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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2025-08-31

Brief Summary

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

Detailed Description

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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

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Coronary Heart Disease Physical Activity Cardiovascular Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single-centre, randomized controlled, open-label trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Fitbit Inspire 2

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Jan Gerrit van der Stouwe, Dr. med.

Role: CONTACT

+41 61 265 44 44

Patrick Badertscher, Dr. med.

Role: CONTACT

+41 61 265 52 14

Facility Contacts

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Jan Gerrit van der Stouwe, Dr. med.

Role: primary

+41 61 265 44 44

Patrick Badertscher, Dr. med.

Role: backup

+41 61 265 52 14

Other Identifiers

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2023-D0040; kt23vanderstouwe

Identifier Type: -

Identifier Source: org_study_id

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