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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Males and females aged between 18 and 65 years old.

• Clinical diagnosis of type 1 diabetes for at least five years.

• Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid or basal). The type of insulin should be stable for at least 1 month. Participants not using an insulin analog will be offered the opportunity to switch to an insulin analog and this will be done at least 1 month before inclusion.

• 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).

Locations
Other Locations
Canada
Institut de recherches cliniques de Montréal
RECRUITING
Montreal
Contact Information
Primary
Roxane St-Amand
roxane.st-amand@ircm.qc.ca
514-987-5597
Time Frame
Start Date: 2021-08-03
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 62
Treatments
Active_comparator: Standard educational program
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.
Active_comparator: Standard educational program combined with high intensity interval training
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.
Related Therapeutic Areas
Sponsors
Leads: Institut de Recherches Cliniques de Montreal

This content was sourced from clinicaltrials.gov

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