Prevalence of Distal Symmetrical Polyneuropathy by Diabetes Prevention Program Treatment Group, Diabetes Status, Duration of Diabetes, and Cumulative Glycemic Exposure.

OBJECTIVE: To assess associations between distal symmetric polyneuropathy (DSPN) and Diabetes Prevention Program (DPP) treatment groups, diabetes status or duration, and cumulative glycemic exposure approximately 21 years after DPP randomization. RESEARCH DESIGN AND METHODS: In the DPP, 3,234 adults ≥25 years old at high risk for diabetes were randomized to an intensive lifestyle (ILS), metformin, or placebo intervention to prevent diabetes. After the DPP ended, 2,779 joined the Diabetes Prevention Program Outcomes Study (DPPOS). Open-label metformin was continued, placebo was discontinued, ILS was provided in the form of semiannual group-based classes, and all participants were offered quarterly lifestyle classes. Symptoms and signs of DSPN were assessed in 1,792 participants at DPPOS year 17. Multivariable logistic regression models were used to evaluate DSPN associations with treatment group, diabetes status/duration, and cumulative glycemic exposure. RESULTS: At 21 years after DPP randomization, 66% of subjects had diabetes. DSPN prevalence did not differ by initial DPP treatment assignment (ILS 21.5%, metformin 21.5%, and placebo 21.9%). There was a significant interaction between treatment assignment to ILS and age (P < 0.05) on DSPN. At DPPOS year 17, the odds ratio for DSPN in comparison with ILS with placebo was 17.4% (95% CI 3.0, 29.3) lower with increasing 5-year age intervals. DSPN prevalence was slightly lower for those at risk for diabetes (19.6%) versus those with diabetes (22.7%) and was associated with longer diabetes duration and time-weighted HbA1c (P values <0.001). CONCLUSIONS: The likelihood of DSPN was similar across DPP treatment groups but higher for those with diabetes, longer diabetes duration, and higher cumulative glycemic exposure. ILS may have long-term benefits on DSPN for older adults.

Prediabetes and Cardiometabolic Risk: The Need for Improved Diagnostic Strategies and Treatment to Prevent Diabetes and Cardiovascular Disease.

The progression from prediabetes to type-2 diabetes depends on multiple pathophysiological, clinical, and epidemiological factors that generally overlap. Both insulin resistance and decreased insulin secretion are considered to be the main causes. The diagnosis and approach to the prediabetic patient are heterogeneous. There is no agreement on the diagnostic criteria to identify prediabetic subjects or the approach to those with insufficient responses to treatment, with respect to regression to normal glycemic values or the prevention of complications. The stratification of prediabetic patients, considering the indicators of impaired fasting glucose, impaired glucose tolerance, or HbA1c, can help to identify the sub-phenotypes of subjects at risk for T2DM. However, considering other associated risk factors, such as impaired lipid profiles, or risk scores, such as the Finnish Diabetes Risk Score, may improve classification. Nevertheless, we still do not have enough information regarding cardiovascular risk reduction. The sub-phenotyping of subjects with prediabetes may provide an opportunity to improve the screening and management of cardiometabolic risk in subjects with prediabetes.

Poor Glycemic Control Increases Dental Risk in a Sri Lankan Population.

Introduction: The aim of our study was to investigate the impact of diabetes-related factors on the dental disease outcomes of diabetes patients in Trincomalee, Sri Lanka. Materials and Methods: Dental data were collected from 80 type-2-diabetic individuals. A dental risk score was calculated based on the frequency of dental outcomes observed and categorized as low risk (≤3 dental outcomes) and high risk (>3 dental outcomes). Results: In this cohort of men and women with type 2 diabetes, there was a high frequency of periodontal related outcomes, including missing teeth (70%), gingival recessions (40%), tooth mobility (41%), and bleeding (20%). Thirty-nine (39%) of participants had high dental risk, while forty-nine (61%) had low risk. Conclusions: After controlling for age, participants with higher capillary blood glucose levels had 3-fold greater odds of a high dental risk score (OR = 2.93, 95%CI = 1.13, 7.61). We found that poor glycemic control indicated by elevated capillary blood glucose was associated with increased dental risk.

Neuropathic Pain With and Without Diabetic Peripheral Neuropathy in Type 1 Diabetes.

OBJECTIVE: Diabetic peripheral neuropathy (DPN) is common; however, the features and burden of neuropathic pain (NP) in type 1 diabetes (T1D) are poorly understood. We evaluated the incidence of first occurrence, annual prevalence, remission, and risk factors for NP during long-term follow-up of participants with T1D. RESEARCH DESIGN AND METHODS: The Michigan Neuropathy Screening Instrument (MNSI) was administered annually (1994-2020) for 1,324 participants in the Epidemiology of Diabetes Interventions and Complications (EDIC) study. NP with clinical signs of DPN (NP DPN+) was defined according to self-reported NP plus an examination score >2, while NP without clinical signs of DPN (NP DPN-) was defined according to self-reported NP and an examination score ≤2. RESULTS: At EDIC year 1, median age for participants was 36 years (interquartile range 30, 41), diabetes duration 13 years (10, 18), and HbA1c 7.9% (7.2, 8.9). At year 26 (median diabetes duration 39 years), cumulative incidence of NP was 57%, regardless of concomitant clinical signs of DPN (36% NP DPN+ vs. 46% NP DPN-). NP prevalence was 20% at 26 years (11% NP DPN+ and 9% NP DPN-), suggesting frequent remission. Annualized remission rates were similar regardless of pain medication use. In addition to HbA1c, female sex was associated with NP DPN-. CONCLUSIONS: NP incidence in T1D was high and frequently occurred in the absence of clinical signs of neuropathy, as assessed with the MNSI. Pain remission was not explained by pain medication use. Effective clinical strategies for identification and management are needed.

Impact of Glucose-Lowering Medications on Health-Related Quality of Life in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

OBJECTIVE: Diabetes is associated with reduced health-related quality of life (HRQoL). Information on the relationship between HRQoL and glucose-lowering medications in recently diagnosed type 2 diabetes (T2D) is limited. We assessed changes in HRQoL in participants with T2D receiving metformin plus one of four glucose-lowering medications in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). RESEARCH DESIGN AND METHODS: A total of 5,047 participants, baseline mean age 57 years, with <10 years T2D duration and glycated hemoglobin level 6.8-8.5% and taking metformin monotherapy, were randomly assigned to glargine, glimepiride, liraglutide, or sitagliptin. HRQoL was evaluated at baseline for 4,885 participants, and at years 1, 2, and 3, with use of the self-administered version of the Quality of Well-being Scale (QWB-SA) and SF-36 physical (PCS) and mental (MCS) component summary scales. Linear models were used to analyze changes in HRQoL over time in intention-to-treat analyses. RESULTS: None of the medications worsened HRQoL. There were no differences in QWB-SA or MCS by treatment group at any time point. PCS scores improved with liraglutide versus other groups at year 1 only. Greater weight loss during year 1 explained half the improvement in PCS scores with liraglutide versus glargine and glimepiride. Liraglutide participants in the upper tertile of baseline BMI showed the greatest improvement in PCS scores at year 1. CONCLUSIONS: Adding liraglutide to metformin in participants within 10 years of T2D diagnosis showed improvement in the SF-36 PCS in comparisons with the other medications at 1 year, which was no longer significant at years 2 and 3. Improvement was related to weight loss and baseline BMI.

The effect of parental diabetes prevention program participation on weight loss in dependent children: a prospective cohort study.

INTRODUCTION: Obesity has reached epidemic proportions in children and adolescents in the United States. Children's behaviors are strongly influenced by parental behaviors, and weight loss in parents is positively associated with weight changes in their overweight/obese children. Research is limited on how parents' National Diabetes Prevention Program (DPP) participation affects the health outcomes of their dependent children. Analyzing the impact of parental DPP participation on weight loss in their dependent children may provide valuable insight into an important secondary benefit of DPP participation. METHODS: In this study, we identified 128 adults with prediabetes who were offered the opportunity to participate in a DPP (n = 54 DPP participants and n = 74 DPP non-participants) and who had at least one child 3 to 17 years of age living with them. Age and BMI percentile for dependent children were collected from insurance claims data for 203 children (n = 90 children of DPP participants and n = 113 children of DPP non-participants). Parental practices related to diet and physical activity were assessed by surveys. RESULTS: There were no significant changes in BMI percentiles of overweight or obese children (i.e. BMI percentile ≥ 50%) of DPP participants vs DPP non-participants with prediabetes over one-year. Parents who enrolled and did not enroll in the DPP did not report differences in their parenting practices related to diet and physical activity. DISCUSSION: These results are not consistent with the literature that suggests parent-based interventions may influence their children's weight trajectories. Limitations include small sample size, short time span of intervention, and limited availability of additional health/biographic data on dependent children. Future studies should collect primary outcome data on children, investigate whether there is a minimum duration of parental involvement and level of parental adherence, and assess the effect of parent-child dynamics on child weight trajectories.

Retention and weight outcomes after transitioning an intensive behavioral weight management program from an in-person to a virtual format.

Background: Virtual care offers many potential advantages over traditional in-person care for people with chronic diseases including obesity. Before the COVID-19 pandemic, virtual care was not broadly implemented because of regulatory, legal, and reimbursement barriers. Objective: To evaluate the impact of the transition from an entirely in-person format to a virtual format during the COVID-19 pandemic on retention and weight reduction in a 2-year, structured, intensive behavioral weight management program for people with moderate to severe obesity. Methods: Retrospective cohort study of 1313 program participants stratified according to the phase of the program during which the transition to virtual visits occurred. Results: Age, sex, and baseline weight were independent predictors of program retention. Transition to virtual visits was associated with greater 2-year program retention. Retention but not mode of program delivery was associated with reduction in weight at 2-year. Conclusions: Transition from in-person to virtual program delivery improved retention and by doing so, indirectly improved weight loss at 2 years. Telemedicine has the potential to overcome many of the limitations associated with traditional in-person weight loss interventions. Clinical Trial Registration: This research was reviewed and approved by the University of Michigan Institutional Review Board and registered on ClinicalTrials.gov (NCT02043457). All participants provided written informed consent.

Effects of metformin and intensive lifestyle interventions on the incidence of kidney disease in adults in the DPP/DPPOS.

AIMS: We analyzed the incidence of kidney disease in the Diabetes Prevention Program Outcomes Study (DPPOS) by originally randomized treatment group assignment: Intensive Lifestyle (ILS), Metformin (MET) or Placebo (PLB). METHODS: The current analyses used a time-to-event approach in which the primary outcome was kidney disease, ascertained as urine albumin-to-creatinine ratio (ACR) ≥ 3.39 mg/mmol (30 mg/g) or eGFR <45 mL/min/1.73m2, with confirmation required at the next visit, or adjudicated end-stage kidney disease (ESKD). RESULTS: At a median of 21 years following randomization in DPP, diabetes development was reduced in both the ILS (HR 0.73 [95%CI = 0.62, 0.85]) and MET groups (HR 0.85 [0.73, 0.99]) compared to the PLB group. Although risk for developing the primary kidney disease outcome was higher among those with incident diabetes compared to those without (HR 1.81 [1.43, 2.30]), it did not differ by intervention groups (ILS vs. PLB 1.02 (0.81, 1.29); MET vs. PLB 1.08 (0.86, 1.35). There was a non-significant metformin by age interaction (p = 0.057), with metformin being beneficial for kidney disease in the younger but potentially harmful in the older participants. CONCLUSIONS: Development of kidney disease was increased in participants who developed diabetes but did not differ by original treatment group assignment. CLINICAL TRIAL REGISTRATIONS: Diabetes Prevention Program (DPP) Clinical trial reg. no. NCT00004992 DPP Outcomes Study (DPPOS) Clinical trial reg. no. NCT0038727.

Rethinking diabetes in the United States.

Despite the availability of effective medical treatments, the diabetes epidemic has accelerated in the United States, efforts to translate treatments into routine clinical practice have stalled, and health inequities have persisted. The National Clinical Care Commission (NCCC) was established by the Congress to make recommendations to better leverage federal policies and programs to more effectively prevent and control diabetes and its complications. The NCCC developed a guiding framework that incorporated elements of the Socioecological and Chronic Care Models. It gathered information from both health-related and non-health-related federal agencies, held 12 public meetings, solicited public comments, met with interested parties and key informants, and performed comprehensive literature reviews. The final report of the NCCC was transmitted to the Congress in January 2022. It called for a rethinking of the problem of diabetes in the United States, including the recognition that the lack of progress is due to a failure to confront diabetes as both a complex societal problem as well as a biomedical problem. To prevent and control diabetes, public policies and programs must be aligned to address both social and environmental determinants of health and health care delivery as they impact diabetes. In this article, we discuss the findings and recommendations of the NCCC as they relate to the social and environmental factors that influence the risk of type 2 diabetes and argue that the prevention and control of type 2 diabetes in the U.S. must begin with concrete population-level interventions to address social and environmental determinants of health.

Retention and outcomes of National Diabetes Prevention Program enrollees and non-enrollees with prediabetes: The University of Michigan experience.

AIMS: To evaluate retention and outcomes of insured adults with prediabetes who enrolled or did not enroll in National Diabetes Prevention Programs (NDPPs). METHODS: Between 2015 and 2019, 776 University of Michigan employees, dependents, and retirees with prediabetes and overweight or obesity enrolled in one-year NDPPs. RESULTS: Enrollees attended a median of 18 sessions. Median retention was 38 weeks. Retention was associated with older age, greater initial weight loss, and physical activity. At both 1- and 2-years, body mass index, triglycerides, and HbA1c were significantly improved among enrollees. After adjusting for age group, sex, and race, the odds of developing diabetes based on HbA1c ≥6.5 % was 40 % lower at 1-year and 20 % lower at 2-years, and the odds of self-reported diabetes was 57 % lower at 1-year and 46 % lower at 2-years in enrollees compared to non-enrollees. Enrollees who disenrolled before completing the core curriculum had higher odds and enrollees who completed the NDPP had lower odds of developing diabetes that non-enrollees. CONCLUSIONS: In this population with prediabetes, NDPP retention was generally good, risk factors were improved, and diabetes was delayed or prevented for up to two years.

Uptake, retention, and outcomes of the National Diabetes Prevention Program by enrollee characteristics and program type.

AIMS: To describe National Diabetes Prevention Program (NDPP) uptake, retention, and outcomes by enrollee characteristics and program type. METHODS: We studied 776 adult University of Michigan employees, dependents, and retirees with prediabetes and overweight or obesity who enrolled in one of four CDC-recognized NDPPs at no out-of-pocket cost. Programs included 1) an in-person classroom-based program led by certified diabetes educators in an endocrinology outpatient clinic; 2) an in-person classroom-based program led by trained peer instructors in community settings; 3) an in-person fitness-focused program led by trained lifestyle coaches; and 4) an online digital program led by personal health coaches with virtual group meetings. Data from the insurer and surveys were analyzed. RESULTS: Older individuals with hypertension and cardiovascular disease were more likely to enroll in classroom-based programs. Program time, location, and perceived focus on diet or physical activity influenced program selection. Retention, weight loss, and physical activity were greater among enrollees in in-person classroom-based programs. Changes in blood pressure, lipid levels, self-rated health, and health-related quality-of-life did not differ by program, nor did Type 2 diabetes mellitus incidence. CONCLUSIONS: Individuals with prediabetes who enrolled in a NDPP achieved health benefits regardless of the type of program they chose.

Diabetes Care Barriers, Use, and Health Outcomes in Younger Adults With Type 1 and Type 2 Diabetes.

Importance: Treatment challenges exist for younger adults with type 1 (T1D) and type 2 diabetes (T2D). Health care coverage, access to, and use of diabetes care are not well delineated in these high-risk populations. Objective: To compare patterns of health care coverage, access to, and use of diabetes care and determine their associations with glycemia among younger adults with T1D and with T2D. Design, Setting, and Participants: This cohort study analyzed data from a survey that was jointly developed by 2 large, national cohort studies: the SEARCH for Diabetes in Youth (SEARCH) study, an observational study of individuals with youth-onset T1D or T2D, and the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, a randomized clinical trial (2004-2011) followed by an observational study (2012-2020). The interviewer-directed survey was administered during in-person study visits in both studies between 2017 and 2019. Data analyses were performed between May 2021 and October 2022. Main Outcomes and Measures: Survey questions addressed health care coverage, usual sources of diabetes care, and frequency of care use. Glycated hemoglobin (HbA1c) levels were assayed in a central laboratory. Patterns of health care factors and HbA1c levels were compared by diabetes type. Results: The analysis included 1371 participants (mean [range] age, 25 [18-36] years; 824 females [60.1%]), of whom 661 had T1D and 250 had T2D from the SEARCH study and 460 had T2D from the TODAY study. Participants had a mean (SD) diabetes duration of 11.8 (2.8) years. More participants with T1D than T2D in both the SEARCH and TODAY studies reported health care coverage (94.7%, 81.6%, and 86.7%), access to diabetes care (94.7%, 78.1%, and 73.4%), and use of diabetes care (88.1%, 80.5%, and 73.6%). Not having health care coverage was associated with significantly higher mean (SE) HbA1c levels in participants with T1D in the SEARCH study (no coverage, 10.8% [0.5%]; public, 9.4% [0.2%]; private, 8.7% [0.1%]; P < .001) and participants with T2D from the TODAY study (no coverage, 9.9% [0.3%]; public, 8.7% [0.2%]; private, 8.7% [0.2%]; P = .004). Medicaid expansion vs without expansion was associated with more health care coverage (participants with T1D: 95.8% vs 90.2%; participants with T2D in SEARCH: 86.1% vs 73.9%; participants with T2D in TODAY: 93.6% vs 74.2%) and lower HbA1c levels (participants with T1D: 9.2% vs 9.7%; participants with T2D in SEARCH: 8.4% vs 9.3%; participants with T2D in TODAY: 8.7% vs 9.3%). The T1D group incurred higher median (IQR) monthly out-of-pocket expenses than the T2D group ($74.50 [$10.00-$309.00] vs $10.00 [$0-$74.50]). Conclusions and Relevance: Results of this study suggested that lack of health care coverage and of an established source of diabetes care were associated with significantly higher HbA1c levels for participants with T1D, but inconsistent results were found for participants with T2D. Increased access to diabetes care (eg, through Medicaid expansion) may be associated with improved health outcomes, but additional strategies are needed, particularly for individuals with T2D.

The Impact of New and Renewed Restrictive State Abortion Laws on Pregnancy-Capable People with Diabetes.

PURPOSE OF REVIEW: When the Supreme Court handed down its decision in Dobbs v Jackson Women's Health Organization in June 2022, the constitutional right to abortion was no longer protected by Roe v Wade. Fifteen states now have total or near-total bans on abortion care or no clinics providing abortion services. We review how these restrictions affect the medical care of people with pregestational diabetes. RECENT FINDINGS: Of the ten states with the highest percent of adult women living with diabetes, eight currently have complete or 6-week abortion bans. People with diabetes are at high risk of diabetes-related pregnancy complications and pregnancy-related diabetes complications and are disproportionately burdened by abortion bans. Abortion is an essential part of comprehensive, evidence-based diabetes care, yet no medical society has published guidelines on pregestational diabetes that explicitly discuss the importance and role of safe abortion care. Medical societies enacting standards for diabetes care and clinicians providing diabetes care must advocate for access to abortion to reduce pregnancy-related morbidity and mortality for pregnant people with diabetes.

Phthalates and Incident Diabetes in Midlife Women: The Study of Women's Health Across the Nation (SWAN).

CONTEXT: Phthalates are hypothesized to contribute to diabetes, but longitudinal evidence in humans is limited. OBJECTIVE: We examined whether phthalate exposure was associated with a higher incidence of diabetes in a racially/ethnically diverse cohort of midlife women. METHODS: In the Study of Women's Health Across the Nation Multipollutant Study, we followed 1308 women without diabetes in 1999-2000 for 6 years. Eleven phthalate metabolites were measured in spot urine samples in 1999-2000 and 2002-2003. Incident diabetes was ascertained between 1999-2000 and 2005-2006. Cox proportional hazards models with time-varying exposure were used to estimate the hazard ratio (HR) of diabetes associated with each phthalate metabolite, adjusting for demographic, lifestyle, and health-related factors. Effect modification by race/ethnicity was examined with interaction terms. RESULTS: Sixty-one women developed diabetes over 6 years (cumulative incidence = 4.7%). Among all women, several high-molecular-weight phthalate metabolites were associated with a higher incidence of diabetes, but none were statistically significant. There was effect modification by race/ethnicity. Among White women, each doubling of the concentrations of mono-isobutyl phthalate (MiBP), monobenzyl phthalate, mono-carboxyoctyl phthalate, mono-carboxyisononyl phthalate (MCNP), and mono(3-carboxypropyl) phthalate was associated with a 30% to 63% higher incidence of diabetes (HR = 1.30, 95% CI, 1.03-1.65 for MCNP; HR = 1.63, 95% CI, 1.18-2.25 for MiBP). In contrast, phthalates were not associated with diabetes incidence in Black or Asian women. CONCLUSIONS: Some phthalate metabolites were associated with a higher incidence of diabetes over 6 years, but the associations were inconsistent across racial/ethnic groups. Whether phthalates cause diabetes requires further investigation.