BACKGROUND: Tight glucose control is needed to prevent long-term diabetes complications; this is hindered by the risk of hypoglycemia, especially at night. OBJECTIVE: To assess the safety and efficacy of the closed-loop MD-Logic Artificial Pancreas (MDLAP), controlling nocturnal glucose levels in patients with type 1 diabetes mellitus (T1DM). RESEARCH DESIGN AND METHODS: This was a randomized, multicenter, multinational, crossover trial conducted in Slovenia, Germany, and Israel. Twelve patients with T1DM (age 23.8 ± 15.6 yr; duration of diabetes13.5 ± 11.9 yr; A1c 8.1 ± 0.8%, mean± SD) were randomly assigned to participate in two sequential overnight sessions: one using continuous subcutaneous insulin infusion (CSII) and the other, closed-loop insulin delivery by MDLAP. The primary outcome was the number of hypoglycemic events below 63 mg/dL. Endpoints analyses were based on sensor glucose readings. RESULTS: Three events of nocturnal hypoglycemia occurred during CSII and none during the closed-loop control (p = 0.18). The percentage of time spent in the near normal range of 63-140 mg/dL was significantly higher in the overnight closed-loop sessions [76% (54-85)] than during CSII therapy [29% (11-44)] [p = 0.02, median (interquartile range)]. The mean overnight glucose level was reduced by 36 mg/dL with closed-loop insulin delivery (p = 0.02) with a significantly less glucose variability when compared with the CSII nights (p < 0.001). CONCLUSION: The results of this study demonstrate the ability of the MDLAP to safely improve overnight glucose control without increased risk of hypoglycemia in patients with T1DM at three different national, geographic, and clinical centers (ClinicalTrials.gov number, NCT 01238406).
RCT Entities:
BACKGROUND: Tight glucose control is needed to prevent long-term diabetes complications; this is hindered by the risk of hypoglycemia, especially at night. OBJECTIVE: To assess the safety and efficacy of the closed-loop MD-Logic Artificial Pancreas (MDLAP), controlling nocturnal glucose levels in patients with type 1 diabetes mellitus (T1DM). RESEARCH DESIGN AND METHODS: This was a randomized, multicenter, multinational, crossover trial conducted in Slovenia, Germany, and Israel. Twelve patients with T1DM (age 23.8 ± 15.6 yr; duration of diabetes 13.5 ± 11.9 yr; A1c 8.1 ± 0.8%, mean ± SD) were randomly assigned to participate in two sequential overnight sessions: one using continuous subcutaneous insulin infusion (CSII) and the other, closed-loop insulin delivery by MDLAP. The primary outcome was the number of hypoglycemic events below 63 mg/dL. Endpoints analyses were based on sensor glucose readings. RESULTS: Three events of nocturnal hypoglycemia occurred during CSII and none during the closed-loop control (p = 0.18). The percentage of time spent in the near normal range of 63-140 mg/dL was significantly higher in the overnight closed-loop sessions [76% (54-85)] than during CSII therapy [29% (11-44)] [p = 0.02, median (interquartile range)]. The mean overnight glucose level was reduced by 36 mg/dL with closed-loop insulin delivery (p = 0.02) with a significantly less glucose variability when compared with the CSII nights (p < 0.001). CONCLUSION: The results of this study demonstrate the ability of the MDLAP to safely improve overnight glucose control without increased risk of hypoglycemia in patients with T1DM at three different national, geographic, and clinical centers (ClinicalTrials.gov number, NCT 01238406).
Authors: Stephen T Bartlett; James F Markmann; Paul Johnson; Olle Korsgren; Bernhard J Hering; David Scharp; Thomas W H Kay; Jonathan Bromberg; Jon S Odorico; Gordon C Weir; Nancy Bridges; Raja Kandaswamy; Peter Stock; Peter Friend; Mitsukazu Gotoh; David K C Cooper; Chung-Gyu Park; Phillip OʼConnell; Cherie Stabler; Shinichi Matsumoto; Barbara Ludwig; Pratik Choudhary; Boris Kovatchev; Michael R Rickels; Megan Sykes; Kathryn Wood; Kristy Kraemer; Albert Hwa; Edward Stanley; Camillo Ricordi; Mark Zimmerman; Julia Greenstein; Eduard Montanya; Timo Otonkoski Journal: Transplantation Date: 2016-02 Impact factor: 4.939
Authors: Howard Zisser; Eric Renard; Boris Kovatchev; Claudio Cobelli; Angelo Avogaro; Revital Nimri; Lalo Magni; Bruce A Buckingham; H Peter Chase; Francis J Doyle; John Lum; Peter Calhoun; Craig Kollman; Eyal Dassau; Anne Farret; Jerome Place; Marc Breton; Stacey M Anderson; Chiara Dalla Man; Simone Del Favero; Daniela Bruttomesso; Alessio Filippi; Rachele Scotton; Moshe Phillip; Eran Atlas; Ido Muller; Shahar Miller; Chiara Toffanin; Davide Martino Raimondo; Giuseppe De Nicolao; Roy W Beck Journal: Diabetes Technol Ther Date: 2014-07-08 Impact factor: 6.118
Authors: Jennifer L Sherr; Neha S Patel; Camille I Michaud; Miladys M Palau-Collazo; Michelle A Van Name; William V Tamborlane; Eda Cengiz; Lori R Carria; Eileen M Tichy; Stuart A Weinzimer Journal: Diabetes Care Date: 2016-05-05 Impact factor: 19.112
Authors: Martin Tauschmann; Janet M Allen; Malgorzata E Wilinska; Hood Thabit; Carlo L Acerini; David B Dunger; Roman Hovorka Journal: Diabetes Care Date: 2016-09-09 Impact factor: 19.112
Authors: Lalantha Leelarathna; Hood Thabit; Janet M Allen; Marianna Nodale; Malgorzata E Wilinska; Kevin Powell; Stephen Lane; Mark L Evans; Roman Hovorka Journal: J Diabetes Sci Technol Date: 2014-03-24