title: Clinical results of an automated artificial pancreas using technosphere inhaled insulin to mimic first-phase insulin secretion.
abstract: OBJECTIVE
  The purpose of this study was to investigate whether or not adding a fixed preprandial dose of inhaled insulin to a fully automated closed loop artificial pancreas would improve the postprandial glucose control without adding an increased risk of hypoglycemia.
  
  
  METHODS
  Nine subjects with T1DM were recruited for the study. The patients were on closed-loop control for 24 hours starting around 4:30 pm. Mixed meals (~50 g CHO) were given at 6:30 pm and 7:00 am the following day. For the treatment group each meal was preceded by the inhalation of one 10 U dose of Technosphere Insulin (TI). Subcutaneous insulin delivery was controlled by a zone model predictive control algorithm (zone-MPC). At 11:00 am, the patient exercised for 30 ± 5 minutes at 50% of predicted heart rate reserve.
  
  
  RESULTS
  The use of TI resulted in increasing the median percentage time in range (70-180 mg/dl, BG) during the 5-hour postprandial period by 21.6% (81.6% and 60% in the with/without TI cases, respectively, P = .06) and reducing the median postprandial glucose peak by 33 mg/dl (172 mg/dl and 205 mg/dl in the with and without TI cases, respectively, P = .004). The median percentage time in range 80-140 mg/dl during the entire study period was 67.5% as compared to percentage time in range without the use of TI of 55.2% (P = .03).
  
  
  CONCLUSIONS
  Adding preprandial TI (See video supplement) to an automated closed-loop AP system resulted in superior postprandial control as demonstrated by lower postprandial glucose exposure without addition hypoglycemia.
authors.affiliation: Sansum Diabetes Research Institute, Santa Barbara, CA, USA Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA, USA hzisser@gmail.com.
authors.forename: Howard
authors.initials: H
authors.lastname: Zisser
authors.affiliation: Sansum Diabetes Research Institute, Santa Barbara, CA, USA Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA, USA Institute for Collaborative Biotechnologies, University of California, Santa Barbara, Santa Barbara, CA, USA.
authors.forename: Eyal
authors.initials: E
authors.lastname: Dassau
authors.affiliation: Sansum Diabetes Research Institute, Santa Barbara, CA, USA Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA, USA.
authors.forename: Justin J
authors.initials: JJ
authors.lastname: Lee
authors.affiliation: Sansum Diabetes Research Institute, Santa Barbara, CA, USA Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA, USA.
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Harvey
authors.affiliation: Sansum Diabetes Research Institute, Santa Barbara, CA, USA.
authors.forename: Wendy
authors.initials: W
authors.lastname: Bevier
authors.affiliation: Sansum Diabetes Research Institute, Santa Barbara, CA, USA Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA, USA Institute for Collaborative Biotechnologies, University of California, Santa Barbara, Santa Barbara, CA, USA.
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Doyle
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004435:Eating; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006339:Heart Rate; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019397:Pancreas, Artificial
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Health Monitoring System; artificial pancreas; closed-loop; glucose control; hypoglycemia mitigation; inhaled insulin; telemedicine; type 1 diabetes; unannounced meals; zone-MPC