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

Pediatr Diabetes. 2013 May;14(3):159-67. doi: 10.1111/pedi.12025. Epub 2013 Feb 28.


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 ( number, NCT 01238406).

Trial registration: NCT01238406.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Blood Glucose / analysis
  • Child
  • Cross-Over Studies
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Drug Administration Schedule
  • Feasibility Studies
  • Female
  • Fuzzy Logic
  • Humans
  • Hyperglycemia / prevention & control*
  • Hypoglycemia / prevention & control*
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use
  • Insulin / administration & dosage
  • Insulin / adverse effects
  • Insulin / therapeutic use
  • Insulin Infusion Systems / adverse effects
  • Male
  • Pancreas, Artificial* / adverse effects
  • Young Adult


  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin

Associated data