High-Intensity Exercise for Type 1 Diabetes

(FEEL-HIIT Trial)

Overseen By Roxane St-Amand

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institut de Recherches Cliniques de Montreal

Must be taking: Insulin analogs

Must not be taking: Beta-blockers, Oral steroids

Disqualifiers: Microvascular complications, Heart disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

62 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable type of insulin for at least one month before joining. If you're not using an insulin analog, you may need to switch to one at least a month before starting the trial.

What data supports the effectiveness of the treatment Home-based High Intensity Interval Training for Type 1 Diabetes?

Research shows that Home-based High Intensity Interval Training (Home-HIT) can help people with type 1 diabetes by reducing the fear of low blood sugar during exercise and making it easier to fit exercise into their daily lives. It also improves muscle strength and balance, which are often affected in people with type 1 diabetes. ^{1 2 3 4 5}

Is high-intensity interval training safe for people with type 1 diabetes?

High-intensity interval training (HIIT) is considered safe for people with type 1 diabetes, as studies show it prevents severe hypoglycemia (low blood sugar) and does not require much time, addressing common exercise barriers for this group. ^{1 2 3 4 6}

How does high-intensity exercise differ from other treatments for type 1 diabetes?

High-intensity exercise, specifically high-intensity interval training (HIIT), is unique for people with type 1 diabetes because it reduces the fear of low blood sugar (hypoglycemia) and is time-efficient, making it easier to fit into daily life compared to traditional exercise routines. Unlike continuous aerobic exercise, HIIT can improve cardiovascular health and quality of life without the need for long sessions or gym memberships. ^{2 6 7 8 9}

Research Team

Rémi Rabasa-Lhoret

Principal Investigator

Institut de recherches cliniques de Montréal

Eligibility Criteria

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.

Inclusion Criteria

You need to have a device that can support the Polar Beat app and a heart rate monitor.

You have a condition that makes it hard for you to recognize when your blood sugar is too low.

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

Exclusion Criteria

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

Your blood tests show abnormal results, or you have low levels of hemoglobin.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to a 12-week program of standard educational program with or without high intensity interval training

12 weeks

Weekly virtual sessions with exercise specialist

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Home-based High Intensity Interval Training

Trial Overview 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.

Participant Groups

Group I: Standard educational program combined with high intensity interval training Active Control 13 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 program Active Control 11 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.

Who Is Running the Clinical Trial?

Institut de Recherches Cliniques de Montreal

Lead Sponsor

Trials

72

Recruited

10,300+

Findings from Research

A 6-week virtually supervised home-based high-intensity interval training (Home-HIT) program for 11 individuals with type 1 diabetes showed excellent adherence (95%) and compliance (99%), indicating that this approach is feasible and effective for this population.

Home-HIT led to a significant 7% increase in aerobic capacity and a 13% reduction in insulin dosage, while blood glucose levels remained stable, suggesting that this training can improve fitness without negatively impacting blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Evaluation of a Virtually Supervised Home-Based High-Intensity Interval Training Intervention in People With Type 1 Diabetes. Scott, SN., Shepherd, SO., Andrews, RC., et al.[2020]

A virtually monitored home-based high-intensity interval training (Home-HIT) program can help reduce the fear of hypoglycaemia in people with type 1 diabetes, encouraging them to exercise more regularly.

Home-HIT addresses common barriers to exercise, such as time constraints, travel costs, and discomfort exercising in public, making it a practical and effective option for individuals with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based high-intensity interval training reduces barriers to exercise in people with type 1 diabetes. Scott, SN., Shepherd, SO., Strauss, JA., et al.[2021]

A 12-week high-intensity interval training (HIIT) program led to a reduction in HbA1c levels in adults with type 1 diabetes, but this change was not significantly different from the control group overall.

Participants who adhered to at least 50% of the HIIT sessions experienced a significant reduction in HbA1c compared to the control group, suggesting that greater adherence to HIIT may improve glycemic control in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training on Glycemic Control in Adults With Type 1 Diabetes and Overweight or Obesity: A Randomized Controlled Trial With Partial Crossover. Lee, AS., Johnson, NA., McGill, MJ., et al.[2021]

A 6-week high-intensity interval training (HIIT) program significantly improved lower limb muscle power, ankle dorsiflexion range of motion, and dynamic balance in 19 individuals with type 1 diabetes mellitus, demonstrating its safety and efficacy.

Participants in the HIIT group showed notable improvements in squat execution velocity (up to 11.3%) and dynamic balance across various directions, while the control group showed no significant changes, highlighting HIIT's effectiveness in enhancing physical functionality for those with T1DM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a HIIT protocol on the lower limb muscle power, ankle dorsiflexion and dynamic balance in a sedentary type 1 diabetes mellitus population: a pilot study. Alarcón-Gómez, J., Martin Rivera, F., Madera, J., et al.[2022]

In a study involving type 1 diabetes patients, both high-intensity interval training (HIIT) and strength training (ST) improved glycemic control and antioxidant levels, indicating their efficacy in managing diabetes-related health issues.

The combination of strength training and HIIT (ST + HIIT) was particularly beneficial, leading to a reduction in daily insulin dosage, suggesting it may be the most effective training approach for additional metabolic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic, inflammatory and oxidative stress responses to different high-intensity training protocols in type 1 diabetes: A randomized clinical trial. Farinha, JB., Ramis, TR., Vieira, AF., et al.[2019]

A 6-week high-intensity interval training (HIIT) program was found to be safe for sedentary adults with Type 1 Diabetes Mellitus (T1DM), as no severe hypoglycemia events occurred during the study.

HIIT significantly improved cardiovascular risk factors, including VO2max, body composition, heart rate variability, and fasting glucose levels, making it an effective exercise strategy for individuals with T1DM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a HIIT Protocol on Cardiovascular Risk Factors in a Type 1 Diabetes Mellitus Population. Alarcón-Gómez, J., Calatayud, J., Chulvi-Medrano, I., et al.[2021]

Exercise training, particularly a combination of strength exercises and high-intensity interval training, may help reduce the risk of hypoglycemia in individuals with Type 1 diabetes mellitus (T1DM) compared to continuous aerobic exercise.

This proposed training regimen, performed three times a week, aims to improve long-term health markers and reduce the risk of complications associated with T1DM by enhancing glycemic control and overall physical fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for type 1 diabetes mellitus management: General considerations and new directions. Farinha, JB., Krause, M., Rodrigues-Krause, J., et al.[2022]

A 6-week high-intensity interval training (HIIT) program was found to be safe for sedentary adults with type 1 diabetes, as no severe hypoglycemia events were reported during the study.

Participants in the HIIT group experienced significant improvements in health-related quality of life, sleep quality, and exercise motivation, highlighting HIIT as an effective strategy for enhancing psychological well-being in individuals with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training on Quality of Life, Sleep Quality, Exercise Motivation and Enjoyment in Sedentary People with Type 1 Diabetes Mellitus. Alarcón-Gómez, J., Chulvi-Medrano, I., Martin-Rivera, F., et al.[2021]

High Intensity Interval Training and Resistance training (HIITR) significantly improved heart rate variability (HRV), aerobic capacity (VO2peak), and levels of beneficial plasma biomarkers like HDL-C in adolescents with type 1 diabetes after 12 weeks of training.

The study found that exercise training led to significant reductions in HbA1c and fasting blood sugar levels, highlighting the potential of HIITR to enhance cardiovascular health and metabolic control in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A High intensity Interval training (running and swimming) and resistance training intervention on heart rate variability and the selected biochemical factors in boys with type 1 diabetes. Saki, H., Nazem, F., Fariba, F., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Evaluation of a Virtually Supervised Home-Based High-Intensity Interval Training Intervention in People With Type 1 Diabetes. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Home-based high-intensity interval training reduces barriers to exercise in people with type 1 diabetes. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training on Glycemic Control in Adults With Type 1 Diabetes and Overweight or Obesity: A Randomized Controlled Trial With Partial Crossover. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a HIIT protocol on the lower limb muscle power, ankle dorsiflexion and dynamic balance in a sedentary type 1 diabetes mellitus population: a pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Glycemic, inflammatory and oxidative stress responses to different high-intensity training protocols in type 1 diabetes: A randomized clinical trial. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a HIIT Protocol on Cardiovascular Risk Factors in a Type 1 Diabetes Mellitus Population. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Exercise for type 1 diabetes mellitus management: General considerations and new directions. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training on Quality of Life, Sleep Quality, Exercise Motivation and Enjoyment in Sedentary People with Type 1 Diabetes Mellitus. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

A High intensity Interval training (running and swimming) and resistance training intervention on heart rate variability and the selected biochemical factors in boys with type 1 diabetes. [2023]