title: Feasibility study of automated overnight closed-loop glucose control under MD-logic artificial pancreas in patients with type 1 diabetes: the DREAM Project.
abstract: BACKGROUND
  Artificial pancreas systems may offer a potential major impact on the normalization of metabolic control and preventing hypoglycemic events. This study aims to establish near-normal overnight glucose control and reduce the risk of nocturnal hypoglycemia using the MD-Logic Artificial Pancreas (MDLAP), an algorithm that was developed by our research group. This inpatient feasibility study is the first step towards implementing an overnight closed-loop MDLAP system at the patient's home.
  
  
  METHODS
  Seven patients with type 1 diabetes (three adolescents and four adults; mean±SD age, 20.6±4.7 years; duration of diabetes, 9.6±2.6 years; body mass index, 24.3±3.9 kg/m(2); and glycated hemoglobin, 7.8±0.8%) participated in a total of 14 closed-loop overnight sessions. Each participant underwent two closed-loop inpatient sessions starting at dinner alone and at dinner following exercise. The closed-loop inpatient sessions were compared with data derived from nights spent at home with an open-loop system in a similar scenario to the study protocol.
  
  
  RESULTS
  The mean percentage of time spent in the near normal glucose range of 63-140 mg/dL was 83±16%, and the median (interquartile range) was 85% (78-92%) for the overnight closed-loop sessions compared with 34±31% and 27% (6-57%) in the homecare open-loop setting, respectively. During the overnight closed-loop sessions at dinner alone 92±9% of the sensor values ranged within target range, compared with 73±19% for the sessions following exercise (P=0.03). No hypoglycemic (<63 mg/dL) events occurred during the closed-loop sessions.
  
  
  CONCLUSIONS
  Closed-loop insulin delivery under MDLAP is a feasible and safe solution to control overnight glycemia.
authors.affiliation: Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, The National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, 14 Kaplan St., Petah Tikva, Israel .
authors.forename: Revital
authors.initials: R
authors.lastname: Nimri
authors.forename: Eran
authors.initials: E
authors.lastname: Atlas
authors.forename: Michal
authors.initials: M
authors.lastname: Ajzensztejn
authors.forename: Shahar
authors.initials: S
authors.lastname: Miller
authors.forename: Tal
authors.initials: T
authors.lastname: Oron
authors.forename: Moshe
authors.initials: M
authors.lastname: Phillip
mesh_terms: D000465:Algorithms; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring; D002940:Circadian Rhythm; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D008991:Monitoring, Physiologic; D019397:Pancreas, Artificial; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human