التفاصيل البيبلوغرافية
| العنوان: |
Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial. |
| المؤلفون: |
Tauschmann, Martin, Allen, Janet M., Wilinska, Malgorzata E., Thabit, Hood, Acerini, Carlo L., Dunger, David B., Hovorka, Roman |
| المصدر: |
Diabetes Care; Nov2016, Vol. 39 Issue 11, p2019-2025, 7p, 2 Charts, 2 Graphs |
| مصطلحات موضوعية: |
INSULIN, TYPE 1 diabetes, CROSSOVER trials, CLOSED loop systems, HYPOGLYCEMIA, INSULIN therapy, BLOOD sugar, C-peptide, COMPARATIVE studies, GLYCOSYLATED hemoglobin, RESEARCH methodology, MEDICAL cooperation, RESEARCH, RESEARCH funding, TIME, URINALYSIS, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness |
| مستخلص: |
Objective: This study evaluated the feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions.Research Design and Methods: In an open-label randomized crossover study, 12 suboptimally controlled adolescents on insulin pump therapy (mean ± SD age 14.6 ± 3.1 years; HbA1c 69 ± 8 mmol/mol [8.5 ± 0.7%]; duration of diabetes 7.8 ± 3.5 years) underwent two 21-day periods in which hybrid closed-loop insulin delivery was compared with sensor-augmented insulin pump therapy in random order. During the closed-loop intervention, a model predictive algorithm automatically directed insulin delivery between meals and overnight. Participants used a bolus calculator to administer prandial boluses.Results: The proportion of time that sensor glucose was in the target range (3.9-10 mmol/L; primary end point) was increased during the closed-loop intervention compared with sensor-augmented insulin pump therapy by 18.8 ± 9.8 percentage points (mean ± SD; P < 0.001), the mean sensor glucose level was reduced by 1.8 ± 1.3 mmol/L (P = 0.001), and the time spent above target was reduced by 19.3 ± 11.3 percentage points (P < 0.001). The time spent with sensor glucose levels below 3.9 mmol/L was low and comparable between interventions (median difference 0.4 [interquartile range -2.2 to 1.3] percentage points; P = 0.33). Improved glucose control during closed-loop was associated with increased variability of basal insulin delivery (P < 0.001) and an increase in the total daily insulin dose (53.5 [39.5-72.1] vs. 51.5 [37.6-64.3] units/day; P = 0.006). Participants expressed positive attitudes and experience with the closed-loop system.Conclusions: Free-living home use of day-and-night closed-loop in suboptimally controlled adolescents with type 1 diabetes is safe, feasible, and improves glucose control without increasing the risk of hypoglycemia. Larger and longer studies are warranted. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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