Back to resultsRestoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training (FEEL-HIIT)
Primary Purpose
Type 1 Diabetes, Hypoglycemia Unawareness
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continuous glucose monitoring device
Gold method
Clarke questionnaire
Edinburgh Hypoglycemia Symptom Scale
BAPAD questionnaire
Hypoglycemia Fear Survey II
Physical activity questionnaire
Well-being
Treatment satisfaction
Hypoglycemia diary
Piezo RxD
Heart rate monitor
Exercise diary
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Hypoglycemia unawareness, Education, Avoidance of hypoglycemia, High intensity interval training
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- Severe hypoglycemic episode or diabetic ketoacidosis within 1 month of screening.
- Taking any medication that affects heart rate (e.g., beta-blockers).
- 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.
Sites / Locations
- Institut de recherches cliniques de MontréalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard educational program
Standard educational program combined with high intensity interval training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Change in the score of the Edinburgh Hypoglycemia Symptom Scale
Symptoms of hypoglycemia
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.
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.
Change in physical activity practice
Score of the International Physical Activity Questionnaire
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.
Change in treatment satisfaction
Score of the Diabetes Treatment Satisfaction questionnaire. The score can be between 0 and 36. Higher score means better satisfaction.
Percentage of participants who no longer have impaired awareness of hypoglycemia
Percentage of time of glucose levels spent < 4.0 mmol/L
Based on continous glucose monitor data
Percentage of time of glucose levels spent < 3.0 mmol/L
Based on continous glucose monitor data
Percentage of time of glucose levels spent between 3.9-10.0 mmol/L
Based on continous glucose monitor data
Percentage of time of glucose levels spent > 10.0 mmol/L
Based on continous glucose monitor data
Standard deviation of glucose levels
Based on continous glucose monitor data
Coefficient of variation of glucose levels
Based on continous glucose monitor data
Number of hypoglycemic events
Glucose levels < 4 mmol/L or < 3 mmol/L
Number of treated hypoglycemic events
Number of time that carbohydrates were taken to treat a hypoglycemia event
Number of severe hypoglycemia
Full Information
NCT ID
NCT04825366
First Posted
March 28, 2021
Last Updated
July 28, 2023
Sponsor
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT04825366
Brief Title
Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training
Acronym
FEEL-HIIT
Official Title
Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Hypoglycemia Unawareness
Keywords
Type 1 diabetes, Hypoglycemia unawareness, Education, Avoidance of hypoglycemia, High intensity interval training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard educational program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard educational program combined with high intensity interval training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring device
Intervention Description
Participants will have to wear their continuous glucose monitoring device throughout the study.
Intervention Type
Other
Intervention Name(s)
Gold method
Intervention Description
The Gold method will be used to assess impaired awareness of hypoglycemia
Intervention Type
Other
Intervention Name(s)
Clarke questionnaire
Intervention Description
The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia
Intervention Type
Other
Intervention Name(s)
Edinburgh Hypoglycemia Symptom Scale
Intervention Description
The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia
Intervention Type
Other
Intervention Name(s)
BAPAD questionnaire
Intervention Description
The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity
Intervention Type
Other
Intervention Name(s)
Hypoglycemia Fear Survey II
Intervention Description
The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia
Intervention Type
Other
Intervention Name(s)
Physical activity questionnaire
Intervention Description
The International Physical Activity Questionnaire will be used to assess physical activity practice
Intervention Type
Other
Intervention Name(s)
Well-being
Intervention Description
The WHO-5 well-being index will be used to assess well-being.
Intervention Type
Other
Intervention Name(s)
Treatment satisfaction
Intervention Description
The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.
Intervention Type
Other
Intervention Name(s)
Hypoglycemia diary
Intervention Description
Participants will be asked to record in a diary treatments for hypoglycemic events
Intervention Type
Device
Intervention Name(s)
Piezo RxD
Intervention Description
Participants will be asked to wear a pedometer throughout the study
Intervention Type
Device
Intervention Name(s)
Heart rate monitor
Intervention Description
During training sessions, participants will be asked to wear a heart rate monitor
Intervention Type
Other
Intervention Name(s)
Exercise diary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Gold score
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in the Clarke score
Description
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
Time Frame
12 weeks
Title
Change in the score of the Edinburgh Hypoglycemia Symptom Scale
Description
Symptoms of hypoglycemia
Time Frame
12 weeks
Title
Change in the score of the BAPAD questionnaire
Description
Barriers to physical activity. The score can be between 12 and 84. A higher score means more barriers to physical activity.
Time Frame
12 weeks
Title
Change in the score of the Hypoglycemia Fear Survey II
Description
Fear of hypoglycemia. The score can be between 0 and 132. A higher score means higher level of fear of hypoglycemia.
Time Frame
12 weeks
Title
Change in physical activity practice
Description
Score of the International Physical Activity Questionnaire
Time Frame
12 weeks
Title
Change in well-being
Description
Score of the WHO-5 well-being index. The score can be between 0 and 5. Higher scores means better well-being.
Time Frame
12 weeks
Title
Change in treatment satisfaction
Description
Score of the Diabetes Treatment Satisfaction questionnaire. The score can be between 0 and 36. Higher score means better satisfaction.
Time Frame
12 weeks
Title
Percentage of participants who no longer have impaired awareness of hypoglycemia
Time Frame
12 weeks
Title
Percentage of time of glucose levels spent < 4.0 mmol/L
Description
Based on continous glucose monitor data
Time Frame
12 weeks
Title
Percentage of time of glucose levels spent < 3.0 mmol/L
Description
Based on continous glucose monitor data
Time Frame
12 weeks
Title
Percentage of time of glucose levels spent between 3.9-10.0 mmol/L
Description
Based on continous glucose monitor data
Time Frame
12 weeks
Title
Percentage of time of glucose levels spent > 10.0 mmol/L
Description
Based on continous glucose monitor data
Time Frame
12 weeks
Title
Standard deviation of glucose levels
Description
Based on continous glucose monitor data
Time Frame
12 weeks
Title
Coefficient of variation of glucose levels
Description
Based on continous glucose monitor data
Time Frame
12 weeks
Title
Number of hypoglycemic events
Description
Glucose levels < 4 mmol/L or < 3 mmol/L
Time Frame
12 weeks
Title
Number of treated hypoglycemic events
Description
Number of time that carbohydrates were taken to treat a hypoglycemia event
Time Frame
12 weeks
Title
Number of severe hypoglycemia
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Severe hypoglycemic episode or diabetic ketoacidosis within 1 month of screening.
Taking any medication that affects heart rate (e.g., beta-blockers).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roxane St-Amand
Phone
514-987-5597
Email
roxane.st-amand@ircm.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret
Organizational Affiliation
Institut de recherches cliniques de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roxane St-Amand
Phone
514-987-5597
Email
roxane.st-amand@ircm.qc.ca
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret
12. IPD Sharing Statement
Learn more about this trial
Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training
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