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Insulin

Automated Lyumjev Delivery 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 up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
166,949 Total Patients Enrolled
Michael Tsoukas, M.D.Principal InvestigatorRoyal Victoria Hospital
2 Previous Clinical Trials
42 Total Patients Enrolled
Ahmad Haidar, Ph.D.Study ChairResearch Institute of the McGill University University Health Centre
1 Previous Clinical Trials
30 Total Patients Enrolled
~0 spots leftby Dec 2024
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