Randomized summer camp crossover trial in 5-to 9-year-old children: Outpatient wearable artificial pancreas is feasible and safe

Abstract

Objective The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5-to 9-yearold children during a camp. RESEARCH DESIGN AND METHODS A total of 30 children, 5-to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensoraugmented pump (SAP). RESULTS Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25th-75thpercentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P 5 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P < 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P < 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P < 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001). CONCLUSIONS This trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.