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BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P

Objective: To assess the performance of continuous glucose monitoring (CGM)-measured glycemic metrics in predicting development of gestational diabetes mellitus (GDM) and select perinatal complications. Research Methods: In a prospective observational study, CGM data were collected from 760 pregnant females throughout gestation after study enrollment. GDM was diagnosed using the oral glucose tolerance test (OGTT) at 24–34 weeks of gestation. Predictive models were built using logistic and elastic net regression. Predictive performance was assessed by the area under the receiver-operating characteristic (AUROC) curve. Results: The AUROCs of using second trimester percent time >140 mg/dL (TA140) and week 13–14 TA140 in predicting GDM were 0.81 and 0.74, respectively. The AUROCs for predicting large-for-gestational-age (LGA) births and hypertensive disorders of pregnancy (HDP) using second trimester TA140 were both 0.58. When matching the specificity of OGTT, a model using TA140 in weeks 13–14 achieved similar sensitivity to OGTT in predicting HDP (13% vs. 10%, respectively) and LGA (6% for both methods). Elastic net also demonstrated similar AUROC and diagnostic performance with no meaningful improvement by using multiple predictors. Conclusion: CGM-measured hyperglycemic metrics such as TA140 predicted GDM with high AUROCs as early as 13–14 weeks of gestation. These metrics were also similar statistically to the OGTT at 24–34 weeks in predicting perinatal complications, although sensitivity was low for both. CGM could potentially be used as an early screening tool for elevated hyperglycemia during gestation, which could be used in addition to or instead of the OGTT. [ABSTRACT FROM AUTHOR]

Context Adults with type 1 diabetes (T1D) face the necessity of balancing the benefits of exercise with the potential hazards of hypoglycemia. Objective This work aimed to assess whether impaired awareness of hypoglycemia (IAH) affects exercise-associated hypoglycemia in adults with T1D. Methods We compared continuous glucose monitoring (CGM)-measured glucose during exercise and for 24 hours following exercise from 95 adults with T1D and IAH (Clarke score ≥4 or ≥1 severe hypoglycemic event within the past year) to 95 "aware" adults (Clarke score ≤2 and no severe hypoglycemic event within the past year) matched on sex, age, insulin delivery modality, and glycated hemoglobin A1c. A total of 4236 exercise sessions, and 1794 exercise days and 839 sedentary days, defined as 24 hours following exercise or a day without exercise, respectively, were available for analysis. Results Participants with IAH exhibited a nonsignificant trend toward greater decline in glucose during exercise compared to "aware" (−21 ± 44 vs −19 ± 43 mg/dL [−1.17 ± 2.44 vs −1.05 ± 2.39 mmol/L], adjusted group difference of −4.2 [95% CI, −8.4 to 0.05] mg/dL [−0.23 95% CI, −.47 to 0.003 mmol/L]; P =.051). Individuals with IAH had a higher proportion of days with hypoglycemic events below 70 mg/dL [3.89 mmol/L] (≥15 minutes <70 mg/dL [<3.89 mmol/L]) both on exercise days (51% vs 43%; P =.006) and sedentary days (48% vs 30%; P =.001). The increased odds of experiencing a hypoglycemic event below 70 mg/dL (<3.89 mmol/L) for individuals with IAH compared to "aware" did not differ significantly between exercise and sedentary days (interaction P =.36). Conclusion Individuals with IAH have a higher underlying risk of hypoglycemia than "aware" individuals. Exercise does not appear to differentially increase risk for hypoglycemia during the activity, or in the subsequent 24 hours for IAH compared to aware individuals with T1D. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To determine whether continuous glucose monitoring (CGM)-derived glycemic patterns can characterize pregnancies with gestational diabetes mellitus (GDM) as diagnosed by standard oral glucose tolerance test at 24–28 weeks' gestation compared with those without GDM. RESEARCH DESIGN AND METHODS: The analysis includes 768 individuals enrolled from two sites prior to 17 weeks' gestation between June 2020 and December 2021 in a prospective observational study. Participants wore blinded Dexcom G6 CGMs throughout gestation. Main outcome of interest was a diagnosis of GDM by oral glucose tolerance test (OGTT). Glycemic levels in participants with GDM versus without GDM were characterized using CGM-measured glycemic metrics. RESULTS: Participants with GDM (n = 58 [8%]) had higher mean glucose (109 ± 13 vs. 100 ± 8 mg/dL [6.0 ± 0.7 vs. 5.6 ± 0.4 mmol/L], P < 0.001), greater glucose SD (23 ± 4 vs. 19 ± 3 mg/dL [1.3 ± 0.2 vs. 1.1 ± 0.2 mmol/L], P < 0.001), less time in range 63–120 mg/dL (3.5–6.7 mmol/L) (70% ± 17% vs. 84% ± 8%, P < 0.001), greater percent time >120 mg/dL (>6.7 mmol/L) (median 23% vs. 12%, P < 0.001), and greater percent time >140 mg/dL (>7.8 mmol/L) (median 7.4% vs. 2.7%, P < 0.001) than those without GDM throughout gestation prior to OGTT. Median percent time >120 mg/dL (>6.7 mmol/L) and time >140 mg/dL (>7.8 mmol/L) were higher as early as 13–14 weeks of gestation (32% vs. 14%, P < 0.001, and 5.2% vs. 2.0%, P < 0.001, respectively) and persisted during the entire study period prior to OGTT. CONCLUSIONS: Prior to OGTT at 24–34 weeks' gestation, pregnant individuals who develop GDM have higher CGM-measured glucose levels and more hyperglycemia compared with those who do not develop GDM. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Maintenance of glycemic control during and after exercise remains a major challenge for individuals with type 1 diabetes. Glycemic responses to exercise may differ by exercise type (aerobic, interval, or resistance), and the effect of activity type on glycemic control after exercise remains unclear. RESEARCH DESIGN AND METHODS: The Type 1 Diabetes Exercise Initiative (T1DEXI) was a real-world study of at-home exercise. Adult participants were randomly assigned to complete six structured aerobic, interval, or resistance exercise sessions over 4 weeks. Participants self-reported study and nonstudy exercise, food intake, and insulin dosing (multiple daily injection [MDI] users) using a custom smart phone application and provided pump (pump users), heart rate, and continuous glucose monitoring data. RESULTS: A total of 497 adults with type 1 diabetes (mean age ± SD 37 ± 14 years; mean HbA1c ± SD 6.6 ± 0.8% [49 ± 8.7 mmol/mol]) assigned to structured aerobic (n = 162), interval (n = 165), or resistance (n = 170) exercise were analyzed. The mean (± SD) change in glucose during assigned exercise was −18 ± 39, −14 ± 32, and −9 ± 36 mg/dL for aerobic, interval, and resistance, respectively (P < 0.001), with similar results for closed-loop, standard pump, and MDI users. Time in range 70–180 mg/dL (3.9–10.0 mmol/L) was higher during the 24 h after study exercise when compared with days without exercise (mean ± SD 76 ± 20% vs. 70 ± 23%; P < 0.001). CONCLUSIONS: Adults with type 1 diabetes experienced the largest drop in glucose level with aerobic exercise, followed by interval and resistance exercise, regardless of insulin delivery modality. Even in adults with well-controlled type 1 diabetes, days with structured exercise sessions contributed to clinically meaningful improvement in glucose time in range but may have slightly increased time below range. [ABSTRACT FROM AUTHOR]

Capillary hemoglobin A1c (HbA1c) collection has grown in importance due to its convenience during situations such as the coronavirus disease 2019 (COVID-19) pandemic and virtual visits. The viability of capillary blood samples as an accurate alternative to venous samples has previously only been assessed in smaller sample sizes. In this brief report, 773 paired capillary and venous samples taken from 258 study participants in the Insulin-Only Bionic Pancreas Trial were analyzed at the University of Minnesota Advanced Research and Diagnostic Laboratory and assessed for HbA1c value congruency. Results showed that 97.7% of the capillary samples were within 5% of their respective venous measurement, and R2 between the two HbA1c sources was 0.95. These results are consistent with previous studies that also reported high concordance between capillary and venous HbA1c values using the same laboratory method, providing further evidence that capillary HbA1c measurements are an accurate alternative to venous measurements. Clinical Trial Registration number: NCT04200313. [ABSTRACT FROM AUTHOR]

Background: People with life-limiting illness are increasingly having more care provided to them by informal caregivers (ICs) such as family members and friends. Although there is a substantial amount of literature surrounding informal caregiving, there is a paucity of research from a hospice palliative care angle. To address this knowledge gap, this scoping review explored the effects of/challenges to informal caregiving at the end of life in Canada. Methods: Scoping review of the literature following Arksey and O'Malley's framework. Key healthcare and social sciences databases alongside the gray literature were searched. Relevant scholarly and gray literature sources from 2005 to 2019 were screened for inclusion criteria, and a thematic content analysis employed to summarize findings. Results: Of 2,717 initial search results, 257 distinct full text articles were obtained. Following deduplication and screening, 33 met inclusion criteria. Four major themes were identified: (1) Physical health challenges, (2) Psycho-socio-spiritual health challenges, (3) Financial issues, and (4) Health system issues. Gender of ICs was also found to be an important contributor to the differing effects of providing support. Conclusions: This review raises awareness toward ICs regarding the numerous physical, psycho-socio-spiritual, financial, and health system challenges faced during care for people with life-limiting illness. The knowledge gained will inform and advance future practice, policy, and research. Application to interventions (such as caregiver benefits) will assist to improve informal caregiving experiences and outcomes alongside quality of life. Further research is required to understand these unique experiences and the challenges of minority IC populations. [ABSTRACT FROM AUTHOR]

Background: People with type 1 diabetes estimate meal carbohydrate content to accurately dose insulin, yet, protein and fat content of meals also influences postprandial glycemia. We examined accuracy of macronutrient content estimation via a novel phone app. Participant estimates were compared with expert nutrition analyses performed via the Remote Food Photography Method© (RFPM©). Methods: Data were collected through a novel phone app. Participants were asked to take photos of meals/snacks on the day of and day after scheduled exercise, enter carbohydrate estimates, and categorize meals as low, typical, or high protein and fat. Glycemia was measured via continuous glucose monitoring. Results: Participants (n = 48) were 15-68 years (34 ± 14 years); 40% were female. The phone app plus RFPM© analysis captured 88% ± 29% of participants' estimated total energy expenditure. The majority (70%) of both low-protein and low-fat meals were accurately classified. Only 22% of high-protein meals and 17% of high-fat meals were accurately classified. Forty-nine percent of meals with <30 g of carbohydrates were overestimated by an average of 25.7 ± 17.2 g. The majority (64%) of large carbohydrate meals (≥60 g) were underestimated by an average of 53.6 ± 33.8 g. Glycemic response to large carbohydrate meals was similar between participants who underestimated or overestimated carbohydrate content, suggesting that factors beyond carbohydrate counting may impact postprandial glycemic response. Conclusions: Accurate estimation of total macronutrients in meals could be leveraged to improve insulin decision support tools and closed loop insulin delivery systems; development of tools to improve macronutrient estimation skills should be considered. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the contemporary prevalence of diabetic peripheral neuropathy (DPN) in participants with type 1 diabetes in the T1D Exchange Clinic Registry throughout the U.S.Research Design and Methods: DPN was assessed with the Michigan Neuropathy Screening Instrument Questionnaire (MNSIQ) in adults with ≥5 years of type 1 diabetes duration. A score of ≥4 defined DPN. Associations of demographic, clinical, and laboratory factors with DPN were assessed.Results: Among 5,936 T1D Exchange participants (mean ± SD age 39 ± 18 years, median type 1 diabetes duration 18 years [interquartile range 11, 31], 55% female, 88% non-Hispanic white, mean glycated hemoglobin [HbA1c] 8.1 ± 1.6% [65.3 ± 17.5 mmol/mol]), DPN prevalence was 11%. Compared with those without DPN, DPN participants were older, had higher HbA1c, had longer duration of diabetes, were more likely to be female, and were less likely to have a college education and private insurance (all P < 0.001). DPN participants also were more likely to have cardiovascular disease (CVD) (P < 0.001), worse CVD risk factors of smoking (P = 0.008), hypertriglyceridemia (P = 0.002), higher BMI (P = 0.009), retinopathy (P = 0.004), reduced estimated glomerular filtration rate (P = 0.02), and Charcot neuroarthropathy (P = 0.002). There were no differences in insulin pump or continuous glucose monitor use, although DPN participants were more likely to have had severe hypoglycemia (P = 0.04) and/or diabetic ketoacidosis (P < 0.001) in the past 3 months.Conclusions: The prevalence of DPN in this national cohort with type 1 diabetes is lower than in prior published reports but is reflective of current clinical care practices. These data also highlight that nonglycemic risk factors, such as CVD risk factors, severe hypoglycemia, diabetic ketoacidosis, and lower socioeconomic status, may also play a role in DPN development. [ABSTRACT FROM AUTHOR]