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.

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.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RW serves as a consultant to Medtronic, Inc. SKG, RMB, DCK, BWB, TSB, JT, and FS received research support from Medtronic, Inc. JBW and FRK are employees of Medtronic, Inc.

© 2015 Diabetes Technology Society.

Figures

Figure 1.

Distribution of the starting times of 1309 nocturnal hypoglycemia events.