- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jan Gerrit van der Stouwe, Dr. med.
- Phone Number: +41 61 265 44 44
- Email: jangerrit.vanderstouwe@usb.ch
Study Contact Backup
- Name: Patrick Badertscher, Dr. med.
- Phone Number: +41 61 265 52 14
- Email: patrick.badertscher@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- University Hospital Basel
-
Contact:
- Jan Gerrit van der Stouwe, Dr. med.
- Phone Number: +41 61 265 44 44
- Email: jangerrit.vanderstouwe@usb.ch
-
Contact:
- Patrick Badertscher, Dr. med.
- Phone Number: +41 61 265 52 14
- Email: patrick.badertscher@usb.ch
-
Principal Investigator:
- Jan Gerrit van der Stouwe, Dr. med.
-
Sub-Investigator:
- Patrick Badertscher, Dr. med.
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Sub-Investigator:
- Otmar Pfister, Prof. Dr. med.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive.
|
|
Experimental: 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.
|
A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
at baseline and after 3 month
|
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 |
at baseline and after 3 month
|
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 % |
at baseline and after 3 month
|
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 |
at baseline and after 3 month
|
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 |
at baseline and after 3 month
|
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 |
at baseline and after 3 month
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Change in cardiovascular risk factor score smoking
Time Frame: at baseline and after 3 month
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For the risk factor smoking 0 or 3 points will be awarded. Points according to goals: Smoking (yes/no) 3 = no 0 = yes |
at baseline and after 3 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jan Gerrit van der Stouwe, Dr. med., University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-D0040; kt23vanderstouwe
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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