title: Multicenter outpatient dinner/overnight reduction of hypoglycemia and increased time of glucose in target with a wearable artificial pancreas using modular model predictive control in adults with type 1 diabetes.
abstract: OBJECTIVE
  To test in an outpatient setting the safety and efficacy of continuous subcutaneous insulin infusion (CSII) driven by a modular model predictive control (MMPC) algorithm informed by continuous glucose monitoring (CGM) measurement.
  
  
  METHODS
  13 patients affected by type 1 diabetes participated to a non-randomized outpatient 42-h experiment that included two evening meals and overnight periods (in short, dinner & night periods). CSII was patient-driven during dinner & night period 1 and MMPC-driven during dinner&night period 2. The study was conducted in hotels, where patients could move around freely. A CGM system (G4 Platinum; Dexcom Inc., San Diego, CA, USA) and insulin pump (AccuChek Combo; Roche Diagnostics, Mannheim, Germany) were connected wirelessly to a smartphone-based platform (DiAs, Diabetes Assistant; University of Virginia, Charlottesville, VA, USA) during both periods.
  
  
  RESULTS
  A significantly lower percentage of time spent with glucose levels <3.9 mmol/l was achieved in period 2 compared with period 1: 1.96 ± 4.56% vs 12.76 ± 15.84% (mean ± standard deviation, p < 0.01), together with a greater percentage of time spent in the 3.9-10 mmol/l target range: 83.56 ± 14.02% vs 62.43 ± 29.03% (p = 0.04). In addition, restricting the analysis to the overnight phases, a lower percentage of time spent with glucose levels <3.9 mmol/l (1.92 ± 4.89% vs 12.7 ± 19.75%; p = 0.03) was combined with a greater percentage of time spent in 3.9-10 mmol/l target range in period 2 compared with period 1 (92.16 ± 8.03% vs 63.97 ± 2.73%; p = 0.01). Average glucose levels were similar during both periods.
  
  
  CONCLUSIONS
  The results suggest that MMPC managed by a wearable system is safe and effective during evening meal and overnight. Its sustained use during this period is currently being tested in an ongoing randomized 2-month study.
authors.affiliation: Department of Information Engineering, University of Padova, Padova, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Del Favero
authors.forename: J
authors.initials: J
authors.lastname: Place
authors.forename: J
authors.initials: J
authors.lastname: Kropff
authors.forename: M
authors.initials: M
authors.lastname: Messori
authors.forename: P
authors.initials: P
authors.lastname: Keith-Hynes
authors.forename: R
authors.initials: R
authors.lastname: Visentin
authors.forename: M
authors.initials: M
authors.lastname: Monaro
authors.forename: S
authors.initials: S
authors.lastname: Galasso
authors.forename: F
authors.initials: F
authors.lastname: Boscari
authors.forename: C
authors.initials: C
authors.lastname: Toffanin
authors.forename: F
authors.initials: F
authors.lastname: Di Palma
authors.forename: G
authors.initials: G
authors.lastname: Lanzola
authors.forename: S
authors.initials: S
authors.lastname: Scarpellini
authors.forename: A
authors.initials: A
authors.lastname: Farret
authors.forename: B
authors.initials: B
authors.lastname: Kovatchev
authors.forename: A
authors.initials: A
authors.lastname: Avogaro
authors.forename: D
authors.initials: D
authors.lastname: Bruttomesso
authors.forename: L
authors.initials: L
authors.lastname: Magni
authors.forename: J H
authors.initials: JH
authors.lastname: DeVries
authors.forename: C
authors.initials: C
authors.lastname: Cobelli
authors.forename: E
authors.initials: E
authors.lastname: Renard
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D000553:Ambulatory Care; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D055870:Drug Chronotherapy; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D062407:Meals; D008875:Middle Aged; D019397:Pancreas, Artificial; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Artificial Pancreas; Clinical Trial; Closed-Loop; Glycaemic Control; Insulin Delivery; Outpatient; Technology and Diabetes; Type 1 Diabetes