Safety and Performance of Omnipod HCL for Children With Type 1 Diabetes
In children with type 1 diabetes, the Omnipod hybrid closed-loop personal model system was safe and performed well.
|The following article is part of conference coverage from the American Diabetes Association's 78th Scientific Sessions (ADA 2018) in Orlando,Florida. Endocrinology Advisor's staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back for the latest news from ADA 2018.|
In children aged between 6 and 12 years with type 1 diabetes (T1D), the Omnipod hybrid closed-loop (HCL) personal model system was safe and performed well, according to research presented at the American Diabetes Association's 78th Scientific Sessions held in Orlando, Florida, from June 22 to 26, 2018.
This study assessed the safety of the Omnipod HCL for children with T1D. The investigational device was tested over the course of 5 days in a hotel setting, under free-living conditions. Children with A1C <10% using continuous subcutaneous insulin infusion or multiple daily dose insulin injections, aged 6 to 11.9 years were eligible to participate.
The 96-hour HCL phase was preceded by a 7-day open-loop phase of standard therapy (continuous subcutaneous insulin infusion/multiple daily dose insulin injections) plus continuous glucose monitor use at home. During HCL, meals were unrestricted, and moderate-intensity exercise was performed for at least 30 minutes every day. During first 48 hours of HCL, an adaptive approach was used to update participant parameters.
Overall, compared with open-loop, the percentage of time spent in the target range of 70 to 180 mg/dL was 14.3% higher during HCL (HCL 69.2±13.5 vs open-loop 54.9±12.8) and 20.4% higher overnight (HCL 73.8±19.3 vs open-loop 53.4±18.8). A reduction in the time spent below the target range (<70 mg/dL) was 2.2±1.9 in the HCL group and 2.9±2.4 in the open-loop group. In addition, the time spent below target range also decreased overnight: 1.0±1.9 in the HCL group vs 2.6±2.5 in the open-loop group.
For children between the ages of 6 and 12 years with type 1 diabetes under free-living conditions with unrestricted meals and moderate-intensity exercise, the Omnipod HCL system was safe and performed well.
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Sherr J, Forlenza GP, Buckingham B, et al. Safety and performance of the Omnipod hybrid closed-loop system in children aged 6-12 years with type 1 diabetes over five days under free-living conditions. Presented at: ADA 2018 78th Scientific Sessions; June 22-26, 2018; Orlando, FL. Abstract 1377-P.