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

Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04825366
• Other study ID #: 2021-1117
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: Institut de Recherches Cliniques de Montreal
• Contact: Roxane St-Amand
• Phone: 514-987-5597
• Email: roxane.st-amand[@]ircm.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: August 31, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Hypoglycemia Unawareness
• Type 1 Diabetes
• Unconsciousness

Intervention

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
• 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

Device:
• 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

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.

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

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