Status:
COMPLETED
Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting
Lead Sponsor:
McGill University
Collaborating Sponsors:
Diabetes Canada
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 nov...
Detailed Description
Meal carbohydrate content is the main determinant of prandial insulin needs, and consequently, accurate carbohydrate counting is recommended for type 1 diabetes. Advances in glucose sensors have motiv...
Eligibility Criteria
Inclusion
- Males and females ≥ 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.
- Insulin pump therapy for at least 6 months.
- HbA1c ≤ 12% in the last 6 months.
Exclusion
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.…).
- Severe hypoglycemic episode within one month of admission.
- Severe diabetic ketoacidosis episode within one month of admission.
- Pregnancy.
- Known or suspected allergy to the study drugs.
- Gastroparesis.
- Use of prokinetic drugs that stimulate gastric emptying (domperidone, cisapride, metoclopramide).
- 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.
- Current use of glucocorticoid medication.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03800875
Start Date
February 8 2019
End Date
September 19 2020
Last Update
June 8 2021
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1