Coronary Heart DiseaseNCT05969665
Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors
A study testing Fitbit Inspire 2 and Abbott Freestyle Libre 3 in people with Coronary Heart Disease and Physical Activity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Physical Activity, Cardiovascular Risk Factors
- What is being tested?
- Fitbit Inspire 2 and Abbott Freestyle Libre 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Feb 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Jan Gerrit van der Stouwe, Dr. med., +41 61 265 44 44, jangerrit.vanderstouwe@usb.ch
Patrick Badertscher, Dr. med., +41 61 265 52 14, patrick.badertscher@usb.ch
About this study
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
The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.
Read the 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).
- Being tested
- Fitbit Inspire 2, Abbott Freestyle Libre 3
- Keywords
- blood pressure, lipids, glucose level, smoking, weight, diet
- Medical subject headings
- Coronary Disease, Motor Activity, Smoking, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Inspire 2Device
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 3Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearing a smartwatch and glucose measuring device | Experimental | 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. Receives: Device: Fitbit Inspire 2; Device: Abbott Freestyle Libre 3 |
| Standard care | No intervention | The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular risk factor score blood pressure
For the risk factor blood pressure 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC (European Society of Cardiology) -Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
Goals according to ESC Guidelines:
Systolic 120-130 mmHg (18-69y.) Systolic < 140 mmHg (70y.) Diastolic < 80 mmHg (all ages)
Points according to goals:
2 = age related SBP (systolic blood pressure) \& DBP (diastolic blood pressure) goals
1 = < 140 mmHg, > 130 mmHg 18-69yr. or < 140 mmHg and > 90 mmHg DBP >70yr 0 = SBP > 140 mmHg
Measured: at baseline and after 3 month
Change in cardiovascular risk factor score LDL
For the risk factor LDL 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
Goals according to ESC Guidelines:
LDL <1.4 mmol/l and 50% reduction from baseline
Points according to goals:
2 = < 1.4 mmol/l
1 = < 1.8 mmol/l 0 = > 1.8 mmol/l
Measured: at baseline and after 3 month
Change in cardiovascular risk factor score HbA1c
For the risk factor HbA1c 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
Goals according to ESC Guidelines:
DM (diabetes mellitus) HbA1c < 7.0% or < 6.5% in recent diagnosis No DM < 5.7% (cut-off prediabetes)
Points according to goals:
2 = < 5.7 %
1 = 5.7 - 6.5 % 0 = > 6.5 %
Measured: at baseline and after 3 month
Change in cardiovascular risk factor score BMI
For the risk factor BMI 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
Goals according to ESC Guidelines:
BMI 20-25 kg/m2 AC (Abdominal circumference) < 102 (men) < 88 (women) WHR (waist to hip ratio) 0.75-0.9 men \& 0.70-0.85 women
Points according to goals:
2 = BMI and AC in range
1 = only BMI or AC in range 0 = nothing in range
Measured: at baseline and after 3 month
Change in cardiovascular risk factor score physical activity
For the risk factor physical activity 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
Goals according to ESC Guidelines:
> 150min/week moderate PA (mPA), better 300min/week (self-reported) or > 75min/week vigorous PA (vPA), better 150min/week (self-reported)
Points according to goals:
2 = > 300 min. mPA or > 150 min. vPA
1 = > 150 min. mPA or > 75 min. vPA 0 = < 150 min. mPA or < 75 min. vPA Or mix or mPA and vPA respectively
Measured: at baseline and after 3 month
Change in cardiovascular risk factor score nutrition
For the risk factor nutrition 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal.
Goals according to ESC Guidelines:
≥ 5 portions fruit/vegetables a day Unsalted nuts ≥ 3x/week Reduction in saturated fats
Points according to goals:
2 = 5/day OR 4/day + nuts 3x/week + reduction in saturated fats
1 = 4/day OR 3/day + nuts 3x/week + reduction in saturated fats 0 = < 4/day
Measured: at baseline and after 3 month
Change in cardiovascular risk factor score smoking
For the risk factor smoking 0 or 3 points will be awarded.
Points according to goals:
Smoking (yes/no) 3 = no 0 = yes
Measured: at baseline and after 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start7 Feb 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-centre, randomized controlled, open-label trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Gerrit van der Stouwe, Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969665
- Sponsor's protocol ID
- 2023-D0040; kt23vanderstouwe
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05969665
- Acronym / sponsor ID
- 2023-D0040; kt23vanderstouwe
- Keywords
- blood pressure, lipids, glucose level, smoking, weight, diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-centre, randomized controlled, open-label trial
| Arm | Type | Receives |
|---|---|---|
| Wearing a smartwatch and glucose measuring device | Experimental | Device: Fitbit Inspire 2, Device: Abbott Freestyle Libre 3The 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. |
| Standard care | No intervention | –The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Inspire 2A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months. | Device | Wearing a smartwatch and glucose measuring device |
| Abbott Freestyle Libre 3A 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. | Device | Wearing a smartwatch and glucose measuring device |
Primary outcome
Change in cardiovascular risk factor score blood pressure
Time frame: at baseline and after 3 month
For the risk factor blood pressure 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC (European Society of Cardiology) -Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: Systolic 120-130 mmHg (18-69y.) Systolic < 140 mmHg (70y.) Diastolic < 80 mmHg (all ages) Points according to goals: 2 = age related SBP (systolic blood pressure) \& DBP (diastolic blood pressure) goals 1 = < 140 mmHg, > 130 mmHg 18-69yr. or < 140 mmHg and > 90 mmHg DBP >70yr 0 = SBP > 140 mmHg
Change in cardiovascular risk factor score LDL
Time frame: at baseline and after 3 month
For the risk factor LDL 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: LDL <1.4 mmol/l and 50% reduction from baseline Points according to goals: 2 = < 1.4 mmol/l 1 = < 1.8 mmol/l 0 = > 1.8 mmol/l
Change in cardiovascular risk factor score HbA1c
Time frame: at baseline and after 3 month
For the risk factor HbA1c 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: DM (diabetes mellitus) HbA1c < 7.0% or < 6.5% in recent diagnosis No DM < 5.7% (cut-off prediabetes) Points according to goals: 2 = < 5.7 % 1 = 5.7 - 6.5 % 0 = > 6.5 %
Change in cardiovascular risk factor score BMI
Time frame: at baseline and after 3 month
For the risk factor BMI 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: BMI 20-25 kg/m2 AC (Abdominal circumference) < 102 (men) < 88 (women) WHR (waist to hip ratio) 0.75-0.9 men \& 0.70-0.85 women Points according to goals: 2 = BMI and AC in range 1 = only BMI or AC in range 0 = nothing in range
Change in cardiovascular risk factor score physical activity
Time frame: at baseline and after 3 month
For the risk factor physical activity 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: > 150min/week moderate PA (mPA), better 300min/week (self-reported) or > 75min/week vigorous PA (vPA), better 150min/week (self-reported) Points according to goals: 2 = > 300 min. mPA or > 150 min. vPA 1 = > 150 min. mPA or > 75 min. vPA 0 = < 150 min. mPA or < 75 min. vPA Or mix or mPA and vPA respectively
Change in cardiovascular risk factor score nutrition
Time frame: at baseline and after 3 month
For the risk factor nutrition 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: ≥ 5 portions fruit/vegetables a day Unsalted nuts ≥ 3x/week Reduction in saturated fats Points according to goals: 2 = 5/day OR 4/day + nuts 3x/week + reduction in saturated fats 1 = 4/day OR 3/day + nuts 3x/week + reduction in saturated fats 0 = < 4/day
Change in cardiovascular risk factor score smoking
Time frame: at baseline and after 3 month
For the risk factor smoking 0 or 3 points will be awarded. Points according to goals: Smoking (yes/no) 3 = no 0 = yes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Gerrit van der Stouwe, Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Inspire 2 and Abbott Freestyle Libre 3 in people with Coronary Heart Disease and Physical Activity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Gerrit van der Stouwe, Dr. med. (+41 61 265 44 44, jangerrit.vanderstouwe@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiovascular risk factor score blood pressure (time frame: at baseline and after 3 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.