Predictive hyperglycemia and hypoglycemia minimization: In-home double-blind randomized controlled evaluation in children and young adolescents PEDIATRIC DIABETES Forlenza, G. P., Raghinaru, D., Cameron, F., Bequette, B., Chase, H., Wadwa, R., Maahs, D. M., Jost, E., Ly, T. T., Wilson, D. M., Norlander, L., Ekhlaspour, L., Min, H., Clinton, P., Njeru, N., Lum, J. W., Kollman, C., Beck, R. W., Buckingham, B. A., In-Home Closed-Loop IHCL Study Grp 2018; 19 (3): 420–28

Abstract

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.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.The addition of automated insulin delivery with PHHM increased time in target range (70-180?mg/dL) from 66?±?11% 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).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.

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