• Yoeri M Luijf, J Hans DeVries, Koos Zwinderman, Lalantha Leelarathna, Marianna Nodale, Karen Caldwell, Kavita Kumareswaran, Daniela Elleri, Janet M Allen, Malgorzata E Wilinska, Mark L Evans, Roman Hovorka, Werner Doll, Martin Ellmerer, Julia K Mader, Eric Renard, Jerome Place, Anne Farret, Claudio Cobelli, Simone Del Favero, Chiara Dalla Man, Angelo Avogaro, Daniela Bruttomesso, Alessio Filippi, Rachele Scotton, Lalo Magni, Giordano Lanzola, Federico Di Palma, Paola Soru, Chiara Toffanin, Giuseppe De Nicolao, Sabine Arnolds, Carsten Benesch, Lutz Heinemann, and AP@home Consortium.
• Corresponding author: Yoeri M. Luijf, y.m.luijf@gmail.com.
• Diabetes Care. 2013 Dec 1; 36 (12): 3882-7.

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 (<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.

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