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

March 28, 2024 updated by: Michael Tsoukas, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Research Institute of the McGill University Health Centre (RI-MUHC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria.
  • Insulin pump use for at least 3 months.
  • Individuals of childbearing potential must agree to use a highly effective method of birth control.
  • Willing to switch to Lyumjev insulin for the duration of the study.

Exclusion Criteria:

  • Use of oral antihyperglycemic agents within 2 weeks of admission (SGLT2i, metformin…); 1 month for GLP1-RA.
  • Use of glucocorticoids (except low, stable doses and inhaled steroids).
  • Use of hydroxyurea.
  • Planned or ongoing pregnancy.
  • Breastfeeding.
  • Diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions) within one month of admission.
  • Clinically significant retinopathy, nephropathy, or neuropathy as judged by the investigator.
  • Recent (<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
  • Known hypersensitivity to the study drug or its excipients.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial, as judged by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AID-count
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).
Experimental: AID-estimate
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).
Experimental: AID-detect
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of time of glucose levels spent in the following ranges: - between 3.9 and 7.8 mmol/L - below 3.9 mmol/L - below 3.0 mmol/L - above 10.0 mmol/L - above 13.9 mmol/L
Time Frame: 14 days
14 days
Mean glucose levels
Time Frame: 14 days
14 days
Standard deviation of glucose levels
Time Frame: 14 days
14 days
Standard deviation of insulin delivery
Time Frame: 14 days
14 days
Coefficient of variance of glucose levels
Time Frame: 14 days
14 days
Coefficient of variance of insulin delivery
Time Frame: 14 days
14 days
Total insulin delivery (overall, basal, and bolus)
Time Frame: 14 days
14 days
Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after meal insulin boluses
Time Frame: 14 days
14 days
Area under the sensor glucose concentration-time curve (AUC) from 1-2 hours, 2-3 hours, 3-4 hours, and 4-5 hours after meal insulin boluses
Time Frame: 14 days
14 days
Decremental sensor glucose concentration for the duration of announced exercise periods
Time Frame: 14 days
14 days
Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after the end of announced exercise periods
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Michael Tsoukas, M.D., Royal Victoria Hospital
  • Study Chair: Ahmad Haidar, Ph.D., Research Institute of the McGill University University Health Centre
  • Study Chair: Laurent Legault, M.D., Montreal Children's Hospital of the MUHC
  • Study Chair: Melissa-Rosina Pasqua, M.D., Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-9583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the completion of the trial, raw data will be shared for academic purposes upon request, according to the Materials Transfer Agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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