Day and Night Closed-Loop Control in Adults With Type 1 Diabetes Mellitus
A comparison of two closed-loop algorithms driving continuous subcutaneous insulin infusion versus patient self-management
- Yoeri M. Luijf, PHD1⇑,
- J. Hans DeVries, PHD1,
- Koos Zwinderman, PHD2,
- Lalantha Leelarathna, MRCP3,
- Marianna Nodale, MSC3,
- Karen Caldwell, RN3,
- Kavita Kumareswaran, PHD3,
- Daniela Elleri, MD3,
- Janet M. Allen, RN3,
- Malgorzata E. Wilinska, PHD3,
- Mark L. Evans, MD3,
- Roman Hovorka, PHD3,
- Werner Doll, MS4,
- Martin Ellmerer, PHD4,
- Julia K. Mader, MD4,
- Eric Renard, PHD5,
- Jerome Place, MS5,
- Anne Farret, MD5,
- Claudio Cobelli, PHD6,
- Simone Del Favero, PHD6,
- Chiara Dalla Man, PHD6,
- Angelo Avogaro, PHD7,
- Daniela Bruttomesso, PHD7,
- Alessio Filippi, MD7,
- Rachele Scotton, MD7,
- Lalo Magni, PHD8,
- Giordano Lanzola, PHD8,
- Federico Di Palma, PHD8,
- Paola Soru, MS8,
- Chiara Toffanin, MS8,
- Giuseppe De Nicolao, PHD8,
- Sabine Arnolds, MD9,
- Carsten Benesch, PHD9,
- Lutz Heinemann, PHD9,
- on behalf of the AP@home consortium
- 1Department of Internal Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
- 2Department of Statistics, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
- 3Wellcome Trust-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre, University of Cambridge, Cambridge, U.K.
- 4Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria
- 5Department of Endocrinology, Diabetes, and Nutrition and INSERM Clinical Investigation Center CIC 1001, Centre Hospitalier Regional Universitaire Montpellier and University of Montpellier I, Montpellier, France
- 6Department of Information Engineering, University of Padova, Padova, Italy
- 7Department of Medicine, University of Padova, Padova, Italy
- 8Department of Computer Engineering and System Sciences, University of Pavia, Pavia, Italy
- 9Profil Institute for Metabolic Research, Neuss, Germany
- Corresponding author: Yoeri M. Luijf, .
OBJECTIVE To compare two validated closed-loop (CL) algorithms versus patient self-control with CSII in terms of glycemic control.
RESEARCH DESIGN AND METHODS This 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).
RESULTS Time 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, 8.27, 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.
CONCLUSIONS Both CAM and iAP algorithms provide safe glycemic control.
- Received September 25, 2012.
- Accepted July 10, 2013.
- © 2013 by the American Diabetes Association.
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