title: Predictive Hyperglycemia and Hypoglycemia Minimization: In-Home Evaluation of Safety, Feasibility, and Efficacy in Overnight Glucose Control in Type 1 Diabetes.
abstract: The objective of this study was to determine the safety, feasibility, and efficacy of a predictive hyperglycemia and hypoglycemia minimization (PHHM) system compared with predictive low-glucose insulin suspension (PLGS) alone in overnight glucose control.
  
  
  
  A 42-night trial was conducted in 30 individuals with type 1 diabetes in the age range 15-45 years. Participants were randomly assigned each night to either PHHM or PLGS and were blinded to the assignment. The system suspended the insulin pump on both the PHHM and PLGS nights for predicted hypoglycemia but delivered correction boluses for predicted hyperglycemia on PHHM nights only. The primary outcome was the percentage of time spent in a sensor glucose range of 70-180 mg/dL during the overnight period.
  
  
  
  The addition of automated insulin delivery with PHHM increased the time spent in the target range (70-180 mg/dL) from 71 ± 10% during PLGS nights to 78 ± 10% during PHHM nights (P< 0.001). The average morning blood glucose concentration improved from 163 ± 23 mg/dL after PLGS nights to 142 ± 18 mg/dL after PHHM nights (P< 0.001). Various sensor-measured hypoglycemic outcomes were similar on PLGS and PHHM nights. All participants completed 42 nights with no episodes of severe hypoglycemia, diabetic ketoacidosis, or other study- or device-related adverse events.
  
  
  
  The addition of a predictive hyperglycemia minimization component to our existing PLGS system was shown to be safe, feasible, and effective in overnight glucose control.
authors.affiliation: St. Joseph's Health Care London, London, Ontario, Canada.
authors.forename: Tamara
authors.initials: T
authors.lastname: Spaic
authors.affiliation: St. Joseph's Health Care London, London, Ontario, Canada.
authors.forename: Marsha
authors.initials: M
authors.lastname: Driscoll
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: Dan
authors.initials: D
authors.lastname: Raghinaru
authors.affiliation: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Buckingham
authors.affiliation: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA.
authors.forename: Darrell M
authors.initials: DM
authors.lastname: Wilson
authors.affiliation: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA.
authors.forename: Paula
authors.initials: P
authors.lastname: Clinton
authors.affiliation: Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO.
authors.forename: H Peter
authors.initials: HP
authors.lastname: Chase
authors.affiliation: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA.|Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO.
authors.forename: David M
authors.initials: DM
authors.lastname: Maahs
authors.affiliation: Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Forlenza
authors.affiliation: Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Emily
authors.initials: E
authors.lastname: Jost
authors.affiliation: St. Joseph's Health Care London, London, Ontario, Canada.
authors.forename: Irene
authors.initials: I
authors.lastname: Hramiak
authors.affiliation: St. Joseph's Health Care London, London, Ontario, Canada.
authors.forename: Terri
authors.initials: T
authors.lastname: Paul
authors.affiliation: Rensselaer Polytechnic Institute, Troy, NY.
authors.forename: B Wayne
authors.initials: BW
authors.lastname: Bequette
authors.affiliation: Rensselaer Polytechnic Institute, Troy, NY.
authors.forename: Faye
authors.initials: F
authors.lastname: Cameron
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: Roy W
authors.initials: RW
authors.lastname: Beck
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 jlum@jaeb.org.
authors.forename: John W
authors.initials: JW
authors.lastname: Lum
authors.affiliation: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA.
authors.forename: Trang T
authors.initials: TT
authors.lastname: Ly
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy*; D007003:Hypoglycemia / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D008297:Male; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin