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Fiasp-and-pramlintide fully automated system (10μg) for Type 1 Diabetes (FCL Trial)

N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 +/- 28 hours
Awards & highlights

FCL Trial Summary

This trial will compare two treatments to help people with diabetes manage blood sugar levels: one with insulin and pramlintide, and one with insulin only.

Eligible Conditions
  • Type 1 Diabetes

FCL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 +/- 28 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 +/- 28 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Each participant's percentage of time glucose levels spent in the target range
Secondary outcome measures
Each participant's coefficient of variance of glucose levels
Each participant's mean glucose levels
Each participant's percentage of time of glucose levels spent above 10.0 mmol/L
+10 more
Other outcome measures
Safety Endpoints

FCL Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Fiasp-and-pramlintide fully automated system (8μg)Experimental Treatment3 Interventions
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
Group II: Fiasp-and-pramlintide fully automated system (10μg)Experimental Treatment3 Interventions
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
Group III: Aspart-and-pramlintide fully automated system (8μg)Experimental Treatment3 Interventions
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
Group IV: Aspart-and-pramlintide fully automated system (10μg)Experimental Treatment3 Interventions
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
Group V: Fiasp-alone with carbohydrate-matched bolusesActive Control1 Intervention
The Fiasp-alone intervention will have a 14 hour duration. During which, carbohydrate counting will inform insulin bolus doses based on insulin to carbohydrate ratios.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pramlintide
2022
Completed Phase 4
~110
Artificial Pancreas
2020
N/A
~270
Aspart
2022
Completed Phase 4
~260
Fiasp
2019
Completed Phase 4
~150

Find a Location

Who is running the clinical trial?

Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,772 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
443 Previous Clinical Trials
159,486 Total Patients Enrolled
Michael Tsoukas, M.D.Principal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Who else is applying?

How old are they?
< 18
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes
Michael Tsoukas 2022. "A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05199714.
~4 spots leftby Apr 2025
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