title: Feasibility study of a bio-inspired artificial pancreas in adults with type 1 diabetes.
abstract: BACKGROUND
  This study assesses proof of concept and safety of a novel bio-inspired artificial pancreas (BiAP) system in adults with type 1 diabetes during fasting, overnight, and postprandial conditions. In contrast to existing glucose controllers in artificial pancreas systems, the BiAP uses a control algorithm based on a mathematical model of β-cell physiology. The algorithm is implemented on a miniature silicon microchip within a portable hand-held device that interfaces the components of the artificial pancreas.
  
  
  METHODS
  In this nonrandomized open-label study each subject attended for a 6-h fasting study followed by a 13-h overnight and post-breakfast study on a separate occasion. During both study sessions the BiAP system was used, and microboluses of insulin were recommended every 5 min by the control algorithm according to subcutaneous sensor glucose levels. The primary outcome was percentage time spent in the glucose target range (3.9-10.0 mmol/L).
  
  
  RESULTS
  Twenty subjects (55% male; mean [SD] age, 44 [10] years; duration of diabetes, 22 [12] years; glycosylated hemoglobin, 7.4% [0.7%] [57 (7) mmol/mol]; body mass index, 25 [4] kg/m(2)) participated in the fasting study, and the median (interquartile range) percentage time in target range was 98.0% (90.8-100.0%). Seventeen of these subjects then participated in the overnight/postprandial study, where 70.7% (63.9-77.4%) of time was spent in the target range and, reassuringly, 0.0% (0.0-2.3%) of time was spent in hypoglycemia (<3.9 mmol/L).
  
  
  CONCLUSIONS
  The BiAP achieves safe glycemic control during fasting, overnight, and postprandial conditions.
authors.affiliation: 1 Division of Diabetes, Endocrinology and Metabolism, Imperial College London , London, United Kingdom .
authors.forename: Monika
authors.initials: M
authors.lastname: Reddy
authors.forename: Pau
authors.initials: P
authors.lastname: Herrero
authors.forename: Mohamed
authors.initials: M
authors.lastname: El Sharkawy
authors.forename: Peter
authors.initials: P
authors.lastname: Pesl
authors.forename: Narvada
authors.initials: N
authors.lastname: Jugnee
authors.forename: Hazel
authors.initials: H
authors.lastname: Thomson
authors.forename: Darrell
authors.initials: D
authors.lastname: Pavitt
authors.forename: Christofer
authors.initials: C
authors.lastname: Toumazou
authors.forename: Desmond
authors.initials: D
authors.lastname: Johnston
authors.forename: Pantelis
authors.initials: P
authors.lastname: Georgiou
authors.forename: Nick
authors.initials: N
authors.lastname: Oliver
mesh_terms: D000328:Adult; D000465:Algorithms; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation; D002940:Circadian Rhythm; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage* / Q000378:metabolism; D007332:Insulin Infusion Systems; D000078790:Insulin Secretion; D056656:Lab-On-A-Chip Devices; D008297:Male; D008991:Monitoring, Physiologic; D019397:Pancreas, Artificial; D019518:Postprandial Period; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human