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

NARecruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

August 3, 2021

Primary Completion Date

December 15, 2024

Study Completion Date

August 31, 2025

Conditions
Type 1 DiabetesHypoglycemia 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.

Trial Locations (1)

H2W 1R7

RECRUITING

Institut de recherches cliniques de Montréal, Montreal

All Listed Sponsors
lead

Institut de Recherches Cliniques de Montreal

OTHER

NCT04825366 - Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training | Biotech Hunter | Biotech Hunter