Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training (FEEL-HIIT)

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.

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 Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes; Hypoglycemia Unawareness
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roxane St-Amand; Phone Number: 514-987-5597; Email: roxane.st-amand@ircm.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Recruiting
      • Institut de Recherches Cliniques de Montreal
      • Principal Investigator: Remi Rabasa-Lhoret
      • Contact: Roxane St-Amand; Phone Number: 514-987-5597; Email: roxane.st-amand@ircm.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Continuous glucose monitoring device; Participants will have to wear their continuous glucose monitoring device throughout the study.; Other: Gold method; The Gold method will be used to assess impaired awareness of hypoglycemia; Other: Clarke questionnaire; The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia; Other: Edinburgh Hypoglycemia Symptom Scale; The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia; Other: BAPAD questionnaire; The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity; Other: Hypoglycemia Fear Survey II; The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia; Other: Physical activity questionnaire; The International Physical Activity Questionnaire will be used to assess physical activity practice; Other: Well-being; The WHO-5 well-being index will be used to assess well-being.; Other: Treatment satisfaction; The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.; Other: Hypoglycemia diary; Participants will be asked to record in a diary treatments for hypoglycemic events; Device: Piezo RxD; Participants will be asked to wear a pedometer throughout the study
Active Comparator: 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.	Device: Continuous glucose monitoring device; Participants will have to wear their continuous glucose monitoring device throughout the study.; Other: Gold method; The Gold method will be used to assess impaired awareness of hypoglycemia; Other: Clarke questionnaire; The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia; Other: Edinburgh Hypoglycemia Symptom Scale; The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia; Other: BAPAD questionnaire; The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity; Other: Hypoglycemia Fear Survey II; The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia; Other: Physical activity questionnaire; The International Physical Activity Questionnaire will be used to assess physical activity practice; Other: Well-being; The WHO-5 well-being index will be used to assess well-being.; Other: Treatment satisfaction; The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.; Other: Hypoglycemia diary; Participants will be asked to record in a diary treatments for hypoglycemic events; Device: Piezo RxD; Participants will be asked to wear a pedometer throughout the study; Device: Heart rate monitor; During training sessions, participants will be asked to wear a heart rate monitor; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks
Change in the score of the Edinburgh Hypoglycemia Symptom Scale	Symptoms of hypoglycemia	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.	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.	12 weeks
Change in physical activity practice	Score of the International Physical Activity Questionnaire	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.	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.	12 weeks
Percentage of participants who no longer have impaired awareness of hypoglycemia		12 weeks
Percentage of time of glucose levels spent < 4.0 mmol/L	Based on continous glucose monitor data	12 weeks
Percentage of time of glucose levels spent < 3.0 mmol/L	Based on continous glucose monitor data	12 weeks
Percentage of time of glucose levels spent between 3.9-10.0 mmol/L	Based on continous glucose monitor data	12 weeks
Percentage of time of glucose levels spent > 10.0 mmol/L	Based on continous glucose monitor data	12 weeks
Standard deviation of glucose levels	Based on continous glucose monitor data	12 weeks
Coefficient of variation of glucose levels	Based on continous glucose monitor data	12 weeks
Number of hypoglycemic events	Glucose levels < 4 mmol/L or < 3 mmol/L	12 weeks
Number of treated hypoglycemic events	Number of time that carbohydrates were taken to treat a hypoglycemia event	12 weeks
Number of severe hypoglycemia		12 weeks

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Investigators: Principal Investigator: Remi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: March 28, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Education; High intensity interval training; Hypoglycemia unawareness; Avoidance of hypoglycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Endocrine System Diseases; Diabetes Mellitus; Consciousness Disorders; Diabetes Mellitus, Type 1; Hypoglycemia; Unconsciousness
• Other Study ID Numbers: 2021-1117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No