Type 1 DiabetesFEEL-HIITNCT04825366
Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training
A study testing Continuous glucose monitoring device, Gold method and Clarke questionnaire in people with Type 1 Diabetes and Hypoglycemia Unawareness, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial 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 episodes will restore hypoglycemia awareness in people living with type 1 diabetes and impaired awareness of hypoglycemia… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia Unawareness
- What is being tested?
- Continuous glucose monitoring device, Gold method and Clarke questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
Official title: Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia
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.
Read more
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.
- Conditions
- Type 1 Diabetes, Hypoglycemia Unawareness
- Being tested
- Continuous glucose monitoring device, Gold method, Clarke questionnaire, Edinburgh Hypoglycemia Symptom Scale, BAPAD questionnaire
- Keywords
- Type 1 diabetes, Hypoglycemia unawareness, Education, Avoidance of hypoglycemia, High intensity interval training
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring deviceDevice
Participants will have to wear their continuous glucose monitoring device throughout the study.
Gold methodOther
The Gold method will be used to assess impaired awareness of hypoglycemia
Clarke questionnaireOther
The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia
Edinburgh Hypoglycemia Symptom ScaleOther
The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia
BAPAD questionnaireOther
The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity
Hypoglycemia Fear Survey IIOther
The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia
Physical activity questionnaireOther
The International Physical Activity Questionnaire will be used to assess physical activity practice
Well-beingOther
The WHO-5 well-being index will be used to assess well-being.
Treatment satisfactionOther
The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.
Hypoglycemia diaryOther
Participants will be asked to record in a diary treatments for hypoglycemic events
Piezo RxDDevice
Participants will be asked to wear a pedometer throughout the study
Heart rate monitorDevice
During training sessions, participants will be asked to wear a heart rate monitor
Exercise diaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard educational program | Active comparator | 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. Receives: Device: Continuous glucose monitoring device; Other: Gold method; Other: Clarke questionnaire; Other: Edinburgh Hypoglycemia Symptom Scale; Other: BAPAD questionnaire; Other: Hypoglycemia Fear Survey II; Other: Physical activity questionnaire; Other: Well-being; Other: Treatment satisfaction; Other: Hypoglycemia diary; Device: Piezo RxD |
| Standard educational program combined with high intensity interval training | Active comparator | 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. Receives: Device: Continuous glucose monitoring device; Other: Gold method; Other: Clarke questionnaire; Other: Edinburgh Hypoglycemia Symptom Scale; Other: BAPAD questionnaire; Other: Hypoglycemia Fear Survey II; Other: Physical activity questionnaire; Other: Well-being; Other: Treatment satisfaction; Other: Hypoglycemia diary; Device: Piezo RxD; Device: Heart rate monitor; Other: Exercise diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Gold score
The Gold method is used to assess impaired awareness of hypoglycemia. The scale is from 1 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia
Measured: 12 weeks
Secondary outcomes (17)
Change in the Clarke score
The Clarke questionnaire is used to assess impaired awareness of hypoglycemia. The scale is from 0 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia
Measured: 12 weeks
Change in the score of the Edinburgh Hypoglycemia Symptom Scale
Symptoms of hypoglycemia
Measured: 12 weeks
Change in the score of the BAPAD questionnaire
Barriers to physical activity. The score can be between 12 and 84. A higher score means more barriers to physical activity.
Measured: 12 weeks
Change in the score of the Hypoglycemia Fear Survey II
Fear of hypoglycemia. The score can be between 0 and 132. A higher score means higher level of fear of hypoglycemia.
Measured: 12 weeks
Change in physical activity practice
Score of the International Physical Activity Questionnaire
Measured: 12 weeks
Change in well-being
Score of the WHO-5 well-being index. The score can be between 0 and 5. Higher scores means better well-being.
Measured: 12 weeks
Change in treatment satisfaction
Score of the Diabetes Treatment Satisfaction questionnaire. The score can be between 0 and 36. Higher score means better satisfaction.
Measured: 12 weeks
Percentage of participants who no longer have impaired awareness of hypoglycemia
Measured: 12 weeks
Percentage of time of glucose levels spent < 4.0 mmol/L
Based on continous glucose monitor data
Measured: 12 weeks
Percentage of time of glucose levels spent < 3.0 mmol/L
Based on continous glucose monitor data
Measured: 12 weeks
Percentage of time of glucose levels spent between 3.9-10.0 mmol/L
Based on continous glucose monitor data
Measured: 12 weeks
Percentage of time of glucose levels spent > 10.0 mmol/L
Based on continous glucose monitor data
Measured: 12 weeks
Standard deviation of glucose levels
Based on continous glucose monitor data
Measured: 12 weeks
Coefficient of variation of glucose levels
Based on continous glucose monitor data
Measured: 12 weeks
Number of hypoglycemic events
Glucose levels < 4 mmol/L or < 3 mmol/L
Measured: 12 weeks
Number of treated hypoglycemic events
Number of time that carbohydrates were taken to treat a hypoglycemia event
Measured: 12 weeks
Number of severe hypoglycemia
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start3 Aug 2021
- Primary completion15 Dec 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825366
- Sponsor's protocol ID
- 2021-1117
- Acronym
- FEEL-HIIT
- Status last verified
- Jan 2026
- First submitted
- 28 Mar 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia
- ClinicalTrials.gov ID
- NCT04825366
- Acronym / sponsor ID
- FEEL-HIIT / 2021-1117
- Conditions
- Type 1 Diabetes, Hypoglycemia Unawareness
- Keywords
- Type 1 diabetes, Hypoglycemia unawareness, Education, Avoidance of hypoglycemia, High intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard educational program | Active comparator | Device: Continuous glucose monitoring device, Other: Gold method, Other: Clarke questionnaire, Other: Edinburgh Hypoglycemia Symptom Scale, Other: BAPAD questionnaire, Other: Hypoglycemia Fear Survey II, Other: Physical activity questionnaire, Other: Well-being, Other: Treatment satisfaction, Other: Hypoglycemia diary, Device: Piezo RxDParticipants 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. |
| Standard educational program combined with high intensity interval training | Active comparator | Device: Continuous glucose monitoring device, Other: Gold method, Other: Clarke questionnaire, Other: Edinburgh Hypoglycemia Symptom Scale, Other: BAPAD questionnaire, Other: Hypoglycemia Fear Survey II, Other: Physical activity questionnaire, Other: Well-being, Other: Treatment satisfaction, Other: Hypoglycemia diary, Device: Piezo RxD, Device: Heart rate monitor, Other: Exercise diaryParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoring deviceParticipants will have to wear their continuous glucose monitoring device throughout the study. | Device | Standard educational program, Standard educational program combined with high intensity interval training |
| Gold methodThe Gold method will be used to assess impaired awareness of hypoglycemia | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| Clarke questionnaireThe Clarke questionnaire will be used to assess impaired awarness of hypoglycemia | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| Edinburgh Hypoglycemia Symptom ScaleThe Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| BAPAD questionnaireThe BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| Hypoglycemia Fear Survey IIThe Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| Physical activity questionnaireThe International Physical Activity Questionnaire will be used to assess physical activity practice | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| Well-beingThe WHO-5 well-being index will be used to assess well-being. | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| Treatment satisfactionThe Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction. | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| Hypoglycemia diaryParticipants will be asked to record in a diary treatments for hypoglycemic events | Other | Standard educational program, Standard educational program combined with high intensity interval training |
| Piezo RxDParticipants will be asked to wear a pedometer throughout the study | Device | Standard educational program, Standard educational program combined with high intensity interval training |
| Heart rate monitorDuring training sessions, participants will be asked to wear a heart rate monitor | Device | Standard educational program combined with high intensity interval training |
| Exercise diaryBefore 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. | Other | Standard educational program combined with high intensity interval training |
Primary outcome
Change in the Gold score
Time frame: 12 weeks
The Gold method is used to assess impaired awareness of hypoglycemia. The scale is from 1 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia
17 secondary outcomes
Change in the Clarke score
Time frame: 12 weeks
Change in the score of the Edinburgh Hypoglycemia Symptom Scale
Time frame: 12 weeks
Change in the score of the BAPAD questionnaire
Time frame: 12 weeks
Change in the score of the Hypoglycemia Fear Survey II
Time frame: 12 weeks
Change in physical activity practice
Time frame: 12 weeks
Change in well-being
Time frame: 12 weeks
Change in treatment satisfaction
Time frame: 12 weeks
Percentage of participants who no longer have impaired awareness of hypoglycemia
Time frame: 12 weeks
Percentage of time of glucose levels spent < 4.0 mmol/L
Time frame: 12 weeks
Percentage of time of glucose levels spent < 3.0 mmol/L
Time frame: 12 weeks
Percentage of time of glucose levels spent between 3.9-10.0 mmol/L
Time frame: 12 weeks
Percentage of time of glucose levels spent > 10.0 mmol/L
Time frame: 12 weeks
Standard deviation of glucose levels
Time frame: 12 weeks
Coefficient of variation of glucose levels
Time frame: 12 weeks
Number of hypoglycemic events
Time frame: 12 weeks
Number of treated hypoglycemic events
Time frame: 12 weeks
Number of severe hypoglycemia
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring device, Gold method and Clarke questionnaire in people with Type 1 Diabetes and Hypoglycemia Unawareness, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Gold score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.