Pramlintide + Insulin with Artificial Pancreas for Type 1 Diabetes

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McGill University

Trial Summary

What is the purpose of this trial?

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period. The aim of this project is to assess whether co-administration of pramlintide with rapid insulin in an artificial pancreas system will improve glycemic control in adults with Type 1 Diabetes.

Research Team

Eligibility Criteria

Adults over 18 with Type 1 Diabetes using an insulin pump and practicing carbohydrate counting can join. They must not be pregnant, planning pregnancy, or breastfeeding, and agree to use effective birth control if applicable. Excluded are those on certain diabetes medications, have had severe hypoglycemia or ketoacidosis recently, take drugs affecting stomach emptying or glucocorticoids (except low stable doses), have gastroparesis, major heart events in the last 6 months, or serious illnesses.

Inclusion Criteria

I am not on any medications that the study does not allow.

I can and will use effective birth control during the trial.

I have been diagnosed with type 1 diabetes for over a year.

Exclusion Criteria

I had a heart attack or heart surgery in the last 6 months.

I have not had a severe diabetic ketoacidosis episode in the last 3 months.

Planned or ongoing pregnancy

Treatment Details

Interventions

• Artificial Pancreas (Device)
• Pramlintide Acetate (Synthetic Amylin Analog)
• Rapid-Acting Insulin (Rapid-Acting Insulin)

Trial Overview The trial tests a dual-hormone artificial pancreas system that delivers both pramlintide and rapid-acting insulin based on glucose levels to improve blood sugar control after meals in adults with Type 1 Diabetes. It aims to see if this approach is better than current methods at normalizing glucose especially post-meal.

Participant Groups

Group I: Rapid Insulin-Plus-Pramlintide Experimental Treatment 3 Interventions

Rapid insulin and pramlintide infusion in two insulin pumps

Group II: Rapid Insulin-Plus-Placebo Placebo Group 3 Interventions

Rapid insulin and placebo (saline) infusion in two insulin pumps

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Philippe Drouet

McGill University

Chief Executive Officer since 2021

Master of Science and Bachelor in Chemical Engineering from McGill University

Marianne Mancini

McGill University

Chief Medical Officer

BS in Nutritional Sciences from McGill University

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa