Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training
NCT ID: NCT04825366
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2021-08-03
2025-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard educational program
Participants will be closely followed by a team of diabetes specialists. Participants will attend two education sessions to discuss the following topics: avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a continuous glucose monitor (CGM) and understand CGM reports to adjust insulin doses.
Continuous glucose monitoring device
Participants will have to wear their continuous glucose monitoring device throughout the study.
Gold method
The Gold method will be used to assess impaired awareness of hypoglycemia
Clarke questionnaire
The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia
Edinburgh Hypoglycemia Symptom Scale
The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia
BAPAD questionnaire
The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity
Hypoglycemia Fear Survey II
The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia
Physical activity questionnaire
The International Physical Activity Questionnaire will be used to assess physical activity practice
Well-being
The WHO-5 well-being index will be used to assess well-being.
Treatment satisfaction
The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.
Hypoglycemia diary
Participants will be asked to record in a diary treatments for hypoglycemic events
Piezo RxD
Participants will be asked to wear a pedometer throughout the study
Standard educational program combined with high intensity interval training
Participants will be closely followed by a team of diabetes specialists. Participants will attend two education sessions to discuss the following topics: avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a continuous glucose monitor (CGM) and understand CGM reports to adjust insulin doses.
Each study participant will be asked to train 3 times per week following the home-based program that will be provided to them. Participants will be asked to perform at least 2 training sessions per week with the exercise specialist on a virtual platform. The training session will consist of a 3 to 5-minute low-intensity warm-up followed by 6 to 12 1-minute bouts of high-intensity exercise interspersed with 1-minute bouts of low-intensity exercise. Each session will end with a 3-minutes cool-down period.
Continuous glucose monitoring device
Participants will have to wear their continuous glucose monitoring device throughout the study.
Gold method
The Gold method will be used to assess impaired awareness of hypoglycemia
Clarke questionnaire
The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia
Edinburgh Hypoglycemia Symptom Scale
The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia
BAPAD questionnaire
The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity
Hypoglycemia Fear Survey II
The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia
Physical activity questionnaire
The International Physical Activity Questionnaire will be used to assess physical activity practice
Well-being
The WHO-5 well-being index will be used to assess well-being.
Treatment satisfaction
The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.
Hypoglycemia diary
Participants will be asked to record in a diary treatments for hypoglycemic events
Piezo RxD
Participants will be asked to wear a pedometer throughout the study
Heart rate monitor
During training sessions, participants will be asked to wear a heart rate monitor
Exercise diary
Before each training session, participants will be asked to note in a diary their glucose levels, if they have taken a snack or not and if insulin was administered. After each training session, participants will be asked to note that same information. In addition, they will be asked to note their bedtime blood glucose, if they have taken a bedtime snack and if adjustment to insulin doses was made.
Interventions
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Continuous glucose monitoring device
Participants will have to wear their continuous glucose monitoring device throughout the study.
Gold method
The Gold method will be used to assess impaired awareness of hypoglycemia
Clarke questionnaire
The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia
Edinburgh Hypoglycemia Symptom Scale
The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia
BAPAD questionnaire
The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity
Hypoglycemia Fear Survey II
The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia
Physical activity questionnaire
The International Physical Activity Questionnaire will be used to assess physical activity practice
Well-being
The WHO-5 well-being index will be used to assess well-being.
Treatment satisfaction
The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.
Hypoglycemia diary
Participants will be asked to record in a diary treatments for hypoglycemic events
Piezo RxD
Participants will be asked to wear a pedometer throughout the study
Heart rate monitor
During training sessions, participants will be asked to wear a heart rate monitor
Exercise diary
Before each training session, participants will be asked to note in a diary their glucose levels, if they have taken a snack or not and if insulin was administered. After each training session, participants will be asked to note that same information. In addition, they will be asked to note their bedtime blood glucose, if they have taken a bedtime snack and if adjustment to insulin doses was made.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Institut de Recherches Cliniques de Montreal
OTHER
Responsible Party
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Rémi Rabasa-Lhoret
Full professor
Principal Investigators
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Rémi Rabasa-Lhoret
Role: PRINCIPAL_INVESTIGATOR
Institut de recherches cliniques de Montréal
Locations
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Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2021-1117
Identifier Type: -
Identifier Source: org_study_id
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