Status:
UNKNOWN
Insulin-based Strategies to Prevent Hypoglycemia During Exercise
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Institut de Recherches Cliniques de Montreal
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exe...
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 :
May 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03349489
Start Date
May 18 2018
End Date
January 1 2019
Last Update
May 22 2018
Active Locations (2)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
2
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1