title: Efficacy of an Overnight Predictive Low-Glucose Suspend System in Relation to Hypoglycemia Risk Factors in Youth and Adults With Type 1 Diabetes.
abstract: We developed a system to suspend insulin pump delivery overnight when the glucose trend predicts hypoglycemia. This predictive low-glucose suspend (PLGS) system substantially reduces nocturnal hypoglycemia without an increase in morning ketosis. Evaluation of hypoglycemia risk factors that could potentially influence the efficacy of the system remains critical for understanding possible problems with the system and identifying patients that may have the greatest benefit when using the system.
  
  
  
  The at-home randomized trial consisted of 127 study participants with hemoglobin A1c (A1C) of ≤8.5% (mmol/mol) for patients aged 4-14 years and ≤8.0% for patient aged 15-45 years. Factors assessed included age, gender, A1C, diabetes duration, daily percentage basal insulin, total daily dose of insulin (units/kg-day), bedtime BG, bedtime snack, insulin on board, continuous glucose monitor (CGM) rate of change (ROC), day of the week, time system activated, daytime exercise intensity, and daytime CGM-measured hypoglycemia.
  
  
  
  The PLGS system was effective in preventing hypoglycemia for each factor subgroup. There was no evidence that the PLGS system was more or less effective in preventing hypoglycemia in any one subgroup compared with the other subgroups based on that factor. In addition, the effect of the system on overnight hyperglycemia did not differ in subgroups.
  
  
  
  The PLGS system tested in this study effectively reduced hypoglycemia without a meaningful increase in hyperglycemia across a variety of factors.
authors.affiliation: Jaeb Center for Health Research, Tampa, FL, USA.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Calhoun
authors.affiliation: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Buckingham
authors.affiliation: Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora CO, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Maahs
authors.affiliation: St. Joseph's Health Care, London, Ontario, Canada.
authors.forename: Irene
authors.initials: I
authors.lastname: Hramiak
authors.affiliation: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA, USA.
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, USA.
authors.forename: Tandy
authors.initials: T
authors.lastname: Aye
authors.affiliation: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford, CA, USA.
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, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Chase
authors.affiliation: Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora CO, USA.
authors.forename: Laurel
authors.initials: L
authors.lastname: Messer
authors.affiliation: Jaeb Center for Health Research, Tampa, FL, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Kollman
authors.affiliation: Jaeb Center for Health Research, Tampa, FL, USA.
authors.forename: Roy W
authors.initials: RW
authors.lastname: Beck
authors.affiliation: Jaeb Center for Health Research, Tampa, FL, USA jlum@jaeb.org.
authors.forename: John
authors.initials: J
authors.lastname: Lum
mesh_terms: D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D012372:ROC Curve; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: hypoglycemia; insulin pump; predictive low glucose suspend; sensor; type 1 diabetes