Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors

Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors After Cardiac Rehabilitation - A Randomised Controlled Trial: MITIGATE-RF

The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.

Within a period of 4 months 100 patients will be recruited and randomised to the intervention or control arm (1:1) for a duration of 3 months. Randomisation will be stratified by age, sex, BMI, diabetes, blood pressure, and duration after finishing cardiac rehabilitation. Patients randomised to the intervention arm will be given a smart watch as well as a continuous blood glucose measurement device with detailed instructions. At baseline and at the end of the study questionnaires will be answered and anthropomorphic measurements attained. Blood samples will be drawn at baseline and after an intervention period of 3 months in all subjects. Additional data on sleep, temperature, heart rate (resting and exercise), breathing rate, activity and exercise, oxygen saturation and daily weight will be collected through the Fitbit web application programming interface (API).

Inclusion Criteria:

• Informed Consent signed by the subject
• Completed outpatient cardiac rehabilitation
• Diagnosis of coronary heart disease
• Access to a smartphone for the duration of the study
• 18 years or older on the date of consent

Exclusion Criteria:

• Diseases which limit physical activity including angina with incomplete revascularisation, arrhythmogenic cardiomyopathy, stroke with residual disease, and major orthopaedic disorders
• Known or suspected non-compliance
• Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject
• Diabetic patients receiving insulin therapy
• Lack of proficiency with smart phone/watch
• Current participation in any other clinical trial, which may confound the results of this trial.
• NYHA (New York Heart Association) class III or IV congestive heart failure
• Pregnancy