A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
The aim of this clinical trial is to investigate whether a fully automated
Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1
diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed
loop system improves time in range compared to a hybrid closed loop system with carbohydrate
counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control
in the fully automated system.
In this cross-over study, patients will undergo the following three interventions in a random
order:
(i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev
insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with
carbohydrate-matched boluses
For all interventions, participants will be required to wear two Ypsomed pumps programmed by
our developed EuGlide system.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre