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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

Must not have

Uncontrolled hypertension (blood pressure >160/100 mm Hg)

History of significant lung disease that would limit exercise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 1 diabetes for 5 years or more.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is not higher than 160/100 mm Hg.

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I have a lung condition that limits my ability to exercise.

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I have chest pain that isn't managed by medication.

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I have serious kidney, nerve, or eye problems due to diabetes.

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I do not have any physical conditions that stop me from completing a 12-week training program.

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I am taking medication that influences my heart rate.

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I am unable to understand and give consent for treatment.

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I have not taken oral steroids in the last 3 months.

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I have a high-risk foot condition, such as a past amputation or severe nerve damage.

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I have not had a seizure in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Gold score

Secondary study objectives

Change in physical activity practice

Change in the Clarke score

Change in the score of the BAPAD questionnaire

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met