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
University Hospital, Basel, Switzerland
100 participants
Feb 7, 2024
INTERVENTIONAL
Conditions
Summary
The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.
Eligibility
Inclusion Criteria5
- 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
- years or older on the date of consent
Exclusion Criteria8
- 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
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Interventions
A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months.
A continuous glucose measuring device (Abbott Freestyle Libre 3) with its respective app will be worn by the patients in the intervention group for 3 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05969665