title: Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes.
abstract: The safety and effectiveness of the in-home use of a hybrid closed-loop (HCL) system that automatically increases, decreases, and suspends insulin delivery in response to continuous glucose monitoring were investigated.
  
  
  
  Adolescents (n = 30, ages 14-21 years) and adults (n = 94, ages 22-75 years) with type 1 diabetes participated in a multicenter (nine sites in the United States, one site in Israel) pivotal trial. The Medtronic MiniMed®670G system was used during a 2-week run-in phase without HCL control, or Auto Mode, enabled (Manual Mode) and, thereafter, with Auto Mode enabled during a 3-month study phase. A supervised hotel stay (6 days/5 nights) that included a 24-h frequent blood sample testing with a reference measurement (i-STAT) occurred during the study phase.
  
  
  
  Adolescents (mean ± standard deviation [SD] 16.5 ± 2.29 years of age and 7.7 ± 4.15 years of diabetes) used the system for a median 75.8% (interquartile range [IQR] 68.0%-88.4%) of the time (2977 patient-days). Adults (mean ± SD 44.6 ± 12.79 years of age and 26.4 ± 12.43 years of diabetes) used the system for a median 88.0% (IQR 77.6%-92.7%) of the time (9412 patient-days). From baseline run-in to the end of study phase, adolescent and adult HbA1clevels decreased from 7.7% ± 0.8% to 7.1% ± 0.6% (P < 0.001) and from 7.3% ± 0.9% to 6.8% ± 0.6% (P < 0.001, Wilcoxon signed-rank test), respectively. The proportion of overall in-target (71-180 mg/dL) sensor glucose (SG) values increased from 60.4% ± 10.9% to 67.2% ± 8.2% (P < 0.001) in adolescents and from 68.8% ± 11.9% to 73.8% ± 8.4% (P < 0.001) in adults. During the hotel stay, the proportion of in-target i-STAT®blood glucose values was 67.4% ± 27.7% compared to SG values of 72.0% ± 11.6% for adolescents and 74.2% ± 17.5% compared to 76.9% ± 8.3% for adults. There were no severe hypoglycemic or diabetic ketoacidosis events in either cohort.
  
  
  
  HCL therapy was safe during in-home use by adolescents and adults and the study phase demonstrated increased time in target, and reductions in HbA1c,hyperglycemia and hypoglycemia, compared to baseline.
  
  
  
  Clinicaltrials.gov identifier: NCT02463097.
authors.affiliation: 1 Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, Colorado.
authors.forename: Satish K
authors.initials: SK
authors.lastname: Garg
authors.affiliation: 2 Yale University , New Haven, Connecticut.
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Weinzimer
authors.affiliation: 2 Yale University , New Haven, Connecticut.
authors.forename: William V
authors.initials: WV
authors.lastname: Tamborlane
authors.affiliation: 3 Stanford University , Stanford, California.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Buckingham
authors.affiliation: 4 Atlanta Diabetes Associates , Atlanta, Georgia .
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Bode
authors.affiliation: 5 AMCR Institute , Escondido, California.
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Bailey
authors.affiliation: 6 Rainier Clinical Research Center , Renton, Washington.
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Brazg
authors.affiliation: 7 Sheba Medical Center , Tel Hashomer, Israel .
authors.forename: Jacob
authors.initials: J
authors.lastname: Ilany
authors.affiliation: 1 Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, Colorado.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Slover
authors.affiliation: 8 University of Virginia , Charlottesville, Virginia.
authors.forename: Stacey M
authors.initials: SM
authors.lastname: Anderson
authors.affiliation: 9 International Diabetes Center , Minneapolis, Minnesota.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bergenstal
authors.affiliation: 10 Medtronic , Northridge, California.
authors.forename: Benyamin
authors.initials: B
authors.lastname: Grosman
authors.affiliation: 10 Medtronic , Northridge, California.
authors.forename: Anirban
authors.initials: A
authors.lastname: Roy
authors.affiliation: 10 Medtronic , Northridge, California.
authors.forename: Toni L
authors.initials: TL
authors.lastname: Cordero
authors.affiliation: 10 Medtronic , Northridge, California.
authors.forename: John
authors.initials: J
authors.lastname: Shin
authors.affiliation: 10 Medtronic , Northridge, California.
authors.forename: Scott W
authors.initials: SW
authors.lastname: Lee
authors.affiliation: 10 Medtronic , Northridge, California.
authors.forename: Francine R
authors.initials: FR
authors.lastname: Kaufman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Continuous glucose monitoring; Hybrid closed loop; Hyperglycemia; Hypoglycemia; Insulin pump; Sensor; Type 1 diabetes