Changes in Diabetes Care and Management Practices during the COVID-19 Pandemic.

Background: Evidence suggests diabetes management was negatively impacted early in the pandemic. However, the impact of the pandemic on key healthcare services for diabetes control and diabetes self-management practices is less known. We examined changes in diabetes care and management practices before and during the COVID-19 pandemic. Methods: Population-based data regarding 4 diabetes-related healthcare engagement and 4 self-management indicators were obtained from adults with diabetes surveyed in 19 US States and Washington DC through the Behavioral Risk Factor Surveillance System. Using logistic regression, we estimated changes in the prevalence of each indicator, overall and by sociodemographic subgroups, before (2019; n = 15,307) and during (2021; n = 13,994) the COVID-19 pandemic. Results: Between 2019 and 2021, the prevalence of biannual HbA1c tests reduced by 2.6 percentage points (pp, 95% CI :-4.8, -0.4), from 75.4-73.1%, and prevalence of annual eye exams fell by 4.0 pp (-6.2, -2.8), from 72.2-68.7%. The composite indicator of engagement with healthcare for diabetes control fell by 3.5 pp (-5.9, -1.1), from 44.9-41.9%. Reductions in engagement with healthcare were largely seen across sex, age, education, employment status, marital status, insurance status, and urbanicity; and were more pronounced among those aged 18-34 and the uninsured. Reductions in engagement with healthcare were seen in several states, with Delaware and Washington DC reporting the largest decrease. Of self-management behaviors, we only observed change in avoidance of smoking, an increase of 2.0 pp (0.4, 3.6) from 84.7-87.1%. Conclusions: The pandemic had mixed impacts on diabetes care and self-management. The findings suggest a deterioration of the uptake of evidence-based, preventive health services requiring laboratory services and clinical examination for diabetes control during the pandemic. On the other hand, smoking rates decreased, suggesting potential positive impacts of the pandemic on health behaviors in people with diabetes.

Blood-derived miRNA levels are not correlated with metabolic or anthropometric parameters in obese pre-diabetic subjects but with systemic inflammation.

As blood-derived miRNAs (c-miRNAs) are modulated by exercise and nutrition, we postulated that they might be used to monitor the effects of a lifestyle intervention (LI) to prevent diabetes development. To challenge this hypothesis, obese Asian Indian pre-diabetic patients were submitted to diet modifications and physical activity for 4 months (LI group) and compared to a control group which was given recommendations only. We have considered 2 periods of time to analyze the data, i.e.; a first one to study the response to the intervention (4 months), and a second one post-intervention (8 months). At basal, 4 months and 8 months post-intervention the levels of 17 c-miRNAs were quantified, selected either for their relevance to the pathology or because they are known to be modulated by physical activity or diet. Their variations were correlated with variations of 25 metabolic and anthropometric parameters and cytokines. As expected, fasting-glycaemia, insulin-sensitivity, levels of exercise- and obesity-induced cytokines were ameliorated after 4 months. In addition, the levels of 4 miRNAs (i.e.; miR-128-3p, miR-374a-5p, miR-221-3p, and miR-133a-3p) were changed only in the LI group and were correlated with metabolic improvement (insulin sensitivity, cytokine levels, waist circumference and systolic blood pressure). However, 8 months post-intervention almost all ameliorated metabolic parameters declined indicating that the volunteers did not continue the protocol on their own. Surprisingly, the LI positive effects on c-miRNA levels were still detected, and were even more pronounced 8 months post-intervention. In parallel, MCP-1, involved in tissue infiltration by immune cells, and Il-6, adiponectin and irisin, which have anti-inflammatory effects, continued to be significantly and positively modified, 8 months post-intervention. These data demonstrated for the first time, that c-miRNA correlations with metabolic parameters and insulin sensitivity are in fact only indirect and likely associated with the level systemic inflammation. More generally speaking, this important result explains the high variability between the previous studies designed to identify specific c-miRNAs associated with the severity of insulin-resistance. The results of all these studies should take into account the level of inflammation of the patients. In addition, this finding could also explain why, whatever the pathology considered (i.e.; cancers, diabetes, neurodegenerative disorders, inflammatory diseases) the same subset of miRNAs is always found altered in the blood of patients vs healthy subjects, as these pathologies are all associated with the development of inflammation.

Cost-effectiveness of a Stepwise Approach vs Standard Care for Diabetes Prevention in India.

Importance: A stepwise approach that includes screening and lifestyle modification followed by the addition of metformin for individuals with high risk of diabetes is recommended to delay progression to diabetes; however, there is scant evidence regarding whether this approach is cost-effective. Objective: To estimate the cost-effectiveness of a stepwise approach in the Diabetes Community Lifestyle Improvement Program. Design, Setting, and Participants: This economic evaluation study included 578 adults with impaired glucose tolerance, impaired fasting glucose, or both. Participants were enrolled in the Diabetes Community Lifestyle Improvement Program, a randomized clinical trial with 3-year follow-up conducted at a diabetes care and research center in Chennai, India. Interventions: The intervention group underwent a 6-month lifestyle modification curriculum plus stepwise addition of metformin; the control group received standard lifestyle advice. Main Outcomes and Measures: Cost, health benefits, and incremental cost-effectiveness ratios (ICERs) were estimated from multipayer (including direct medical costs) and societal (including direct medical and nonmedical costs) perspectives. Costs and ICERs were reported in 2019 Indian rupees (INR) and purchasing power parity-adjusted international dollars (INT $). Results: The mean (SD) age of the 578 participants was 44.4 (9.3) years, and 364 (63.2%) were men. Mean (SD) body mass index was 27.9 (3.7), and the mean (SD) glycated hemoglobin level was 6.0% (0.5). Implementing lifestyle modification and metformin was associated with INR 10 549 (95% CI, INR 10 134-10 964) (INT $803 [95% CI, INT $771-834]) higher direct costs; INR 5194 (95% CI, INR 3187-INR 7201) (INT $395; 95% CI, INT $65-147) higher direct nonmedical costs, an absolute diabetes risk reduction of 10.2% (95% CI, 1.9% to 18.5%), and an incremental gain of 0.099 (95% CI, 0.018 to 0.179) quality-adjusted life-years per participant. From a multipayer perspective (including screening costs), mean ICERs were INR 1912 (INT $145) per 1 percentage point diabetes risk reduction, INR 191 090 (INT $14 539) per diabetes case prevented and/or delayed, and INR 196 960 (INT $14 986) per quality-adjusted life-year gained. In the scenario of a 50% increase or decrease in screening and intervention costs, the mean ICERs varied from INR 855 (INT $65) to INR 2968 (INT $226) per 1 percentage point diabetes risk reduction, from INR 85 495 (INT $6505) to INR 296 681 (INT $22 574) per diabetes case prevented, and from INR 88 121 (INT $6705) to INR 305 798 (INT $23 267) per quality-adjusted life-year gained. Conclusions and Relevance: The findings of this study suggest that a stepwise approach for diabetes prevention is likely to be cost-effective, even if screening costs for identifying high-risk individuals are added.

Tailoring lifestyle programmes for diabetes prevention for US South Asians.

Objective: The purpose of this study was to develop and test the feasibility of a culturally tailored Diabetes Prevention Programme (DPP) for US South Asians, a large population with high diabetes risk. Design: The South Asian Health and Prevention Education (SHAPE) study included: (1) focus group discussions with South Asian adults to understand views of lifestyle behaviours and diabetes prevention; (2) modification of the US DPP for South Asians and (3) a pilot, pre-post study to test the feasibility and impact of delivering the culturally tailored programme. Setting: The study was conducted in Atlanta, Georgia, USA. Focus group discussions and intervention classes were held at locations within the community (eg, South Asian restaurants, a public library, university classrooms, a South Asian owned physical therapy studio). Participants: The focus group discussions (n=17 with 109 individuals) included adults aged 25 years of older who self-identified as South Asian. Groups were stratified by age (25-40 years or older than 40 years) and sex. The SHAPE pilot study included 17 (76.5% male with a mean age of 46.9±12 years) South Asian adults aged 25 years or older with pre-diabetes and body mass index (BMI) >22 kg/m2. Results: Formative data from 17 focus group discussions and a community board guided the modification of the DPP curriculum to reflect cultural food preferences and include tools to leverage social support, create a stronger foundation in exercise and overcome culturally specific barriers. The SHAPE pilot study included 17 South Asian adults with pre-diabetes and BMI >22 kg/m2. There were positive changes in participants' weight, waist circumference, blood pressure, plasma lipids, HbA1c and other cardiometabolic markers postintervention and 55% of participants regressed to normoglycaemia. Conclusion: These results provide important information on the barriers faced by US South Asians in participating in 'standard' lifestyle change programs, indicate the feasibility of culturally tailored programmes and show positive impact of a culturally tailored programme for diabetes prevention in the South Asian population.

Physical activity promotion for patients transitioning to dialysis using the "Exercise is Medicine" framework: a multi-center randomized pragmatic trial (EIM-CKD trial) protocol.

BACKGROUND: Patients on dialysis are physically inactive, with most reporting activity levels below the fifth percentile of healthy age-matched groups. Several small studies have reported efficacy of diverse exercise interventions among persons with CKD and those on dialysis. However, no single intervention has been widely adopted in real-world practice, despite a clear need in this vulnerable population with high rates of mortality, frailty, and skilled nursing hospitalizations. METHODS/DESIGN: We describe a pragmatic clinical trial for an exercise intervention among patients transitioning to dialysis. We will use an existing framework - Exercise is Medicine (EIM) - developed by the American College of Sports Medicine. After undertaking formative qualitative research to tailor the EIM framework to the advanced CKD population (eGFR < 30 ml/min/1.73m2), we will randomize 96 patients from two regions-Atlanta and Bay Area-in two intervention arms with incremental levels of clinical-community integration: physical activity assessment during Nephrology clinical visit, brief counseling at pre-dialysis education, and physical activity wearable (group 1) versus group 1 intervention components plus a referral to a free, EIM practitioner-led group exercise program over 16 weeks (group 2; 8 week core intervention; 8-week follow up). We will assess efficacy by comparing between group differences in minutes/week of objectively measured moderate intensity physical activity. To evaluate implementation, we will use questionnaires for assessing barriers to referral, participation and retention along the path of the intervention. Further we will have a plan for dissemination of the intervention by partnering with relevant stakeholders. DISCUSSION: The overall goal is to inform the development of a practical, cost-conscious intervention "package" that addresses barriers and challenges to physical activity commonly faced by patients with advanced CKD and can be disseminated amongst interested practices. TRIAL REGISTRATION: ClinicalTrials.gov identifier (Dated:10/17/2017): NCT03311763 .

Long-term Sustainability of Diabetes Prevention Approaches: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

Importance: Diabetes prevention is imperative to slow worldwide growth of diabetes-related morbidity and mortality. Yet the long-term efficacy of prevention strategies remains unknown. Objective: To estimate aggregate long-term effects of different diabetes prevention strategies on diabetes incidence. Data Sources: Systematic searches of MEDLINE, EMBASE, Cochrane Library, and Web of Science databases. The initial search was conducted on January 14, 2014, and was updated on February 20, 2015. Search terms included prediabetes, primary prevention, and risk reduction. Study Selection: Eligible randomized clinical trials evaluated lifestyle modification (LSM) and medication interventions (>6 months) for diabetes prevention in adults (age ≥18 years) at risk for diabetes, reporting between-group differences in diabetes incidence, published between January 1, 1990, and January 1, 2015. Studies testing alternative therapies and bariatric surgery, as well as those involving participants with gestational diabetes, type 1 or 2 diabetes, and metabolic syndrome, were excluded. Data Extraction and Synthesis: Reviewers extracted the number of diabetes cases at the end of active intervention in treatment and control groups. Random-effects meta-analyses were used to obtain pooled relative risks (RRs), and reported incidence rates were used to compute pooled risk differences (RDs). Main Outcomes and Measures: The main outcome was aggregate RRs of diabetes in treatment vs control participants. Treatment subtypes (ie, LSM components, medication classes) were stratified. To estimate sustainability, post-washout and follow-up RRs for medications and LSM interventions, respectively, were examined. Results: Forty-three studies were included and pooled in meta-analysis (49 029 participants; mean [SD] age, 57.3 [8.7] years; 48.0% [n = 23 549] men): 19 tested medications; 19 evaluated LSM, and 5 tested combined medications and LSM. At the end of the active intervention (range, 0.5-6.3 years), LSM was associated with an RR reduction of 39% (RR, 0.61; 95% CI, 0.54-0.68), and medications were associated with an RR reduction of 36% (RR, 0.64; 95% CI, 0.54-0.76). The observed RD for LSM and medication studies was 4.0 (95% CI, 1.8-6.3) cases per 100 person-years or a number-needed-to-treat of 25. At the end of the washout or follow-up periods, LSM studies (mean follow-up, 7.2 years; range, 5.7-9.4 years) achieved an RR reduction of 28% (RR, 0.72; 95% CI, 0.60-0.86); medication studies (mean follow-up, 17 weeks; range, 2-52 weeks) showed no sustained RR reduction (RR, 0.95; 95% CI, 0.79-1.14). Conclusions and Relevance: In adults at risk for diabetes, LSM and medications (weight loss and insulin-sensitizing agents) successfully reduced diabetes incidence. Medication effects were short lived. The LSM interventions were sustained for several years; however, their effects declined with time, suggesting that interventions to preserve effects are needed.

The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial.

OBJECTIVE: This study tests the effectiveness of expert guidelines for diabetes prevention: lifestyle intervention with addition of metformin, when required, among people with prediabetes. RESEARCH DESIGN AND METHODS: The Diabetes Community Lifestyle Improvement Program (D-CLIP) is a randomized, controlled, translation trial of 578 overweight/obese Asian Indian adults with isolated impaired glucose tolerance (iIGT), isolated impaired fasting glucose (iIFG), or IFG+IGT in Chennai, India. Eligible individuals were identified through community-based recruitment and randomized to standard lifestyle advice (control) or a 6-month, culturally tailored, U.S. Diabetes Prevention Program-based lifestyle curriculum plus stepwise addition of metformin (500 mg, twice daily) for participants at highest risk of conversion to diabetes at ≥4 months of follow-up. The primary outcome, diabetes incidence, was assessed biannually and compared across study arms using an intention-to-treat analysis. RESULTS: During 3 years of follow-up, 34.9% of control and 25.7% of intervention participants developed diabetes (P = 0.014); the relative risk reduction (RRR) was 32% (95% CI 7-50), and the number needed to treat to prevent one case of diabetes was 9.8. The RRR varied by prediabetes type (IFG+IGT, 36%; iIGT, 31%; iIFG, 12%; P = 0.77) and was stronger in participants 50 years or older, male, or obese. Most participants (72.0%) required metformin in addition to lifestyle, although there was variability by prediabetes type (iIFG, 76.5%; IFG+IGT, 83.0%; iIGT, 51.3%). CONCLUSIONS: Stepwise diabetes prevention in people with prediabetes can effectively reduce diabetes incidence by a third in community settings; however, people with iIFG may require different interventions.

Behavioral and psychosocial correlates of adiposity and healthy lifestyle in Asian Indians.

AIMS: Adiposity is an important diabetes risk factor, and Asian Indians have elevated diabetes risk. This analysis assessed the relationship between behavioral and psychosocial factors and adiposity among Asian Indians to better understand factors driving elevated weight/waist circumference in this population. METHODS: This study used screening data (N=1285) from the D-CLIP study, a randomized controlled diabetes prevention trial in Chennai, India. Correlation tests and linear regression models were done to describe relationships among exposure variables (weight loss/exercise self-efficacy, fruit/vegetable intake, weekly exercise, past weight loss experience) and between these exposures and BMI or waist circumference. RESULTS: Exercise and weight loss self-efficacy were positively correlated with average minutes per week exercising (R=0.26, p<0.0001) and fruit (R=0.07, p<0.05) and vegetable intake (R=0.12, p<0.0001). Weekly fruit consumption, past weight loss experience, and weight loss self-efficacy, along with sex, age, and marital status, explained 13.6% and 25.9% in the variation in BMI and waist circumference, respectively. CONCLUSIONS: Low fruit consumption, unsuccessful past weight loss attempts, and low self-efficacy for weight loss are associated with higher BMI and waist circumference in this population. Understanding factors related to adiposity is important for preventing and treating weight gain.

The role of lifestyle change for prevention of cardiovascular disease in diabetes.

The burden of cardiovascular disease (CVD) is disproportionately greater in those with diabetes than in the general population, including higher rates of hospitalization, stroke, myocardial infarction, and mortality. Health-promoting lifestyle factors reduce both diabetes and CVD in healthy individuals; however, the efficacy of these strategies for CVD reduction in people with preexisting diabetes is unclear. In this review, we describe the most recent evidence (2013-2014) surrounding the effects of lifestyle changes on CVD outcomes in those with diabetes, and we contextualize the evidence against a backdrop of earlier key findings. Two major randomized controlled trials were identified, providing opposing conclusions about the role of lifestyle factors on CVD events in those with diabetes. Other recent prospective observational analyses support associations of physical activity and reduced CVD risk in diabetes. Limitations across studies include the use of self-report for measurement of lifestyle or lifestyle change, the length of follow-up needed to measure CVD outcomes, and the role of participants' medications on associations of lifestyle factors and CVD outcomes. Equivocal findings from the two randomized controlled trials support the need for additional research to identify the specific lifestyle factors that reduce CVD mortality and macrovascular complications in populations with diabetes.

A systematic review of overweight, obesity, and type 2 diabetes among Asian American subgroups.

This systematic review synthesizes data published between 1988 and 2009 on mean BMI and prevalence of overweight, obesity, and type 2 diabetes among Asian subgroups in the U.S. We conducted systematic searches in Pub- Med for peer-reviewed, English-language citations that reported mean BMI and percent overweight, obesity, and diabetes among South Asians/Asian Indians, Chinese, Filipinos, Koreans, and Vietnamese. We identified 647 database citations and 23 additional citations from hand-searching. After screening titles, abstracts, and full-text publications, 97 citations remained. None were published between 1988 and 1992, 28 between 1993 and 2003, and 69 between 2004 and 2009. Publications were identified for the following Asian subgroups: South Asian (n=8), Asian Indian (n=20), Chinese (n=44), Filipino (n=22), Korean (n= 8), and Vietnamese (n=3). The observed sample sizes ranged from 32 to 4245 subjects with mean ages from 24 to 78 years. Among samples of men and women, the lowest reported mean BMI was in South Asians (22.1 kg/m(2)), and the highest was in Filipinos (26.8 kg/m(2)). Estimates for overweight (12.8-46.7%) and obesity (2.1-59.0%) were variable. Among men and women, the highest rate of diabetes was reported in Asian Indians with BMI ≥ 30 kg/m(2) (32.9%, age and sex standardized). This review suggests heterogeneity among U.S. Asian populations in cardiometabolic risk factors, yet comparisons are limited due to variability in study populations, methods, and definitions used in published reports. Future efforts should adopt standardized methods to understand overweight, obesity and diabetes in this growing U.S. ethnic population.

Recommendations for accelerating global action to prevent folic acid-preventable birth defects and other folate-deficiency diseases: meeting of experts on preventing folic acid-preventable neural tube defects.

BACKGROUND: In April of 2003, The Micronutrient Initiative, in collaboration with several other organizations, convened a group of knowledgeable scientists and policy experts to discuss ways to accelerate the global pace at which countries implement effective and sustainable programs to prevent folic acid-preventable birth defects and other folate-deficiency diseases. Programs implemented to date by fewer than 40 countries have prevented only 10% of the estimated 240,000 annual cases of folic acid-preventable spina bifida and anencephaly. METHODS: Participants in this meeting summarized and presented scientific evidence showing that increased consumption of synthetic folic acid prevents a large proportion of spina bifida and anencephaly cases. They also reviewed related guidance and endorsement issued by national professional societies and advisory bodies as well as policies and programs implemented by some countries that have already demonstrated successful results in terms of reduced rates of neural tube defects and improved folate nutrition. CONCLUSIONS: The group formulated and discussed recommendations and strategies for increasing the pace of neural tube defect prevention globally. The recommendations and strategies are published here.