Home Use of an Artificial Beta Cell in Type 1 Diabetes

作者：Hood Thabit, Martin Tauschmann, Janet M. Allen, Lalantha Leelarathna, Sara Hartnell, Malgorzata E. Wilinska, Carlo L. Acerini, Sibylle Dellweg, Carsten Benesch, Lutz Heinemann, Julia K. Mader, Manuel Holzer, Harald Kojzar, Jane Exall, James Yong, Jennifer Pichierri, Katharine Barnard, Craig Kollman, Peiyao Cheng, Peter C. Hindmarsh, Fiona Campbell, Sabine Arnolds, Thomas R. Pieber, Mark L. Evans, David B. Dunger, Roman Hovorka · 发表于：New England Journal of Medicine · 年份：2015 · DOI：10.1056/nejmoa1509351 · 被引用次数：451 · 研究领域：Diabetes Management and Research、Pancreatic function and diabetes、Hyperglycemia and glycemic control in critically ill and hospitalized patients

BACKGROUND: The feasibility, safety, and efficacy of prolonged use of an artificial beta cell (closed-loop insulin-delivery system) in the home setting have not been established. METHODS: In two multicenter, crossover, randomized, controlled studies conducted under free-living home conditions, we compared closed-loop insulin delivery with sensor-augmented pump therapy in 58 patients with type 1 diabetes. The closed-loop system was used day and night by 33 adults and overnight by 25 children and adolescents. Participants used the closed-loop system for a 12-week period and sensor-augmented pump therapy (control) for a similar period. The primary end point was the proportion of time that the glucose level was between 70 mg and 180 mg per deciliter for adults and between 70 mg and 145 mg per deciliter for children and adolescents. RESULTS: Among adults, the proportion of time that the glucose level was in the target range was 11.0 percentage points (95% confidence interval [CI], 8.1 to 13.8) greater with the use of the closed-loop system day and night than with control therapy (P<0.001). The mean glucose level was lower during the closed-loop phase than during the control phase (difference, -11 mg per deciliter; 95% CI, -17 to -6; P<0.001), as were the area under the curve for the period when the glucose level was less than 63 mg per deciliter (39% lower; 95% CI, 24 to 51; P<0.001) and the mean glycated hemoglobin level (difference, -0.3%; 95% CI, -0.5 to -0.1; P=0.002). Among c...