expectations of participants, and the CE Studio process.

The navigator scheduled the Studio at a time that was convenient for most people. At the start of the CE Studio, the researchers (L.C.J. and S.S.J.) gave a brief presentation about the project and posed specific questions to the community experts. The facilitator guided the discussion and kept the meeting length to 1.5 hours. The navigator captured feedback by taking notes. The feedback included major themes from the discussion, as well as suggestions from individual community experts. Community experts were compensated $50 for their time. Because the CE Studio has a nonresearch designation by institutional review boards (IRBs), informed consent was not needed ( 9 ).

Feasibility Survey Summary

A total of 21 parents completed the survey over 4 months; 30% reported an annual family income <$50,000, and the median parental level of education was a college degree. The average child age was 8.7 ± 1.7 years, 90% of participants identified as non-Hispanic White, 10% identified as Black or African American, and 57% were male. Of the 34 families approached by phone, only five completed the feasibility survey (15%), but 16 of the 20 families approached in person completed the survey (80%). Missing data were minimal; one parent did not answer the question about family income.

Compensation and scheduling

The majority of parents (57%) preferred a gift card as compensation, 14% preferred a check, and 29% preferred a check plus a small gift for the child. The majority of parents (86%) found $40–50 to be a reasonable compensation for the MRI portion of the study, which takes ∼60 minutes, and 90% supported $50 as reasonable compensation for the cognitive testing, which takes ∼90 minutes. Most parents indicated that travel reimbursement was either somewhat important (43%) or very important (43%). Scheduling study visits and clinic visits on the same day was very important to most parents (67%), as well as having weekend and evening scheduling options available (67%).

Barriers and facilitators to participation

Overall, 69% of parents indicated that they would participate in a study like this. Most parents (62%) said needing a blood draw from their child would not make a difference in their decision to participate, but 76% supported having numbing cream available for their child during the blood draw. If a child were to object to having blood drawn, 90% of parents indicated that they would allow the laboratory to draw extra blood (about two extra tubes) at the time of their child’s next routine blood testing for diabetes care.

When asked if they could think of a child the same age who might be interested in participating in a study as a control participant (i.e., a neighborhood control subject without diabetes), parents either said no (38%) or that they were not sure (38%). In addition, 38% of parents reported that having a friend participate along with their child would not make their child more or less likely to participate.

The majority of parents (67%) indicated that they would prefer to receive information on their child’s cognitive testing portion of the study. Parents deemed that provision of this information would be somewhat important (43%) or very important (43%) in their decision to participate. Most parents (76%) agreed that receiving a picture of their child’s brain after the MRI would make their child more interested in participating.

CE Studio Summary

The CE Studio hosted a diverse sample of caregivers ( n = 7), termed “community experts,” of whom four identified as African American or Black, two as White, and one as other race. All of the caregivers were aged 30–55 years; one had a child <5 years of age, three had children aged 5–12 years, and three had children ≥12 years of age. In terms of diabetes duration, three children were diagnosed <3 years before the Studio, 1 had been diagnosed 3–5 years before the Studio, and two had been diagnosed ≥5 years before the Studio. Community expert feedback from the session is presented in Table 1 .

CE Studio Recommendations

Recruitment recommendations

In the discussion around the timing of recruitment and enrollment, a two-part consent method was preferred for enrolling families with newly diagnosed children. Given concerns around the stressful nature of the diagnosis, community experts recommended that consent be obtained at the time of diagnosis for an initial blood draw and baseline data collection from the medical record only. Then, several weeks later, but within 3–6 months after diagnosis, these families could be approached to consent for participation in the full, longitudinal study protocol, including an MRI of the brain and cognitive assessments with the child, as well as parent surveys and EMA at multiple time points.

Scheduling preferences

Community experts expressed a preference for pairing study visits with diabetes clinic visits to minimize burden. They also recommended offering travel-related compensation and childcare, when possible. As a strategy to enhance retention in the longitudinal study, community experts expressed interest in receiving retention items with the study logo (e.g., water bottles and small toys).

Study-related information

When asked about recruitment approaches, community experts noted the need for clear communication about the study protocol. For example, they wanted an explanation of the research being conducted in pediatric type 1 diabetes focused on cognition and risk and protective factors. Given concerns about children’s comfort level with the MRI machine, community experts suggested that a curated playlist of videos related to MRI sounds and procedures could be offered to comfort the child before participation. Community experts also requested feedback on their child’s cognitive testing results after study participation. They also expressed interest in receiving study updates and reminders via emailed newsletters, videos, and text messages.

The current study describes methods to engage community members in protocol decisions to enhance study feasibility. Caregivers for children with type 1 diabetes identified strategies to optimize recruitment and retention, especially among underrepresented populations. The feasibility survey was helpful in determining which aspects of the study design potential participants considered important when deciding whether to consent to study participation. The CE Studio offered more detailed suggestions for the recruitment and enrollment process. Findings from both the feasibility survey and the CE Studio indicated that most families were willing to participate in a study design that offered fair compensation, flexible scheduling, and a summary of their child’s cognitive functioning. Uniquely, the CE Studio allowed for dialogue and rich details that the feasibility survey could not capture.

Findings from both the feasibility survey and the CE Studio indicated high levels of support for a research study of this nature. Community experts expressed interest in learning about risk and protective factors for cognitive function in youth with type 1 diabetes but noted that participating in a research study at the time of diagnosis could be challenging, given that it is a time of high stress and confusion for caregivers. The community experts advised that deciding to enroll in a longitudinal research study at the time of diagnosis would be overwhelming; however, they supported a two-step consent plan to facilitate participation.

Findings from both the feasibility survey and the CE Studio supported aligning study visits with clinic visits, and community experts offered additional suggestions to make scheduling study visits more convenient, such as travel accommodations and meal vouchers, in line with strategies found to be successful in recruiting and retaining parents of newly diagnosed children ( 10 ). In general, the community experts provided context and solutions to potential barriers to study participation ( Table 1 ).

Strengths and Limitations

The efficiency of the CE Studio model and the group dialogue with community experts were strengths of this approach. However, it is important to note that most of the caregivers who completed the feasibility survey and took part in the Studio had a child diagnosed with diabetes for >3 years and were answering based on their recollection of their mindset after their child’s diagnosis. In addition, the majority of the caregivers who completed the feasibility survey identified as non-Hispanic White, and these findings may not be generalizable to other populations. Finally, we did not have information on sociodemographic characteristics for families who were invited to complete the survey or take part in the Studio, so we cannot determine the representativeness of our sample.

We found the CE Studio process to be a helpful and efficient mechanism to obtain caregiver input during the study planning and design phase. Based on discussions with the community experts, we developed a study protocol that incorporated their concerns and suggestions around recruitment, scheduling, and receipt of study-related information. We believe their recommendations will translate into better study recruitment and retention and wanted to share this mechanism with other research teams. Before enrolling participants for a longitudinal cohort study, we plan to conduct an additional CE Studio at each study site and to invite community experts to be paid members of the research team (i.e., consultants).

The CE Studio approach is a consultative model ( 4 , 8 ) used to engage people with lived experience to inform aspects of study selection, design, conduct, or dissemination; it is typically exempt from IRB approval and provides rich information in a relatively short amount of time ( 9 ). Feasibility surveys offer information from a larger pool of potential participants but require IRB approval and substantial time by the research team for recruitment and enrollment (e.g., reviewing clinic schedules and meeting families in clinic before or after their diabetes visit). The alignment of themes and recommendations from these two approaches supports the potential benefit of the CE Studio as an efficient model for obtaining valuable information from community members when planning a study.

This article contains supplementary material online at https://doi.org/10.2337/figshare.24050397 .

This study was sponsored by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (U34 DK123895-01).

Duality of Interest

No potential conflicts of interest relevant to this article were reported.

Author Contributions

F.A. collected data and wrote the manuscript. L.C.J. and S.S.J. conceptualized the study, secured funding, and reviewed and edited the manuscript. L.L. developed the database and reviewed and edited the manuscript. S.S.J. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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StatPearls [Internet].

Amit Sapra ; Priyanka Bhandari .

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Last Update: June 21, 2023 .

  • Continuing Education Activity

Diabetes mellitus (DM) is a disease of inadequate control of blood levels of glucose. It has many subclassifications, including type 1, type 2, maturity-onset diabetes of the young (MODY), gestational diabetes, neonatal diabetes, and steroid-induced diabetes. Type 1 and 2 DM are the main subtypes, each with different pathophysiology, presentation, and management, but both have a potential for hyperglycemia. This activity outlines the pathophysiology, evaluation, and management of DM and highlights the role of the interprofessional team in managing patients with this condition.

  • Describe the pathophysiology of diabetes mellitus.
  • Outline the epidemiology and risk factors of diabetes mellitus.
  • Review the treatment considerations and common complications of diabetes mellitus.
  • Identify the importance of improving collaboration and care coordination amongst the interprofessional team to enhance the delivery of care for patients affected by diabetes mellitus.
  • Introduction

Diabetes mellitus is taken from the Greek word diabetes , meaning siphon - to pass through and the Latin word  mellitus  meaning sweet. A review of the history shows that the term "diabetes" was first used by Apollonius of Memphis around 250 to 300 BC. Ancient Greek, Indian, and Egyptian civilizations discovered the sweet nature of urine in this condition, and hence the propagation of the word Diabetes Mellitus came into being. Mering and Minkowski, in 1889, discovered the role of the pancreas in the pathogenesis of diabetes. In 1922 Banting, Best, and Collip purified the hormone insulin from the pancreas of cows at the University of Toronto, leading to the availability of an effective treatment for diabetes in 1922. Over the years, exceptional work has taken place, and multiple discoveries, as well as management strategies, have been created to tackle this growing problem. Unfortunately, even today, diabetes is one of the most common chronic diseases in the country and worldwide. In the US, it remains as the seventh leading cause of death.

Diabetes mellitus (DM) is a metabolic disease, involving inappropriately elevated blood glucose levels. DM has several categories, including type 1, type 2, maturity-onset diabetes of the young (MODY), gestational diabetes, neonatal diabetes, and secondary causes due to endocrinopathies, steroid use, etc. The main subtypes of DM are Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM), which classically result from defective insulin secretion (T1DM) and/or action (T2DM). T1DM presents in children or adolescents, while T2DM is thought to affect middle-aged and older adults who have prolonged hyperglycemia due to poor lifestyle and dietary choices. The pathogenesis for T1DM and T2DM is drastically different, and therefore each type has various etiologies, presentations, and treatments.

In the islets of Langerhans in the pancreas, there are two main subclasses of endocrine cells: insulin-producing beta cells and glucagon secreting alpha cells. Beta and alpha cells are continually changing their levels of hormone secretions based on the glucose environment. Without the balance between insulin and glucagon, the glucose levels become inappropriately skewed. In the case of DM, insulin is either absent and/or has impaired action (insulin resistance), and thus leads to hyperglycemia.

T1DM is characterized by the destruction of beta cells in the pancreas, typically secondary to an autoimmune process. The result is the absolute destruction of beta cells, and consequentially, insulin is absent or extremely low.

T2DM involves a more insidious onset where an imbalance between insulin levels and insulin sensitivity causes a functional deficit of insulin. Insulin resistance is multifactorial but commonly develops from obesity and aging.

The genetic background for both types is critical as a risk factor. As the human genome gets further explored, there are different loci found that confer risk for DM. Polymorphisms have been known to influence the risk for T1DM, including major histocompatibility complex (MHC) and human leukocyte antigen (HLA). [1]

T2DM involves a more complex interplay between genetics and lifestyle. There is clear evidence suggesting that T2DM is has a stronger hereditary profile as compared to T1DM. The majority of patients with the disease have at least one parent with T2DM. [2]

Monozygotic twins with one affected twin have a 90% likelihood of the other twin developing T2DM in his/her lifetime. [3]  Approximately 50 polymorphisms to date have been described to contribute to the risk or protection for T2DM. These genes encode for proteins involved in various pathways leading to DM, including pancreatic development, insulin synthesis, secretion, and development, amyloid deposition in beta cells, insulin resistance, and impaired gluconeogenesis regulation. A genome-wide association study (GWAS) found genetic loci for transcription factor 7-like 2 gene (TCF7L2), which increases the risk for T2DM. [4] [5]  Other loci that have implications in the development of T2DM include NOTCH2, JAZF1, KCNQ1, and WFS1. [6] [7]

MODY is a heterogeneous disorder identified by non-insulin-dependent diabetes diagnosed at a young age (usually under 25 years). It carries an autosomal dominant transmission and does not involve autoantibodies as in T1DM. Several genes have implications in this disease, including mutations to hepatocyte nuclear factor-1-alpha (HNF1A) and the glucokinase (GCK) gene, which occurs in 52 to 65 and 15 to 32 percent of MODY cases, respectively. [8] [9]  The genetics of this disease are still unclear as some patients have mutations but never develop the disease, and others will develop clinical symptoms of MODY but have no identifiable mutation.

Gestational diabetes is essentially diabetes that manifests during pregnancy. It is still unknown why it develops; however, some speculate that HLA antigens may play a role, specifically HLA DR2, 3, and 4. Excessive proinsulin is also thought to play a role in gestational diabetes, and some suggest that proinsulin may induce beta-cell stress. Others believe that high concentrations of hormones such as progesterone, cortisol, prolactin, human placental lactogen, and estrogen may affect beta-cell function and peripheral insulin sensitivity. [10]

Several endocrinopathies, including acromegaly, Cushing syndrome, glucagonoma, hyperthyroidism, hyperaldosteronism, and somatostatinomas, have been associated with glucose intolerance and diabetes mellitus, due to the inherent glucogenic action of the endogenous hormones excessively secreted in these conditions. Conditions like idiopathic hemochromatosis are associated with diabetes mellitus due to excessive iron deposition in the pancreas and the destruction of the beta cells.

  • Epidemiology

Globally, 1 in 11 adults has DM (90% having T2DM). The onset of T1DM gradually increases from birth and peaks at ages 4 to 6 years and then again from 10 to 14 years. [11]  Approximately 45% of children present before age ten years. [12]  The prevalence in people under age 20 is about 2.3 per 1000. While most autoimmune diseases are more common in females, there are no apparent gender differences in the incidence of childhood T1DM. In some populations, such as in older males of European origin (over 13 years), they may be more likely to develop T1DM compared to females (3:2 male to female ratio). [13]  The incidence of T1DM has been increasing worldwide. In Europe, Australia, and the Middle East, rates are rising by 2% to 5% annually. [14] [15] [16]  In the United States, T1DM rates rose in most age and ethnic groups by about 2% yearly, and rates are higher in Hispanic youth. [17]  The exact reason for this pattern remains unknown. However, some metrics, such as the United States Military Health System data repository, found plateauing over 2007 to 2012 with a prevalence of 1.5 per 1000 and incidence of 20.7 to 21.3 per 1000. [18]

The onset of T2DM is usually later in life, though obesity in adolescents has led to an increase in T2DM in younger populations. T2DM has a prevalence of about 9% in the total population of the United States, but approximately 25% in those over 65 years. The International Diabetes Federation estimates that 1 in 11 adults between 20 and 79 years had DM globally in 2015. Experts expect the prevalence of DM to increase from 415 to 642 million by 2040, with the most significant increase in populations transitioning from low to middle-income levels. [19]  T2DM varies among ethnic groups and is 2 to 6 times more prevalent in Blacks, Native Americans, Pima Indians, and Hispanic Americans compared to Whites in the United States. [20] [21]  While ethnicity alone plays a vital role in T2DM, environmental factors also greatly confer risk for the disease. For example, Pima Indians in Mexico are less likely to develop T2DM compared to Pima Indians in the United States (6.9% vs. 38%). [22]

  • Pathophysiology

A patient with DM has the potential for hyperglycemia. The pathology of DM can be unclear since several factors can often contribute to the disease. Hyperglycemia alone can impair pancreatic beta-cell function and contributes to impaired insulin secretion. Consequentially, there is a vicious cycle of hyperglycemia leading to an impaired metabolic state. Blood glucose levels above 180 mg/dL are often considered hyperglycemic in this context, though because of the variety of mechanisms, there is no clear cutoff point. Patients experience osmotic diuresis due to saturation of the glucose transporters in the nephron at higher blood glucose levels. Although the effect is variable, serum glucose levels above 250 mg/dL are likely to cause symptoms of polyuria and polydipsia.

Insulin resistance is attributable to excess fatty acids and proinflammatory cytokines, which leads to impaired glucose transport and increases fat breakdown. Since there is an inadequate response or production of insulin, the body responds by inappropriately increasing glucagon, thus further contributing to hyperglycemia. While insulin resistance is a component of T2DM, the full extent of the disease results when the patient has inadequate production of insulin to compensate for their insulin resistance. 

Chronic hyperglycemia also causes nonenzymatic glycation of proteins and lipids. The extent of this is measurable via the glycation hemoglobin (HbA1c) test. Glycation leads to damage in small blood vessels in the retina, kidney, and peripheral nerves. Higher glucose levels hasten the process. This damage leads to the classic diabetic complications of diabetic retinopathy, nephropathy, and neuropathy and the preventable outcomes of blindness, dialysis, and amputation, respectively. [23]

  • History and Physical

During patient history, questions about family history, autoimmune diseases, and insulin-resistant are critical to making the diagnosis of DM. It often presents asymptomatically, but when symptoms develop, patients usually present with polyuria, polydipsia, and weight loss. On physical examination of someone with hyperglycemia, poor skin turgor (from dehydration) and a distinctive fruity odor of their breath (in patients with ketosis) may be present. In the setting of diabetic ketoacidosis (DKA), clinicians may note Kussmaul respirations, fatigue, nausea, and vomiting. Funduscopic examination in a patient with DM may show hemorrhages or exudates on the macula. In frank diabetic retinopathy, retinal venules may appear dilated or occluded. The proliferation of new blood vessels is also a concern for ophthalmologists and can hasten retinal hemorrhages and macular edema, ultimately resulting in blindness. While T1DM and T2DM can present similarly, they can be distinguished based on clinical history and examination. T2DM patients are typically overweight/obese and present with signs of insulin resistance, including acanthosis nigricans, which are hyperpigmented, velvety patches on the skin of the neck, axillary, or inguinal folds. Patients with a longer course of hyperglycemia may have blurry vision, frequent yeast infections, numbness, or neuropathic pain. The clinicians must ask the patient bout any recent skin changes in their feet during each visit. The diabetic foot exam, including the monofilament test, should be a part of the routine physical exam.

The diagnosis of T1DM is usually through a characteristic history supported by elevated serum glucose levels (fasting glucose greater than 126 mg/dL, random glucose over 200 mg/dL, or hemoglobin A1C (HbA1c exceeding 6.5%) with or without antibodies to glutamic acid decarboxylase (GAD) and insulin.

Fasting glucose levels and HbA1c testing are useful for the early identification of T2DM. If borderline, a glucose tolerance test is an option to evaluate both fasting glucose levels and serum response to an oral glucose tolerance test (OGTT). Prediabetes, which often precedes T2DM, presents with a fasting blood glucose level of 100 to 125 mg/dL or a 2-hour post-oral glucose tolerance test (post-OGTT) glucose level of 140 to 200 mg/dL. [24] [25]

According to the American Diabetes Association (ADA), a diagnosis of diabetes is through any of the following: An HbA1c level of 6.5% or higher; A fasting plasma glucose level of 126 mg/dL (7.0 mmol/L) or higher (no caloric intake for at least 8 hours); A two-hour plasma glucose level of 11.1 mmol/L or 200 mg/dL or higher during a 75-g OGTT; A random plasma glucose of 11.1 mmol/L or 200 mg/dL or higher in a patient with symptoms of hyperglycemia (polyuria, polydipsia, polyphagia, weight loss) or hyperglycemic crisis. [24] The ADA recommends screening adults aged 45 years and older regardless of risk, while the United States Preventative Service Task Force suggests screening individuals between 40 to 70 years who are overweight. [26] .

To test for gestational diabetes, all pregnant patients have screening between 24 to 28 weeks of gestation with a 1-hour fasting glucose challenge test. If blood glucose levels are over 140mg/dL, patients have a 3-hour fasting glucose challenge test to confirm a diagnosis. A positive 3-hours OGTT test is when there is at least one abnormal value (greater than or equal to 180, 155, and 140 mg/dL for fasting one-hour, two-hour, and 3-hour plasma glucose concentration, respectively). [27]

Several lab tests are useful in the management of chronic DM. Home glucose testing can show trends of hyper- and hypoglycemia. The HbA1c test indicates the extent of glycation due to hyperglycemia over three months (the life of the red blood cell). Urine albumin testing can identify the early stages of diabetic nephropathy. Since patients with diabetes are also prone to cardiovascular disease, serum lipid monitoring is advisable at the time of diagnosis. Similarly, some recommend monitoring thyroid status by obtaining a blood level of thyroid-stimulating hormone annually due to a higher incidence of hypothyroidism. [24] [25]

  • Treatment / Management

The physiology and treatment of diabetes are complex and require a multitude of interventions for successful disease management. Diabetic education and patient engagement are critical in management. Patients have better outcomes if they can manage their diet (carbohydrate and overall caloric restriction), exercise regularly (more than 150 minutes weekly), and independently monitor glucose. [28] Lifelong treatment is often necessary to prevent unwanted complications. Ideally, glucose levels should be maintained at 90 to 130 mg/dL and HbA1c at less than 7%. While glucose control is critical, excessively aggressive management may lead to hypoglycemia, which can have adverse or fatal outcomes.

Since T1DM is a disease primarily due to the absence of insulin, insulin administration through daily injections, or an insulin pump, is the mainstay of treatment. In T2DM, diet and exercise may be adequate treatments, especially initially. Other therapies may target insulin sensitivity or increase insulin secretion by the pancreas. The specific subclasses for drugs include biguanides (metformin), sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinediones, glucagonlike-peptide-1 agonist, dipeptidyl peptidase IV inhibitors (DPP-4), selective, amylinomimetics, and sodium-glucose transporter-2 (SGLT-2) inhibitors. Metformin is the first line of the prescribed diabetic medications and works by lowering basal and postprandial plasma glucose. Insulin administration may also be necessary for T2DM patients, especially those with inadequate glucose management in the advanced stages of the disease. In morbidly obese patients, bariatric surgery is a possible means to normalize glucose levels. It is recommended for individuals who have been unresponsive to other treatments and who have significant comorbidities. [29]  The GLP-1 agonists liraglutide and semaglutide correlate with improved cardiovascular outcomes. The SGLT-2 inhibitors empagliflozin and canagliflozin have also shown to improve cardiovascular outcomes along with potential renoprotection as well as prevention for the development of heart failure.

Regular screenings are necessary since microvascular complications are a feared complication of diabetes. Regular diabetic retinal exams should be performed by qualified medical personnel to assess for diabetic retinopathy. Neurologic examination with monofilament testing can identify patients with neuropathy at risk for amputation. Clinicians can also recommend patients perform daily foot inspections to identify foot lesions that may go unnoticed due to neuropathy. Low-dose tricyclic antidepressants, duloxetine, anticonvulsants, topical capsaicin, and pain medications may be necessary to manage neuropathic pain in diabetes. Urine microalbumin testing can also assess for early renal changes from diabetes with albuminuria greater than 30mg/g creatinine along with the estimated GFR. The antiproteinuric effect of the angiotensin-converting enzyme (ACE) inhibitors and the angiotensin receptor blockers (ARBs) makes them the preferred agents to delay the progression from microalbuminuria to macroalbuminuria in patients with both Type 1 or Type 2 diabetes mellitus.

The FDA has approved pregabalin and duloxetine for the treatment of diabetic peripheral neuropathy. Tricyclic antidepressants and anticonvulsants have also seen use in the management of the pain of diabetic neuropathy with variable success. 

The ADA also recommends regular blood pressure screening for diabetics, with the goal being 130 mmHg systolic blood pressure and 85 mmHg diastolic blood pressure. [30]  Pharmacologic therapy for hypertensive diabetics typically involves angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, diuretics, beta-blockers, and/or calcium channel blockers. The ADA recommends lipid monitoring for diabetics with a goal of low-density lipoprotein cholesterol (LDL-C) being less than 100 mg/dL if no cardiovascular disease (CVD) and less than 70 mg/dl if atherosclerotic cardiovascular disease (ASCVD) is present. Statins are the first-line treatment for the management of dyslipidemia in diabetics. The ADA suggests that low dose aspirin may also be beneficial for diabetic patients who are at high risk for cardiovascular events; however, the role of aspirin in reducing cardiovascular events in patients with diabetes remains unclear. [31] [32] [33]

  • Differential Diagnosis

In addition to T1DM, T2DM, and MODY, any disorder that damages the pancreas can result in DM. There are several diseases of the exocrine pancreas, including: [34]  

  • Cystic fibrosis
  • Hereditary hemochromatosis
  • Pancreatic cancer
  • Chronic pancreatitis

Hormonal syndromes that can lead to impaired insulin secretion include:

  • Pheochromocytoma
  • Cushing syndrome

Drug-induced insulin resistance is also in the differential of classical diabetes. These drugs include:

  • Glucocorticoids

Other diseases in the differential of diabetes mellitus include:

  • Gestational diabetes [10]
  • Thyroid disorders
  • Pertinent Studies and Ongoing Trials

Various trials have been undertaken to understand the cardiovascular outcomes with antidiabetic medications. The LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results), was a double-blinded trial comparing the use of liraglutide, which is a GLP -1 agonist to placebo in around 10000 patients. After a follow-up period of about four years, liraglutide was shown to reduce mortality from cardiovascular causes as well as all-cause mortality. It also seemed to reduce the first occurrence of the first nonfatal myocardial infarction (MI) and stroke.

The EMPA-REG OUTCOME trial ([Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) have shown considerable reductions in mortality and heart failure hospitalization risks in patients with type 2 diabetes mellitus (T2D), by and cardiovascular disease with empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor.

The CANVAS trial (Canagliflozin Cardiovascular Assessment Study) subsequently reported a reduction in 3-point major adverse cardiovascular events and heart failure (HF) hospitalization risk. The proposed mechanism through which SGLT2 inhibitors work helps patients with heart failure is via the promotion of natriuresis and osmotic diuresis and reduced preload. SGLT2 inhibition is also associated with the preservation of renal function. Based on data from mechanistic studies and clinical trials, large clinical trials with SGLT2 inhibitors are now investigating the potential use of SGLT2 inhibition in patients who have HF with and without T2 diabetes mellitus.

  • Toxicity and Adverse Effect Management

One of the most common adverse effects of insulin is hypoglycemia. Gastrointestinal upset is the most common side effect of many of the T2DM medications. Metformin can lead to lactic acidosis and should be used with caution in patients with renal disease and discontinued if the estimated glomerular filtration rate (e-GFR) is under 30 mL/min. Sulfonylureas can lead to hypoglycemia and may promote cardiovascular death in patients with diabetes. [35]  Thiazolidinediones have fallen out of favor in clinical practice due to their adverse effects, specifically resulting in fluid retention, worsening heart failure, and fractures. [36] [37]  DPP-4 may increase the risk for upper respiratory tract infections but may have less nausea and diarrhea compared to other drugs such as metformin. [38] [39]  SGLT-2 inhibitors can lead to increased urinary tract infections due to increased urinary glucose excretion. [40]  Both SGLT2 inhibitors and GLP-1 Receptor agonists reduce ASCVD events and are now considered the second line to metformin in such patients.

Diabetes mellitus was the seventh leading cause of death in the United States in 2015. [41]  The prognosis of DM gets significantly influenced by the degree of glucose management. Chronic hyperglycemia significantly increases the risk of DM complications. The Diabetes Control and Complications Trial and the United Kingdom Prospective Diabetes Study found that individuals with T1DM and T2DM respectively had increased microvascular complications with chronic hyperglycemia. [42] [43]  Patients who can revert to normal glucose during the progression from pre-diabetes to frank DM had a good prognosis and may be able to slow disease progression. [44]

  • Complications

Regardless of the specific type of diabetes, complications involve microvascular, macrovascular, and neuropathic issues. Microvascular and macrovascular complications vary according to the degree and the duration of poorly control diabetes and include nephropathy, retinopathy, neuropathy, and ASCVD events, especially if it is associated with other comorbidities like dyslipidemia and hypertension. [45]  One of the most devastating consequences of DM is its effect on cardiovascular disease (ASCVD). Approximately two-thirds of those with DM will die from a myocardial infarction or stroke. [46]  In T2DM, fasting glucose of more than 100 mg/dL significantly contributes to the risk of ASCVD, and cardiovascular risk can develop before frank hyperglycemia. [47] [48]

DM is also a common cause of blindness in adults aged 20 to 74 years in the United States. Diabetic retinopathy contributes to 12000 to 24000 new cases of blindness annually, and treatments generally consist of laser surgery and glucose control. [49]

Renal disease is another significant cause of morbidity and mortality in DM patients. It is the leading contributor to end-stage renal disease (ESRD) in the United States, and many patients with ESRD will need to start dialysis or receive a kidney transplant. [49]  If the albuminuria persists in the range of 30 to 300 mg/day (microalbuminuria), it seems to be a predictable earliest marker for the onset of diabetic neuropathy. Once macroalbuminuria (greater than 300 mg/24 hr) sets in, the progression to ESRD hastens up. The random spot urine specimen for measurement of the albumin-to-creatinine ratio is a quick, easy, predictable method that is the most widely used and preferred method to detect microalbuminuria. Two of three tests, done over a six month showing a persistent level greater than 30 mcg/mg creatinine, confirms the diagnosis of microalbuminuria.

DM is also the leading cause of limb amputations in the United States; this is primarily due to vasculopathy and neuropathy associated with DM. [49]  Many patients who develop neuropathy need to have regular foot exams to prevent infection from wounds that go unnoticed.

The duration of diabetes is the most crucial risk factor for the development of diabetic retinopathy. In people with type 1 diabetes, it typically sets in about 5 years after disease onset. Hence it is recommended to start the yearly retinal exams in these patients about five years after diagnosis. Among patients with type 2 diabetes, many patients might already have retinal changes at the time of diagnosis. Approximately 10% at ten years, 40% at 15 years, and 60% at 20 years will have nonproliferative retinal disease. In these patients, the recommendation is to start the yearly retinal screening at the time of diagnosis. Study after study has shown that reasonable glycemic control favorably affected the onset and progression of diabetic retinopathy. Uncontrolled blood pressure is an added risk factor for macular edema. Lowering the blood pressure in patients with diabetes thus also affects the risk of progression of the retinopathy. Injection of antibodies vascular endothelial growth factor (anti-VEGF) agents are generally in use as the initial therapy in cases of macular edema. In cases of nonproliferative diabetic retinopathy, pan-retinal photocoagulation is being used. In cases of diabetic proliferative retinopathy, combined modalities of anti-VEGF agents and pan-retinal photocoagulation are now in use. Sudden loss of vision can occur for several reasons in patients with diabetes mellitus, the most common being vitreous hemorrhage. Less common causes that merit consideration include vascular occlusion (central retinal vein or branch vein occlusion involving the macula), retinal detachment, end-stage glaucoma, and ischemic optic neuropathy.

Furthermore, evidence suggests that T2DM may also contribute to cancer development, specifically bladder cancer, in those using pioglitazone. [50]  Patients using metformin had improved cancer-specific survival in those with prostate, pancreatic, breast, and colorectal cancers. However, it is unclear how metformin plays a role in modulating cancer in patients with diabetes. [51]

Those with gestational diabetes are at a higher risk for cesarean delivery and chronic hypertension. Pregnant patients with T2DM generally have a better prognosis in terms of neonatal and pregnancy complications compared to those with T1DM. Generally, neonates of DM mothers will present with hypoglycemia and macrosomia. [52]

The most acute complication of DM is diabetic ketoacidosis (DKA), which typically presents in T1DM. This condition is usually either due to inadequate dosing, missed doses, or ongoing infection. [53]  In this condition, the lack of insulin means that tissues are unable to obtain glucose from the bloodstream. Compensation for this causes the metabolism of lipids into ketones as a substitute energy source, which causes systemic acidosis, and can be calculated as a high anion-gap metabolic acidosis. The combination of hyperglycemia and ketosis causes diuresis, acidemia, and vomiting leading to dehydration and electrolyte abnormalities, which can be life-threatening. In T2DM, hyperosmolar hyperglycemic syndrome (HHS) is an emergent concern. It presents similarly to DKA with excessive thirst, elevated blood glucose, dry mouth, polyuria, tachypnea, and tachycardia. However, unlike DKA, HHS typically does not present with excessive urinary ketones since insulin still gets produced by pancreatic beta cells. Treatment for DKA or HHS involves insulin administration and aggressive intravenous hydration. Careful management of electrolytes, particularly potassium, is critical in the management of these emergent conditions. [54]

  • Deterrence and Patient Education

Healthcare professionals should take an active approach to educate patients with DM. It is misguided for patients to think that lifestyle changes for a limited time are appropriate, and instead, lifelong lifestyle changes may be necessary to control their DM adequately. A randomized, controlled trial identified that individualized education is more effective compared to group education in patients who had poorly controlled DM. [55]  Often, non-clinician healthcare professionals (e.g., nurses, pharmacists) have extensive training in DM education and have more time for individualized education.

  • Pearls and Other Issues

Amino acid metabolism may play a critical role in the development of T2DM. Studies have shown that there is a 4-fold increase in isoleucine, phenylalanine, and tyrosine in individuals with hyperglycemia. Researchers found that these amino acids were elevated up to 12 years before the onset of the disease. [56]  Recent studies have further elucidated the role of these metabolites in the development, screening, and treatment of metabolic syndrome (MetS), a cardiometabolic cluster that predisposes patients to T2DM and CVD. Studies have shown that choline, L-carnitine, and trimethylamine-N-oxide were associated with inflammatory pathways and increased the risk of metabolic dysfunction in nascent MetS patients, who meet classification for MetS but do not have T2DM and cardiovascular disease. [57]  Literature has also shown increased levels of isoleucine and tyrosine and decreased levels of lysine and methionine. These metabolites appear to be early biomarkers of nascent MetS and significant contributors to the pro-inflammatory burden of MetS.

Low levels of lysine, in particular, were associated with increased inflammation and elevated blood glucose. Thus, increased dietary lysine may promote anti-inflammatory effects. [58]  In a recent investigation, researchers found phosphatidylcholine 34:2, PC (34:2), GABA, and d-pyroglutamic acid (PGA) were significantly increased in nascent MetS and correlated positively with certain inflammatory parameters. [59] [60]  These findings further support the role of metabolites in the early development of T2DM and suggest that they may have a role in the pro-inflammatory state associated with diabetes.

  • Enhancing Healthcare Team Outcomes

Primary care clinicians are often the first to identify diabetes in their patients. Since DM is a complex disease, it requires an interprofessional team approach to management. Nurse practitioners and physician assistants can be critical to ensuring proper patient follow-ups and monitoring the efficacy of treatments. Nutritionists and diabetes educators can also provide consultations to help educate patients on appropriate lifestyle modifications and at-home glucose management.

Ophthalmologists, neurologists, podiatrists, and nephrologists may also be part of the healthcare team to ensure that patients with DM have adequate screenings to prevent devastating microvascular complications. Endocrinologists may be consulted when patients have a complex presentation or are unresponsive to initial treatments. Of course, pharmacists play a crucial role in evaluating proper medication administration and preventing polypharmacy in DM patients who are often taking multiple medications for the frank disease and its complications; they can ensure optimal dosing and recommend the most efficient regimens to achieve glycemic control, and also educate the patient on the medications and disease process.

Sperl-Hillen et al. found that patients with suboptimally controlled diabetes had better glucose control outcomes when given individualized education compared to group education. These patients also had better psychosocial and behavioral outcomes. [55]  Consequentially this emphasizes the role of an interprofessional team approach, including clinicians, specialists, specialty trained diabetic nurses educators, and pharmacists who are conversing across disciplines to optimize patient-specific management leading to improved outcomes. [Level 5]

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Disclosure: Amit Sapra declares no relevant financial relationships with ineligible companies.

Disclosure: Priyanka Bhandari declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

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