Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors

University Hospital Basel

Status: Enrolling

Conditions: Physical Activity; Coronary Heart Disease; Cardiovascular Risk Factors

Treatments: Device: Fitbit Inspire 2; Device: Abbott Freestyle Libre 3

Study type: Interventional

Funder types: Other

Identifiers

NCT05969665

2023-D0040 kt23vanderstouwe;

Details and patient eligibility

About

The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Wearing a smartwatch and glucose measuring device

Experimental group

Description:

The intervention will be wearing a smart watch as well as continuous glucose monitoring with direct feedback via an application. Participants will wear these devices for 3 months.

Treatment:

Device: Abbott Freestyle Libre 3

Device: Fitbit Inspire 2

Standard care

No Intervention group

Description:

The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive.