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

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.

Conditions

• type1diabetes
• Diabetes Mellitus, Type 1

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.

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Michael Tsoukas, M.D. · Research Institute of the McGill University Health Center

• Ahmad Haidar, Ph.D. · Research Institute of the McGill University Health Center

• Laurent Legault, M.D. · Montreal's Children's Hospital Division of Endocrinology

• Michael Vallis, Ph.D. · Dalhousie University Psychologist

• Natasha Garfield, M.D. · Royal Victoria Hospital Division of Endocrinology

• Melissa-Rosina Pasqua, M.D. · Research Institute of the McGill University Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-30

Primary Completion

2025-04-30

Completion

2025-06-30

Countries

• Canada

Study Locations