Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes; Hypoglycemia Unawareness
• Interventions: 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

• Registration Number: NCT04825366
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-03-28
• Study First Posted: 2021-04-01
• Study Start: 2021-08-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2024-12-15
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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. Taking any medication that affects heart rate (e.g., beta-blockers).
9. Uncontrolled hypertension (blood pressure >160/100 mm Hg).
10. Uncontrolled angina.
11. Treatment with oral steroids within the last 3 months.
12. History of significant lung disease that would limit exercise.
13. Seizure within the last 3 months.
14. Participation in high-intensity interval training (or equivalent) in the past 6 months.
15. Physical ability preventing the completion of the 12-week training program (e.g., orthopedic limitation).
16. Inability to give consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard educational program	Clarke questionnaire	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.
Standard educational program	Edinburgh Hypoglycemia Symptom Scale	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.
Standard educational program	Hypoglycemia Fear Survey II	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.
Standard educational program	Physical activity questionnaire	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.
Standard educational program combined with high intensity interval training	Edinburgh Hypoglycemia Symptom Scale	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.
Standard educational program	Gold method	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.
Standard educational program	Hypoglycemia diary	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.
Standard educational program combined with high intensity interval training	Continuous glucose monitoring device	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.
Standard educational program	Continuous glucose monitoring device	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.
Standard educational program	Well-being	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.
Standard educational program combined with high intensity interval training	Hypoglycemia Fear Survey II	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.
Standard educational program combined with high intensity interval training	Hypoglycemia diary	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.
Standard educational program	BAPAD questionnaire	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.
Standard educational program	Piezo RxD	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.
Standard educational program combined with high intensity interval training	Gold method	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.
Standard educational program combined with high intensity interval training	Clarke questionnaire	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.
Standard educational program	Treatment satisfaction	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.
Standard educational program combined with high intensity interval training	BAPAD questionnaire	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.
Standard educational program combined with high intensity interval training	Physical activity questionnaire	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.
Standard educational program combined with high intensity interval training	Piezo RxD	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.
Standard educational program combined with high intensity interval training	Well-being	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.
Standard educational program combined with high intensity interval training	Treatment satisfaction	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.
Standard educational program combined with high intensity interval training	Heart rate monitor	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.
Standard educational program combined with high intensity interval training	Exercise diary	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.

Primary Outcome Measures

Name	Time	Method
Change in the Gold score	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

Secondary Outcome Measures

Name	Time	Method
Change in well-being	12 weeks	Score of the WHO-5 well-being index. The score can be between 0 and 5. Higher scores means better well-being.
Percentage of participants who no longer have impaired awareness of hypoglycemia	12 weeks
Percentage of time of glucose levels spent < 3.0 mmol/L	12 weeks	Based on continous glucose monitor data
Change in treatment satisfaction	12 weeks	Score of the Diabetes Treatment Satisfaction questionnaire. The score can be between 0 and 36. Higher score means better satisfaction.
Standard deviation of glucose levels	12 weeks	Based on continous glucose monitor data
Change in the score of the BAPAD questionnaire	12 weeks	Barriers to physical activity. The score can be between 12 and 84. A higher score means more barriers to physical activity.
Change in the Clarke score	12 weeks	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 physical activity practice	12 weeks	Score of the International Physical Activity Questionnaire
Percentage of time of glucose levels spent > 10.0 mmol/L	12 weeks	Based on continous glucose monitor data
Number of severe hypoglycemia	12 weeks
Change in the score of the Edinburgh Hypoglycemia Symptom Scale	12 weeks	Symptoms of hypoglycemia
Percentage of time of glucose levels spent < 4.0 mmol/L	12 weeks	Based on continous glucose monitor data
Coefficient of variation of glucose levels	12 weeks	Based on continous glucose monitor data
Number of treated hypoglycemic events	12 weeks	Number of time that carbohydrates were taken to treat a hypoglycemia event
Change in the score of the Hypoglycemia Fear Survey II	12 weeks	Fear of hypoglycemia. The score can be between 0 and 132. A higher score means higher level of fear of hypoglycemia.
Percentage of time of glucose levels spent between 3.9-10.0 mmol/L	12 weeks	Based on continous glucose monitor data
Number of hypoglycemic events	12 weeks	Glucose levels \< 4 mmol/L or \< 3 mmol/L

Trial Locations

Locations (1)

Institut de recherches cliniques de Montréal; 🇨🇦 Montreal, Quebec, Canada