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Automated Insulin + Pramlintide Delivery for Type 1 Diabetes (FCL Trial)

Phase 2 & 3
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
Using insulin pump therapy for at least three months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 days
Awards & highlights

FCL Trial Summary

This trial will investigate how an automated delivery system of insulin and pramlintide can help adults with Type 1 Diabetes to better manage their blood sugar levels.

Who is the study for?
Adults over 18 with type 1 diabetes using insulin pump therapy for at least three months can join. They must not have had diabetic ketoacidosis or severe hypoglycemia recently, be pregnant or breastfeeding, use certain diabetes medications like SGLT2I or GLP1-RA, and should agree to effective birth control if applicable.Check my eligibility
What is being tested?
The trial tests a fully automated system delivering insulin and pramlintide in different ratios (8 μg/u and 10 μg/u) against an automated system with insulin and placebo. The goal is to see which method keeps blood sugar levels within the target range best using two Ypsomed pumps.See study design
What are the potential side effects?
Possible side effects include low blood sugar (hypoglycemia), skin reactions at the infusion site, weight changes, nausea, headaches, potential allergic reactions to pramlintide or insulins lispro/aspart.

FCL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been using an insulin pump for at least 3 months.

FCL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 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
Coefficient of variance of glucose levels.
Mean glucose levels.
Mean score on a Treatment Satisfaction Questionnaire (TSQ) taken from Marrero et al.
+11 more
Other outcome measures
Safety Endpoints

FCL Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)Experimental Treatment3 Interventions
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.
Group II: Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)Experimental Treatment3 Interventions
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.
Group III: Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched bolusesActive Control1 Intervention
Lyumjev and saline placebo hybrid automated delivery system with meal announcement. Participants must input the carbohydrate content of their meals to inform the insulin bolus doses based on their pre-programmed insulin-to-carbohydrate ratios.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lyumjev
2022
Completed Phase 1
~30
Pramlintide
2022
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,754 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
447 Previous Clinical Trials
159,722 Total Patients Enrolled
Natasha Garfield, M.D.Study ChairRoyal Victoria Hospital Division of Endocrinology

Frequently Asked Questions

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

Are opportunities still available for participants in this research endeavor?

"The data available on clinicaltrials.gov demonstrates that this medical trial is not presently enrolling patients; the experiment was initially posted on October 1st 2023 and its most recent update was made on September 18th of the same year. However, there are 1285 other studies actively looking for participants at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
Michael Tsoukas 2023. "A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046417.
All > Type 1 Diabetes
~20 spots leftby Apr 2025
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