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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)

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ClinicalTrials.gov Identifier: NCT06021158
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : March 29, 2024
Sponsor:
Information provided by (Responsible Party):
Michael Tsoukas, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Type 1 Diabetes Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting Combination Product: Hybrid automated Lyumjev delivery system with meal size estimation Combination Product: Fully automated Lyumjev delivery system with meal detection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : December 20, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L) [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Mean glucose levels [ Time Frame: 14 days ]
  3. Standard deviation of glucose levels [ Time Frame: 14 days ]
  4. Standard deviation of insulin delivery [ Time Frame: 14 days ]
  5. Coefficient of variance of glucose levels [ Time Frame: 14 days ]
  6. Coefficient of variance of insulin delivery [ Time Frame: 14 days ]
  7. Total insulin delivery (overall, basal, and bolus) [ Time Frame: 14 days ]
  8. 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 ]
  9. 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 ]
  10. Decremental sensor glucose concentration for the duration of announced exercise periods [ Time Frame: 14 days ]
  11. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021158


Contacts
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Contact: Carolyne Schumacher 514-258-5431 carolyne.schumacher@mail.mcgill.ca

Locations
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Canada, Quebec
Research Institute of the McGill University Health Centre (RI-MUHC) Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Carolyne Schumacher    5142585431    carolyne.schumacher@mail.mcgill.ca   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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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
More Information
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Responsible Party: Michael Tsoukas, Associate Professor, Endocrinology & Metabolism, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT06021158    
Other Study ID Numbers: 2024-9583
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the completion of the trial, raw data will be shared for academic purposes upon request, according to the Materials Transfer Agreement.

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases