Clinical trial NCT05969665: Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Physical Activity
Cardiovascular Risk Factors
Keywords: blood pressure
lipids
glucose level
smoking
weight
diet
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-centre, randomized controlled, open-label trial
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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

Primary outcomes:
measure: Change in cardiovascular risk factor score blood pressure
timeFrame: at baseline and after 3 month
measure: Change in cardiovascular risk factor score LDL
timeFrame: at baseline and after 3 month
measure: Change in cardiovascular risk factor score HbA1c
timeFrame: at baseline and after 3 month
measure: Change in cardiovascular risk factor score BMI
timeFrame: at baseline and after 3 month
measure: Change in cardiovascular risk factor score physical activity
timeFrame: at baseline and after 3 month
measure: Change in cardiovascular risk factor score nutrition
timeFrame: at baseline and after 3 month
measure: Change in cardiovascular risk factor score smoking
timeFrame: at baseline and after 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jan Gerrit van der Stouwe, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: