Overview

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

Status:
Not yet recruiting
Trial end date:
2022-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Treatments:
Pancrelipase
Pramlintide
Criteria
Inclusion Criteria:

- Females and males ≥ 18 years of age.

- 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.

- 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.

Exclusion Criteria:

- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2I (sodium-glucose
transporter), GLP-1(glucagon-like peptide), Metformin, etc.).

- Current use of glucocorticoid medication (except low, stable does and inhaled
steroids).

- Individuals with confirmed gastroparesis.

- Use of medication that alters gastrointestinal motility.

- Planned or ongoing pregnancy.

- Breastfeeding individuals.

- Severe hypoglycemia requiring hospitalization in the past three months.

- Severe diabetic ketoacidosis episode in the past three months.

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

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

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