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High-Intensity Exercise for Type 1 Diabetes (FEEL-HIIT Trial)
N/A
Recruiting
Led By Rémi Rabasa-Lhoret
Research Sponsored by Institut de Recherches Cliniques de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of type 1 diabetes for at least five years
Males and females aged between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
FEEL-HIIT Trial Summary
This trial will investigate if adding a 12-week high intensity interval training program to a standard educational program will help people with type 1 diabetes and impaired awareness of hypoglycemia to better understand and avoid hypoglycemia episodes.
Who is the study for?
This trial is for adults aged 18-65 with type 1 diabetes and a reduced ability to detect low blood sugar, who've had diabetes for at least five years. They must use or be willing to use a continuous glucose monitor and have stable insulin treatment. Exclusions include heart rate-affecting meds, pregnancy, physical limitations preventing exercise, severe diabetic complications, recent high-intensity training, uncontrolled hypertension or significant heart disease.Check my eligibility
What is being tested?
The study tests if adding a home-based high intensity interval training (HIIT) program to standard educational sessions on hypoglycemia prevention can better restore awareness of low blood sugar in type 1 diabetics than education alone. Participants will either receive the education or combine it with HIIT over 12 weeks and track their progress using various tools like glucose monitors and questionnaires.See study design
What are the potential side effects?
Potential side effects from the intervention may include typical exercise-related risks such as muscle soreness or strain. Since participants have diabetes, there's also a risk of hypoglycemia during or after exercise which they'll need to monitor closely with their devices.
FEEL-HIIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 1 diabetes for 5 years or more.
Select...
I am between 18 and 65 years old.
FEEL-HIIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the Gold score
Secondary outcome measures
Change in physical activity practice
Change in the Clarke score
Change in the score of the BAPAD questionnaire
+14 moreFEEL-HIIT Trial Design
2Treatment groups
Active Control
Group I: Standard educational program combined with high intensity interval trainingActive Control13 Interventions
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.
Group II: Standard educational programActive Control11 Interventions
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.
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Who is running the clinical trial?
Institut de Recherches Cliniques de MontrealLead Sponsor
70 Previous Clinical Trials
10,306 Total Patients Enrolled
Rémi Rabasa-LhoretPrincipal InvestigatorInstitut de recherches cliniques de Montréal
17 Previous Clinical Trials
578 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a device that can support the Polar Beat app and a heart rate monitor.My blood pressure is not higher than 160/100 mm Hg.Your blood tests show abnormal results, or you have low levels of hemoglobin.You have a condition that makes it hard for you to recognize when your blood sugar is too low.I have a lung condition that limits my ability to exercise.I have had a heart attack or heart surgery in the last 3 months, or have significant heart disease.I have chest pain that isn't managed by medication.I have been diagnosed with type 1 diabetes for 5 years or more.I have serious kidney, nerve, or eye problems due to diabetes.You have a heart rhythm problem that the doctor thinks is important.I do not have any physical conditions that stop me from completing a 12-week training program.I am using or willing to use a continuous glucose monitor.I haven't had a severe low blood sugar or diabetic ketoacidosis in the last month.I've been on a stable insulin regimen with injections or a pump for over a month.Your HbA1c level is less than or equal to 10%.You have done very intense exercise, like sprinting or heavy weightlifting, in the last 6 months.I am taking medication that influences my heart rate.I am between 18 and 65 years old.I am unable to understand and give consent for treatment.I have not taken oral steroids in the last 3 months.I have a high-risk foot condition, such as a past amputation or severe nerve damage.I have not had a seizure in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Standard educational program combined with high intensity interval training
- Group 2: Standard educational program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research team accept applicants younger than 80 years of age?
"This study adheres to strict eligibility criteria that demand participants are at least 18 years old and not more than 65."
Answered by AI
Is there still an opportunity for people to participate in this research?
"Yes, the data listed on clinicaltrials.gov affirms that this research program is actively seeking volunteers. Launched on August 3rd 2021, it was last updated a fortnight later. This study seeks to enroll 62 individuals across 1 centre."
Answered by AI
How many individuals can feasibly participate in this trial?
"Affirmative. The information posted on clinicaltrials.gov indicates that the research is currently seeking participants, with an initial posting date of August 3rd 2021 and a most recent edit occurring on August 16th 2021. 62 volunteers are required across 1 location for this trial to be completed successfully."
Answered by AI
Are there any particular demographics being targeted for enrollment in this trial?
"This clinical trial seeks 62 individuals aged 18 to 65 who are suffering from hypoglycemia. Additionally, male and female participants must have had a diagnosis of type 1 diabetes for at least five years, possess an electronic device with the Polar Beat app installed (heart rate monitor), receive multiple daily insulin injections or use an insulin pump with analogs that has been stable for one month prior to enrollment, present impaired awareness of hypoglycemia (Gold score ≥ 4), boast HbA1c ≤ 10%, and be willing to start using continuous glucose monitoring when applicable."
Answered by AI
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