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Background: Meeting glycemic recommendations is challenging for youth with type 1 diabetes. Diabetes technology, including continuous glucose monitoring (CGM) and hybrid closed-loop (HCL) automated insulin delivery systems, significantly increase achievement of glycemic targets; however, many youth struggle to sustain use of early HCL systems. Nocturnal alarm fatigue contributes to disrupted sleep and device discontinuation., Methods: We examined the frequency and causes of nocturnal (10:00 p.m. to 6:00 a.m.) alarms in pediatric patients ( N = 76, median age 14.5 years [interquartile range 11.8-17.0 years, range 7-24 years]) starting on a first-generation HCL system in a prospective observational study. Device data were analyzed with linear mixed-effects models to examine change across time at 3-month intervals for 12 months., Results: At baseline (HCL system in nonautomated mode), participants averaged 3.3 ± 0.6 alarms per night. In the 2 weeks after starting HCL (automated) mode, alarm frequency significantly increased to 5.4 ± 0.5 times per night ( P <0.001). Alarm frequency decreased through the remainder of the observational period; however, CGM sensor and HCL system use also declined. The types of alarms were evenly distributed among sensor maintenance, sensor threshold, pump, and HCL-specific alarms., Conclusion: These data show that HCL system nocturnal alarms are frequent and may be barriers to sleep quality and device use. Further research is needed to assess the impact of diabetes technology on sleep and to determine method to improve sleep quality with technology use., Competing Interests: C.B. is a consultant/speaker for Insulet. L.H.M. has received speaking/consulting honoraria from Dexcom and Tandem Diabetes Care and also consults for Beta Bionics and Capillary Biomedical. R.P.W. has received research funding from Dexcom, Eli Lilly, and Tandem Diabetes Care; conference travel support from Dexcom and Eli Lilly; consulting honoraria from Eli Lilly; and speaker honoraria from Dexcom. G.P.F. conducts research sponsored by and has been a consultant/speaker for Abbott, Beta Bionics, Dexcom, Insulet, Medtronic, and Tandem Diabetes Care. No other potential conflicts of interest relevant to this article were reported., (© 2024 by the American Diabetes Association.)

Despite evidence of improved diabetes outcomes with diabetes technology such as continuous glucose monitoring (CGM) systems, insulin pumps, and hybrid closed-loop (HCL) insulin delivery systems, these devices are underutilized in clinical practice for the management of insulin-requiring diabetes. This low uptake may be the result of health care providers' (HCPs') lack of confidence or time to prescribe and manage devices for people with diabetes. We administered a survey to HCPs in primary care, pediatric endocrinology, and adult endocrinology practices in the United States. Responding HCPs expressed a need for device-related insurance coverage tools and online data platforms with integration to electronic health record systems to improve diabetes technology uptake in these practice settings across the United States., Competing Interests: L.H.M. has received research/education grants from Beta Bionics, Insulet, the Leona M. and Harry B. Helmsley Charitable Trust, the National Institutes of Health, and Tandem Diabetes Care. She has served as a consultant/speaker for Capillary Biomedical, Dexcom, and Tandem Diabetes Care and on an advisory board for Eli Lilly. As of January 2023, she is also employed by Tandom Diabetes Care. H.K.A. has received research grants from Dexcom, Eli Lilly, the Institute for the Advancement of Food and Nutrition Sciences, IM Therapeutics, Mannkind, Medtronic, REMD Biotherapeutics, and Senseonics. He has served as a consultant for Eli Lilly and on advisory boards for Ascensia and Mannkind. G.P.F. has received research grants from Abbott, Beta Bionics, Dexcom, Eli Lilly, Insulet, JDRF, Medtronic, and Tandem Diabetes Care and has served as a consultant/speaker for Abbott, Beta Bionics, Dexcom, Insulet, Eli Lilly, Medtronic, and Tandem Diabetes Care. S.M.O. has received research grants from the AAFP, the Colorado Department of Public Health & Environment, and the Leona M. and Harry B. Helmsley Charitable Trust. He has served on advisory boards for the ADA, ADCES, Cecelia Health, Dexcom, the Jaeb Center for Health Research, Medtronic, the National Committee on Quality Assurance, and Pendulum Therapeutics. S.P. has received research grants from Dexcom, Eli Lilly, JDRF, the Leona M. and Harry B. Helmsley Charitable Trust, Medtronic, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Sanofi and has served on an advisory board for Medtronic. V.N.S. has received research grants from Dexcom, Eli Lilly, Insulet, JDRF, the National Institutes of Health, Novo Nordisk, and Tandem Diabetes Care. He has served as a consultant/speaker for Dexcom and Insulet and on advisory boards for DKSH Singapore, LifeScan, and Medscape. R.P.W. has received research grant support from Dexcom and Tandem Diabetes Care and has served as a consultant/speaker for Tandem Diabetes Care. T.K.O. has received research grants from Abbott, the AAFP, the Leona M. and Harry B. Helmsley Charitable Trust, the National Institute of Nursing Research, and NIDDK. She has served on advisory boards for ADA, ADCES, Cecelia Health, Dexcom, and the Jaeb Center for Health Research. No other potential conflicts of interest relevant to this article were reported., (© 2023 by the American Diabetes Association.)

Objective: While continuous glucose monitors (CGMs), insulin pumps, and hybrid closed-loop (HCL) systems each improve glycemic control in type 1 diabetes, it is unclear how the use of these technologies impacts real-world pediatric care., Research Design and Methods: We found 1,455 patients aged <22 years, with type 1 diabetes duration >3 months, and who had data from a single center in between both 2016-2017 (n = 2,827) and 2020-2021 (n = 2,731). Patients were grouped by multiple daily injections or insulin pump, with or without an HCL system, and using a blood glucose monitor or CGM. Glycemic control was compared using linear mixed-effects models adjusting for age, diabetes duration, and race/ethnicity., Results: CGM use increased from 32.9 to 75.3%, and HCL use increased from 0.3 to 27.9%. Overall A1C decreased from 8.9 to 8.6% (P < 0.0001)., Conclusions: Adoption of CGM and HCL was associated with decreased A1C, suggesting promotion of these technologies may yield glycemic benefits., (© 2023 by the American Diabetes Association.)

Objective: Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population., Research Design and Methods: A total of 80 children aged 2.0-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy., Results: There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70-180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204)., Conclusions: Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline., (© 2022 by the American Diabetes Association.)

Automated insulin delivery (AID) systems, which connect an insulin pump, continuous glucose monitoring system, and software algorithm to automate insulin delivery based on real-time glycemic data, hold promise for improving outcomes and reducing therapeutic burden for people with diabetes. This article reviews the features of the Omnipod 5 Automated Insulin Delivery System and how it compares to other AID systems available on or currently under review for the U.S. market. It also provides practical guidance for clinicians on how to effectively train and onboard people with diabetes on the Omnipod 5 System, including how to personalize therapy and optimize glycemia. Many people with diabetes receive their diabetes care in primary care settings rather than in a diabetes specialty clinic. Therefore, it is important that primary care providers have access to resources to support the adoption of AID technologies such as the Omnipod 5 System., (© 2022 by the American Diabetes Association.)

Objective: Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets., Research Design and Methods: This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA 1c and percent time in sensor glucose range 70-180 mg/dL ("time in range")., Results: A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA 1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure., Conclusions: This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA 1c levels and time in target glucose range with a very low occurrence of hypoglycemia., (© 2021 by the American Diabetes Association.)

Objective: To further evaluate the safety and efficacy of the Control-IQ closed-loop control (CLC) system in children with type 1 diabetes., Research Design and Methods: After a 16-week randomized clinical trial (RCT) comparing CLC with sensor-augmented pump (SAP) therapy in 101 children 6-13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks., Results: In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55 ± 13% using SAP during the RCT to 65 ± 10% using CLC ( P < 0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP ( P = 0.03). Substantial improvement in TIR was seen after the 1st day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% ( P < 0.001). In the CLC-CLC cohort, mean TIR increased from 53 ± 17% prerandomization to 67 ± 10% during the RCT and remained reasonably stable at 66 ± 10% through the 12 weeks post-RCT. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either cohort., Conclusions: This further evaluation of the Control-IQ CLC system supports the findings of the preceding RCT that use of a closed-loop system can safely improve glycemic control in children 6-13 years old with type 1 diabetes from the 1st day of use and demonstrates that these improvements can be sustained through 28 weeks of use., (© 2020 by the American Diabetes Association.)

Objective: Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system., Research Design and Methods: After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14-72 years; mean HbA 1c , 7.1% [54 mmol/mol]) were randomly assigned to CLC ( N = 54, Control-IQ) or PLGS ( N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70-180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study., Results: All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; P < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI -8.4%, -3.7%; P < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI -0.05%, 0.13%; P = 0.41). HbA 1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol]; 95% CI -0.57% [-6.2 mmol/mol], -0.11% [1.2 mmol/mol]; P = 0.0035)., Conclusions: Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA 1c toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS., (© 2020 by the American Diabetes Association.)

Objective: Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system., Research Design and Methods: This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA 1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L., Results: Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC ( n = 65) versus SAP ( n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device., Conclusions: In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable., (© 2020 by the American Diabetes Association.)

IN BRIEF Insulin pump therapy is advancing rapidly. This article summarizes the variety of insulin pump technologies available to date and discusses important clinical considerations for each type of technology.

Objective: 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., Research Design and Methods: Individuals with type 1 diabetes ( n = 103, age 6-72 years, mean HbA 1c 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., Results: 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., Conclusions: 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., (© 2018 by the American Diabetes Association.)

Objective: The MiniMed 670G System is the first commercial hybrid closed-loop (HCL) system for management of type 1 diabetes. Using data from adolescent and young adult participants, we compared insulin delivery patterns and time-in-range metrics in HCL (Auto Mode) and open loop (OL). System alerts, usage profiles, and operational parameters were examined to provide suggestions for optimal clinical use of the system., Research Design and Methods: Data from 31 adolescent and young adult participants (14-26 years old) at three clinical sites in the 670G pivotal trial were analyzed. Participants had a 2-week run-in period in OL, followed by a 3-month in-home study phase with HCL functionality enabled. Data were compared between baseline OL and HCL use after 1 week, 1 month, 2 months, and 3 months., Results: Carbohydrate-to-insulin (C-to-I) ratios were more aggressive for all meals with HCL compared with baseline OL. Total daily insulin dose and basal-to-bolus ratio did not change during the trial. Time in range increased 14% with use of Auto Mode after 3 months ( P < 0.001), and HbA 1c decreased 0.75%. Auto Mode exits were primarily due to sensor/insulin delivery alerts and hyperglycemia. The percentage of time in Auto Mode gradually declined from 87%, with a final use rate of 72% (-15%)., Conclusions: In transitioning young patients to the 670G system, providers should anticipate immediate C-to-I ratio adjustments while also assessing active insulin time. Users should anticipate occasional Auto Mode exits, which can be reduced by following system instructions and reliably bolusing for meals. Unique 670G system functionality requires ongoing clinical guidance and education from providers., (© 2018 by the American Diabetes Association.)

Objective: Intense exercise is a major challenge to the management of type 1 diabetes (T1D). Closed-loop control (CLC) systems (artificial pancreas) improve glycemic control during limited intensity and short duration of physical activity (PA). However, CLC has not been tested during extended vigorous outdoor exercise common among adolescents., Research Design and Methods: Skiing presents unique metabolic challenges: intense prolonged PA, cold, altitude, and stress/fear/excitement. In a randomized controlled trial, 32 adolescents with T1D (ages 10-16 years) participated in a 5-day ski camp (∼5 h skiing/day) at two sites: Wintergreen, VA, and Breckenridge, CO. Participants were randomized to the University of Virginia CLC system or remotely monitored sensor-augmented pump (RM-SAP). The CLC and RM-SAP groups were coarsely paired by age and hemoglobin A 1c (HbA 1c ). All subjects were remotely monitored 24 h per day by the study physicians and clinical team., Results: Compared with physician-monitored open loop, percent time in range (70-180 mg/dL) improved using CLC: 71.3 vs. 64.7% (+6.6% [95% CI 1-12]; P = 0.005), with maximum effect late at night. Hypoglycemia exposure and carbohydrate treatments were improved overall ( P = 0.001 and P = 0.007) and during the daytime with strong ski level effects ( P = 0.0001 and P = 0.006); ski/snowboard proficiency was balanced between groups but with a very strong site effect: naive in Virginia and experienced in Colorado. There was no adverse event associated with CLC; the participants' feedback was overwhelmingly positive., Conclusions: CLC in adolescents with T1D improved glycemic control and reduced exposure to hypoglycemia during prolonged intensive winter sport activities, despite the added challenges of cold and altitude., (© 2017 by the American Diabetes Association.)

Objective: As artificial pancreas (AP) becomes standard of care, consideration of extended use of insulin infusion sets (IIS) and continuous glucose monitors (CGMs) becomes vital. We conducted an outpatient randomized crossover study to test the safety and efficacy of a zone model predictive control (zone-MPC)-based AP system versus sensor augmented pump (SAP) therapy in which IIS and CGM failures were provoked via extended wear to 7 and 21 days, respectively., Research Design and Methods: A smartphone-based AP system was used by 19 adults (median age 23 years [IQR 10], mean 8.0 ± 1.7% HbA 1c ) over 2 weeks and compared with SAP therapy for 2 weeks in a crossover, unblinded outpatient study with remote monitoring in both study arms., Results: AP improved percent time 70-140 mg/dL (48.1 vs. 39.2%; P = 0.016) and time 70-180 mg/dL (71.6 vs. 65.2%; P = 0.008) and decreased median glucose (141 vs. 153 mg/dL; P = 0.036) and glycemic variability (SD 52 vs. 55 mg/dL; P = 0.044) while decreasing percent time <70 mg/dL (1.3 vs. 2.7%; P = 0.001). AP also improved overnight control, as measured by mean glucose at 0600 h (140 vs. 158 mg/dL; P = 0.02). IIS failures (1.26 ± 1.44 vs. 0.78 ± 0.78 events; P = 0.13) and sensor failures (0.84 ± 0.6 vs. 1.1 ± 0.73 events; P = 0.25) were similar between AP and SAP arms. Higher percent time in closed loop was associated with better glycemic outcomes., Conclusions: Zone-MPC significantly and safely improved glycemic control in a home-use environment despite prolonged CGM and IIS wear. This project represents the first home-use AP study attempting to provoke and detect component failure while successfully maintaining safety and effective glucose control., (© 2017 by the American Diabetes Association.)

Objective: The objective of this study was to determine the safety, feasibility, and efficacy of a predictive hyperglycemia and hypoglycemia minimization (PHHM) system compared with predictive low-glucose insulin suspension (PLGS) alone in overnight glucose control., Research Design and Methods: A 42-night trial was conducted in 30 individuals with type 1 diabetes in the age range 15-45 years. Participants were randomly assigned each night to either PHHM or PLGS and were blinded to the assignment. The system suspended the insulin pump on both the PHHM and PLGS nights for predicted hypoglycemia but delivered correction boluses for predicted hyperglycemia on PHHM nights only. The primary outcome was the percentage of time spent in a sensor glucose range of 70-180 mg/dL during the overnight period., Results: The addition of automated insulin delivery with PHHM increased the time spent in the target range (70-180 mg/dL) from 71 ± 10% during PLGS nights to 78 ± 10% during PHHM nights ( P < 0.001). The average morning blood glucose concentration improved from 163 ± 23 mg/dL after PLGS nights to 142 ± 18 mg/dL after PHHM nights ( P < 0.001). Various sensor-measured hypoglycemic outcomes were similar on PLGS and PHHM nights. All participants completed 42 nights with no episodes of severe hypoglycemia, diabetic ketoacidosis, or other study- or device-related adverse events., Conclusions: The addition of a predictive hyperglycemia minimization component to our existing PLGS system was shown to be safe, feasible, and effective in overnight glucose control., (© 2017 by the American Diabetes Association.)