BMJ Open Diabetes Research & Care最新文献

Introduction: Diabetes technologies may improve glycemic control and psychological well-being among adolescents and young adults (AYA) with type 1 diabetes. This cross-sectional study examines perceptions of automated insulin dosing (AID) systems and their association with glycemic and psychological outcomes compared with multiple daily insulin injections (MDI) and continuous subcutaneous insulin infusion (CSII).

Research design and methods: Participants were recruited from the largest diabetes camp for AYA in Germany. A total of 151 participants (70% female, mean age 20.7±2.9 years, 33% AID users) completed a questionnaire that included self-reported glycated hemoglobin A1c (HbA1c), global health status, emotional well-being (WHO-5), Generalized anxiety (GAD-7) and diabetes distress (PAID-5). AID users also rated their experiences with the system.

Results: AID users reported significantly lower HbA1c levels (7.3±1.0%) than CSII users (7.5±1.1%) and MDI users (8.4±2.0%, p=0.003). Approximately 75% of AID users viewed their current system as an improvement over previous therapy, reporting greater ease (84%), comfort (82%) and safety (80%). They reported higher treatment satisfaction than CSII users (p=0.044) and lower diabetes burden than MDI users (p=0.044) after controlling for age and gender. Treatment groups did not differ in well-being or anxiety. Better global health status was associated with the absence of other chronic health conditions (p=0.024), greater well-being (WHO-5; p<0.001), lower HbA1c (p=0.038) and fewer anxiety symptoms (GAD-7, p=0.007). Despite these positive indicators, a substantial proportion of participants reported symptoms of depression (18%), anxiety (30%), and diabetes distress (39%).

Conclusions: AID systems were associated with improved glycemic control and high satisfaction among AYA. However, psychological distress remained prevalent across all treatment modalities, underscoring a discrepancy between metabolic benefits and persistent mental health challenges. These findings highlight the need to integrate psychological support alongside technological advances in the care of AYA living with diabetes.

Background: Diabetes technology can improve glycemic variability and diabetes outcomes, but there are disparities in patient use.

Aims: Identify racial, ethnic, and socioeconomic disparities in technology utilization and determine provider-, patient-, and parent-identified barriers.

Methods: Technology (continuous glucose monitors (CGM) and pump) usage and demographic data on patients at a large urban pediatric hospital were obtained from a clinical database. Providers (16 attending physicians, five fellow physicians, five nurse practitioners, 13 diabetes educators) completed a survey on diabetes technology prescribing habits. English and Spanish-speaking patients ages 8 to 17 years with diabetes (n=109) and caregivers of pediatric patients with diabetes (n=117) completed surveys that assessed attitudes and perceived benefits/burdens of diabetes technology.

Results: From August 2020 to 2021, independent of insurance payor status, non-Hispanic Black (NHB) and Hispanic youth with type 1 diabetes were less likely to use pump therapy (OR 0.4 and 0.35, respectively) or CGM (OR 0.74 and 0.54) compared with non-Hispanic White (NHW) youth. For pump eligibility, diabetes educators placed higher importance on subjective factors such as parental education, health literacy, and psychosocial stability (p value <0.05) compared with physicians. Hispanic and NHB patients and parents learned about diabetes technology later after diabetes diagnosis compared with NHW patients/caregivers. Physicians and diabetes educators, but not patients themselves, identified patient-perceived barriers to CGM use (ie, embarrassment and/or discomfort in wearing devices) as reasons for not utilizing diabetes technology.

Conclusions: There are marked disparities in diabetes technology use among youth with diabetes. Findings from the provider surveys showed reliance on subjective variables as opposed to objective criteria. Youth with diabetes and caregivers of underrepresented race/ethnicities learned about diabetes technology later and were less likely to use technology. Though clinic providers perceived multiple barriers to technology utilization, responses from families showed low perceived burden and highly positive attitudes.

Introduction: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) improve cardiovascular outcomes in type 2 diabetes (T2D), and SGLT2i reduces events in heart failure (HF). However, the benefit of their combination in patients with both conditions remains unclear. This study assessed the risk of all-cause death and hospitalization with combination therapy versus SGLT2i monotherapy.

Research design and methods: This multicenter, retrospective, observational study used the TriNetX database between January 1, 2018, and December 31, 2021. We identified 928,981 patients aged ≥18 years with HF and T2D. Of these, 168,422 received an SGLT2i. The exposure group comprised patients who initiated a GLP-1 RA within 6 months of SGLT2i initiation, while the control group included those who did not receive a GLP-1 RA after SGLT2i initiation. The index date was defined as 6 months after SGLT2i. 25,989 patients received SGLT2i and GLP-1 RA and 54,619 received SGLT2i monotherapy. Following propensity score matching, each group comprised 23,240 patients.

Results: Over 1 year, the risk of all-cause death in patients who received SGLT2i and GLP-1 RA relative to those who received SGLT2i monotherapy was significantly lower (2.8% vs 6.3%, p<0.001; HR 0.43; 95% CI 0.39 to 0.48). Similarly, the risk of hospitalization in patients who received SGLT2i and GLP-1 RA was also lower (32.9% vs 36.4%, p<0.001; HR, 0.87; 95% CI 0.84 to 0.90).

Conclusions: The risk of all-cause death and hospitalization in patients who received combination therapy with SGLT2i and GLP-1 RA relative to those who received SGLT2i monotherapy was significantly lower in patients with HF and T2D.

Introduction: This analysis investigated whether use of real-time continuous glucose monitoring (CGM) compared with blood glucose monitoring (BGM) results in rapidly improved glycemic management in adults with type 2 diabetes (T2D) treated with basal insulin.

Research design and methods: Using data from the MOBILE study where adults (n=175) with T2D treated with basal insulin without prandial insulin were randomized (2:1) to either CGM (n=116) or BGM (n=59), the treatment effect on glycemic management was determined over 3 months. The main outcome was a between-group difference in hemoglobin A_1c (HbA_1c) at 3 months adjusted for baseline value. Other outcomes included changes in CGM-derived glucose metrics and hypoglycemic events.

Results: After 3 months, there was a greater reduction from baseline in mean HbA_1c in the CGM group compared with the BGM group, from 9.1±1.0% (76±11 mmol/mol) to 8.0±1.2% (64±13 mmol/mol) in the CGM group and from 9.0±0.9% (75±10 mmol/mol) to 8.5±1.5% (69±16 mmol/mol) in the BGM group (adjusted difference, -0.6% (95% CI -0.9% to -0.3%); -6.6 mmol/mol (95% CI -10.2 to -2.9), p<0.001). Mean time spent in range 70-180 mg/dL (3.9-10.0 mmol/L) increased significantly more in the CGM group than the BGM group (adjusted difference, +9.3% (95% CI 2.1% to 16.4%), p<0.001). There also was a greater reduction in mean time >250 mg/dL (>13.9 mmol/L) with CGM (adjusted difference, -5.8% (95% CI -10.4% to -1.2%), p<0.001) without an increase in time <70 mg/dL (<3.9 mmol/L). Mean weekly hypoglycemic event rate was lower with CGM than BGM (adjusted difference, -0.2 events per week (95% CI -0.4 to -0.1), p<0.001). Further, in the CGM group, significant improvements in CGM metrics were observed during the first 7 days of CGM use.

Conclusions: In adults with basal insulin-treated T2D, use of CGM compared with BGM resulted in rapidly improved glycemic management, with a substantial reduction in HbA_1c over 3 months.

Trial registration number: NCT03566693.

Introduction: The prevalence of type 2 diabetes (T2D) has surged, yet body mass index (BMI) fails to explain the 30%-40% of cases that occur in individuals with a healthy weight. Emerging evidence suggests that regional fat distribution differentially impacts glucose metabolism, independent of total adiposity. This study investigated the independent association between regional body composition and T2D risk using BMI-matched National Health and Nutrition Examination Survey (NHANES) data to identify sex-specific effects and the mediating role of insulin resistance.

Research design and methods: Our study employed data from the 2011-2018 cycles of NHANES. Participants were classified into a high-risk T2D group if they met one or more of the following criteria: fasting blood glucose≥6.1 mmol/L, 2-hour blood glucose≥7.8 mmol/L following an oral glucose tolerance test or self-reported physician's diagnosis of diabetes or pre-diabetes. Body composition data were assessed via dual-energy X-ray absorptiometry, which provides a precise assessment of regional fat and muscle mass distribution.

Results: Participants at high T2D risk exhibited significantly reduced lower limb fat mass compared with healthy controls (p<0.001), with higher amounts of lower limb fat serving as a protective factor against both diabetes and insulin resistance. Notably, this protective effect of lower-limb fat (OR 0.86 (0.76-0.97), p=0.01) along with the detrimental impact of visceral fat (OR 7.35 (1.57-34.4), p=0.01) was particularly pronounced in male subjects. Additionally, 36.18% of the protective effect of lower limb fat on diabetes is mediated by improved insulin sensitivity.

Conclusions: This study delineates a protective role for lower-body fat in diabetes pathogenesis, mediated substantially through ameliorating insulin resistance. The sex-specific associations underscore the protective effect of lower-body fat and the detrimental impact of visceral adiposity in men after controlling for BMI.

Introduction: Hepatic fibrosis caused by metabolic dysfunction-associated steatotic liver disease (MASLD) predicts adverse atherosclerotic cardiovascular disease (ASCVD) outcomes in the general patient population. However, it is unclear whether this association extends to type 2 diabetes mellitus (T2DM) patients, who have distinct metabolic profiles and high comorbidity of both MASLD and ASCVD. To address this gap, we investigated the association between hepatic fibrosis caused by MASLD and ASCVD risk in T2DM patients as well as potentially moderators of this association.

Research design and methods: This multisite cross-sectional study included 1238 hospitalized T2DM patients with MASLD (mean age=57.81±10.23, 37% female). Hepatic fibrosis was assessed via the Steatosis-Associated Fibrosis Estimator (SAFE) score, and 10-year ASCVD risk was assessed via the ASCVD Risk Calculator.

Results: Advanced fibrosis was present in 25.6% of patients. Multivariable regression revealed a significant association between the SAFE score and 10-year ASCVD risk (p<0.001), after adjusting for covariates. Each unit increase in SAFE score was associated with 0.07-unit increase in 10-year ASCVD risk score. Increase in SAFE score was associated with greater increase in 10-year ASCVD risk score among patients with hypertension, insulin resistance and elevated low-density lipoprotein (LDL) cholesterol (ps<0.05). Overweight/obesity, triglycerides, high-density lipoprotein cholesterol, uric acid, thyroid-stimulating hormone, hemoglobin A1c and high-sensitivity C reactive protein showed no moderating effects.

Conclusions: In T2DM patients, hepatic fibrosis caused by MASLD is associated with elevated ASCVD risks, particularly among those with hypertension, insulin resistance and elevated LDL cholesterol. It is crucial to incorporate hepatic fibrosis assessment into ASCVD risk stratification in T2DM patients with comorbid MASLD to inform early prevention of ASCVD.

Introduction: Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA) used to treat type 2 diabetes mellitus (T2D), has potential associations with higher rates of diabetic retinopathy (DR) complications including proliferative DR (PDR) and diabetic macular edema (DME). The purpose of this study was to determine whether an association exists between semaglutide and PDR and treatment-requiring DR/DME.

Research design and methods: This was a retrospective cohort study of 14 databases (six administrative claims and eight electronic health records) in the Observational Health Data Sciences and Informatics Evidence Network. Adults with T2D on semaglutide, other GLP-1RA (dulaglutide, exenatide), or non-GLP-1RA medications (empagliflozin, sitagliptin, glipizide) from 1 December 2017 to 31 December 2023 were included. The association between semaglutide and PDR or treatment-requiring DR/DME was assessed using an active-comparator cohort design comparing new users of semaglutide as second-line T2D treatment to those on other GLP-1RAs and non-GLP-1RAs. Propensity score-adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs). Network-wide HR estimates were generated using a random-effects meta-analysis.

Results: The study included 810 390 new semaglutide users for T2D. PDR risk for semaglutide was similar to dulaglutide (HR 0.81, 95% CI 0.42 to 1.54, p=0.51), empagliflozin (HR 0.83, 95% CI 0.53 to 1.30, p=0.41) and sitagliptin (HR 0.83, 95% CI 0.45 to 1.55, p=0.57) but was lower than glipizide (HR 0.59, 95% CI 0.39 to 0.88, p=0.01). The risk for treatment-requiring DR/DME for semaglutide was similar to empagliflozin (HR 0.66, 95% CI 0.43 to 1.02, p=0.06) but lower than dulaglutide (HR 0.53, 95% CI 0.31 to 0.91, p=0.02), sitagliptin (HR 0.46, 95% CI 0.26 to 0.81, p=0.008) and glipizide (HR 0.55, 95% CI 0.33 to 0.91, p=0.02).

Conclusions and relevance: We did not identify increased risk for either PDR or treatment-requiring DR/DME comparing semaglutide with other GLP-1RAs or non-GLP-1RAs. Patients with T2D should still undergo close eye care follow-up, particularly when initiating new antihyperglycemic medications.

Introduction: Prediabetes presents an opportunity for early intervention. Growing evidence suggests that psychological stress may contribute to glucose dysregulation, but the findings are inconsistent.This study aimed to clarify the association between perceived stress and glycemic measures, by first testing gender as a moderator, and then examining age as a moderator within each gender group.

Research design and methods: We analyzed cross-sectional data from 470 diabetes-free adults in Singapore. Participants completed the 10-item Perceived Stress Scale, comprising two subscales: perceived helplessness and perceived self-efficacy. Glycemic measures included fasting plasma glucose, glycated hemoglobin, and 2-hour plasma glucose (2h-PG) following an oral glucose tolerance test. Prediabetes was classified according to the American Diabetes Association diagnostic criteria.

Results: Multivariable regression analyses revealed significant moderating effects of gender on the relationship between perceived stress factors and both prediabetes status and 2h-PG levels. Specifically, higher perceived helplessness and perceived self-efficacy were significantly associated with a lower prevalence of prediabetes and lower 2h-PG levels among men. However, these associations were non-significant among women. Age significantly moderated the relationship between perceived helplessness (but not perceived self-efficacy) on prediabetes and 2h-PG levels in women; higher perceived helplessness was associated with a greater prevalence of prediabetes and higher 2h-PG levels among younger women.

Conclusions: Gender moderated the associations between perceived stress and both prediabetes prevalence and 2h-PG levels. Among women, age further moderated the association between perceived helplessness and these outcomes. Future research should consider both moderators. Tailored psychosocial stress management strategies may help reduce the prevalence of prediabetes and diabetes.

Trial registration number: NCT02838693.

Introduction: Hemoglobin A1c (A1c) treatment goals in older adults often consider life expectancy and comorbidities. A1c stability may also inform the risks of major outcomes. We studied the association of individualized A1c time-in-range (A1c TIR) with mortality and diabetes complications.

Research design and methods: We conducted a retrospective observational cohort study of patients with diabetes, 65 years or older, from the Department of Veterans Affairs (VA) and Kaiser Permanente (KP) from 2004 to 2018. Patients had at least four A1c tests during a 3-year baseline, and A1c TIR was calculated as the percentage of days when A1c levels were within patient-specific target ranges. We estimated associations among A1c TIR and mortality, cardiovascular, and microvascular outcomes using time to event models and instrumental variable (IV) models.

Results: We identified 386 287 VA patients and 24 885 KP patients with a mean age of 74.3 years (SD 5.8) and 72.3 years (SD 5.7), respectively. Among VA patients, when compared with higher A1c TIR (80-100%), lower A1c TIR (0% to <20%) was associated with increased mortality (HR, 1.22; 95% CI 1.20 to 1.23) and cardiovascular outcomes (HR, 1.10; 95% CI 1.07 to 1.13). IV models showed similar associations. Among KP patients, lower A1c TIR (0% to <20%) was associated with mortality (HR, 1.36; 95% CI 1.27 to 1.45). IV models showed associations with increased mortality and cardiovascular outcomes. Among both VA and KP patients, greater A1c time below and time above range were associated with increased mortality.

Conclusions: A1c stability within patient-specific target ranges is associated with a lower risk of major adverse outcomes among older adults with diabetes.

Objective: Using national claims databases, we sought to emulate the design of the ongoing SEPRA trial and predict its findings, comparing the effects of once weekly semaglutide to SoC medications on glycemic control (A1C <7%) in type-2 diabetes mellitus (T2D).

Research design and methods: Using Optum Clinformatics (July 2017 - May 2022), we identified a 1:1 propensity score-matched (PSM) cohort of adults with T2D on metformin monotherapy, who had recorded A1C and initiated either injectable semaglutide or SoC medications (dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors, SUs, or glucagon-like peptide-1 agonists) and met eligibility criteria adapted from the SEPRA trial. The primary outcome was the proportion of patients achieving A1C <7%. The study protocol was preregistered (NCT05577728, ClinicalTrials.gov) before any etiologic analyses. Risk ratios and corresponding 95% CIs were estimated.

Results: We identified 1,144 PSM pairs of injectable semaglutide and SoC initiators with balance in pre-exposure covariates. Semaglutide initiators were 30% (risk ratio (95% CI), 1.30 (1.16 to 1.45)) more likely to achieve glycemic control (A1C <7%) than those initiating SoC. Additionally, semaglutide initiators had a 1.3% reduction in A1C, compared with a 1.1% reduction in the SoC group. These results were consistent with interim results of the SEPRA trial, which were released after the protocol for our database study was preregistered.

Conclusion: This claims database study, designed to predict the results of the SEPRA trial, found results consistent with interim trial results. Our findings support the notion that well-designed non-randomized studies using fit-for-purpose data can effectively complement pragmatic randomized controlled trials.