title: A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes.
abstract: OBJECTIVE
  Overnight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness, seizure, or even death. We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring (CGM) glucose levels.
  
  
  METHODS
  Following an initial run-in phase, a 42-night trial was conducted in 45 individuals aged 15-45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active (intervention night) or inactive (control night). The primary outcome was the proportion of nights in which ≥1 CGM glucose values ≤60 mg/dL occurred.
  
  
  RESULTS
  Overnight hypoglycemia with at least one CGM value ≤60 mg/dL occurred on 196 of 942 (21%) intervention nights versus 322 of 970 (33%) control nights (odds ratio 0.52 [95% CI 0.43-0.64]; P < 0.001). Median hypoglycemia area under the curve was reduced by 81%, and hypoglycemia lasting >2 h was reduced by 74%. Overnight sensor glucose was >180 mg/dL during 57% of control nights and 59% of intervention nights (P = 0.17), while morning blood glucose was >180 mg/dL following 21% and 27% of nights, respectively (P < 0.001), and >250 mg/dL following 6% and 6%, respectively. Morning ketosis was present <1% of the time in each arm.
  
  
  CONCLUSIONS
  Use of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis.
authors.affiliation: Barbara Davis Center for Childhood Diabetes, Aurora, CO.
authors.forename: David M
authors.initials: DM
authors.lastname: Maahs
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: Peter
authors.initials: P
authors.lastname: Calhoun
authors.affiliation: Stanford University, Stanford, CA.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Buckingham
authors.affiliation: Barbara Davis Center for Childhood Diabetes, Aurora, CO.
authors.forename: H Peter
authors.initials: HP
authors.lastname: Chase
authors.affiliation: St. Joseph's Health Care, London, Ontario, Canada.
authors.forename: Irene
authors.initials: I
authors.lastname: Hramiak
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: John
authors.initials: J
authors.lastname: Lum
authors.affiliation: Rensselaer Polytechnic Institute, Troy, NY.
authors.forename: Fraser
authors.initials: F
authors.lastname: Cameron
authors.affiliation: Rensselaer Polytechnic Institute, Troy, NY.
authors.forename: B Wayne
authors.initials: BW
authors.lastname: Bequette
authors.affiliation: Stanford University, Stanford, CA.
authors.forename: Tandy
authors.initials: T
authors.lastname: Aye
authors.affiliation: St. Joseph's Health Care, London, Ontario, Canada.
authors.forename: Terri
authors.initials: T
authors.lastname: Paul
authors.affiliation: Barbara Davis Center for Childhood Diabetes, Aurora, CO.
authors.forename: Robert
authors.initials: R
authors.lastname: Slover
authors.affiliation: Barbara Davis Center for Childhood Diabetes, Aurora, CO.
authors.forename: R Paul
authors.initials: RP
authors.lastname: Wadwa
authors.affiliation: Stanford University, Stanford, CA.
authors.forename: Darrell M
authors.initials: DM
authors.lastname: Wilson
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 rbeck@jaeb.org.
authors.forename: Roy W
authors.initials: RW
authors.lastname: Beck
mesh_terms: D000293:Adolescent; D000328:Adult; D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis / Q000187:drug effects; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D016883:Diabetic Ketoacidosis / Q000453:epidemiology; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin