Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting

• Status: Completed
• Trial end date: 2020-09-19
• Target enrollment: 0
• Participant gender: All

Summary

Closed-loop system systems that are shown to alleviate the burden of carbohydrate counting without degrading glucose control are still lacking. In this proposal, the investigators aim to develop a novel, fully-automated, closed-loop system that delivers insulin and pramlintide that controls postprandial glucose levels without any input from the user.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University
• Collaborator: Diabetes Canada
• Treatments: Glucagon; Glucagon-Like Peptide 1; Hormones; Insulin; Insulin, Globin Zinc; Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

1. Males and females ≥ 18 years of age.

2. 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.

3. Insulin pump therapy for at least 6 months.

4. HbA1c ≤ 12% in the last 6 months.

Exclusion Criteria:

1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.…).

2. Severe hypoglycemic episode within one month of admission.

3. Severe diabetic ketoacidosis episode within one month of admission.

4. Pregnancy.

5. Known or suspected allergy to the study drugs.

6. Gastroparesis.

7. Use of prokinetic drugs that stimulate gastric emptying (domperidone, cisapride, metoclopramide).

8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.

9. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

10. Current use of glucocorticoid medication.

11. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

12. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).