title: Home Use of an Artificial Beta Cell in Type 1 Diabetes.
abstract: BACKGROUND
  The feasibility, safety, and efficacy of prolonged use of an artificial beta cell (closed-loop insulin-delivery system) in the home setting have not been established.
  
  
  METHODS
  In two multicenter, crossover, randomized, controlled studies conducted under free-living home conditions, we compared closed-loop insulin delivery with sensor-augmented pump therapy in 58 patients with type 1 diabetes. The closed-loop system was used day and night by 33 adults and overnight by 25 children and adolescents. Participants used the closed-loop system for a 12-week period and sensor-augmented pump therapy (control) for a similar period. The primary end point was the proportion of time that the glucose level was between 70 mg and 180 mg per deciliter for adults and between 70 mg and 145 mg per deciliter for children and adolescents.
  
  
  RESULTS
  Among adults, the proportion of time that the glucose level was in the target range was 11.0 percentage points (95% confidence interval [CI], 8.1 to 13.8) greater with the use of the closed-loop system day and night than with control therapy (P<0.001). The mean glucose level was lower during the closed-loop phase than during the control phase (difference, -11 mg per deciliter; 95% CI, -17 to -6; P<0.001), as were the area under the curve for the period when the glucose level was less than 63 mg per deciliter (39% lower; 95% CI, 24 to 51; P<0.001) and the mean glycated hemoglobin level (difference, -0.3%; 95% CI, -0.5 to -0.1; P=0.002). Among children and adolescents, the proportion of time with the nighttime glucose level in the target range was higher during the closed-loop phase than during the control phase (by 24.7 percentage points; 95% CI, 20.6 to 28.7; P<0.001), and the mean nighttime glucose level was lower (difference, -29 mg per deciliter; 95% CI, -39 to -20; P<0.001). The area under the curve for the period in which the day-and-night glucose levels were less than 63 mg per deciliter was lower by 42% (95% CI, 4 to 65; P=0.03). Three severe hypoglycemic episodes occurred during the closed-loop phase when the closed-loop system was not in use.
  
  
  CONCLUSIONS
  Among patients with type 1 diabetes, 12-week use of a closed-loop system, as compared with sensor-augmented pump therapy, improved glucose control, reduced hypoglycemia, and, in adults, resulted in a lower glycated hemoglobin level. (Funded by the JDRF and others; AP@home04 and APCam08 ClinicalTrials.gov numbers, NCT01961622 and NCT01778348.).
authors.forename: H
authors.initials: H
authors.lastname: Thabit
authors.forename: M
authors.initials: M
authors.lastname: Tauschmann
authors.forename: J M
authors.initials: JM
authors.lastname: Allen
authors.forename: L
authors.initials: L
authors.lastname: Leelarathna
authors.forename: S
authors.initials: S
authors.lastname: Hartnell
authors.forename: M E
authors.initials: ME
authors.lastname: Wilinska
authors.forename: C L
authors.initials: CL
authors.lastname: Acerini
authors.forename: S
authors.initials: S
authors.lastname: Dellweg
authors.forename: C
authors.initials: C
authors.lastname: Benesch
authors.forename: L
authors.initials: L
authors.lastname: Heinemann
authors.forename: J K
authors.initials: JK
authors.lastname: Mader
authors.forename: M
authors.initials: M
authors.lastname: Holzer
authors.forename: H
authors.initials: H
authors.lastname: Kojzar
authors.forename: J
authors.initials: J
authors.lastname: Exall
authors.forename: J
authors.initials: J
authors.lastname: Yong
authors.forename: J
authors.initials: J
authors.lastname: Pichierri
authors.forename: K D
authors.initials: KD
authors.lastname: Barnard
authors.forename: C
authors.initials: C
authors.lastname: Kollman
authors.forename: P
authors.initials: P
authors.lastname: Cheng
authors.forename: P C
authors.initials: PC
authors.lastname: Hindmarsh
authors.forename: F M
authors.initials: FM
authors.lastname: Campbell
authors.forename: S
authors.initials: S
authors.lastname: Arnolds
authors.forename: T R
authors.initials: TR
authors.lastname: Pieber
authors.forename: M L
authors.initials: ML
authors.lastname: Evans
authors.forename: D B
authors.initials: DB
authors.lastname: Dunger
authors.forename: R
authors.initials: R
authors.lastname: Hovorka
mesh_terms: D000293:Adolescent; D000328:Adult; D000465:Algorithms; D002648:Child; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004867:Equipment Design; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D015918:Infusion Pumps, Implantable; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects*; D007332:Insulin Infusion Systems / Q000009:adverse effects; D008297:Male; D008875:Middle Aged
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin