title: Day and night closed-loop control in adults with type 1 diabetes: a comparison of two closed-loop algorithms driving continuous subcutaneous insulin infusion versus patient self-management.
abstract: OBJECTIVE
  To compare two validated closed-loop (CL) algorithms versus patient self-control with CSII in terms of glycemic control.
  
  
  METHODS
  This study was a multicenter, randomized, three-way crossover, open-label trial in 48 patients with type 1 diabetes mellitus for at least 6 months, treated with continuous subcutaneous insulin infusion. Blood glucose was controlled for 23 h by the algorithm of the Universities of Pavia and Padova with a Safety Supervision Module developed at the Universities of Virginia and California at Santa Barbara (international artificial pancreas [iAP]), by the algorithm of University of Cambridge (CAM), or by patients themselves in open loop (OL) during three hospital admissions including meals and exercise. The main analysis was on an intention-to-treat basis. Main outcome measures included time spent in target (glucose levels between 3.9 and 8.0 mmol/L or between 3.9 and 10.0 mmol/L after meals).
  
  
  RESULTS
  Time spent in the target range was similar in CL and OL: 62.6% for OL, 59.2% for iAP, and 58.3% for CAM. While mean glucose level was significantly lower in OL (7.19, 8.15, and 8.26 mmol/L, respectively) (overall P = 0.001), percentage of time spent in hypoglycemia (<3.9 mmol/L) was almost threefold reduced during CL (6.4%, 2.1%, and 2.0%) (overall P = 0.001) with less time ≤2.8 mmol/L (overall P = 0.038). There were no significant differences in outcomes between algorithms.
  
  
  CONCLUSIONS
  Both CAM and iAP algorithms provide safe glycemic control.
authors.affiliation: Corresponding author: Yoeri M. Luijf, y.m.luijf@gmail.com.
authors.forename: Yoeri M
authors.initials: YM
authors.lastname: Luijf
authors.forename: J Hans
authors.initials: JH
authors.lastname: DeVries
authors.forename: Koos
authors.initials: K
authors.lastname: Zwinderman
authors.forename: Lalantha
authors.initials: L
authors.lastname: Leelarathna
authors.forename: Marianna
authors.initials: M
authors.lastname: Nodale
authors.forename: Karen
authors.initials: K
authors.lastname: Caldwell
authors.forename: Kavita
authors.initials: K
authors.lastname: Kumareswaran
authors.forename: Daniela
authors.initials: D
authors.lastname: Elleri
authors.forename: Janet M
authors.initials: JM
authors.lastname: Allen
authors.forename: Malgorzata E
authors.initials: ME
authors.lastname: Wilinska
authors.forename: Mark L
authors.initials: ML
authors.lastname: Evans
authors.forename: Roman
authors.initials: R
authors.lastname: Hovorka
authors.forename: Werner
authors.initials: W
authors.lastname: Doll
authors.forename: Martin
authors.initials: M
authors.lastname: Ellmerer
authors.forename: Julia K
authors.initials: JK
authors.lastname: Mader
authors.forename: Eric
authors.initials: E
authors.lastname: Renard
authors.forename: Jerome
authors.initials: J
authors.lastname: Place
authors.forename: Anne
authors.initials: A
authors.lastname: Farret
authors.forename: Claudio
authors.initials: C
authors.lastname: Cobelli
authors.forename: Simone
authors.initials: S
authors.lastname: Del Favero
authors.forename: Chiara
authors.initials: C
authors.lastname: Dalla Man
authors.forename: Angelo
authors.initials: A
authors.lastname: Avogaro
authors.forename: Daniela
authors.initials: D
authors.lastname: Bruttomesso
authors.forename: Alessio
authors.initials: A
authors.lastname: Filippi
authors.forename: Rachele
authors.initials: R
authors.lastname: Scotton
authors.forename: Lalo
authors.initials: L
authors.lastname: Magni
authors.forename: Giordano
authors.initials: G
authors.lastname: Lanzola
authors.forename: Federico
authors.initials: F
authors.lastname: Di Palma
authors.forename: Paola
authors.initials: P
authors.lastname: Soru
authors.forename: Chiara
authors.initials: C
authors.lastname: Toffanin
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Nicolao
authors.forename: Sabine
authors.initials: S
authors.lastname: Arnolds
authors.forename: Carsten
authors.initials: C
authors.lastname: Benesch
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000465:Algorithms; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007260:Infusion Pumps; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D012648:Self Care / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin