Multinational Home Use of Closed-Loop Control Is Safe and Effective

作者：Anderson Stacey M; Raghinaru Dan; Pinsker Jordan E; Boscari Federico; Renard Eric; Buckingham Bruce A; Nimri Revital; Doyle Francis J III; Brown Sue A; Keith Hynes Patrick; Breton Marc D; Chernavvsky Daniel; Bevier Wendy C; Bradley Paige K; Bruttomesso Daniela; Del Favero Simone; Calore Roberta; Cobelli Claudio; Avogaro Angelo; Farret Anne; Place Jerome; Ly Trang T; Shanmugham Satya; Phillip Moshe; Dassau Eyal; Dasanayake Isuru S; Kollman Craig

来源：Diabetes Care, 2016, 39(7): 1143-1150.

DOI：10.2337/dc15-2468

OBJECTIVE
To evaluate the efficacy of a portable, wearable, wireless artificial pancreas system (the Diabetes Assistant [DiAs] running the Unified Safety System) on glucose control at home in overnight-only and 24/7 closed-loop control (CLC) modes in patients with type 1 diabetes.
RESEARCH DESIGN AND METHODS
At six clinical centers in four countries, 30 participants 18-66 years old with type 1 diabetes (43% female, 96% non-Hispanic white, median type 1 diabetes duration 19 years, median A1C 7.3%) completed the study. The protocol included a 2-week baseline sensor-augmented pump (SAP) period followed by 2 weeks of overnight-only CLC and 2 weeks of 24/7 CLC at home. Glucose control during CLC was compared with the baseline SAP.
RESULTS
Glycemic control parameters for overnight-only CLC were improved during the night-time period compared with baseline for hypoglycemia (time <70 mg/dL, primary end point median 1.1% vs. 3.0%; P < 0.001), time in target (70-180 mg/dL: 75% vs. 61%; P < 0.001), and glucose variability (coefficient of variation: 30% vs. 36%; P < 0.001). Similar improvements for day/night combined were observed with 24/7 CLC compared with baseline: 1.7% vs. 4.1%, P < 0.001; 73% vs. 65%, P < 0.001; and 34% vs. 38%, P < 0.001, respectively.
CONCLUSIONS
CLC running on a smartphone (DiAs) in the home environment was safe and effective. Overnight-only CLC reduced hypoglycemia and increased time in range overnight and increased time in range during the day; 24/7 CLC reduced hypoglycemia and increased time in range both overnight and during the day. Compared with overnight-only CLC, 24/7 CLC provided additional hypoglycemia protection during the day.

• 出版日期2016-7