Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors
NCT ID: NCT05969665
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-02-07
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Wearing a smartwatch and glucose measuring device
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.
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.
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.
Standard care
The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Jan Gerrit van der Stouwe, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-D0040; kt23vanderstouwe
Identifier Type: -
Identifier Source: org_study_id
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