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Exercise at home may restore low blood sugar warning signs in type 1 diabetes

NCT ID NCT04825366

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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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.

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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

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.

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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

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