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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AID-count | Active Comparator |
| |
| AID-estimate | Experimental |
| |
| AID-detect | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid automated Lyumjev delivery system with carbohydrate counting | Combination Product | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L) | 14 days |
| Measure | Description | 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 | 14 days | |
| Mean glucose levels | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyne Schumacher | Contact | 514-258-5431 | carolyne.schumacher@mail.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Tsoukas, M.D. | Royal Victoria Hospital, Belfast | Principal Investigator |
| Ahmad Haidar, Ph.D. | Research Institute of the McGill University University Health Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of the McGill University Health Centre (RI-MUHC) | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42267693 | Derived | Schumacher C, Tsoukas MA, Legault L, Pasqua MR, Kemp G, Cohen E, Jones R, Dassau E, Haidar A. Comparing Automated Lyumjev(R) Delivery with Carbohydrate Counting, Qualitative Meal-Size Estimation, and Fully Closed-Loop in Type 1 Diabetes: A Pilot, Randomized, Crossover Trial. Diabetes Technol Ther. 2026 Jun 10:15209156261456440. doi: 10.1177/15209156261456440. Online ahead of print. |
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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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|
| Hybrid automated Lyumjev delivery system with meal size estimation | Combination Product | 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 | Combination Product | 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. |
|
| Standard deviation of glucose levels | 14 days |
| Standard deviation of insulin delivery | 14 days |
| Coefficient of variance of glucose levels | 14 days |
| Coefficient of variance of insulin delivery | 14 days |
| Total insulin delivery (overall, basal, and bolus) | 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 | 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 | 14 days |
| Decremental sensor glucose concentration for the duration of announced exercise periods | 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 | 14 days |
| 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 Chair |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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