The “Glucositter” overnight automated closed loop system for type 1 diabetes: A randomized crossover trial
Version of Record online: 28 FEB 2013
© 2013 John Wiley & Sons A/S
Volume 14, Issue 3, pages 159–167, May 2013
How to Cite
The “Glucositter” overnight automated closed loop system for type 1 diabetes: A randomized crossover trial., , , , , , , , , , .
- Issue online: 23 APR 2013
- Version of Record online: 28 FEB 2013
- Manuscript Accepted: 9 JAN 2013
- Manuscript Revised: 7 JAN 2013
- Manuscript Received: 18 OCT 2012
- Slovenian National Research Agency. Grant Number: P3-0343, J3-4116, J3-2412
- MD-logic AP;
- overnight glucose control;
- type 1 diabetes
Tight glucose control is needed to prevent long-term diabetes complications; this is hindered by the risk of hypoglycemia, especially at night.
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.
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).
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).