title: Predictive Low-Glucose Insulin Suspension Reduces Duration of Nocturnal Hypoglycemia in Children Without Increasing Ketosis.
abstract: OBJECTIVE
  Nocturnal hypoglycemia can cause seizures and is a major impediment to tight glycemic control, especially in young children with type 1 diabetes. We conducted an in-home randomized trial to assess the efficacy and safety of a continuous glucose monitor-based overnight predictive low-glucose suspend (PLGS) system.
  
  
  METHODS
  In two age-groups of children with type 1 diabetes (11-14 and 4-10 years of age), a 42-night trial for each child was conducted wherein each night was assigned randomly to either having the PLGS system active (intervention night) or inactive (control night). The primary outcome was percent time <70 mg/dL overnight.
  
  
  RESULTS
  Median time at <70 mg/dL was reduced by 54% from 10.1% on control nights to 4.6% on intervention nights (P < 0.001) in 11-14-year-olds (n = 45) and by 50% from 6.2% to 3.1% (P < 0.001) in 4-10-year-olds (n = 36). Mean overnight glucose was lower on control versus intervention nights in both age-groups (144 ± 18 vs. 152 ± 19 mg/dL [P < 0.001] and 153 ± 14 vs. 160 ± 16 mg/dL [P = 0.004], respectively). Mean morning blood glucose was 159 ± 29 vs. 176 ± 28 mg/dL (P < 0.001) in the 11-14-year-olds and 154 ± 25 vs. 158 ± 22 mg/dL (P = 0.11) in the 4-10-year-olds, respectively. No differences were found between intervention and control in either age-group in morning blood ketosis.
  
  
  CONCLUSIONS
  In 4-14-year-olds, use of a nocturnal PLGS system can substantially reduce overnight hypoglycemia without an increase in morning ketosis, although overnight mean glucose is slightly higher.
authors.affiliation: Stanford University, Stanford, CA.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Buckingham
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: Dan
authors.initials: D
authors.lastname: Raghinaru
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: Barbara Davis Center for Childhood Diabetes, Aurora, CO.
authors.forename: H Peter
authors.initials: HP
authors.lastname: Chase
authors.affiliation: Barbara Davis Center for Childhood Diabetes, Aurora, CO.
authors.forename: David M
authors.initials: DM
authors.lastname: Maahs
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: Stanford University, Stanford, CA.
authors.forename: Trang
authors.initials: T
authors.lastname: Ly
authors.affiliation: Stanford University, Stanford, CA.
authors.forename: Tandy
authors.initials: T
authors.lastname: Aye
authors.affiliation: St. Joseph's Health Care, London, ON, Canada.
authors.forename: Irene
authors.initials: I
authors.lastname: Hramiak
authors.affiliation: Children's Hospital, London Health Sciences Centre, London, ON, Canada.
authors.forename: Cheril
authors.initials: C
authors.lastname: Clarson
authors.affiliation: Children's Hospital, London Health Sciences Centre, London, ON, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Stein
authors.affiliation: Children's Hospital, London Health Sciences Centre, London, ON, Canada.
authors.forename: Patricia H
authors.initials: PH
authors.lastname: Gallego
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: John
authors.initials: J
authors.lastname: Lum
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: Judy
authors.initials: J
authors.lastname: Sibayan
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: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D002648:Child; D002675:Child, Preschool; D002940:Circadian Rhythm; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000175:diagnosis; D016883:Diabetic Ketoacidosis / Q000097:blood* / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood* / Q000175:diagnosis; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008991:Monitoring, Physiologic / Q000379:methods*; D012890:Sleep
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents