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RECRUITING
NCT06046417
PHASE2/PHASE3

A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

View on ClinicalTrials.gov

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.

Official title: A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-11-30

Completion Date

2025-06

Last Updated

2024-04-18

Healthy Volunteers

No

Interventions

DRUG

Pramlintide

Pramlintide delivered in a basal-bolus manner.

DRUG

Lyumjev

Lyumjev delivered in a basal-bolus manner.

DEVICE

Automated Insulin Delivery (AID) system

The AID system consists of a set of devices that work inter-connectedly to automate insulin (and pramlintide) delivery in response to an individual's glucose levels. It consists of a (i) Dexcom G6 glucose sensor, (ii) a smartphone-based algorithm, (iii) an insulin YpsoPump, and (iv) a pramlintide/placebo YpsoPump in a dual hormone configuration.

Locations (1)

Research Institute of the McGill University Health Center

Montreal, Quebec, Canada