NCT05969665

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Heart Disease
• Physical Activity
• Cardiovascular Risk Factors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-07
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-08-01
• Last updated: 2024-08-14

Locations

1 site across 1 country: Switzerland