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

Institut de Recherches Cliniques de Montreal47 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Hypoglycemia Unawareness

Interventions

Continuous glucose monitoring deviceDEVICE

Participants will have to wear their continuous glucose monitoring device throughout the study.

Gold methodOTHER

The Gold method will be used to assess impaired awareness of hypoglycemia

Clarke questionnaireOTHER

The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia

Edinburgh Hypoglycemia Symptom ScaleOTHER

The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia

BAPAD questionnaireOTHER

The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity

Hypoglycemia Fear Survey IIOTHER

The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia

Physical activity questionnaireOTHER

The International Physical Activity Questionnaire will be used to assess physical activity practice

Well-beingOTHER

The WHO-5 well-being index will be used to assess well-being.

Treatment satisfactionOTHER

The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.

Hypoglycemia diaryOTHER

Participants will be asked to record in a diary treatments for hypoglycemic events

Piezo RxDDEVICE

Participants will be asked to wear a pedometer throughout the study

Heart rate monitorDEVICE

During training sessions, participants will be asked to wear a heart rate monitor

Exercise diaryOTHER

Before each training session, participants will be asked to note in a diary their glucose levels, if they have taken a snack or not and if insulin was administered. After each training session, participants will be asked to note that same information. In addition, they will be asked to note their bedtime blood glucose, if they have taken a bedtime snack and if adjustment to insulin doses was made.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. Uncontrolled hypertension (blood pressure \>160/100 mm Hg). 9. Uncontrolled angina. 10. Treatment with oral steroids within the last 3 months. 11. History of significant lung disease that would limit exercise. 12. Seizure within the last 3 months. 13. Participation in high-intensity interval training (or equivalent) in the past 6 months. 14. Physical ability preventing the completion of the 12-week training program (e.g., orthopedic limitation). 15. Inability to give consent.

Outcomes

Primary Outcomes

Change in the Gold score

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

Time frame: 12 weeks

Secondary Outcomes

Change in the Clarke score

The Clarke questionnaire is used to assess impaired awareness of hypoglycemia. The scale is from 0 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia

Time frame: 12 weeks

Change in the score of the Edinburgh Hypoglycemia Symptom Scale

Symptoms of hypoglycemia

Time frame: 12 weeks

Change in the score of the BAPAD questionnaire

Barriers to physical activity. The score can be between 12 and 84. A higher score means more barriers to physical activity.

Time frame: 12 weeks

Change in the score of the Hypoglycemia Fear Survey II

Fear of hypoglycemia. The score can be between 0 and 132. A higher score means higher level of fear of hypoglycemia.

Time frame: 12 weeks

Change in physical activity practice

Score of the International Physical Activity Questionnaire

Time frame: 12 weeks

Change in well-being

Score of the WHO-5 well-being index. The score can be between 0 and 5. Higher scores means better well-being.

Time frame: 12 weeks

Change in treatment satisfaction

Score of the Diabetes Treatment Satisfaction questionnaire. The score can be between 0 and 36. Higher score means better satisfaction.

Time frame: 12 weeks

Percentage of participants who no longer have impaired awareness of hypoglycemia

Time frame: 12 weeks

Percentage of time of glucose levels spent < 4.0 mmol/L