OBJECTIVE We evaluated the performance of the iLet bionic pancreas (BP) in non-Hispanic White individuals (here referred to as “Whites”) and in Black, Hispanic, and other individuals (here collectively referred to as “Minorities”). RESEARCH DESIGN AND METHODS A multicenter, randomized controlled trial evaluated glycemic management with the BP versus standard of care (SC) in 161 adult and 165 pediatric participants with type 1 diabetes over 13 weeks. RESULTS In Whites (n = 240), the mean baseline-adjusted difference in 13-week HbA1c between the BP and SC groups was −0.45% (95% CI −0.61 to −0.29 [−4.9 mmol/mol; −6.6 to −3.1]; P < 0.001), while this difference among Minorities (n = 84) was −0.53% (−0.83 to −0.24 [−6.0 mmol/mol; −9.2 to −2.8]; P < 0.001). In Whites, the mean baseline-adjusted difference in time in range between the BP and SC groups was 10% (95% CI 7–12; P < 0.001) and in Minorities was 14% (10–18; P < 0.001). CONCLUSIONS The BP improves glycemic control in both Whites and Minorities and offers promise in decreasing health care disparities.
Learning personalized self-management routines is pivotal for people with type 1 diabetes (T1D), particularly early in diagnosis. Context-aware technologies, such as hybrid closed-loop (HCL) insulin pumps, are important tools for diabetes self-management. However, clinicians have observed that practices using these technologies involve significant individual differences. We conducted interviews with 20 adolescents and young adults who use HCL insulin pump systems for managing T1D, and we found that these individuals leverage both technological and non-technological means to maintain situational awareness about their condition. We discuss how these practices serve to infrastructure their self-management routines, including medical treatment, diet, and glucose measurement-monitoring routines. Our study provides insights into adolescents' and young adults' lived experiences of using HCL systems and related technology to manage diabetes, and contributes to a more nuanced understanding of how the HCI community can support the contextualized management of diabetes through technology design.
Objective: To analyze insulin delivery and glycemic metrics throughout the menstrual cycle for women with type 1 diabetes using closed loop control (CLC) insulin delivery. Methods: Menstruating women using a CLC system in a clinical trial were invited to record their menstrual cycles through a cycle-tracking application. Sixteen participants provided data for this secondary analysis over three or more complete cycles. Insulin delivery and continuous glucose monitoring (CGM) data were analyzed in relation to reported cycle phases. Results: Insulin delivery and CGM metrics remained consistent during cycle phases. Intraparticipant variability of CGM metrics and weight-based insulin delivery did not change through cycle phases. Conclusions: For this sample of menstruating women with type 1 diabetes using a CLC system, insulin delivery and glycemic metrics remained stable throughout menstrual cycle phases. Additional studies in this population are needed, particularly among women who report variable glycemic control during their cycles. Trial Registration: NCT03591354.
This study evaluated a new insulin delivery system designed to reduce insulin delivery when trends in continuous glucose monitoring (CGM) glucose concentrations predict future hypoglycemia.Individuals with type 1 diabetes (n = 103, age 6-72 years, mean HbA1c 7.3% [56 mmol/mol]) participated in a 6-week randomized crossover trial to evaluate the efficacy and safety of a Tandem Diabetes Care t:slim X2 pump with Basal-IQ integrated with a Dexcom G5 sensor and a predictive low-glucose suspend algorithm (PLGS) compared with sensor-augmented pump (SAP) therapy. The primary outcome was CGM-measured time <70 mg/dL.Both study periods were completed by 99% of participants; median CGM usage exceeded 90% in both arms. Median time <70 mg/dL was reduced from 3.6% at baseline to 2.6% during the 3-week period in the PLGS arm compared with 3.2% in the SAP arm (difference [PLGS - SAP] = -0.8%, 95% CI -1.1 to -0.5, P < 0.001). The corresponding mean values were 4.4%, 3.1%, and 4.5%, respectively, represent-ing a 31% reduction in the time <70 mg/dL with PLGS. There was no increase in mean glucose concentration (159 vs. 159 mg/dL, P = 0.40) or percentage of time spent >180 mg/dL (32% vs. 33%, P = 0.12). One severe hypoglycemic event occurred in the SAP arm and none in the PLGS arm. Mean pump suspension time was 104 min/day.The Tandem Diabetes Care Basal-IQ PLGS system significantly reduced hypoglycemia without rebound hyperglycemia, indicating that the system can benefit adults and youth with type 1 diabetes in improving glycemic control.
Importance In preclinical studies, thioredoxin-interacting protein overexpression induces pancreatic beta cell apoptosis and is involved in glucotoxicity-induced beta cell death. Calcium channel blockers reduce these effects and may be beneficial to beta cell preservation in type 1 diabetes. Objective To determine the effect of verapamil on pancreatic beta cell function in children and adolescents with newly diagnosed type 1 diabetes. Design, Setting, and Participants This double-blind, randomized clinical trial including children and adolescents aged 7 to 17 years with newly diagnosed type 1 diabetes who weighed 30 kg or greater was conducted at 6 centers in the US (randomized participants between July 20, 2020, and October 13, 2021) and follow-up was completed on September 15, 2022. Interventions Participants were randomly assigned 1:1 to once-daily oral verapamil (n = 47) or placebo (n = 41) as part of a factorial design in which participants also were assigned to receive either intensive diabetes management or standard diabetes care. Main Outcomes and Measures The primary outcome was area under the curve values for C-peptide level (a measure of pancreatic beta cell function) stimulated by a mixed-meal tolerance test at 52 weeks from diagnosis of type 1 diabetes. Results Among 88 participants (mean age, 12.7 [SD, 2.4] years; 36 were female [41%]; and the mean time from diagnosis to randomization was 24 [SD, 4] days), 83 (94%) completed the trial. In the verapamil group, the mean C-peptide area under the curve was 0.66 pmol/mL at baseline and 0.65 pmol/mL at 52 weeks compared with 0.60 pmol/mL at baseline and 0.44 pmol/mL at 52 weeks in the placebo group (adjusted between-group difference, 0.14 pmol/mL [95% CI, 0.01 to 0.27 pmol/mL]; P = .04). This equates to a 30% higher C-peptide level at 52 weeks with verapamil. The percentage of participants with a 52-week peak C-peptide level of 0.2 pmol/mL or greater was 95% (41 of 43 participants) in the verapamil group vs 71% (27 of 38 participants) in the placebo group. At 52 weeks, hemoglobin A 1c was 6.6% in the verapamil group vs 6.9% in the placebo group (adjusted between-group difference, −0.3% [95% CI, −1.0% to 0.4%]). Eight participants (17%) in the verapamil group and 8 participants (20%) in the placebo group had a nonserious adverse event considered to be related to treatment. Conclusions and Relevance In children and adolescents with newly diagnosed type 1 diabetes, verapamil partially preserved stimulated C-peptide secretion at 52 weeks from diagnosis compared with placebo. Further studies are needed to determine the longitudinal durability of C-peptide improvement and the optimal length of therapy. Trial Registration ClinicalTrials.gov Identifier: NCT04233034
Youth with T1D and their parents are susceptible to diabetes-related nocturnal awakenings, which have been associated with reduced sleep duration and quality. We conducted an observational study of youth with T1D starting on the Tandem Control-IQ (CIQ) hybrid closed-loop (HCL) system to evaluate the impact of system use on sleep. Thirty-nine youth (age 11.1±3.6 yrs, T1D duration 2.5±3.0 yrs, 54% male) and a parent (age 42.5±6.7 yrs, 18% male) completed sleep diaries capturing the number of and reasons for nocturnal awakenings over a 7-day period. Analyses compared diaries from before starting CIQ (baseline) to 3- and 6-months after starting CIQ using a zero-inflated Poisson mixed model with random intercept for participants. Youth and parents reported significantly fewer total awakenings per night at 3- and 6-months compared to baseline (Table) . A significant decrease in diabetes-related awakenings was observed after 6 months in youth but not in parents. Following CIQ initiation, fewer nocturnal awakenings were reported by parents and youth, with youth additionally reporting significantly fewer diabetes-related awakenings at 6 months. Due to the subjective nature of diaries, the number of true awakenings may be different. The results suggest that HCL technology may be beneficial in reducing sleep disruptions in youth and parents. Disclosure A.J.Karami: None. L.Pyle: None. T.B.Vigers: None. E.Jost: Other Relationship; Tandem Diabetes Care, Inc. R.Wadwa: Advisory Panel; Dompé, Consultant; Beta Bionics, Inc., Other Relationship; Tandem Diabetes Care, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. E.C.Cobry: None.
Continuous glucose monitors (CGMs) used for type 1 diabetes management are associated with lower hemoglobin A1c. CGMs are not approved for inpatient use, when close glucose monitoring and intensive insulin management are essential for optimal health. Accuracy data from adult hospitalizations have been published, but pediatric data are limited.
Many youth with T1D and their parents do not achieve sufficient sleep duration or quality. While HCL use improves nocturnal glycemic control, it is unclear whether sleep duration and quality are impacted. The objective of this study was to measure sleep outcomes in children with T1D and parents after HCL initiation. Youth with T1D starting the Tandem Control-IQ (CIQ) and a parent enrolled in an observational study. Actigraphy data (sleep duration, sleep efficiency, and wake after sleep onset (WASO)) and sleep surveys (Pittsburgh Sleep Quality Index (PSQI) , PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment) were collected at baseline and 3- and 6-months after CIQ initiation. Thirty-nine youth (11.1±3.6 yrs (range 3-17) , T1D duration 2.5±3.0 yrs, 54% male) and parents (42.5±6.7 yrs, 18% male) participated. Parents significantly improved WASO at 3- and 6-months (p=0.0 and 0.007) and sleep quality at 3-months (p=0.011) . No significant changes in subjective or objective sleep outcomes for children occurred other than a decrease in PROMIS Sleep-Related Impairment parent proxy at 3 months (p=0.041) . Youth with T1D and their parents experience insufficient sleep duration and poor sleep quality. Parent subjective sleep quality and WASO improved with CIQ use. Improving sleep quality is complex and further research is needed to identify causes of sleep disruptions and intervention methods. Disclosure E.C.Cobry: None. A.J.Karami: None. T.B.Vigers: None. L.Pyle: None. E.Jost: Other Relationship; Tandem Diabetes Care, Inc. L.J.Meltzer: None. R.Wadwa: Advisory Panel; Dompé, Consultant; Beta Bionics, Inc., Other Relationship; Tandem Diabetes Care, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. Funding National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases (K12DK094712)
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