Predictive hyperglycemia and hypoglycemia minimization: In-home double-blind randomized controlled evaluation in children and young adolescents.

Objective: The primary objective of this trial was to evaluate the feasibility, safety, and efficacy of a predictive hyperglycemia and hypoglycemia minimization (PHHM) system vs predictive low glucose suspension (PLGS) alone in optimizing overnight glucose control in children 6 to 14 years old. Research Design and Methods: Twenty-eight participants 6 to 14 years old with T1D duration >= 1 year with daily insulin therapy >= 12 months and on insulin pump therapy for >= 6 months were randomized per night into PHHM mode or PLGS- only mode for 42 nights. The primary outcome was percentage of time in sensor-measured range 70 to 180 mg/dL in the overnight period. Results: The addition of automated insulin delivery with PHHM increased time in target range (70-180 mg/dL) from 6611% during PLGS nights to 76 +/- 9% during PHHM nights (P < .001), without increasing hypoglycemia as measured by time below various thresholds. Average morning blood glucose improved from 176 +/- 28 mg/dL following PLGS nights to 154 +/- 19 mg/dL following PHHM nights (P < .001). Conclusions: The PHHM system was effective in optimizing overnight glycemic control, significantly increasing time in range, lowering mean glucose, and decreasing glycemic variability compared to PLGS alone in children 6 to 14 years old.