title: Predictors of Hypoglycemia in the ASPIRE In-Home Study and Effects of Automatic Suspension of Insulin Delivery.
abstract: BACKGROUND
  Hypoglycemia varies between patients with type 1 diabetes and is the main obstacle to therapy intensification. We investigated known and potential risk factors for hypoglycemia in subjects with type 1 diabetes.
  
  
  METHODS
  In the ASPIRE In-Home study (NCT01497938), a randomized trial of the threshold suspend (TS) feature of sensor-augmented insulin pump (SAP) therapy, subjects' propensity to nocturnal hypoglycemia (NH) was established in a 2-week run-in phase and assessed in a 3-month study phase via continuous glucose monitoring. Categorical variables were tested for association with NH rates in both phases.
  
  
  RESULTS
  Elevated rates of NH were significantly associated with baseline A1C ≤7%, with bolus insulin deliveries unassisted by the bolus estimation calculator, and with assignment to the control group during the study phase.
  
  
  CONCLUSIONS
  Routine use of the TS feature and the bolus estimation calculator are strategies that may reduce the risk of NH.
authors.affiliation: Department of Human Metabolism and Nutrition, Hebrew University, and the Department of Pediatrics, Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Ram
authors.initials: R
authors.lastname: Weiss
authors.affiliation: University of Colorado Denver, Aurora, CO, USA.
authors.forename: Satish K
authors.initials: SK
authors.lastname: Garg
authors.affiliation: International Diabetes Center, Minneapolis, MN, USA.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bergenstal
authors.affiliation: Mills-Peninsula Health Services, San Mateo, CA, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Klonoff
authors.affiliation: Atlanta Diabetes Associates, Atlanta, GA, USA.
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Bode
authors.affiliation: AMCR Institute, Escondido, CA, USA.
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Bailey
authors.affiliation: Arkansas Diabetes and Endocrinology Center, Little Rock, AR, USA.
authors.forename: James
authors.initials: J
authors.lastname: Thrasher
authors.affiliation: Ohio University College of Osteopathic Medicine, Athens, OH, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Schwartz
authors.affiliation: Medtronic, Inc., Northridge, CA, USA john.b.welsh@medtronic.com.
authors.forename: John B
authors.initials: JB
authors.lastname: Welsh
authors.affiliation: Medtronic, Inc., Northridge, CA, USA.
authors.forename: Francine R
authors.initials: FR
authors.lastname: Kaufman
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D008297:Male
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: ASPIRE In-Home; hypoglycemia; low glucose suspend; prediction; sensor-augmented pump therapy; threshold suspend