Status:
COMPLETED
Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
Regular exercise is associated with many health benefits for individuals with type 1 diabetes. However, immediate and delayed exercise-induced hypoglycemia is frequent and thus the main limiting facto...
Detailed Description
Each study participant will be admitted at IRCM one to five days after sensor insertion. Participants will be asked to change their pump catheter 24 to 36 hours prior to the intervention visit. On the...
Eligibility Criteria
Inclusion
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least two years.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 2 months) HbA1c ≤ 10%.
Exclusion
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
- Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).
Key Trial Info
Start Date :
June 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03845114
Start Date
June 30 2019
End Date
August 30 2024
Last Update
November 6 2024
Active Locations (2)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
2
McGill University Health Center
Montreal, Quebec, Canada