An interventional study of Continuous glucose monitoring device and Gold method in Type 1 Diabetes and Hypoglycemia Unawareness, sponsored by Institut de Recherches Cliniques de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Institut de Recherches Cliniques de Montreal · Not applicable, Interventional, and Treatment
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.
This study's enrollment of 47 is above the median of 40 across 2,648 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Institut de Recherches Cliniques de Montreal is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Participants will have to wear their continuous glucose monitoring device throughout the study.
The Gold method will be used to assess impaired awareness of hypoglycemia
The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia
The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia
The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity
The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia
The International Physical Activity Questionnaire will be used to assess physical activity practice
The WHO-5 well-being index will be used to assess well-being.
The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.
Participants will be asked to record in a diary treatments for hypoglycemic events
Participants will be asked to wear a pedometer throughout the study
During training sessions, participants will be asked to wear a heart rate monitor
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.
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
Time frame: 12 weeks
Change in the Clarke score
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
Time frame: 12 weeks
Change in the score of the Edinburgh Hypoglycemia Symptom Scale
Symptoms of hypoglycemia
Time frame: 12 weeks
Change in the score of the BAPAD questionnaire
Barriers to physical activity. The score can be between 12 and 84. A higher score means more barriers to physical activity.
Time frame: 12 weeks
Change in the score of the Hypoglycemia Fear Survey II
Fear of hypoglycemia. The score can be between 0 and 132. A higher score means higher level of fear of hypoglycemia.
Time frame: 12 weeks
Change in physical activity practice
Score of the International Physical Activity Questionnaire
Time frame: 12 weeks
Change in well-being
Score of the WHO-5 well-being index. The score can be between 0 and 5. Higher scores means better well-being.
Time frame: 12 weeks
Change in treatment satisfaction
Score of the Diabetes Treatment Satisfaction questionnaire. The score can be between 0 and 36. Higher score means better satisfaction.
Time frame: 12 weeks
Percentage of participants who no longer have impaired awareness of hypoglycemia
Time frame: 12 weeks
Percentage of time of glucose levels spent < 4.0 mmol/L
Based on continous glucose monitor data
Time frame: 12 weeks
Percentage of time of glucose levels spent < 3.0 mmol/L
Based on continous glucose monitor data
Time frame: 12 weeks
Percentage of time of glucose levels spent between 3.9-10.0 mmol/L
Based on continous glucose monitor data
Time frame: 12 weeks
Percentage of time of glucose levels spent > 10.0 mmol/L
Based on continous glucose monitor data
Time frame: 12 weeks
Standard deviation of glucose levels
Based on continous glucose monitor data
Time frame: 12 weeks
Coefficient of variation of glucose levels
Based on continous glucose monitor data
Time frame: 12 weeks
Number of hypoglycemic events
Glucose levels \< 4 mmol/L or \< 3 mmol/L
Time frame: 12 weeks
Number of treated hypoglycemic events
Number of time that carbohydrates were taken to treat a hypoglycemia event
Time frame: 12 weeks
Number of severe hypoglycemia
Time frame: 12 weeks
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Institut de Recherches Cliniques de Montreal