Status:
COMPLETED
A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 bolu...
Detailed Description
The aim of this pilot study is to generate additional data of (i) a Fiasp-alone artificial pancreas with carbohydrate-matched boluses, compared to (ii) a Fiasp-plus-Pramlintide fully automated artific...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05199714
Start Date
February 21 2022
End Date
March 25 2023
Last Update
October 25 2023
Active Locations (1)
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1
Research Institute of the McGill University Health Center
Montreal, Quebec, Canada, H4A 3T2