The "Glucositter" overnight automated closed loop system for type 1 diabetes: A randomized crossover trial

Revital Nimri, Thomas Danne, Olga Kordonouri, Eran Atlas, Natasa Bratina, Torban Biester, Magdalena Avbelj, Shahar Miller, Ido Muller, Moshe Phillip, Tadej Battelino

Research output: Contribution to journalArticlepeer-review

Abstract

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).

Original languageEnglish
Pages (from-to)159-167
Number of pages9
JournalPediatric Diabetes
Volume14
Issue number3
DOIs
StatePublished - May 2013

Keywords

  • Closed-loop
  • MD-logic AP
  • Overnight glucose control
  • Type 1 diabetes

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