title: Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home.
abstract: After testing of a wearable artificial pancreas (AP) during evening and night (E/N-AP) under free-living conditions in patients with type 1 diabetes (T1D), we investigated AP during day and night (D/N-AP) for 1 month.
  
  
  
  Twenty adult patients with T1D who completed a previous randomized crossover study comparing 2-month E/N-AP versus 2-month sensor augmented pump (SAP) volunteered for 1-month D/N-AP nonrandomized extension. AP was executed by a model predictive control algorithm run by a modified smartphone wirelessly connected to a continuous glucose monitor (CGM) and insulin pump. CGM data were analyzed by intention-to-treat with percentage time-in-target (3.9-10 mmol/L) over 24 h as the primary end point.
  
  
  
  Time-in-target (mean ± SD, %) was similar over 24 h with D/N-AP versus E/N-AP: 64.7 ± 7.6 vs. 63.6 ± 9.9 (P = 0.79), and both were higher than with SAP: 59.7 ± 9.6 (P = 0.01 and P = 0.06, respectively). Time below 3.9 mmol/L was similarly and significantly reduced by D/N-AP and E/N-AP versus SAP (both P < 0.001). SD of blood glucose concentration (mmol/L) was lower with D/N-AP versus E/N-AP during whole daytime: 3.2 ± 0.6 vs. 3.4 ± 0.7 (P = 0.003), morning: 2.7 ± 0.5 vs. 3.1 ± 0.5 (P = 0.02), and afternoon: 3.3 ± 0.6 vs. 3.5 ± 0.8 (P = 0.07), and was lower with D/N-AP versus SAP over 24 h: 3.1 ± 0.5 vs. 3.3 ± 0.6 (P = 0.049). Insulin delivery (IU) over 24 h was higher with D/N-AP and SAP than with E/N-AP: 40.6 ± 15.5 and 42.3 ± 15.5 vs. 36.6 ± 11.6 (P = 0.03 and P = 0.0004, respectively).
  
  
  
  D/N-AP and E/N-AP both achieved better glucose control than SAP under free-living conditions. Although time in the different glycemic ranges was similar between D/N-AP and E/N-AP, D/N-AP further reduces glucose variability.
authors.affiliation: Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital; INSERM Clinical Investigation Centre 1411; Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France e-renard@chu-montpellier.fr.
authors.forename: Eric
authors.initials: E
authors.lastname: Renard
authors.affiliation: Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital; INSERM Clinical Investigation Centre 1411; Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Farret
authors.affiliation: Department of Endocrinology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Jort
authors.initials: J
authors.lastname: Kropff
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padova, Padova, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Bruttomesso
authors.affiliation: Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: Mirko
authors.initials: M
authors.lastname: Messori
authors.affiliation: Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital; INSERM Clinical Investigation Centre 1411; Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France.
authors.forename: Jerome
authors.initials: J
authors.lastname: Place
authors.affiliation: Department of Information Engineering, University of Padova, Padova, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Visentin
authors.affiliation: Department of Information Engineering, University of Padova, Padova, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Calore
authors.affiliation: Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Toffanin
authors.affiliation: Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Di Palma
authors.affiliation: Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.
authors.forename: Giordano
authors.initials: G
authors.lastname: Lanzola
authors.affiliation: Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Magni
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padova, Padova, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Boscari
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padova, Padova, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Galasso
authors.affiliation: Unit of Metabolic Diseases, Department of Internal Medicine, University of Padova, Padova, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Avogaro
authors.affiliation: Center for Diabetes Technology, University of Virginia, Charlottesville, VA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Keith-Hynes
authors.affiliation: Center for Diabetes Technology, University of Virginia, Charlottesville, VA.
authors.forename: Boris
authors.initials: B
authors.lastname: Kovatchev
authors.affiliation: Department of Information Engineering, University of Padova, Padova, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Del Favero
authors.affiliation: Department of Information Engineering, University of Padova, Padova, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Cobelli
authors.affiliation: Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: Lalo
authors.initials: L
authors.lastname: Magni
authors.affiliation: Department of Endocrinology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: J Hans
authors.initials: JH
authors.lastname: DeVries
mesh_terms: D000328:Adult; D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis* / Q000187:drug effects; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D002940:Circadian Rhythm / Q000502:physiology*; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D019397:Pancreas, Artificial; D012924:Social Conditions; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin