Predictors of Hypoglycemia in the ASPIRE In-Home Study and Effects of Automatic Suspension of Insulin Delivery

J Diabetes Sci Technol. 2015 May 18;9(5):1016-20. doi: 10.1177/1932296815586014.

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.

Method: 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.

Keywords: ASPIRE In-Home; hypoglycemia; low glucose suspend; prediction; sensor-augmented pump therapy; threshold suspend.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Glucose / analysis*
  • Blood Glucose Self-Monitoring
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Female
  • Humans
  • Hypoglycemia / blood
  • Hypoglycemia / chemically induced*
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use
  • Insulin / administration & dosage*
  • Insulin / adverse effects
  • Insulin / therapeutic use
  • Insulin Infusion Systems
  • Male

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin

Associated data

  • ClinicalTrials.gov/NCT01497938