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The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard care | No Intervention | The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit Inspire 2 | Device | A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 % | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Gerrit van der Stouwe, Dr. med. | Contact | +41 61 265 44 44 | jangerrit.vanderstouwe@usb.ch | |
| Patrick Badertscher, Dr. med. | Contact | +41 61 265 52 14 | patrick.badertscher@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jan Gerrit van der Stouwe, Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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single-centre, randomized controlled, open-label trial
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| Abbott Freestyle Libre 3 | 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. |
|
| 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 | 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 | 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 | at baseline and after 3 month |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D009043 | Motor Activity |
| D012907 | Smoking |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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