TY - JOUR
T1 - The "Glucositter" overnight automated closed loop system for type 1 diabetes
T2 - A randomized crossover trial
AU - Nimri, Revital
AU - Danne, Thomas
AU - Kordonouri, Olga
AU - Atlas, Eran
AU - Bratina, Natasa
AU - Biester, Torban
AU - Avbelj, Magdalena
AU - Miller, Shahar
AU - Muller, Ido
AU - Phillip, Moshe
AU - Battelino, Tadej
PY - 2013/5
Y1 - 2013/5
N2 - 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±15.6yr; duration of diabetes 13.5±11.9yr; 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 63mg/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 63-140mg/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 36mg/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).
AB - 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±15.6yr; duration of diabetes 13.5±11.9yr; 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 63mg/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 63-140mg/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 36mg/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).
KW - Closed-loop
KW - MD-logic AP
KW - Overnight glucose control
KW - Type 1 diabetes
UR - http://www.scopus.com/inward/record.url?scp=84876806368&partnerID=8YFLogxK
U2 - 10.1111/pedi.12025
DO - 10.1111/pedi.12025
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C2 - 23448393
AN - SCOPUS:84876806368
SN - 1399-543X
VL - 14
SP - 159
EP - 167
JO - Pediatric Diabetes
JF - Pediatric Diabetes
IS - 3
ER -