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Insulin

AID-detect for Type 1 Diabetes (Lilly-MEALS Trial)

Phase 2

Recruiting

Led By Michael Tsoukas, M.D.

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to switch to Lyumjev insulin for the duration of the study.

Insulin pump use for at least 3 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Lilly-MEALS Trial Summary

This trial is testing if an automated insulin delivery system and ultra-rapid insulin can simplify carb counting for people with type 1 diabetes.

Who is the study for?

This trial is for people who have had type 1 diabetes for at least a year, use an insulin pump, and are willing to switch to Lyumjev insulin. They must be able to follow one of three meal strategies and agree to use effective birth control if they can have children.Check my eligibility

What is being tested?

The study compares three ways of managing meals with type 1 diabetes using an 'artificial pancreas' system and ultra-rapid insulin (Lyumjev). Participants will try counting carbs, estimating meal size qualitatively, or having the system detect their meals over three weeks each.See study design

What are the potential side effects?

Potential side effects may include those typically associated with insulin therapy such as low blood sugar levels (hypoglycemia), allergic reactions at the injection site, weight gain, swelling in arms or legs, and possible malfunctioning of the delivery device.

Lilly-MEALS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to change my insulin to Lyumjev for the study.

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I have been using an insulin pump for at least 3 months.

Lilly-MEALS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)

Secondary outcome measures

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

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

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

+8 more

Lilly-MEALS Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: AID-estimateExperimental Treatment1 Intervention

Group II: AID-detectExperimental Treatment1 Intervention

Group III: AID-countActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

446 Previous Clinical Trials

159,714 Total Patients Enrolled

Melissa-Rosina Pasqua, M.D.Study ChairResearch Institute of the McGill University Health Centre

1 Previous Clinical Trials

30 Total Patients Enrolled

Michael Tsoukas, M.D.Principal InvestigatorRoyal Victoria Hospital

2 Previous Clinical Trials

42 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still ongoing for this research endeavor?

"Clinicaltrials.gov reveals that this medical experiment has begun recruitment of participants. The initial post was published on December 1st 2023 and the information was most recently modified on December 5th 2023."

Answered by AI

How many participants are in the current research project?

"Affirmative, the information on clinicaltrials.gov indicate that this trial is presently recruiting participants. The study was first introduced on December 1st 2023 and has since been amended as of December 5th. There are 12 available spots at a single medical centre."

Answered by AI

Is there any risk associated with AID-detect?

"The safety of AID-detect was rated a 2 in our team's assessment, since it is currently undergoing Phase 2 testing and the available evidence supports its safety profile but not yet its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes

Michael Tsoukas 2023. "A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06021158.

All > Type 1 Diabetes