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Completed

NCT Number: NCT04825366

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Unawareness Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Continuous glucose monitoring device

Device

Participants will have to wear their continuous glucose monitoring device throughout the study.

Gold method

Other

The Gold method will be used to assess impaired awareness of hypoglycemia

Clarke questionnaire

Other

The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia

Edinburgh Hypoglycemia Symptom Scale

Other

The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia

BAPAD questionnaire

Other

The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity

Hypoglycemia Fear Survey II

Other

The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia

Physical activity questionnaire

Other

The International Physical Activity Questionnaire will be used to assess physical activity practice

Well-being

Other

The WHO-5 well-being index will be used to assess well-being.

Treatment satisfaction

Other

The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.

Hypoglycemia diary

Other

Participants will be asked to record in a diary treatments for hypoglycemic events

Piezo RxD

Device

Participants will be asked to wear a pedometer throughout the study

Heart rate monitor

Device

During training sessions, participants will be asked to wear a heart rate monitor

Exercise diary

Other

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 outcomes

  1. 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

Secondary outcomes

  1. Change in the Clarke score

    Time frame: 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

  2. Change in the score of the Edinburgh Hypoglycemia Symptom Scale

    Time frame: 12 weeks

    Symptoms of hypoglycemia

  3. Change in the score of the BAPAD questionnaire

    Time frame: 12 weeks

    Barriers to physical activity. The score can be between 12 and 84. A higher score means more barriers to physical activity.

  4. Change in the score of the Hypoglycemia Fear Survey II

    Time frame: 12 weeks

    Fear of hypoglycemia. The score can be between 0 and 132. A higher score means higher level of fear of hypoglycemia.

  5. Change in physical activity practice

    Time frame: 12 weeks

    Score of the International Physical Activity Questionnaire

  6. Change in well-being

    Time frame: 12 weeks

    Score of the WHO-5 well-being index. The score can be between 0 and 5. Higher scores means better well-being.

  7. Change in treatment satisfaction

    Time frame: 12 weeks

    Score of the Diabetes Treatment Satisfaction questionnaire. The score can be between 0 and 36. Higher score means better satisfaction.

  8. Percentage of participants who no longer have impaired awareness of hypoglycemia

    Time frame: 12 weeks

  9. Percentage of time of glucose levels spent < 4.0 mmol/L

    Time frame: 12 weeks

    Based on continous glucose monitor data

  10. Percentage of time of glucose levels spent < 3.0 mmol/L

    Time frame: 12 weeks

    Based on continous glucose monitor data

  11. Percentage of time of glucose levels spent between 3.9-10.0 mmol/L

    Time frame: 12 weeks

    Based on continous glucose monitor data

  12. Percentage of time of glucose levels spent > 10.0 mmol/L

    Time frame: 12 weeks

    Based on continous glucose monitor data

  13. Standard deviation of glucose levels

    Time frame: 12 weeks

    Based on continous glucose monitor data

  14. Coefficient of variation of glucose levels

    Time frame: 12 weeks

    Based on continous glucose monitor data

  15. Number of hypoglycemic events

    Time frame: 12 weeks

    Glucose levels < 4 mmol/L or < 3 mmol/L

  16. Number of treated hypoglycemic events

    Time frame: 12 weeks

    Number of time that carbohydrates were taken to treat a hypoglycemia event

  17. Number of severe hypoglycemia

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study title

Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia

Acronym: FEEL-HIIT

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Apr 1, 2021
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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