A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes

(FCL Trial)

Overseen by Michael Tsoukas, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses.

Research Team

Michael Tsoukas, M.D.

Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

Use of insulin pump therapy for at least 3 months.

Effective birth-control use in individuals of childbearing potential. Individuals of child-bearing potential must agree to use a highly effective method of birth control.

Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

Exclusion Criteria

Severe hypoglycemia requiring hospitalization in the past three months.

You are currently breastfeeding.

You are taking medication that affects how your stomach and intestines move.

Treatment Details

Interventions

• Artificial Pancreas (Device)
• Aspart (Insulin Analog)
• Fiasp (Insulin Analog)
• Pramlintide (Amylin Analog)

Participant Groups

Group I: Fiasp-and-pramlintide fully automated system (8μg) Experimental Treatment 3 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 Treatment 3 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 Treatment 3 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 Treatment 3 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 boluses Active Control 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Dr. Lucie Opatrny

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

President and Executive Director since 2023

MDCM and Master's in Epidemiology and Biostatistics from McGill University, Master's in Healthcare Management and Diploma in Advanced Negotiation from Harvard University

Dr. Patrizia Cavazzoni

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

Chief Medical Officer

MD from McGill University, residency in Psychiatry and fellowship in Mood Disorders at the University of Ottawa

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Dr. Aaron J. Kowalski

Juvenile Diabetes Research Foundation

Chief Executive Officer since 2019

PhD in Microbiology and Molecular Genetics from Rutgers University

Dr. Thomas Danne

Juvenile Diabetes Research Foundation

Chief Medical Officer

MD from Albert Einstein College of Medicine