Diabetes Mellitus, Type 1Phase 2Lilly-MEALSNCT06021158
A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes
A Phase 2 study testing Hybrid automated Lyumjev delivery system with carbohydrate counting, Hybrid automated Lyumjev delivery system with meal size estimation and Fully automated Lyumjev delivery system with meal detection in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Type 1 Diabetes
- What is being tested?
- Hybrid automated Lyumjev delivery system with carbohydrate counting, Hybrid automated Lyumjev delivery system with meal size estimation and Fully automated Lyumjev delivery system with meal detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 20 Dec 2023to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Research Institute of the McGill University Health Centre (RI-MUHC)
Montreal, Quebec, H4A 3J1
Carolyne Schumacher, 5142585431, carolyne.schumacher@mail.mcgill.ca
About this study
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
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
- Being tested
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid automated Lyumjev delivery system with carbohydrate countingCombination 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).
Hybrid automated Lyumjev delivery system with meal size estimationCombination 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 detectionCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| AID-count | Active comparator | Not described Receives: Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting |
| AID-estimate | Experimental | Not described Receives: Combination Product: Hybrid automated Lyumjev delivery system with meal size estimation |
| AID-detect | Experimental | Not described Receives: Combination Product: Fully automated Lyumjev delivery system with meal detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)
Measured: 14 days
Secondary outcomes (11)
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
Measured: 14 days
Mean glucose levels
Measured: 14 days
Standard deviation of glucose levels
Measured: 14 days
Standard deviation of insulin delivery
Measured: 14 days
Coefficient of variance of glucose levels
Measured: 14 days
Coefficient of variance of insulin delivery
Measured: 14 days
Total insulin delivery (overall, basal, and bolus)
Measured: 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
Measured: 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
Measured: 14 days
Decremental sensor glucose concentration for the duration of announced exercise periods
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start20 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Tsoukas, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Michael Tsoukas, M.D., Principal investigator, Royal Victoria Hospital, BelfastAhmad Haidar, Ph.D., Study chair, Research Institute of the McGill University University Health CentreLaurent Legault, M.D., Study chair, Montreal Children's Hospital of the MUHCMelissa-Rosina Pasqua, M.D., Study chair, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021158
- Sponsor's protocol ID
- 2024-9583
- Acronym
- Lilly-MEALS
- Status last verified
- Mar 2024
- First submitted
- 24 Aug 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion of the trial, raw data will be shared for academic purposes upon request, according to the Materials Transfer Agreement.
Publications
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.
PubMed 42267693
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06021158
- Acronym / sponsor ID
- Lilly-MEALS / 2024-9583
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AID-count | Active comparator | Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting |
| AID-estimate | Experimental | Combination Product: Hybrid automated Lyumjev delivery system with meal size estimation |
| AID-detect | Experimental | Combination Product: Fully automated Lyumjev delivery system with meal detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid automated Lyumjev delivery system with carbohydrate countingIn 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). | Combination product | AID-count |
| Hybrid automated Lyumjev delivery system with meal size estimationIn this system, a Lyumjev insulin bolus is initiated at mealtime based on the qualitative amount of carbohydrates estimated (e.g., low-carb meal). | Combination product | AID-estimate |
| Fully automated Lyumjev delivery system with meal detectionIn 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. | Combination product | AID-detect |
Primary outcome
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)
Time frame: 14 days
11 secondary outcomes
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
Mean glucose levels
Time frame: 14 days
Standard deviation of glucose levels
Time frame: 14 days
Standard deviation of insulin delivery
Time frame: 14 days
Coefficient of variance of glucose levels
Time frame: 14 days
Coefficient of variance of insulin delivery
Time frame: 14 days
Total insulin delivery (overall, basal, and bolus)
Time frame: 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
Time frame: 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
Time frame: 14 days
Decremental sensor glucose concentration for the duration of announced exercise periods
Time frame: 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
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 42267693Schumacher 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Tsoukas, M.D. principal investigator
Royal Victoria Hospital, Belfast
Ahmad Haidar, Ph.D. study chair
Research Institute of the McGill University University Health Centre
Laurent Legault, M.D. study chair
Montreal Children's Hospital of the MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hybrid automated Lyumjev delivery system with carbohydrate counting, Hybrid automated Lyumjev delivery system with meal size estimation and Fully automated Lyumjev delivery system with meal detection in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolyne Schumacher (514-258-5431, carolyne.schumacher@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.