Clinical trial NCT04825366: Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training
Official title: Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia Unawareness
Keywords: Type 1 diabetes
Hypoglycemia unawareness
Education
Avoidance of hypoglycemia
High intensity interval training
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the Gold score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in the Clarke score
timeFrame: 12 weeks
measure: Change in the score of the Edinburgh Hypoglycemia Symptom Scale
timeFrame: 12 weeks
measure: Change in the score of the BAPAD questionnaire
timeFrame: 12 weeks
measure: Change in the score of the Hypoglycemia Fear Survey II
timeFrame: 12 weeks
measure: Change in physical activity practice
timeFrame: 12 weeks
measure: Change in well-being
timeFrame: 12 weeks
measure: Change in treatment satisfaction
timeFrame: 12 weeks
measure: Percentage of participants who no longer have impaired awareness of hypoglycemia
timeFrame: 12 weeks
measure: Percentage of time of glucose levels spent < 4.0 mmol/L
timeFrame: 12 weeks
measure: Percentage of time of glucose levels spent < 3.0 mmol/L
timeFrame: 12 weeks
measure: Percentage of time of glucose levels spent between 3.9-10.0 mmol/L
timeFrame: 12 weeks
measure: Percentage of time of glucose levels spent > 10.0 mmol/L
timeFrame: 12 weeks
measure: Standard deviation of glucose levels
timeFrame: 12 weeks
measure: Coefficient of variation of glucose levels
timeFrame: 12 weeks
measure: Number of hypoglycemic events
timeFrame: 12 weeks
measure: Number of treated hypoglycemic events
timeFrame: 12 weeks
measure: Number of severe hypoglycemia
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Rémi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: