Monitoring glucose levels and physical activity with wearables to improve heart health
Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors After Cardiac Rehabilitation - A Randomised Controlled Trial: MITIGATE-RF
This study tests if using smart watches and glucose monitors can help people with heart disease improve their heart health by tracking their activity and glucose levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT05969665 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of smart watches and continuous glucose monitoring devices on cardiovascular risk factors in patients with coronary heart disease. Over a period of four months, 100 participants will be randomly assigned to either an intervention group, receiving wearable devices, or a control group. The intervention group will use the devices to track their physical activity and glucose levels, while data on various health metrics will be collected throughout the study. Blood samples and questionnaires will be utilized to assess changes in cardiovascular risk factors before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have completed outpatient cardiac rehabilitation and have a diagnosis of coronary heart disease.
Not a fit: Patients with significant physical activity limitations, severe heart failure, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of cardiovascular risk factors in patients with coronary heart disease.
How similar studies have performed: Previous studies have shown promising results using wearable technology for monitoring health metrics, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jan Gerrit van der Stouwe, Dr. med. — University Hospital, Basel, Switzerland
- Study coordinator: Jan Gerrit van der Stouwe, Dr. med.
- Email: jangerrit.vanderstouwe@usb.ch
- Phone: +41 61 265 44 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.