Status:
COMPLETED
Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Conditions:
Type 1 Diabetes
Hypoglycemia Unawareness
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this study is to investigate if the addition of a 12-week program of home-based high intensity interval training to a standard educational program aiming at preventing hypoglycemia ep...
Eligibility Criteria
Inclusion
- Males and females aged between 18 and 65 years old.
- Clinical diagnosis of type 1 diabetes for at least five years.
- Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid or basal). The type of insulin should be stable for at least 1 month. Participants not using an insulin analog will be offered the opportunity to switch to an insulin analog and this will be done at least 1 month before inclusion.
- Impaired awareness of hypoglycemia (Gold score ≥ 4).
- HbA1c ≤ 10%
- Using a continuous glucose monitor or being willing to start using one for the study
- Having an electronic device supporting the Polar Beat application (heart rate monitor).
Exclusion
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially advanced peripheral neuropathy with significantly lower limb reduced proprioceptive perception) or severe proliferative retinopathy as reported by the patient and/or judged by the investigator.
- High risk foot problem (e.g., previous amputation, history of foot wound, known severe neuropathy or peripheral arterial disease)
- Recent (\< 3 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery or history of significant heart disease.
- Known significant cardiac rhythm abnormality based on investigator judgment.
- Abnormal blood panel and/or anemia (Hb \< 100g/L).
- Ongoing pregnancy or breastfeeding.
- Severe hypoglycemic episode or diabetic ketoacidosis within 1 month of screening.
- Uncontrolled hypertension (blood pressure \>160/100 mm Hg).
- Uncontrolled angina.
- Treatment with oral steroids within the last 3 months.
- History of significant lung disease that would limit exercise.
- Seizure within the last 3 months.
- Participation in high-intensity interval training (or equivalent) in the past 6 months.
- Physical ability preventing the completion of the 12-week training program (e.g., orthopedic limitation).
- Inability to give consent.
Key Trial Info
Start Date :
August 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04825366
Start Date
August 3 2021
End Date
August 31 2025
Last Update
January 8 2026
Active Locations (1)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7