title: The "Glucositter" overnight automated closed loop system for type 1 diabetes: a randomized crossover trial.
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).
  
  
  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).
  
  
  CONCLUSIONS
  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: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors: Revital
authors: R
authors: Nimri
authors: Thomas
authors: T
authors: Danne
authors: Olga
authors: O
authors: Kordonouri
authors: Eran
authors: E
authors: Atlas
authors: Natasa
authors: N
authors: Bratina
authors: Torban
authors: T
authors: Biester
authors: Magdalena
authors: M
authors: Avbelj
authors: Shahar
authors: S
authors: Miller
authors: Ido
authors: I
authors: Muller
authors: Moshe
authors: M
authors: Phillip
authors: Tadej
authors: T
authors: Battelino
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D002648:Child; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D017143:Fuzzy Logic; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007332:Insulin Infusion Systems / Q000009:adverse effects; D008297:Male; D019397:Pancreas, Artificial / Q000009:adverse effects; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin