Home-based high intensity interval training to restore hypoglycemia awareness in type 1 diabetes

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

This study is testing if a 12-week home workout program can help people with type 1 diabetes regain their ability to sense low blood sugar when combined with education about managing it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institut de Recherches Cliniques de Montreal (Academic / other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT04825366 on ClinicalTrials.gov

What this trial studies

This study investigates whether a 12-week program of home-based high intensity interval training, combined with a standard educational program, can restore hypoglycemia awareness in individuals with type 1 diabetes and impaired awareness of hypoglycemia. Participants will be randomized to receive either the educational program alone or the program plus high intensity interval training. The educational sessions will cover topics such as hypoglycemia avoidance, treatment, and the use of continuous glucose monitoring devices. The effectiveness of the intervention will be assessed using various questionnaires and monitoring methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with type 1 diabetes for at least five years and impaired awareness of hypoglycemia.

Not a fit: Patients with clinically significant microvascular complications or those not using insulin analogs may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve hypoglycemia awareness and safety for patients with type 1 diabetes.

How similar studies have performed: Other studies have shown promise in using exercise interventions to improve diabetes management, but this specific combination of home-based training and education is relatively novel.

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.

Where this trial is running

Montreal, Quebec

• Institut de recherches cliniques de Montréal — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Rémi Rabasa-Lhoret — Institut de recherches cliniques de Montréal
• Study coordinator: Roxane St-Amand

Conditions Type 1 Diabetes; Hypoglycemia Unawareness; Type 1 diabetes; Hypoglycemia unawareness; Education; Avoidance of hypoglycemia; High intensity interval training