Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas.

OBJECTIVE: The most promising beta-cell replacement therapy for children with type 1 diabetes is a closed-loop artificial pancreas incorporating continuous glucose sensors and insulin pumps. The Medtronic MiniMed external physiological insulin delivery (ePID) system combines an external pump and sensor with a variable insulin infusion rate algorithm designed to emulate the physiological characteristics of the beta-cell. However, delays in insulin absorption associated with the subcutaneous route of delivery inevitably lead to large postprandial glucose excursions.

RESEARCH DESIGN AND METHODS: We studied the feasibility of the Medtronic ePID system in youth with type 1 diabetes and hypothesized that small manual premeal "priming" boluses would reduce postprandial excursions during closed-loop control. Seventeen adolescents (aged 15.9 +/- 1.6 years; A1C 7.1 +/- 0.8%) underwent 34 h of closed-loop control; 8 with full closed-loop (FCL) control and 9 with hybrid closed-loop (HCL) control (premeal priming bolus).

RESULTS: Mean glucose levels were 135 +/- 45 mg/dl in the HCL group versus 141 +/- 55 mg/dl in the FCL group (P = 0.09); daytime glucose levels averaged 149 +/- 47 mg/dl in the HCL group versus 159 +/- 59 mg/dl in the FCL group (P = 0.03). Peak postprandial glucose levels averaged 194 +/- 47 mg/dl in the HCL group versus 226 +/- 51 mg/dl in the FCL group (P = 0.04). Nighttime control was similar in both groups (111 +/- 27 vs. 112 +/- 28 mg/dl).

CONCLUSIONS: Closed-loop glucose control using an external sensor and insulin pump provides a means to achieve near-normal glucose concentrations in youth with type 1 diabetes during the overnight period. The addition of small manual priming bolus doses of insulin, given 15 min before meals, improves postprandial glycemic excursions.