Exercise at home may restore low blood sugar warning signs in type 1 diabetes
NCT ID NCT04825366
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding a 12-week home-based high intensity interval training program to standard education about preventing low blood sugar (hypoglycemia) helps adults with type 1 diabetes who have lost the ability to sense low blood sugar. 47 participants were randomly assigned to either the education program alone or education plus the exercise program. The goal was to see if exercise could restore awareness of hypoglycemia, measured by the Gold score.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
47 people
The number who actually took part.
- Started
-
Aug 2021
- Finished
-
Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females aged between 18 and 65 years old. 2. Clinical diagnosis of type 1 diabetes for at least five years. 3. 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. 4. Impaired awareness of hypoglycemia (Gold score ≥ 4). 5. HbA1c ≤ 10% 6. Using a continuous glucose monitor or being willing to start using one for the study 7. Having an electronic device supporting the Polar Beat application (heart rate monitor). Exclusion Criteria: 1. 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. 2. High risk foot problem (e.g., previous amputation, history of foot wound, known severe neuropathy or peripheral arterial disease) 3. Recent (\< 3 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery or history of significant heart disease. 4. Known significant cardiac rhythm abnormality based on investigator judgment. 5. Abnormal blood panel and/or anemia (Hb \< 100g/L). 6. Ongoing pregnancy or breastfeeding. 7. Severe hypoglycemic episode or diabetic ketoacidosis within 1 month of screening. 8. Uncontrolled hypertension (blood pressure \>160/100 mm Hg). 9. Uncontrolled angina. 10. Treatment with oral steroids within the last 3 months. 11. History of significant lung disease that would limit exercise. 12. Seizure within the last 3 months. 13. Participation in high-intensity interval training (or equivalent) in the past 6 months. 14. Physical ability preventing the completion of the 12-week training program (e.g., orthopedic limitation). 15. Inability to give consent.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hypoglycemia unawareness are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can skin sensors replace finger pricks for diabetes care in kenya?
- Tiny horses, big lessons: can ponies help kids tame diabetes?
- Can a math model tune insulin pumps better than standard care?
- Can a group program stop eating disorders in type 1 diabetes?
- Can a Two-Punch immune therapy save insulin cells in newly diagnosed diabetes?
- Can a smart insulin pump tailored for pregnancy protect mothers and babies?