Recruiting
Phase 2

Lyumjev vs. Carbohydrate Counting

Sponsor:

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

Code:

NCT06021158

Conditions

Diabetes Mellitus, Type 1

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Diabetes Mellitus, Type 1

Type 1 Diabetes

Study ID

NCT06021158

Start date

Dec 20, 2023

Status verified date

Mar, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: AID-count

experimental: AID-estimate

experimental: AID-detect

Interventions

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).

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).

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Carolyne Schumacher

514-258-5431carolyne.schumacher@mail.mcgill.ca

Locations

Research Institute of the McGill University Health Centre (RI-MUHC)

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Carolyne Schumacher

5142585431carolyne.schumacher@mail.mcgill.ca

More Information

Sponsor

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

Last update posted

Mar 29, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-03-29.