About this trial
The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Fitbit Inspire 2
DeviceA 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
DeviceA 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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
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 %
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
Sponsors and contacts
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