Clinical trial NCT06021158: A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes
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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Type 1 Diabetes
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)
timeFrame: 14 days
Secondary outcomes:
measure: 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
timeFrame: 14 days
measure: Mean glucose levels
timeFrame: 14 days
measure: Standard deviation of glucose levels
timeFrame: 14 days
measure: Standard deviation of insulin delivery
timeFrame: 14 days
measure: Coefficient of variance of glucose levels
timeFrame: 14 days
measure: Coefficient of variance of insulin delivery
timeFrame: 14 days
measure: Total insulin delivery (overall, basal, and bolus)
timeFrame: 14 days
measure: 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
timeFrame: 14 days
measure: 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
timeFrame: 14 days
measure: Decremental sensor glucose concentration for the duration of announced exercise periods
timeFrame: 14 days
measure: 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
timeFrame: 14 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre (RI-MUHC)
state: Quebec
Study officials:
affiliation: Royal Victoria Hospital, Belfast
name: Michael Tsoukas, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute of the McGill University University Health Centre
name: Ahmad Haidar, Ph.D.
role: STUDY_CHAIR
affiliation: Montreal Children's Hospital of the MUHC
name: Laurent Legault, M.D.
role: STUDY_CHAIR
affiliation: Research Institute of the McGill University Health Centre
name: Melissa-Rosina Pasqua, M.D.
role: STUDY_CHAIR
References: