Status:
RECRUITING
A Fully Automated Lyumjev and Pramlintide Delivery System 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:
type1diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim t...
Detailed Description
The aim of this study is to conduct an outpatient, randomized, crossover clinical trial to compare the glycemic outcomes of a fully automated Lyumjev-pramlintide delivery system to a hybrid automated ...
Eligibility Criteria
Inclusion
- Individuals ≥ 18 years of age.
- A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary.
- Using insulin pump therapy for at least three months.
- Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control.
Exclusion
- Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)).
- Current use of glucocorticoid medication (except low, stable doses and inhaled steroids).
- Individuals with confirmed gastroparesis.
- Use of medication that alters gastrointestinal motility (ex: domperidone).
- Use of hydroxyurea.
- Planned or ongoing pregnancy.
- Breastfeeding individuals.
- Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.
- Diabetic ketoacidosis episode in the past month.
- Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator.
- Recent (\< 6 months) acute macrovascular event, e.g., acute coronary syndrome.
- Other serious medical illnesses which are likely to interfere with study participation or the ability to complete the trial by the investigator's judgment.
- Known hypersensitivity to the study drugs or their excipients.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06046417
Start Date
November 30 2023
End Date
June 1 2025
Last Update
April 18 2024
Active Locations (1)
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1
Research Institute of the McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1