SAN FRANCISCO — The Omnipod hybrid closed-loop system was safe and performed well in young children with type 1 diabetes (T1D), according to study results presented at the American Diabetes Association 79th Scientific Sessions, held June 7 to 11, 2019.
This study assessed the safety of the Omnipod hybrid closed-loop personalized model predictive control algorithm in children with T1D aged 2 to 5.9 years. All participants had a hemoglobin A1c (HbA1c) <10%. Before the 48- to 72-hour hybrid closed-loop phase, a 7-day at-home standard therapy phase using a continuous glucose monitor took place. During the hybrid closed-loop phase, meals were unrestricted and boluses were administered as per the patient’s usual routine.
A total of 14 participants (mean age, 4.2 years) were enrolled. They had an average T1D duration of 2.4 ± 1.0 years, HbA1c of 7.4% ± 1.0%, and a total daily dose of 0.77 ± 0.13 U/kg. All participants exercised for ≥30 min/d.
Compared with the continuous glucose monitor phase, the hybrid closed-loop phase resulted in an overall lower mean glucose level (172 ± 27 mg/dL vs 148 ± 16 mg/dL, respectively) and a lower overnight glucose level (167 ± 28 mg/dL vs 135 ± 17 mg/dL, respectively). The percentage of time spent between 70 and 18 mg/dL was overall 32% higher during the hybrid closed-loop phase compared with the continuous glucose monitor phase (72.6% ± 8.4% vs 55.2% ± 13.1%, respectively) and was 47% higher overnight (85.3% ± 9.4% vs 58.2% ± 16.4%, respectively). There was a 2-fold reduction of time spent <70 mg/dL overall and overnight.
There was a single severe hypoglycemic event that occurred after exercise, which was treated with oral carbohydrates.
Overall, the Omnipod hybrid closed-loop system was found to be safe and performed well in young children in a supervised setting.
Disclosure: This study was supported by Insulet Corporation.
Buckingham BA, Forlenza GP, Sherr J, et al. Safety and performance of the Omnipod hybrid closed-loop system in young children aged 2-6 years with type 1 diabetes. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco, CA. Oral Presentation 215-OR.