A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes (FCL)
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Artificial Pancreas, Insulin, Pramlintide, Aspart, Fiasp
Eligibility 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.
Sites / Locations
- Research Institute of the McGill University Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Experimental
Experimental
Experimental
Fiasp-and-pramlintide fully automated system (8μg)
Fiasp-alone with carbohydrate-matched boluses
Aspart-and-pramlintide fully automated system (10μg)
Fiasp-and-pramlintide fully automated system (10μg)
Aspart-and-pramlintide fully automated system (8μg)
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
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.
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.