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

NCT04825366 | Completed

• 1 other identifier: 2021-1117
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Hypoglycemia Unawareness

Keywords

Type 1 diabetes; Hypoglycemia unawareness; Education; Avoidance of hypoglycemia; High intensity interval training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change in the Clarke score

  12 weeks

• Change in the score of the Edinburgh Hypoglycemia Symptom Scale

  12 weeks

• Change in the score of the BAPAD questionnaire

  12 weeks

• Change in the score of the Hypoglycemia Fear Survey II

  12 weeks

• Change in physical activity practice

  12 weeks

Study Arms (2)

Standard educational program

ACTIVE COMPARATOR

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; 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

Standard educational program combined with high intensity interval training

ACTIVE COMPARATOR

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; 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

Interventions

Physical activity questionnaire OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

Treatment satisfaction OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

Hypoglycemia diary OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

Piezo RxD DEVICE

Participants will be asked to wear a pedometer throughout the study

Standard educational program; Standard educational program combined with high intensity interval training

Heart rate monitor DEVICE

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

Standard educational program combined with high intensity interval training

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.

Standard educational program combined with high intensity interval training

Continuous glucose monitoring device DEVICE

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

Standard educational program; Standard educational program combined with high intensity interval training

Gold method OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

Clarke questionnaire OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

Edinburgh Hypoglycemia Symptom Scale OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

BAPAD questionnaire OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

Hypoglycemia Fear Survey II OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

Well-being OTHER

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

Standard educational program; Standard educational program combined with high intensity interval training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged between 18 and 65 years old.
• Clinical diagnosis of type 1 diabetes for at least five years.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring; Health; Heart Rate Determination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Population Characteristics; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Physical Examination

Study Officials

• Rémi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: August 3, 2021
• Primary Completion: December 15, 2024
• Study Completion: August 31, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CA (1)