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Aim: Automated insulin delivery (AID) systems have demonstrated improved glycaemic outcomes in people with type 1 diabetes (T1D), yet limited data exist on these systems in very young children and their impact on caregivers. We evaluated psychosocial outcomes following use of the tubeless Omnipod® 5 AID System in caregivers of very young children., Materials and Methods: This 3-month single-arm, multicentre, pivotal clinical trial enrolled 80 children aged 2.0-5.9 years with T1D to use the Omnipod 5 AID System. Caregivers completed questionnaires assessing psychosocial outcomes-diabetes distress (Problem Areas in Diabetes), hypoglycaemia confidence (Hypoglycemia Confidence Scale), well-being (World Health Organization 5 Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), insulin delivery satisfaction (Insulin Delivery Satisfaction Survey) and system usability (System Usability Scale) at baseline with standard therapy and after 3 months of AID use., Results: Following 3 months of Omnipod 5 use, caregivers experienced significant improvements across all measures, including diabetes-related psychosocial outcomes (Problem Areas in Diabetes; p < 0.0001, Hypoglycemia Confidence Scale; p < 0.01), well-being (World Health Organization 5 Well-Being Index; p < 0.0001) and perceived system usability (System Usability Scale; p < 0.0001). Significant improvements were seen in the Pittsburgh Sleep Quality Index total score and the overall sleep quality, sleep duration and efficiency subscales (all p < 0.05). Insulin Delivery Satisfaction Survey scores improved on all subscales (greater satisfaction, reduced burden and reduced inconvenience; all p < 0.0001)., Conclusions: Caregivers face unique challenges when managing T1D in very young children. While glycaemic metrics have unquestioned importance, these results evaluating psychosocial outcomes reveal additional meaningful benefits and suggest that the Omnipod 5 AID System alleviates some of the burdens caregivers face with diabetes management., (© 2024 Insulet Corporation and The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Background: The Omnipod ® 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. Methods: A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110-150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. Results: In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70-180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130-150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL ( n  = 37,640), median TIR was 65.0% in children and adolescents (2-17 years) and 69.9% in adults (≥18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. Conclusion: These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions.

Aims: To compare glycemic outcomes in adults with type 2 diabetes mellitus (T2DM) before and 90 days after initiating Omnipod® or Omnipod DASH® Insulin Management Systems., Methods: In this retrospective observational study (N = 3,592) change in HbA1c level, total daily dose (TDD) of insulin (n = 3,053), and frequency of self-reported hypoglycemic events (HE, <70 mg/dL, n = 2,922) were assessed overall and by prior treatment modality (multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)), age group, and baseline HbA1c category., Results: Change (mean ± SD) in HbA1c was -1.3 ± 1.7% [-14 ± 19 mmol/mol] overall, -1.4 ± 1.7% [-15 ± 19 mmol/mol] for prior MDI users, and -0.9 ± 1.5% [-10 ± 16 mmol/mol] for prior CSII users (p<0.0001). The percentage of patients with HbA1c ≥9% [≥75 mmol/mol] decreased (49% to 19%), and with HbA1c <7% [<53 mmol/mol] increased (10% to 22%) (p<0.0001). Prior therapy, age, and baseline HbA1c category were factors affecting change in HbA1c (p<0.05). Reductions in TDD (overall, -33 ± 52U, p<0.0001) and HE per week (overall, -0.5 ± 2.0, p<0.0001), were seen regardless of prior treatment, age, or baseline HbA1c., Conclusions: Omnipod System use was associated with statistically and clinically meaningful reductions in HbA1c, TDD, and HE compared to prior treatments in T2DM., (Copyright © 2021 Insulet Corporation. Published by Elsevier B.V. All rights reserved.)

Background: The objective of this study was to assess the safety and performance of the Omnipod ® personalized model predictive control (MPC) algorithm with variable glucose setpoints and moderate intensity exercise using an investigational device in adults with type 1 diabetes (T1D). Materials and Methods: A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient standard treatment phase. Adults aged 18-65 years with T1D and HbA1c between 6.0% and 10.0% were eligible. Subjects completed two moderate intensity exercise sessions of >30 min duration on consecutive days: the first with the glucose set point increased from 130 to 150 mg/dL and the second with a temporary basal rate of 50%, both started 90 min pre-exercise. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL. Results: Twelve subjects participated in the study, with (mean ± standard deviation) age 36.5 ± 14.4 years, diabetes duration 21.7 ± 15.7 years, HbA1c 7.6% ± 1.1%, and total daily dose 0.60 ± 0.22 U/kg. Outcomes for the 54-h HCL period were mean glucose: 136 ± 14 mg/dL, percentage time <70 mg/dL: 1.4% ± 1.3%, 70-180 mg/dL: 85.1% ± 9.3%, and ≥250 mg/dL: 1.8% ± 2.4%. In the 12-h period after exercise start, percentage time <70 mg/dL was 1.4% ± 2.7% with the raised glucose set point and 1.6% ± 3.0% with reduced basal rate. The percentage time <70 mg/dL overnight was 0% ± 0% on both study nights. Conclusions: The Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to variable glucose set points and with temporarily raised glucose set point or reduced basal rate 90 min in advance of moderate intensity exercise in adults with T1D.

The Omnipod DASH™ Insulin Management System (Insulet Corp, Billerica, MA) is a discreet, tubeless, wearable insulin pump that holds up to 200 units of U-100 insulin and delivers therapy through customizable basal rates and bolus amounts. This recently FDA-cleared system consists of the insulin pump ("Pod"), which is worn on body and delivers insulin, and the Personal Diabetes Manager (PDM), which is a handheld device used to wirelessly control and monitor the Pod functionality. The PDM can also be paired with the CONTOUR ® NEXT ONE blood glucose (BG) meter (Ascensia Diabetes Care, Basel, Switzerland) to wirelessly receive BG readings. This review provides a detailed description of the Pod and PDM. Key features of the Pod are described, including the novel pump delivery mechanism, waterproof (IP28) housing design, and automated cannula insertion. The technology introduced in the new system, such as touchscreen PDM interface, Bluetooth ® wireless technology, and wireless internet connectivity, is also presented. Last, Omnipod ® Insulin Management System clinical data are reviewed, including early feasibility results for the Omnipod Horizon™ Automated Glucose Control hybrid closed-loop system.

Background: Medical device technology is evolving at a rapid pace, with increasing patient expectations to use modern technologies for diabetes management. With the significant expansion of the use of wireless technology and complex, securely connected digital platforms in medical devices, end user needs and behaviors have become essential areas of focus., Methods: This article provides a detailed description of the user-centered design approach implemented in developing the Omnipod DASH™ Insulin Management System (Insulet Corp., Billerica, MA) Bluetooth ® -enabled locked-down Android device handheld controller (Personal Diabetes Manager, PDM). Key methodologies used in the PDM design are described, including how the science of user experience (UX) was integrated into new agile product development. UX methods employed included heuristic evaluations of insulin pumps, iterative formative usability testing, information architecture studies, in-home ethnographic visits, participatory design activities, and interviews., Results: Over 343 users participated in UX research and testing. Key design choices informed by UX research included updating the layout of critical data on the PDM home page, providing access to requested contextual information while a bolus is in progress, and creating an easy-to-understand visual of a 24-hour basal program. Task completion rates for comprehending information on the PDM home page were 87% or greater. The System Usability Scale result for the design prior to limited market release was 84.4 ± 13.4 (out of 100; n = 37)., Conclusions: The UX process described in this article can serve as a blueprint for medical device manufacturers seeking to enhance product development. Adopting UX research methodologies will help ensure that new diabetes devices are safe, easy-to-use, and meet the needs of users.

Background: This study assessed the safety and performance of the Omnipod ® personalized model predictive control (MPC) algorithm using an investigational device in adults with type 1 diabetes in response to overestimated and missed meal boluses and extended boluses for high-fat meals., Materials and Methods: A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient open-loop run-in phase. Adults aged 18-65 years with type 1 diabetes and HbA1c 6.0%-10.0% were eligible. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL. Glycemic responses for 4 h to a 130% overestimated bolus and a missed meal bolus were compared with a 100% bolus for identical meals, respectively. The 12-h postprandial responses to a high-fat meal were compared using either a standard or extended bolus., Results: Twelve subjects participated in the study, with (mean ± standard deviation): age 35.4 ± 14.1 years, diabetes duration 16.5 ± 9.3 years, HbA1c 7.7 ± 0.9%, and total daily dose 0.58 ± 0.19 U/kg. Outcomes for the 54-h HCL period were mean glucose 153 ± 15 mg/dL, percentage time <70 mg/dL [median (interquartile range)]: 0.0% (0.0-1.2%), 70-180 mg/dL: 76.1% ± 8.0%, and ≥250 mg/dL: 4.5% ± 3.6%. After both the 100% and 130% boluses, postprandial percentage time <70 mg/dL was 0.0% (0.0-0.0%) (P = 0.50). After the 100% and missed boluses, postprandial percentage time ≥250 mg/dL was 0.2% ± 0.6% and 10.3% ± 16.5%, respectively (P = 0.06). Postprandial percentages time ≥250 mg/dL and <70 mg/dL were similar with standard or extended boluses for a high-fat meal., Conclusions: The Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to overestimated, missed, and extended meal boluses in adults with type 1 diabetes.

Objective: Artificial pancreas (AP) systems are best positioned for optimal treatment of type 1 diabetes (T1D) and are currently being tested in outpatient clinical trials. Our consortium developed and tested a novel adaptive AP in an outpatient, single-arm, uncontrolled multicenter clinical trial lasting 12 weeks., Research Design and Methods: Thirty adults with T1D completed a continuous glucose monitor (CGM)-augmented 1-week sensor-augmented pump (SAP) period. After the AP was started, basal insulin delivery settings used by the AP for initialization were adapted weekly, and carbohydrate ratios were adapted every 4 weeks by an algorithm running on a cloud-based server, with automatic data upload from devices. Adaptations were reviewed by expert study clinicians and patients. The primary end point was change in hemoglobin A 1c (HbA 1c ). Outcomes are reported adhering to consensus recommendations on reporting of AP trials., Results: Twenty-nine patients completed the trial. HbA 1c , 7.0 ± 0.8% at the start of AP use, improved to 6.7 ± 0.6% after 12 weeks (-0.3, 95% CI -0.5 to -0.2, P < 0.001). Compared with the SAP run-in, CGM time spent in the hypoglycemic range improved during the day from 5.0 to 1.9% (-3.1, 95% CI -4.1 to -2.1, P < 0.001) and overnight from 4.1 to 1.1% (-3.1, 95% CI -4.2 to -1.9, P < 0.001). Whereas carbohydrate ratios were adapted to a larger extent initially with minimal changes thereafter, basal insulin was adapted throughout. Approximately 10% of adaptation recommendations were manually overridden. There were no protocol-related serious adverse events., Conclusions: Use of our novel adaptive AP yielded significant reductions in HbA 1c and hypoglycemia., (© 2017 by the American Diabetes Association.)