Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Change in the Gold score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females aged between 18 and 65 years old.
- •Clinical diagnosis of type 1 diabetes for at least five years.
- •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.
- •Impaired awareness of hypoglycemia (Gold score ≥ 4).
- •HbA1c ≤ 10%
- •Using a continuous glucose monitor or being willing to start using one for the study
- •Having an electronic device supporting the Polar Beat application (heart rate monitor).
Exclusion Criteria
- •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.
- •High risk foot problem (e.g., previous amputation, history of foot wound, known severe neuropathy or peripheral arterial disease)
- •Recent (< 3 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery or history of significant heart disease.
- •Known significant cardiac rhythm abnormality based on investigator judgment.
- •Abnormal blood panel and/or anemia (Hb < 100g/L).
- •Ongoing pregnancy or breastfeeding.
- •Severe hypoglycemic episode or diabetic ketoacidosis within 1 month of screening.
- •Uncontrolled hypertension (blood pressure >160/100 mm Hg).
- •Uncontrolled angina.
- •Treatment with oral steroids within the last 3 months.
- •History of significant lung disease that would limit exercise.
- •Seizure within the last 3 months.
- •Participation in high-intensity interval training (or equivalent) in the past 6 months.
- •Physical ability preventing the completion of the 12-week training program (e.g., orthopedic limitation).
- •Inability to give consent.
Outcomes
Primary Outcomes
Change in the Gold score
Time Frame: 12 weeks
The Gold method is used to assess impaired awareness of hypoglycemia. The scale is from 1 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia
Secondary Outcomes
- Change in well-being(12 weeks)
- Change in treatment satisfaction(12 weeks)
- Standard deviation of glucose levels(12 weeks)
- Change in the score of the BAPAD questionnaire(12 weeks)
- Percentage of participants who no longer have impaired awareness of hypoglycemia(12 weeks)
- Percentage of time of glucose levels spent < 3.0 mmol/L(12 weeks)
- Change in the Clarke score(12 weeks)
- Change in physical activity practice(12 weeks)
- Percentage of time of glucose levels spent > 10.0 mmol/L(12 weeks)
- Number of severe hypoglycemia(12 weeks)
- Change in the score of the Edinburgh Hypoglycemia Symptom Scale(12 weeks)
- Percentage of time of glucose levels spent < 4.0 mmol/L(12 weeks)
- Coefficient of variation of glucose levels(12 weeks)
- Number of treated hypoglycemic events(12 weeks)
- Change in the score of the Hypoglycemia Fear Survey II(12 weeks)
- Percentage of time of glucose levels spent between 3.9-10.0 mmol/L(12 weeks)
- Number of hypoglycemic events(12 weeks)
Investigators
Rémi Rabasa-Lhoret
Full professor
Institut de Recherches Cliniques de Montreal