NCT04825366

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Institut de Recherches Cliniques de Montreal · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-08-03
• Primary completion: 2024-12-15
• Completion: 2025-08-31
• First posted: 2021-04-01
• Last updated: 2026-01-08

Locations

1 site across 1 country: Canada