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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 (Lilly-MEALS)

Primary Purpose

Diabetes Mellitus, Type 1, Type 1 Diabetes

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hybrid automated Lyumjev delivery system with carbohydrate counting
Hybrid automated Lyumjev delivery system with meal size estimation
Fully automated Lyumjev delivery system with meal detection
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    AID-count

    AID-estimate

    AID-detect

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)

    Secondary Outcome Measures

    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
    Mean glucose levels
    Standard deviation of glucose levels
    Standard deviation of insulin delivery
    Coefficient of variance of glucose levels
    Coefficient of variance of insulin delivery
    Total insulin delivery (overall, basal, and bolus)
    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
    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
    Decremental sensor glucose concentration for the duration of announced exercise periods
    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

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    August 30, 2023
    Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06021158
    Brief Title
    A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes
    Acronym
    Lilly-MEALS
    Official Title
    A Randomized, Crossover, Pilot Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre

    4. Oversight

    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

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1, Type 1 Diabetes

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AID-count
    Arm Type
    Active Comparator
    Arm Title
    AID-estimate
    Arm Type
    Experimental
    Arm Title
    AID-detect
    Arm Type
    Experimental
    Intervention Type
    Combination Product
    Intervention Name(s)
    Hybrid automated Lyumjev delivery system with carbohydrate counting
    Intervention Description
    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).
    Intervention Type
    Combination Product
    Intervention Name(s)
    Hybrid automated Lyumjev delivery system with meal size estimation
    Intervention Description
    In this system, a Lyumjev insulin bolus is initiated at mealtime based on the qualitative amount of carbohydrates estimated (e.g., low-carb meal).
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fully automated Lyumjev delivery system with meal detection
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Mean glucose levels
    Time Frame
    14 days
    Title
    Standard deviation of glucose levels
    Time Frame
    14 days
    Title
    Standard deviation of insulin delivery
    Time Frame
    14 days
    Title
    Coefficient of variance of glucose levels
    Time Frame
    14 days
    Title
    Coefficient of variance of insulin delivery
    Time Frame
    14 days
    Title
    Total insulin delivery (overall, basal, and bolus)
    Time Frame
    14 days
    Title
    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
    Title
    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
    Title
    Decremental sensor glucose concentration for the duration of announced exercise periods
    Time Frame
    14 days
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carolyne Schumacher
    Phone
    514-258-5431
    Email
    carolyne.schumacher@mail.mcgill.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Tsoukas, M.D.
    Organizational Affiliation
    Royal Victoria Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ahmad Haidar, Ph.D.
    Organizational Affiliation
    Research Institute of the McGill University University Health Centre
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Laurent Legault, M.D.
    Organizational Affiliation
    Montreal Children's Hospital of the MUHC
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Melissa-Rosina Pasqua, M.D.
    Organizational Affiliation
    Research Institute of the McGill University Health Centre
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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