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

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

Interventions

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.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal

  lead OTHER

Principal Investigators

• Rémi Rabasa-Lhoret · Institut de recherches cliniques de Montréal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-03

Primary Completion

2024-12-15

Completion

2025-08-31

Countries

• Canada

Study Locations