Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fitbit Inspire 2, Abbott Freestyle Libre 3.
- Who it may be relevant to
- Registry conditions: Coronary Heart Disease, Physical Activity, Cardiovascular Risk Factors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors After Cardiac Rehabilitation - A Randomised Controlled Trial: MITIGATE-RF
Overview
The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.
Detailed description
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).
Interventions
- Device Fitbit Inspire 2
A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months. - Device Abbott Freestyle Libre 3
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.
Primary outcome measures
- Change in cardiovascular risk factor score blood pressure [Time frame: at baseline and after 3 month]
- Change in cardiovascular risk factor score LDL [Time frame: at baseline and after 3 month]
- Change in cardiovascular risk factor score HbA1c [Time frame: at baseline and after 3 month]
- Change in cardiovascular risk factor score BMI [Time frame: at baseline and after 3 month]
- Change in cardiovascular risk factor score physical activity [Time frame: at baseline and after 3 month]
- Change in cardiovascular risk factor score nutrition [Time frame: at baseline and after 3 month]
- Change in cardiovascular risk factor score smoking [Time frame: at baseline and after 3 month]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT05969665 · 2023-D0040; kt23vanderstouwe