INVESTIGATING THE SAFETY AND GLYCAEMIC CONTROL OF FAST-ACTING INSULIN ASPART WITH A CLOSED-LOOP DELIVERY SYSTEM IN ADULTS WITH TYPE 1 DIABETES
- Steven J. Russell, United States of America
- Steven J. Russell, United States of America
- Courtney A. Balliro, United States of America
- Magnus Ekelund, Denmark
- Firas El-khatib, United States of America
- Tina Graungaard, Denmark
- Rabab Jafri, United States of America
- Naveen Rathor, Denmark
- Jordan Sherwood, United States of America
- Edward R. Damiano, United States of America
Abstract
Background and Aims
Combining the bionic pancreas (iLetTM) with fast-acting insulin aspart (faster aspart) is of interest given the improved pharmacological and glycaemic profile of faster aspart versus conventional rapid-acting insulin analogues. We investigated the safety and glycaemic control of the insulin-only configuration of the iLetTM delivering faster aspart using different algorithm tmax settings in adults with type 1 diabetes.
Methods
We performed a single-centre, single-blind, crossover (two 7-day treatment periods) escalation trial over three sequential cohorts in which subjects were randomised to a default tmax (t65) setting followed by a non-default tmax setting (t50 [cohort 1], t40 [cohort 2], t30 [cohort 3]), or vice versa, all with faster aspart. Each cohort randomised eight new subjects if escalation stopping criteria were not met in the previous cohort.
Results
Two subjects discontinued treatment, one due to “low blood glucose” during the first treatment period of cohort 3 (t30). No severe hypoglycaemic episodes were reported and there were no clinically significant differences in adverse events between groups. Mean time in low (sensor) glucose (<54 mg/dL, primary endpoint) was <1.0% for all tmax settings (Table). Except for the default tmax setting in cohort 1, the mean time in range (70–180 mg/dL) was >70%. Mean glucose in cohorts 1 and 2 was significantly lower at non-default versus default tmax settings, with comparable insulin dosing.
Conclusions
There were no safety concerns with faster aspart in the iLetTM at non-default tmax settings. Improvements in glycaemic control at non-default tmax settings were observed.
