NCT04825366Completed
Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training
Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
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 episodes will restore hypoglycemia awareness in people living with type 1 diabetes and impaired awareness of hypoglycemia to a further extent than a standard educational program alone. Participants will be randomized for 12 weeks to the standard educational program with or without high intensity interval training. The Gold method will be used to identify people with impaired awareness of hypoglycemia. The educational program will consist of two education sessions on avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a CGM/Flash-GM and understand CGM/Flash-GM reports to adjust insulin doses. Participants randomized to the training program will be asked to train three times per week for 12 weeks following the home-based program that will be provided to them. Participants will be asked to perform at least 2 training sessions per week (ideally all 3 sessions) with the exercise specialist on a virtual platform.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 28 Mar 2021
- Start date
- 3 Aug 2021
- Primary completion date
- 15 Dec 2024
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Diseases
- Type 1 diabetes
- NCT number
- NCT04825366
What you commit to
- Study type: Interventional
- Participants enrolled: 47
- From 3 Aug 2021 to the primary completion date, 15 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- High risk foot problem (e.g., previous amputation, history of foot wound, known severe neuropathy or peripheral arterial disease)
- Treatment with oral steroids within the last 3 months.
Other illness
- 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.
- Uncontrolled hypertension (blood pressure \>160/100 mm Hg).
- Uncontrolled angina.
- History of significant lung disease that would limit exercise.
- Seizure within the last 3 months.
Other
- 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.
- Abnormal blood panel and/or anemia (Hb \< 100g/L).
- Ongoing pregnancy or breastfeeding.
- Severe hypoglycemic episode or diabetic ketoacidosis within 1 month of screening.
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Recherches Cliniques de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.