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A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes

NCT06021158 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-03-29

No results posted yet for this study

Summary

The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection. The investigators are doing this research to evaluate if carbohydrate counting can be simplified in patients with type 1 diabetes.

Participants will test each meal strategy in random order, and each meal strategy will be 21 days long. For the duration of each meal strategy, participants will use an automated insulin delivery system or "artificial pancreas" with an ultra-rapid insulin called Lyumjev.

Conditions

Interventions

COMBINATION_PRODUCT

Hybrid automated Lyumjev delivery system with carbohydrate counting

In this system, a Lyumjev insulin bolus is initiated at mealtime based on the total grams of carbohydrates counted. This is the same as commercial hybrid closed-loop insulin therapy (standard treatment).

COMBINATION_PRODUCT

Hybrid automated Lyumjev delivery system with meal size estimation

In this system, a Lyumjev insulin bolus is initiated at mealtime based on the qualitative amount of carbohydrates estimated (e.g., low-carb meal).

COMBINATION_PRODUCT

Fully automated Lyumjev delivery system with meal detection

In this system, the patient does not initiate a Lyumjev insulin bolus at mealtime. An algorithm is used to detect a meal and administer a subsequent bolus, rather than requiring a carbohydrate count.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Michael Tsoukas, M.D. · Royal Victoria Hospital, Belfast

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

  • Laurent Legault, M.D. · Montreal Children's Hospital of the MUHC

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06021158 on ClinicalTrials.gov