Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training

Launched by INSTITUT DE RECHERCHES CLINIQUES DE MONTREAL · Mar 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a 12-week program of home-based high-intensity interval training (HIIT) can help people with type 1 diabetes regain their awareness of hypoglycemia, which means being able to recognize when their blood sugar levels are low. Participants will be divided into two groups: one will receive standard education about avoiding and treating low blood sugar, while the other will get the same education plus the HIIT program. The goal is to see if the exercise component helps people become more aware of their hypoglycemia than education alone.

To be eligible for the study, participants should be between 18 and 65 years old, have been diagnosed with type 1 diabetes for at least five years, and have difficulty recognizing low blood sugar symptoms. They must also be using insulin therapy and a continuous glucose monitor. Participants will be expected to train at home three times a week for 12 weeks, following a provided program and virtual sessions with an exercise specialist. This trial is currently recruiting, and it’s an opportunity for those struggling with hypoglycemia awareness to potentially improve their condition while receiving support and education.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females aged between 18 and 65 years old.
• • 2. Clinical diagnosis of type 1 diabetes for at least five years.
• • 3. 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.
• • 4. Impaired awareness of hypoglycemia (Gold score ≥ 4).
• • 5. HbA1c ≤ 10%
• • 6. Using a continuous glucose monitor or being willing to start using one for the study
• • 7. Having an electronic device supporting the Polar Beat application (heart rate monitor).
• Exclusion Criteria:
• • 1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially advanced peripheral neuropathy with significantly lower limb reduced proprioceptive perception) or severe proliferative retinopathy as reported by the patient and/or judged by the investigator.
• • 2. High risk foot problem (e.g., previous amputation, history of foot wound, known severe neuropathy or peripheral arterial disease)
• • 3. Recent (\< 3 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery or history of significant heart disease.
• • 4. Known significant cardiac rhythm abnormality based on investigator judgment.
• • 5. Abnormal blood panel and/or anemia (Hb \< 100g/L).
• • 6. Ongoing pregnancy or breastfeeding.
• • 7. Severe hypoglycemic episode or diabetic ketoacidosis within 1 month of screening.
• • 8. Taking any medication that affects heart rate (e.g., beta-blockers).
• • 9. Uncontrolled hypertension (blood pressure \>160/100 mm Hg).
• • 10. Uncontrolled angina.
• • 11. Treatment with oral steroids within the last 3 months.
• • 12. History of significant lung disease that would limit exercise.
• • 13. Seizure within the last 3 months.
• • 14. Participation in high-intensity interval training (or equivalent) in the past 6 months.
• • 15. Physical ability preventing the completion of the 12-week training program (e.g., orthopedic limitation).
• • 16. Inability to give consent.