Search

While many older adults with type 2 diabetes have tight glycemic control beyond guideline-recommended targets, deintensifying (stopping or dose-reducing) diabetes medications rarely occurs.To explore the perspectives of older adults with type 2 diabetes around deintensifying diabetes medications.This qualitative study used individual semi-structured interviews, which included three clinical scenarios where deintensification may be indicated.Twenty-four adults aged ≥65 years with medication-treated type 2 diabetes and hemoglobin A1c7.5% were included (to thematic saturation) using a maximal variation sampling strategy for diabetes treatment and physician specialty.Interviews were independently coded by two investigators and analyzed using a grounded theory approach. We identified major themes and subthemes and coded responses to the clinical scenarios as positive (in favor of deintensification), negative, or ambiguous.Participants' mean age was 74 years, half were women, and 58% used a sulfonylurea or insulin. The first of four major themes was fear of losing control of diabetes, which participants weighed against the benefits of taking less medication (Theme 2). Few participants viewed glycemic control below target as a reason for deintensification and a majority would restart the medication if their home glucose increased. Some participants were anchored to their current diabetes treatment (Theme 3) driven by unrealistic views of medication benefits. A trusting patient-provider relationship (Theme 4) was a positive influence. In clinical scenarios, 8%, 4%, and 75% of participants viewed deintensification positively in the setting of poor health, limited life expectancy, and high hypoglycemia risk, respectively.Optimizing deintensification requires patient education that describes both individualized glycemic targets and how they will change over the lifespan. Deintensification is an opportunity for shared decision-making, but providers must understand patients' beliefs about their medications and address misconceptions. Hypoglycemia prevention may be a helpful framing for discussing deintensification.

Reducing hemoglobin A1c (HbA1c) is essential for patients with poorly controlled diabetes. However, delays in HbA1c testing are common, and incomplete electronic health record (EHR) reports hinder identification of patients who are overdue. This study sought to quantify how often an EHR report correctly identifies patients with HbA1c testing delays and to describe potential contributing factors.Using an EHR report, the researchers identified adult patients who had an HbA1c9.0% between October 2017 and March 2018 and a suspected delay (for example, another HbA1c had not resulted within six months). A retrospective chart review of 200 randomly selected records was performed to confirm delays in testing. Secondary measures were collected from 93 charts to evaluate associated factors.A total of 685 patients with suspected delays were identified. On chart review (N = 200), 82.0% were confirmed. Nine percent of patients had a timely repeat result, but the result was not in a discrete field within the EHR. Another 8.5% were never expected to return. Among a subset of confirmed delays, patients often received lifestyle counseling, but less than half had documented discussions about repeat glycemic testing. Also, 74.2% had a timely follow-up appointment scheduled but the majority (85.5%) were missed.Most suspected delays in HbA1c testing were confirmed; however, a substantial minority were misclassified due to missing data or follow-up care outside the health system. Current solutions to improve data quality for HbA1c are labor intensive and highlight the need for better integration of health care data. Missed appointments were commonly noted among patients with delays in care and are a potential target for improvement.

The efficacy of time-restricted eating for weight loss has not been established, as prior studies were limited by a lack of controlled isocaloric designs. This study describes the design and implementation of interventions in a controlled eating study evaluating time-restricted eating. We designed a randomized, controlled, parallel-arm eating study comparing time-restricted eating (TRE) to a usual eating pattern (UEP) for the primary outcome of weight change. Participants were aged 21–69 years with prediabetes and obesity. TRE consumed 80% of calories by 1300 h (military time), and UEP consumed ≥ 50% of calories after 1700 h (military time). Both arms consumed identical macro- and micro-nutrients based on a healthy, palatable diet. We calculated individual calorie requirements, which were maintained throughout the intervention. The desired distribution of calories across eating windows in both arms was achieved, as were the weekly averages for macronutrients and micronutrients. We actively monitored participants and adapted diets to facilitate adherence. We provide the first report, to our knowledge, on the design and implementation of eating study interventions that isolated the effect of meal timing on weight while maintaining constant caloric intake and identical diets during the study period.

PDF - 282KB, Supplementary Table 1. PubMed Search Terms Supplementary Table 2. CINAHL Search Terms Supplementary Table 3. Cochrane Library Search Terms Supplementary Table 4. Studies Excluded because of Duplicate Data Supplementary Table 5. Treatment of Confounding by Included Articles Supplementary Table 6. Quality Information for Included Studies Supplementary Table 7. Relationship between Obesity and Colon Cancer Screening by Sex Supplementary Table 8. Relationship between Obesity and Colon Cancer Screening by Race and Sex Supplementary Figure 1. Steps in the Selection of Included Articles Supplementary Figure 2. Forest Plots for Relative Odds of Colon Cancer Screening by BMI in Unstratified Meta-Analyses Supplementary Figure 3. Forest Plots for Relative Odds of Colon Cancer Screening by BMI in White Women Supplementary Figure 4. Forest Plots for Relative Odds of Colon Cancer Screening by BMI in White Men Supplementary Figure 5. Forest Plots for Relative Odds of Colon Cancer Screening by BMI in Black Men Supplementary Figure 6. Forest Plots for Relative Odds of Colon Cancer Screening by BMI in Black Women

OBJECTIVE To determine physicians’ approach to deintensifying (reducing/stopping) or switching hypoglycemia-causing medications for older adults with type 2 diabetes. RESEARCH DESIGN AND METHODS In this national survey, U.S. physicians in general medicine, geriatrics, or endocrinology reported changes they would make to hypoglycemia-causing medications for older adults in three scenarios: good health, HbA1c of 6.3%; complex health, HbA1c of 7.3%; and poor health, HbA1c of 7.7%. RESULTS There were 445 eligible respondents (response rate 37.5%). In patient scenarios, 48%, 4%, and 20% of physicians deintensified hypoglycemia-causing medications for patients with good, complex, and poor health, respectively. Overall, 17% of physicians switched medications without significant differences by patient health. One-half of physicians selected HbA1c targets below guideline recommendations for older adults with complex or poor health. CONCLUSIONS Most U.S. physicians would not deintensify or switch hypoglycemia-causing medications within guideline-recommended HbA1c targets. Physician preference for lower HbA1c targets than guidelines needs to be addressed to optimize deintensification decisions.

The efficacy of time-restricted feeding for weight loss has not been established as prior studies were limited by lack of controlled isocaloric designs. This study describes the design and implementation of a controlled feeding study evaluating time-restricted feeding. We designed a randomized, controlled, parallel-arm, feeding study comparing time restricted feeding (TRF) to a usual feeding pattern (UFP) for the primary outcome of weight change. Participants were aged 18-69 years with prediabetes and obesity. TRF consumed 80% of calories by 1300, and UFP consumed ≥50% of calories after 1700. Both arms consumed identical macro- and micro-nutrients, based on a healthy palatable diet. We calculated individual calorie requirements which were maintained throughout the intervention. We randomized 41 participants who all completed the study. The desired distribution of calories across feeding windows in both arms was achieved, as were weekly averages for macronutrients and micronutrients. All randomized participants completed the study. We actively monitored participants and adapted diets to facilitate adherence. We provide the first report, to our knowledge, on the design and implementation of a feeding study that isolated the effect of meal timing on weight, while maintaining constant caloric intake and identical diets during the study period.

The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the previous consensus statements on the management of hyperglycaemia in type 2 diabetes in adults, published since 2006 and last updated in 2019. The target audience is the full spectrum of the professional healthcare team providing diabetes care in the USA and Europe. A systematic examination of publications since 2018 informed new recommendations. These include additional focus on social determinants of health, the healthcare system and physical activity behaviours including sleep. There is a greater emphasis on weight management as part of the holistic approach to diabetes management. The results of cardiovascular and kidney outcomes trials involving sodium–glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists, including assessment of subgroups, inform broader recommendations for cardiorenal protection in people with diabetes at high risk of cardiorenal disease. After a summary listing of consensus recommendations, practical tips for implementation are provided.

Many older adults with type 2 diabetes (T2D) are tightly controlled with high hypoglycemia risk medications and may benefit from deintensifying (stopping/reducing) or switching to newer medications. As deintensifying rarely occurs in practice, we aimed to determine how physicians make these decisions. We conducted a national survey of a random sample of US physicians in general medicine, geriatrics, and endocrinology. The survey was designed by a team of patients, caregivers, and physicians, and distributed in 3 mailing waves. Physicians were asked what action they would take in three scenarios of patients with T2D treated below individualized targets: 1) a healthy 79F with HbA1c 6.3% on a sulfonylurea; 2) a 77M with stage 4 kidney disease with HbA1c 7.3% on basal insulin; 3) a 78F with advanced dementia with HbA1c 7.7% on a sulfonylurea. Scenarios started with a base case of the patient reporting no medication issues, then varied hypoglycemia history, health, and patient preferences. Statistical comparisons used multinomial logistic regression accounting for clustering. We received 427 responses to date, response rate 27%. In the base case, 57% of physicians made no change to the high-risk medication, 16% switched, 12% decreased, 12% stopped, and 3% increased. Decreasing/stopping occurred over twice as often in scenario 1 than other scenarios (p95% of physicians to decrease, stop or switch the high-risk medication. Worsening health status also caused substantially more deintensification, but polypharmacy, financial barriers, and patient preference did not. Endocrinologists were 3-5 times as likely to switch medications compared to other specialties (p7.0%. Hypoglycemia and worsening health were strong motivators to deintensify or switch to newer medications. Disclosure S.J.Pilla: None. N.Schoenborn: None. C.Boyd: Other Relationship; Dynamed, UpToDate. S.Golden: Advisory Panel; Abbott Diabetes, Medtronic. N.N.Mathioudakis: None. N.M.Maruthur: Other Relationship; Johns Hopkins HealthCare Solutions. Funding National Institutes of Health (1R24AG064025 and 1K23DK128572)

Deintensifying diabetes medications rarely occurs for older adults with type 2 diabetes (T2D) despite many being tightly controlled with hypoglycemia-inducing medications. We conducted a national survey of US physicians to understand their perspectives on deintensification for older adults with T2D. The survey was designed by a team of patients, caregivers, and physicians, and distributed to a random sample of physicians in general medicine, geriatrics, and endocrinology in three mailing waves. Respondents rated the importance of deintensifying, and of switching to a medication with a better risk/benefit profile, on 5-point Likert scales; the frequency of these actions in the past 3 months; and barriers/facilitators. We received 427 completed surveys to date, response rate 27%. The Figure shows physicians’ responses. Our findings show that the vast majority of US physicians view deintensifying diabetes medications as important to the care of older adults, although they accomplish this infrequently. Major barriers were physicians’ views that patients were reluctant to change medications or to allow their glucose to be higher. Adverse events, especially hypoglycemia, were strong facilitators, as was reducing cost of therapy. Geriatricians reported deintensifying more often than other specialties. Endocrinologists switched medications more often and were more concerned about short-term hyperglycemia. Disclosure S.J.Pilla: None. I.J.Wang: None. N.Schoenborn: None. C.Boyd: Other Relationship; Dynamed, UpToDate. S.Golden: Advisory Panel; Abbott Diabetes, Medtronic. N.N.Mathioudakis: None. N.M.Maruthur: Other Relationship; Johns Hopkins HealthCare Solutions. Funding National Institutes of Health (1R24AG064025 and 1K23DK128572)

BACKGROUND: Hypoglycemia is a common and serious adverse effect of diabetes treatment, especially for patients using insulin or insulin secretagogues. Guidelines recommend that these patients be assessed for interval hypoglycemic events at each clinical encounter and be provided anticipatory guidance for hypoglycemia prevention. OBJECTIVE: To determine the frequency and content of hypoglycemia communication in primary care visits. DESIGN: Qualitative study PARTICIPANTS: We examined 83 primary care visits from one urban health practice representing 8 clinicians and 33 patients using insulin or insulin secretagogues. APPROACH: Using a directed content analysis approach, we analyzed audio-recorded primary care visits collected as part of the Achieving Blood Pressure Control Together study, a randomized trial of behavioral interventions for hypertension. The coding framework included communication about interval hypoglycemia, defined as discussion of hypoglycemic events or symptoms; the components of hypoglycemia anticipatory guidance in diabetes guidelines; and hypoglycemia unawareness. Hypoglycemia documentation in visit notes was compared to visit transcripts. KEY RESULTS: Communication about interval hypoglycemia occurred in 24% of visits, and hypoglycemic events were reported in 16%. Despite patients voicing fear of hypoglycemia, clinicians rarely assessed hypoglycemia frequency, severity, or its impact on quality of life. Hypoglycemia anticipatory guidance was provided in 21% of visits which focused on diet and behavior change; clinicians rarely counseled on hypoglycemia treatment or avoidance of driving. Limited discussions of hypoglycemia unawareness occurred in 8% of visits. Documentation in visit notes had low sensitivity but high specificity for ascertaining interval hypoglycemia communication or hypoglycemic events, compared to visit transcripts. CONCLUSIONS: In this high hypoglycemia risk population, communication about interval hypoglycemia and counseling for hypoglycemia prevention occurred in a minority of visits. There is a need to support clinicians to more regularly assess their patients’ hypoglycemia burden and enhance counseling practices in order to optimize hypoglycemia prevention in primary care. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-020-06385-x.

Introduction: Women with a history of gestational diabetes (GDM) are at increased risk for type 2 diabetes and thus require regular follow-up screening for diabetes; however, many women do not receive this screening, and in particular low-income women face disparities in receipt of recommended follow-up care. While these women may have limited access to healthcare following pregnancy, they may more regularly access social service programs that serve themselves or their young children. Leveraging these social service touchpoints could broaden opportunities to improve follow-up care receipt among women with a history of GDM. To describe these potential opportunities, we used national representative data to characterize diabetes screening needs among women with a history of GDM who access the Special supplemental nutrition program for Women, Infants and Children (WIC) or Head Start programming for their young children. Methods: We analyzed national representative data from the National Health Interview Survey from calendar years 2016 and 2017. Our analytic sample included women aged 18 to 45 years who were linked to at least one of their children in the dataset and who had a self-reported history of GDM but did not have prediabetes or diabetes. We examined the proportion of these women who accessed WIC or Head Start who did not report having testing for diabetes within the past 3 years. Results: Of 432 (representing 2,002,675 weighted) women meeting inclusion criteria, 21.7% accessed WIC and 8.7% Head Start. Nearly 1 in 10 women with a history of GDM in either group did not report recent diabetes screening. In sensitivity analyses that excluded likely pregnancy-related testing, 35.0% of women accessing WIC and 21.2% of those accessing Head Start had not had recent screening. Discussion: There is an unmet need for follow-up diabetes screening among women with a history of GDM who access WIC or Head Start services for their young children. Leveraging women9s touchpoints with these programs could enhance opportunities to improve recommended diabetes screening among a high-risk population.

Summary Objective Understand whether parents lose less weight than nonparents in behavioural weight interventions. Methods The Look AHEAD (Action for Health in Diabetes) trial randomized adults with Type 2 diabetes and overweight to an intensive lifestyle intervention (ILI) or control (diabetes support and education [DSE]). Participants who reported living with a child under age 18 were designated as ‘parents’ for this analysis. Intention to treat analysis was performed of the effect of the ILI on change in weight at 1 year by parental status. Adherence to attending intervention visits was compared between parents and nonparents. Subgroup analyses were done based on previous subgroup findings in the Look AHEAD study. Results Among 4,547 participants, 15% were parents. Parents were younger and more likely to have self‐identified as African American or Hispanic/Latino. Comparing ILI with DSE, parents lost less weight than nonparents (−7.1% vs. −8.3%, p = 0.021). African American female parents lost 4% body weight compared with 7% in African American female nonparents (p = 0.01). Conclusions In a randomized trial, parents lost less weight than nonparents, and this difference was largest for African American women. These findings suggest parents face unique challenges achieving weight loss; more research is needed to understand and optimize interventions for parents.

Background Among patients with type 2 diabetes, minority racial/ethnic groups have a higher burden of cardiovascular disease, chronic kidney disease, and hypoglycaemia. These groups may especially benefit from newer diabetes medication classes, but high cost may limit access. We examined the association of race/ethnicity with the initiation of newer diabetes medications (GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors). Methods We conducted a secondary analysis of the Look AHEAD (Action for Health in Diabetes) trial including participants with at least one study visit after April 28, 2005. Cox proportional hazards models were used to estimate the association between race/ethnicity and socioeconomic factors with time to initiation of any newer diabetes medication from April 2005 to February 2020. Models were adjusted for demographic and clinical characteristics. Findings Among 4,892 participants, 63.6%, 15.7%, 12.6%, 5.2%, and 2.9% were White, Black, Hispanic, American Indian or Alaskan Native (AI/AN), or other race/ethnicity, respectively. During a median follow-up of 8.3 years, 2,180 (45.2%) participants were initiated on newer diabetes medications. Race/ethnicity was associated with newer diabetes medication initiation (p=.019). Specifically, initiation was lower among Black (HR 0.81, 95% CI 0.70–0.94) and AI/AN participants (HR 0.51, 95% CI 0.26–0.99). Yearly family income was inversely associated with initiation of newer diabetes medications (HR 0.78, 95% CI 0.62–0.98) comparing the lowest and highest income groups. Findings were mostly driven by GLP-1 receptor agonists. Interpretation These findings provide evidence of racial/ethnic disparities in the initiation of newer diabetes medications, independent of socioeconomic factors, which may contribute to worse health outcomes. Funding source NIDDK, NIH

Type 2 diabetes can be prevented through lifestyle programs like the Diabetes Prevention Programs (DPP), but few people with prediabetes participate in them, in part because their insurance does not reliably cover DPPs. Prior studies have not focused on payor-level barriers.To understand barriers to DPP uptake that exist and intersect at different levels (patients, PCPs, and payors) to inform strategies to improve diabetes prevention in primary care settings through interviews with PCPs and payors.From May 2020 to October 2021, we conducted remote, semi-structured interviews with PCPs and payors.PCPs were from primary care practices affiliated with one mid-Atlantic academic system. Payor leaders were from regional commercial, Medicare, and Medicaid plans.Using a standardized interview guide focused on barriers, facilitators, and potential intervention components, interviews were audio-recorded using Zoom and professionally transcribed. Two reviewers double-coded transcripts using the framework analytic approach.We interviewed 16 PCPs from 13 primary care clinics and 7 payor leaders representing 6 insurance plans. Two themes emerged from PCP reports of patient-level barriers: (1) lack of programs and insurance coverage of resources to address nutrition and exercise and (2) inadequate resources to address social determinants of health that impact diabetes prevention. Among barriers PCPs faced, we identified two themes: (1) low PCP knowledge about DPPs and misperceptions of insurance coverage of DPPs and (2) inadequate clinical staff to address diabetes prevention. Barriers common to PCPs and payors included (1) absence of prediabetes quality measures and (2) inadequate engagement of PCPs and patients with payors.Discussions with PCPs and payors revealed systemic barriers that suggest important priorities to improve prediabetes clinical care, including universal coverage of DPPs, clarity about coverage benefits, data reporting and outreach by payors to PCPs, and adoption of appropriate prediabetes quality measures.

IntroductionHypoglycemia is the most common serious adverse effect of diabetes treatment and a major cause of medication-related hospitalization. This study aimed to identify trends and predictors of hospital utilization for hypoglycemia among patients with type 2 diabetes using electronic health record data pooled from six academic health systems.Research design and methodsThis retrospective open cohort study included 549 041 adults with type 2 diabetes receiving regular care from the included health systems between 2009 and 2019. The primary outcome was the yearly event rate for hypoglycemia hospital utilization: emergency department visits, observation visits, or inpatient admissions for hypoglycemia identified using a validated International Classification of Diseases Ninth Revision (ICD-9) algorithm from 2009 to 2014. After the transition to ICD-10 in 2015, we used two ICD-10 code sets (limited and expanded) for hypoglycemia hospital utilization from prior studies. We identified independent predictors of hypoglycemia hospital utilization using multivariable logistic regression analysis with data from 2014.ResultsYearly rates of hypoglycemia hospital utilization decreased from 2.7 to 1.6 events per 1000 patients from 2009 to 2014 (p-trend=0.023). From 2016 to 2019, yearly event rates were stable ranging from 5.6 to 6.6, or 6.3 to 7.3, using the limited and expanded ICD-10 code sets, respectively. In 2014, the strongest independent risk factors for hypoglycemia hospital utilization were chronic kidney disease (OR 2.86, 95% CI 2.33 to 3.57), ages 18–39 years (OR 2.43 vs age 40–64 years, 95% CI 1.78 to 3.31), and insulin use (OR 2.13 vs no diabetes medications, 95% CI 1.67 to 2.73).ConclusionsRates of hypoglycemia hospital utilization decreased from 2009 to 2014 and varied considerably by clinical risk factors such that younger adults, insulin users, and those with chronic kidney disease were at especially high risk. There is a need to validate hypoglycemia ascertainment using ICD-10 codes, which detect a substantially higher number of events compared with ICD-9.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) are a recent class of medication approved for the treatment of type 2 diabetes (T2D). Previous meta-analyses have quantified the benefits and harms of SGLT2Is; however, these analyses have been limited to specific outcomes and comparisons and included trials of short duration. We comprehensively reviewed the longer-term benefits and harms of SGLT2Is compared to placebo or other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov from inception to July 2019 for randomized controlled trials of minimum 52 weeks’ duration that enrolled adults with T2D, compared an SGLT2I to either placebo or other anti-hyperglycemic medications, and reported at least one outcome of interest including cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events. We conducted random effects meta-analyses to provide summary estimates using weighted mean differences (MD) and pooled relative risks (RR). The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Fifty articles describing 39 trials (vs. placebo, n = 28; vs. other anti-hyperglycemic medication, n = 12; vs. both, n = 1) and 112,128 patients were included in our analyses. Compared to placebo, SGLT2Is reduced cardiovascular risk factors (e.g., hemoglobin A1c, MD − 0.55%, 95% CI − 0.62, − 0.49), macrovascular outcomes (e.g., hospitalization for heart failure, RR 0.70, 95% CI 0.62, 0.78), and mortality (RR 0.87, 95% CI 0.80, 0.94). Compared to other anti-hyperglycemic medications, SGLT2Is reduced cardiovascular risk factors, but insufficient data existed for other outcomes. About a fourfold increased risk of genital yeast infections for both genders was observed for comparisons vs. placebo and other anti-hyperglycemic medications. DISCUSSION: We found that SGLT2Is led to durable reductions in cardiovascular risk factors compared to both placebo and other anti-hyperglycemic medications. Reductions in macrovascular complications and mortality were only observed in comparisons with placebo, although trials comparing SGLT2Is vs. other anti-hyperglycemic medications were not designed to assess longer-term outcomes. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07227-0.

The incidence of diabetes in the general US population (6.7 per 1000 adults in 2018) has not changed significantly since 2000, suggesting that individuals with prediabetes are not connecting to evidence-based interventions.We sought to describe the clinical care of individuals with prediabetes, determine patient factors associated with this care, and evaluate risk for diabetes development.Retrospective cohort study using linked claims and electronic health record data.We created a cohort of adults with prediabetes based on laboratory measures. We excluded patients with a prior history of diabetes, pregnancy in prior 6 months, or recent steroid use.We measured ordering and completion of clinical services targeting prediabetes management and diabetes incidence within 12 months following cohort entry. We tested the strength of the association between individuals' characteristics and outcomes of interest using bivariate and multiple logistic regression.Our cohort included 3888 patients with a laboratory diagnosis of prediabetes (incident or prevalent prediabetes). Within 12 months, 63.4% had repeat glycemic testing, yet only 10.4% had coded diagnoses of prediabetes, 1.0% were referred for nutrition services, and 5.4% were prescribed metformin. Most patients completed labs and nutrition visits when referred and filled metformin when prescribed. Individuals with a higher glycemic level or BMI were more likely to receive prediabetes clinical care. Six percent of individuals developed diabetes within 12 months of cohort entry and had higher glycemic levels and BMI ≥ 30 kg/mRates of prediabetes clinical care activities are low and have not improved. Strategies are urgently needed to improve prediabetes care delivery thereby preventing or delaying incident diabetes.

OBJECTIVE: To examine whether breakfast consumption frequency (BCF) is associated with weight loss outcomes in the Look AHEAD (Action for Health in Diabetes) trial. METHODS: Data from a subset of participants (n = 3,915) from Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) to diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, were analyzed. BCF was collected by yearly questionnaire. Multivariable linear regression models were used to estimate the association between average BCF and percentage weight change over 4 years, controlling for baseline sociodemographic, anthropometric, and diabetes-related variables. In separate models, adjustment for diet (n = 915) and physical activity level (n = 837) were performed in a subset of participants. RESULTS: 4-year average BCF was similar in DSE (n=1916) and ILI (n=1999) arms (p=0.14). Each 1-day higher average BCF was associated with an additional 0.5% weight loss in the ILI arm (p

OBJECTIVE Patients with type 2 diabetes are encouraged to lose weight, but excessive weight loss in older adults may be a marker of poor health and subsequent mortality. We examined weight change during the postintervention period of Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) with diabetes support and education (DSE) (control) in overweight/obese individuals with type 2 diabetes and sought to identify predictors of excessive postintervention weight loss and its association with mortality. RESEARCH DESIGN AND METHODS These secondary analyses compared postintervention weight change (year 8 to final visit; median 16 years) in ILI and DSE in 3,999 Look AHEAD participants. Using empirically derived trajectory categories, we compared four subgroups: weight gainers (n = 307), weight stable (n = 1,561), steady losers (n = 1,731), and steep losers (n = 380), on postintervention mortality, demographic variables, and health status at randomization and year 8. RESULTS Postintervention weight change averaged −3.7 ± 9.5%, with greater weight loss in the DSE than the ILI group. The steep weight loss trajectory subgroup lost on average 17.7 ± 6.6%; 30% of steep losers died during postintervention follow-up versus 10–18% in other trajectories (P < 0001). The following variables distinguished steep losers from weight stable: baseline, older, longer diabetes duration, higher BMI, and greater multimorbidity; intervention, randomization to control group and less weight loss in years 1–8; and year 8, higher prevalence of frailty, multimorbidity, and depressive symptoms and lower use of weight control strategies. CONCLUSIONS Steep weight loss postintervention was associated with increased risk of mortality. Older individuals with longer duration of diabetes and multimorbidity should be monitored for excessive unintentional weight loss.

Community health centers (CHCs) focus on serving socioeconomically disadvantaged populations with heightened chronic disease burden, making CHCs an ideal setting for implementing diabetes care programs that target vulnerable populations. We aimed to synthesize evidence concerning the effects of CHC interventions in people with diabetes. To do this, four electronic databases were searched, including PubMed, EMBASE, CINAHL, and Scopus, and hand searches of reference collections were undertaken to identify intervention trials published in English. We screened 892 unique titles and abstracts. Two reviewers then independently evaluated 221 full-text articles. We discovered 29 articles met our eligibility criteria for inclusion. We found 27 unique studies with two companion articles. Seventeen studies were randomized controlled trials and the majority had a higher proportion of female and racial/ethnic minorities in the study sample. CHC interventions often involved either one-on-one or group education sessions supplemented by a phone follow-up that were delivered by health providers, nutritionists, or community health workers. CHC interventions using education sessions combined with follow up via phone generally resulted in significant improvements in hemoglobin A1C, while sole telephone-based education studies showed no significant improvements. CHC interventions had no significant effects on physical activity in all six studies that examined the outcome. Overall, we found that CHC interventions were in general effective in improving glucose control when using face-to-face interactions in low-income, underserved, and racial and ethnic minority patients with diabetes. Evidence was limited, however, in regards to other outcomes which suggests the need for continued evaluations of CHC intervention models.

Gut microbiota likely impact obesity and metabolic diseases. We evaluated the changes in gut microbiota after surgical versus medical weight loss in adults with diabetes and obesity. We performed 16S rRNA amplicon sequencing to identify the gut microbial composition at baseline and at 10% weight loss in adults with diabetes who were randomized to medical weight loss (MWL, n = 4), adjustable gastric banding (AGB, n = 4), or Roux-en-Y gastric bypass (RYGB, n = 4). All participants were female, 75% reported black race with mean age of 51 years. At similar weight loss amount and glycemic improvement, the RYGB group had the most number of bacterial species (10 increased, 1 decreased) that significantly changed (p

Bariatric surgery leads to more rapid and greater weight loss (WL) compared to medical weight loss (MWL), but the differences in body composition (BC) changes for these modalities remain unclear. Due to the known health risks associated with central adiposity, we compared the changes in regional distribution of fat mass (FM) and lean mass (LM) after surgical versus MWL. In this 1:1:1 randomized trial among 15 persons with type 2 diabetes and body mass index (BMI) 30–39.9 kg/m2, we compared changes in BC, by dual-energy X-ray absorptiometry and abdominal computerized tomography, at time of 10%WL or 9 months after intervention (whichever came first). Participants underwent MWL, adjustable gastric banding (AGB), or Roux-en-Y gastric bypass (RYGB). Non-parametric tests evaluated BC differences (FM, LM, and visceral adipose tissue [VAT]) within and across all three arms and between pair-wise comparisons. Twelve female participants (75% African American) completed the study. Patient age, BMI, and baseline anthropometric characteristics were similar across study arms. AGB lost more LM (MWL − 5.2%, AGB − 10.3%, p = 0.021) and VAT (MWL + 10.9%, AGB − 28.0%, p = 0.049) than MWL. RYGB tended to lose more VAT (MWL +10.9%, RYGB − 20.2%, p = 0.077) than MWL. AGB tended to lose more LM than RYGB (AGB − 12.38%, RYGB − 7.29%, p = 0.15). At similar WL, AGB lost more LM and VAT than MWL; RYGB similarly lost more VAT. Given the metabolic benefits of reducing VAT and retaining LM, larger studies should confirm the changes in BC after surgical versus medical WL. NCTDK089557 – ClinicalTrials.gov

OBJECTIVE: Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) and diabetes support and education (DSE) (control) in 5,145 individuals with overweight/obesity and type 2 diabetes, found no significant differences in all-cause or cardiovascular mortality or morbidity during 9.6 (median) years of intervention. Participants in ILI who lost ≥10% at 1 year had lower risk of composite cardiovascular outcomes relative to DSE. Since effects of ILI may take many years to emerge, we conducted intent-to-treat analyses comparing mortality in ILI over 16.7 years (9.6 years of intervention and then observation) to DSE. In a secondary exploratory analysis, we compared mortality by magnitude of weight loss in ILI relative to DSE. RESEARCH DESIGN AND METHODS: Primary outcome was all-cause mortality from randomization to 16.7 years. Other outcomes included cause-specific mortality, interactions by subgroups (age, sex, race/ethnicity, and cardiovascular disease history), and an exploratory analysis by magnitude of weight loss in ILI versus DSE as reference. Analyses used proportional hazards regression and likelihood ratio. RESULTS: The incidence of all-cause mortality did not differ significantly in ILI and DSE (549 and 589 participants, respectively) (hazard ratio [HR] 0.91 [95% CI 0.81, 1.02]; P = 0.11). There were no significant differences between treatments in cause-specific mortality or within prespecified subgroups. ILI participants who lost ≥10% at 1 year had a 21% reduced risk of mortality (HR 0.79 [95% CI 0.67, 0.94]; P = 0.007) relative to DSE. CONCLUSIONS: ILI focused on weight loss did not significantly affect mortality risk. However, ILI participants who lost ≥10% had reduced mortality relative to DSE.

BACKGROUND: Previous meta-analyses of the benefits and harms of glucagon-like peptide-1 receptor agonists (GLP1RAs) have been limited to specific outcomes and comparisons and often included short-term results. We aimed to estimate the longer-term effects of GLP1RAs on cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events in patients with type 2 diabetes, compared to placebo and other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov (inception–July 2019) for randomized controlled trials ≥ 52 weeks’ duration that compared a GLP1RA to placebo or other anti-hyperglycemic medication and included at least one outcome of interest. Outcomes included cardiovascular risk factors, microvascular and macrovascular complications, all-cause mortality, and treatment-related adverse events. We performed random effects meta-analyses to give summary estimates using weighted mean differences (MD) and pooled relative risks (RR). Risk of bias was assessed using the Cochrane Collaboration risk of bias in randomized trials tool. Quality of evidence was summarized using the Grading of Recommendations, Assessment, Development, and Evaluation approach. The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Forty-five trials with a mean duration of 1.7 years comprising 71,517 patients were included. Compared to placebo, GLP1RAs reduced cardiovascular risk factors, microvascular complications (including renal events, RR 0.85, 0.80–0.90), macrovascular complications (including stroke, RR 0.86, 0.78–0.95), and mortality (RR 0.89, 0.84–0.94). Compared to other anti-hyperglycemic medications, GLP1RAs only reduced cardiovascular risk factors. Increased gastrointestinal events causing treatment discontinuation were observed in both comparisons. DISCUSSION: GLP1RAs reduced cardiovascular risk factors and increased gastrointestinal events compared to placebo and other anti-hyperglycemic medications. GLP1RAs also reduced MACE, stroke, renal events, and mortality in comparisons with placebo; however, analyses were inconclusive for comparisons with other anti-hyperglycemic medications. Given the high costs of GLP1RAs, the lack of long-term evidence comparing GLP1RAs to other anti-hyperglycemic medications has significant policy and clinical practice implications. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07105-9.

Background: Lower body mass index (BMI) has been associated with lower serum urate (SU), but only in observational studies. We sought to determine the effects of behavioral weight loss and metformin treatment on SU in a randomized trial. Methods and Findings: The Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT) was a parallel three-arm randomized controlled trial of overweight/obese adult cancer survivors without gout at a single center in Maryland, United States. Participants were randomized to: (1) coach-directed weight loss (behavioral telephonic coaching), (2) metformin (up to 2000 mg daily), or (3) self-directed weight loss (informational brochures, reference group). SU and BMI were assessed at baseline and at 3, 6, and 12 months post-randomization. The 121 participants had a mean ± standard deviation (SD) age of 60 ± 9 years, 79% were female, and 45% were Black. At baseline, BMI was 35 ± 5 kg/m2, and SU was 5.6 ± 1.3 mg/dL. Compared to the self-directed group, at 12 months, the coach-directed group reduced BMI by 0.9 kg/m2 (95% confidence interval (CI): −1.5, −0.4) and metformin reduced BMI by 0.6 kg/m2 (95% CI: −1.1, −0.1). However, compared to the self-directed group, the coach-directed group unexpectedly increased SU by 0.3 mg/dL (95% CI: 0.05, 0.6), and metformin non-significantly increased SU by 0.2 mg/dL (95% CI: −0.04, 0.5), these effects were attenuated when analyses included change in estimated glomerular filtration rate (eGFR). Conclusions: In this randomized trial of cancer survivors without gout, reductions in BMI either increased or did not change SU, potentially due to effects on eGFR. These results do not support a focus on BMI reduction for SU reduction, however, long-term studies are needed. ClinicalTrials.gov Registration: NCT02431676.

Hypoglycemia is the most common serious adverse effect of diabetes treatment and a major cause of medication-related hospitalization. This study aimed to identify trends and predictors of hospital utilization for hypoglycemia among adults with type 2 diabetes. Using electronic health record data from six academic health systems, we performed a retrospective open cohort study including 532,323 patients aged ≥18 years with type 2 diabetes receiving regular care between 2009 and 2019. The primary outcome was the yearly event rate for hypoglycemia hospital utilization: emergency department visits, observation visits, or inpatient admissions for hypoglycemia identified using a validated ICD-9 algorithm. After the transition to ICD-10 in 2015, we used two ICD-10 code sets for hypoglycemia (limited and expanded) that were used in prior studies. We identified independent predictors of hypoglycemia hospital utilization using multivariable logistic regression analysis with data from 2014. We found that yearly rates of hypoglycemia hospital utilization decreased non-significantly from 3.4 to 2.6 events per 1,000 patients from 2009 to 2014. From 2016 to 2019, yearly event rates ranged from 15.5 to 16.5, or 21.1 to 21.8, using the limited and expanded ICD-10 code sets, respectively. The strongest independent risk factors for hypoglycemia hospital utilization were chronic kidney disease (OR 3.13, 95% CI 2.63-3.70), age 18-39 years (OR 3.00 vs. age 40-64 years, 95% CI 2.42-3.73), and insulin use (OR 2.61 vs. no diabetes medications, 95% CI 2.16-3.15). In this multicenter open cohort study, we found that rates of hypoglycemia hospital utilization were stable from 2009 to 2014 and varied considerably by clinical risk factors such that younger adults, insulin users, and those with chronic kidney disease were at especially high risk. There is a need to validate hypoglycemia ascertainment using ICD-10 codes, which detect a substantially higher number of events compared to ICD-9. Disclosure S. J. Pilla: None. J. L. Kraschnewski: None. E. Lehman: None. L. Kong: None. E. Francis: None. J. M. Poger: None. C. L. Bryce: None. N. M. Maruthur: Other Relationship; Self; Johns Hopkins HealthCare Solutions. H. Yeh: None. Funding National Institutes of Health (KL2TR003099); Patient-Centered Outcomes Research Institute (1306-04912)

Introduction: Some studies suggest that time-restricted feeding may decrease blood pressure (BP), but the current evidence is inconclusive. Objective: To determine the effect of a time-restricted feeding pattern compared to a usual feeding pattern on ambulatory 24-hour BP in adults. Hypothesis: An isocaloric, time-restricted feeding pattern will lower 24-hour BP more than an isocaloric usual feeding pattern over 12 weeks. Methods: Forty-one persons with prediabetes (HbA1c 5.7-6.9%) and obesity (BMI 30-50 kg/m 2 ) were randomized to consume 80% of their total calories before 1 pm (i.e., time-restricted feeding) or more than 50% of their calories after 5 pm (i.e., usual feeding) with identical macronutrient content. We used ambulatory BP monitoring to measure BP over 24-hours at baseline and 12-weeks. Outcomes of interest were mean systolic and diastolic 24-hr, daytime (7 am - 11 pm), and nighttime (11 pm - 7 am) BP. To examine the difference in BP patterns between time-restricted feeding and usual feeding pattern groups in change in BP outcomes from baseline to 12 weeks, we used linear mixed-effects regression models with participant-specific random intercepts and fixed effects for visit and intervention group. To assess whether feeding patterns affected BP levels over the 12 week intervention period, we tested whether there was an intervention-by-time interaction. Results: Thirty-five adults (mean age 60.4 years; 91% female, 91% African American) had sufficient data. We found reductions from baseline in systolic and diastolic BP for both groups for the 24-hour, daytime, and nighttime periods. The decrease in BP was larger in the usual feeding pattern group compared to the time-restricted feeding group (Table). Conclusion: Time-restricted feeding may attenuate the effect of a healthy isocaloric diet on BP compared to typical feeding patterns, and at this time, should not be recommended as a way to lower BP more than simply adopting a healthy diet.

Background: Serum lipopolysaccharide-binding protein (LBP), a surrogate biomarker for gut barrier permeability, is higher in adults with obesity and type 2 diabetes and may trigger inflammation. It is unknown whether a behavioral weight loss intervention or metformin — current first-line treatments for obesity or diabetes — can reduce gut permeability. Objective: To determine the effects of behavioral weight loss intervention or metformin, compared to self-directed weight loss, on serum LBP. Methods: SPIRIT was a parallel-arm, randomized trial of adult cancer survivors with overweight or obesity. Participants were randomized to a self-directed weight loss (control), metformin, or coach-directed (healthy diet/physical activity) weight loss arm. Of 121 randomized participants, a random subset (n=88) had LBP measured at baseline, 6-months, and 12-months post intervention. The effects of interventions on LBP over time were assessed using generalized estimating equations (GEE). Models were further adjusted for absolute change in fiber intake to investigate potential mediation. Results: Arms were balanced by sex (83% female), race (48% black), and age (mean 60 years). There were no between-group differences in LBP at baseline (median 42.3 μg/dL). Over the 12-month period, only the coach-directed and metformin arms showed weight loss (both mean -3% from baseline). Similar increases in LBP were seen in the self-directed and metformin arms, while a decrease in LBP was seen in the coach-directed arm ( figure ). In GEE models, the difference in slopes between the coach vs. self-directed arms was statistically significant (β=-1.67, p=0.037), but not between the metformin and self-directed arms (β=0.003, p=0.997). The effect of coach-directed weight loss on LBP was similar by sex and race and was not mediated by changes in fiber intake. Conclusion: The manner of weight loss can differentially impact gut permeability and thus subsequent exposure to proinflammatory microbial products.

OBJECTIVE To determine the longer-term effects of metformin treatment and behavioral weight loss on gut microbiota and short-chain fatty acids (SCFAs). RESEARCH DESIGN AND METHODS We conducted a 3-parallel-arm, randomized trial. We enrolled overweight/obese adults who had been treated for solid tumors but had no ongoing cancer treatment and randomized them (n = 121) to either 1) metformin (up to 2,000 mg), 2) coach-directed behavioral weight loss, or 3) self-directed care (control) for 12 months. We collected stool and serum at baseline (n = 114), 6 months (n = 109), and 12 months (n = 105). From stool, we extracted microbial DNA and conducted amplicon and metagenomic sequencing. We measured SCFAs and other biochemical parameters from fasting serum. RESULTS Of the 121 participants, 79% were female and 46% were Black, and the mean age was 60 years. Only metformin treatment significantly altered microbiota composition. Compared with control, metformin treatment increased amplicon sequence variants for Escherichia (confirmed as Escherichia coli by metagenomic sequencing) and Ruminococcus torques and decreased Intestinibacter bartlettii at both 6 and 12 months and decreased the genus Roseburia, including R. faecis and R. intestinalis, at 12 months. Effects were similar in comparison of the metformin group with the behavioral weight loss group. Metformin versus control also increased butyrate, acetate, and valerate at 6 months (but not at 12 months). Behavioral weight loss versus control did not significantly alter microbiota composition but did increase acetate at 6 months (but not at 12 months). Increases in acetate were associated with decreases in fasting insulin. Additional whole-genome metagenomic sequencing of a subset of the metformin group showed that metformin altered 62 metagenomic functional pathways, including an acetate-producing pathway and three pathways in glucose metabolism. CONCLUSIONS Metformin, but not behavioral weight loss, impacted gut microbiota composition at 6 months and 12 months. Both metformin and behavioral weight loss altered circulating SCFAs at 6 months, including increasing acetate, which correlated with lower fasting insulin. Future research is needed to elucidate whether the gut microboime mediates or modifies metformin’s health effects.

BACKGROUND Prediabetes affects 1 in 3 US adults. Most are not receiving evidence-based interventions, so understanding how providers discuss prediabetes with patients will inform how to improve their care. OBJECTIVE This study aimed to develop a natural language processing (NLP) algorithm using machine learning techniques to identify discussions of prediabetes in narrative documentation. METHODS We developed and applied a keyword search strategy to identify discussions of prediabetes in clinical documentation for patients with prediabetes. We manually reviewed matching notes to determine which represented actual prediabetes discussions. We applied 7 machine learning models against our manual annotation. RESULTS Machine learning classifiers were able to achieve classification results that were close to human performance with up to 98% precision and recall to identify prediabetes discussions in clinical documentation. CONCLUSIONS We demonstrated that prediabetes discussions can be accurately identified using an NLP algorithm. This approach can be used to understand and identify prediabetes management practices in primary care, thereby informing interventions to improve guideline-concordant care.

Context Higher levels of insulin-like growth factor-1 (IGF-1) are associated with increased risk of cancers and higher mortality. Therapies that reduce IGF-1 have considerable appeal as means to prevent recurrence. Design Randomized, 3-parallel-arm controlled clinical trial. Interventions and Outcomes Cancer survivors with overweight or obesity were randomized to (1) self-directed weight loss (comparison), (2) coach-directed weight loss, or (3) metformin treatment. Main outcomes were changes in IGF-1 and IGF-1:IGFBP3 molar ratio at 6 months. The trial duration was 12 months. Results Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years. At baseline, the average body mass index was 35 kg/m2; mean IGF-1 was 72.9 (SD, 21.7) ng/mL; and mean IGF1:IGFBP3 molar ratio was 0.17 (SD, 0.05). At 6 months, weight changes were -1.0% (P = 0.07), -4.2% (P Conclusions In cancer survivors with obesity, metformin may have a short-term effect on IGF-1 reduction that wanes over time.