Dataset Information

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® 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 (mean?±?standard 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 free-living conditions with challenges, including daily physical activity and unrestricted meals.

SUBMITTER: Sherr JL

PROVIDER: S-EPMC7047109 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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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.

Sherr Jennifer L JL Buckingham Bruce A BA Forlenza Gregory P GP Galderisi Alfonso A Ekhlaspour Laya L Wadwa R Paul RP Carria Lori L Hsu Liana L Berget Cari C Peyser Thomas A TA Lee Joon Bok JB O'Connor Jason J Dumais Bonnie B Huyett Lauren M LM Layne Jennifer E JE Ly Trang T TT

Diabetes technology & therapeutics 20191029 3

Background: The objective of this study was to assess the safety and performance of the Omnipod® 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) ph ...[more]

PMID: 31596130

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Project description:OBJECTIVE:This study evaluated the feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions. RESEARCH DESIGN AND METHODS:In an open-label randomized crossover study, 12 suboptimally controlled adolescents on insulin pump therapy (mean ± SD age 14.6 ± 3.1 years; HbA1c 69 ± 8 mmol/mol [8.5 ± 0.7%]; duration of diabetes 7.8 ± 3.5 years) underwent two 21-day periods in which hybrid closed-loop insulin delivery was compared with sensor-augmented insulin pump therapy in random order. During the closed-loop intervention, a model predictive algorithm automatically directed insulin delivery between meals and overnight. Participants used a bolus calculator to administer prandial boluses. RESULTS:The proportion of time that sensor glucose was in the target range (3.9-10 mmol/L; primary end point) was increased during the closed-loop intervention compared with sensor-augmented insulin pump therapy by 18.8 ± 9.8 percentage points (mean ± SD; P < 0.001), the mean sensor glucose level was reduced by 1.8 ± 1.3 mmol/L (P = 0.001), and the time spent above target was reduced by 19.3 ± 11.3 percentage points (P < 0.001). The time spent with sensor glucose levels below 3.9 mmol/L was low and comparable between interventions (median difference 0.4 [interquartile range -2.2 to 1.3] percentage points; P = 0.33). Improved glucose control during closed-loop was associated with increased variability of basal insulin delivery (P < 0.001) and an increase in the total daily insulin dose (53.5 [39.5-72.1] vs. 51.5 [37.6-64.3] units/day; P = 0.006). Participants expressed positive attitudes and experience with the closed-loop system. CONCLUSIONS:Free-living home use of day-and-night closed-loop in suboptimally controlled adolescents with type 1 diabetes is safe, feasible, and improves glucose control without increasing the risk of hypoglycemia. Larger and longer studies are warranted.

Dataset Information

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.

Publications

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.

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