Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions

Abstract

Background: The objective of this study was to assess the safety and performance of the Omnipod Ò personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged ‡6 years with type 1 diabetes (T1D) under free-living conditions using an investigational device. Materials and Methods: A 96-h hybrid closed-loop (HCL) study was conducted in a supervised hotel/rental home setting following a 7-day outpatient standard therapy (ST) phase. Eligible participants were aged 6-65 years with A1C <10.0% using insulin pump therapy or multiple daily injections. Meals during HCL were unrestricted, with boluses administered per usual routine. There was daily physical activity. The primary endpoints were percentage of time with sensor glucose <70 and ‡250 mg/dL. Results: Participants were 11 adults, 10 adolescents, and 15 children aged (meanstandard deviation) 28.8 -7.9, 14.3 -1.3, and 9.9 -1.0 years, respectively. Percentage time ‡250 mg/dL during HCL was 4.5% -4.2%, 3.5% -5.0%, and 8.6% -8.8% per respective age group, a 1.6-, 3.4-, and 2.0-fold reduction compared to ST (P = 0.1, P = 0.02, and P = 0.03). Percentage time <70 mg/dL during HCL was 1.9% -1.3%, 2.5% -2.0%, and 2.2% -1.9%, a statistically significant decrease in adults when compared to ST (P = 0.005, P = 0.3, and P = 0.3). Percentage time 70-180 mg/dL increased during HCL compared to ST, reaching significance for adolescents and children: HCL 73.7% -7.5% vs. ST 68.0% -15.6% for adults (P = 0.08), HCL 79.0% -12.6% vs. ST 60.6% -13.4% for adolescents (P = 0.01), and HCL 69.2% -13.5% vs. ST 54.9% -12.9% for children (P = 0.003). Conclusions: The Omnipod personalized MPC algorithm was safe and performed well over 5 days and 4 nights of use by a cohort of participants ranging from youth aged ‡6 years to adults with T1D under supervised freeliving conditions with challenges, including daily physical activity and unrestricted meals.

Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion

“…very small boluses are delivered every few minutes. 19 However, in a recent artificial pancreas study satisfactory glycemic control could be shown with OP 20 suggesting that feedback control may be able to compensate for inaccuracy and variance in insulin delivery. Occlusion detection is a safety mechanism of insulin pumps and alarmingly, is not as reliable as one would expect.…”

7. Diabetes Technology: Standards of Medical Care in Diabetes—2021

“…Multiple studies, using a variety of systems with varying algorithms, pump, and sensors, have been performed in adults and children (163)(164)(165)(166)(167)(168)(169)(170)(171)(172)(173). Evidence suggests such systems may reduce A1C levels and improve time in range (174)(175)(176)(177)(178). They may lower the risk of exerciserelated hypoglycemia (179) and may have psychosocial benefits (180)(181)(182)(183).…”

Current treatment options and challenges in patients with Type 1 diabetes: Pharmacological, technical advances and future perspectives

“…In a randomized crossover trial, an increase of 9.2% of the time spent in the target was observed using this AP [122], and performances were evaluated also in more challenging situations as meals and physical exercise [123]. The Omnipod Horizon system [124] uses a patch pump and both its safety and efficacy were demonstrated in both adults and pediatric T1Ds even also in an outpatient setting [125,126]. CLCs equally allow a better QoL, by reducing the burden related to diabetes by demonstrating a significant reduction of the time spent in diabetes management [127,128].…”