Day and Night Closed-Loop Control in Adults With Type 1 Diabetes A comparison of two closed-loop algorithms driving continuous subcutaneous insulin infusion versus patient self-management

作者：Luijf Yoeri M^*; DeVries J Hans; Zwinderman Koos; Leelarathna Lalantha; Nodale Marianna; Caldwell Karen; Kumareswaran Kavita; Elleri Daniela; Allen Janet M; Wilinska Malgorzata E; Evans Mark L; Hovorka Roman; Doll Werner; Ellmerer Martin; Mader Julia K; Renard Eric; Place Jerome; Farret Anne; Cobelli Claudio; Del Favero Simone; Dalla Man Chiara; Avogaro Angelo; Bruttomesso Daniela; Filippi Alessio; Scotton Rachele; Magni Lalo; Lanzola Giordano; Di Palma Federico

来源：Diabetes Care, 2013, 36(12): 3882-3887.

DOI：10.2337/dc12-1956

OBJECTIVETo compare two validated closed-loop (CL) algorithms versus patient self-control with CSII in terms of glycemic control.RESEARCH DESIGN AND METHODSThis study was a multicenter, randomized, three-way crossover, open-label trial in 48 patients with type 1 diabetes mellitus for at least 6 months, treated with continuous subcutaneous insulin infusion. Blood glucose was controlled for 23 h by the algorithm of the Universities of Pavia and Padova with a Safety Supervision Module developed at the Universities of Virginia and California at Santa Barbara (international artificial pancreas [iAP]), by the algorithm of University of Cambridge (CAM), or by patients themselves in open loop (OL) during three hospital admissions including meals and exercise. The main analysis was on an intention-to-treat basis. Main outcome measures included time spent in target (glucose levels between 3.9 and 8.0 mmol/L or between 3.9 and 10.0 mmol/L after meals).RESULTSTime spent in the target range was similar in CL and OL: 62.6% for OL, 59.2% for iAP, and 58.3% for CAM. While mean glucose level was significantly lower in OL (7.19, 8.15, and 8.26 mmol/L, respectively) (overall P = 0.001), percentage of time spent in hypoglycemia (%26lt;3.9 mmol/L) was almost threefold reduced during CL (6.4%, 2.1%, and 2.0%) (overall P = 0.001) with less time 2.8 mmol/L (overall P = 0.038). There were no significant differences in outcomes between algorithms.CONCLUSIONSBoth CAM and iAP algorithms provide safe glycemic control.

• 出版日期2013-12