Journal
DIABETES CARE
Volume 39, Issue 7, Pages 1168-1174Publisher
AMER DIABETES ASSOC
DOI: 10.2337/dc15-2078
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Funding
- National Institute of Diabetes and Digestive and Kidney Diseases [1R01-DK-085621-01]
- JDRF
- National Institute for Health Research Cambridge Biomedical Research Centre
- Wellcome Strategic Award [100574/Z/12/Z]
- MRC [G0600717] Funding Source: UKRI
- Medical Research Council [G0600717] Funding Source: researchfish
- National Institute for Health Research [NF-SI-0513-10012] Funding Source: researchfish
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OBJECTIVE To evaluate feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions without remote monitoring or supervision. RESEARCH DESIGN AND METHODS In an open-label, randomized, free-living, crossover study design, 12 adolescents receiving insulin pump therapy (mean [+/- SD] age 15.4 +/- 2.6 years; HbA(1c) 8.3 +/- 0.9%; duration of diabetes 8.2 +/- 3.4 years) underwent two 7-day periods of sensor-augmented insulin pump therapy or hybrid closed-loop insulin delivery without supervision or remote monitoring. During the closed-loop insulin delivery, a model predictive algorithm automatically directed insulin delivery between meals and overnight; prandial boluses were administered by participants using a bolus calculator. RESULTS The proportion of time when the sensor glucose level was in the target range (3.9-10 mmol/L) was increased during closed-loop insulin delivery compared with sensor-augmented pump therapy (72 vs. 53%, P < 0.001; primary end point), the mean glucose concentration was lowered (8.7 vs. 10.1 mmol/L, P = 0.028), and the time spent above the target level was reduced (P = 0.005) without changing the total daily insulin amount (P = 0.55). The time spent in the hypoglycemic range was low and comparable between interventions. CONCLUSIONS Unsupervised day-and-night hybrid closed-loop insulin delivery at home is feasible and safe in young people with type 1 diabetes. Compared with sensor-augmented insulin pump therapy, closed-loop insulin delivery may improve glucose control without increasing the risk of hypoglycemia in adolescents with suboptimally controlled type 1 diabetes.
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