Automated Fully Closed-Loop Insulin Delivery in Type 1 Diabetes With Ultra-Rapid Lispro (ACOLYTE Study)
Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
The main objective of the study is to determine whether fully closed-loop insulin delivery
using ultra-rapid acting insulin lispro will improve glucose control compared to standard
lispro under conditions mimicking missed meal bolus. Ultra-rapid acting lispro (Lyumjev) is a
novel formulation of insulin lispro in which two additional excipients (citrate and
trepostinil) have been added, resulting in accelerated initial absorption and more than
double the glucose lowering effect in the first 30 minutes after subcutaneous administration
using insulin pump. To date, no randomised controlled trial involving fully closed-loop in
type 1 diabetes has been performed to evaluate the benefit of Lyumjev over standard lispro.
This is an open-label, single-centre, two-period, randomised, crossover study. The study
involves two 12-hour in-patient stays at the clinical research facility during which glucose
levels will be controlled by the Cambridge closed-loop system with either Lyumjev or standard
lispro. Up to 26 adults with type 1 diabetes treated with insulin pump will be recruited at
Manchester Royal Infirmary, aiming for 19 completed participants.
During the study days, closed-loop will automatically modulate insulin infusion rate based on
real-time glucose sensor measurements. Participants will receive standardised meals with no
meal bolus for the lunch time meal during each study day. Primary outcome is the time spent
in sensor glucose range (3.9-10.0mmol/l) between 11:00 - 17:00 hrs. Secondary outcomes are
the time spent with glucose levels above and below target, and other sensor-based metrics.
Safety evaluation comprises assessment of the frequency of hypo and hyperglycaemic episodes.