title: Multinational Home Use of Closed-Loop Control Is Safe and Effective.
abstract: To evaluate the efficacy of a portable, wearable, wireless artificial pancreas system (the Diabetes Assistant [DiAs] running the Unified Safety System) on glucose control at home in overnight-only and 24/7 closed-loop control (CLC) modes in patients with type 1 diabetes.
  
  
  
  At six clinical centers in four countries, 30 participants 18-66 years old with type 1 diabetes (43% female, 96% non-Hispanic white, median type 1 diabetes duration 19 years, median A1C 7.3%) completed the study. The protocol included a 2-week baseline sensor-augmented pump (SAP) period followed by 2 weeks of overnight-only CLC and 2 weeks of 24/7 CLC at home. Glucose control during CLC was compared with the baseline SAP.
  
  
  
  Glycemic control parameters for overnight-only CLC were improved during the nighttime period compared with baseline for hypoglycemia (time <70 mg/dL, primary end point median 1.1% vs. 3.0%; P < 0.001), time in target (70-180 mg/dL: 75% vs. 61%; P < 0.001), and glucose variability (coefficient of variation: 30% vs. 36%; P < 0.001). Similar improvements for day/night combined were observed with 24/7 CLC compared with baseline: 1.7% vs. 4.1%, P < 0.001; 73% vs. 65%, P < 0.001; and 34% vs. 38%, P < 0.001, respectively.
  
  
  
  CLC running on a smartphone (DiAs) in the home environment was safe and effective. Overnight-only CLC reduced hypoglycemia and increased time in range overnight and increased time in range during the day; 24/7 CLC reduced hypoglycemia and increased time in range both overnight and during the day. Compared with overnight-only CLC, 24/7 CLC provided additional hypoglycemia protection during the day.
authors.affiliation: University of Virginia, Charlottesville, VA.
authors.forename: Stacey M
authors.initials: SM
authors.lastname: Anderson
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: Dan
authors.initials: D
authors.lastname: Raghinaru
authors.affiliation: William Sansum Diabetes Center, Santa Barbara, CA.
authors.forename: Jordan E
authors.initials: JE
authors.lastname: Pinsker
authors.affiliation: University of Padova, Padova, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Boscari
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition and INSERM 1411 Clinical Investigation Center, Montpellier University Hospital, and UMR CNRS 5203/INSERM U1191, Institute of Functional Genomics, University of Montpellier, Montpellier, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Renard
authors.affiliation: Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Buckingham
authors.affiliation: Jesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, and Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel.
authors.forename: Revital
authors.initials: R
authors.lastname: Nimri
authors.affiliation: Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Doyle
authors.affiliation: University of Virginia, Charlottesville, VA.
authors.forename: Sue A
authors.initials: SA
authors.lastname: Brown
authors.affiliation: University of Virginia, Charlottesville, VA TypeZero Technologies, LLC, Charlottesville, VA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Keith-Hynes
authors.affiliation: University of Virginia, Charlottesville, VA.
authors.forename: Marc D
authors.initials: MD
authors.lastname: Breton
authors.affiliation: University of Virginia, Charlottesville, VA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chernavvsky
authors.affiliation: William Sansum Diabetes Center, Santa Barbara, CA.
authors.forename: Wendy C
authors.initials: WC
authors.lastname: Bevier
authors.affiliation: William Sansum Diabetes Center, Santa Barbara, CA.
authors.forename: Paige K
authors.initials: PK
authors.lastname: Bradley
authors.affiliation: University of Padova, Padova, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Bruttomesso
authors.affiliation: University of Padova, Padova, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Del Favero
authors.affiliation: University of Padova, Padova, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Calore
authors.affiliation: University of Padova, Padova, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Cobelli
authors.affiliation: University of Padova, Padova, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Avogaro
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition and INSERM 1411 Clinical Investigation Center, Montpellier University Hospital, and UMR CNRS 5203/INSERM U1191, Institute of Functional Genomics, University of Montpellier, Montpellier, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Farret
authors.affiliation: Department of Endocrinology, Diabetes, and Nutrition and INSERM 1411 Clinical Investigation Center, Montpellier University Hospital, and UMR CNRS 5203/INSERM U1191, Institute of Functional Genomics, University of Montpellier, Montpellier, France.
authors.forename: Jerome
authors.initials: J
authors.lastname: Place
authors.affiliation: Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.
authors.forename: Trang T
authors.initials: TT
authors.lastname: Ly
authors.affiliation: Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.
authors.forename: Satya
authors.initials: S
authors.lastname: Shanmugham
authors.affiliation: Jesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, and Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel.
authors.forename: Moshe
authors.initials: M
authors.lastname: Phillip
authors.affiliation: Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.
authors.forename: Eyal
authors.initials: E
authors.lastname: Dassau
authors.affiliation: Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA.
authors.forename: Isuru S
authors.initials: IS
authors.lastname: Dasanayake
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: Craig
authors.initials: C
authors.lastname: Kollman
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: John W
authors.initials: JW
authors.lastname: Lum
authors.affiliation: Jaeb Center for Health Research, Tampa, FL rbeck@jaeb.org.
authors.forename: Roy W
authors.initials: RW
authors.lastname: Beck
authors.affiliation: University of Virginia, Charlottesville, VA.
authors.forename: Boris
authors.initials: B
authors.lastname: Kovatchev
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis* / Q000187:drug effects; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems; D038622:Internationality; D008297:Male; D008875:Middle Aged; D063731:Mobile Applications; D019397:Pancreas, Artificial / Q000009:adverse effects; D000068997:Smartphone; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin