Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
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).

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

Conditions
-----------------
Coronary Heart Disease, Physical Activity, Cardiovascular Risk Factors

Intervention / Treatment
-----------------
* Device: Fitbit Inspire 2
* Device: Abbott Freestyle Libre 3


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-centre, randomized controlled, open-label trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearing a smartwatch and glucose measuring device<br>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. | Device: Fitbit Inspire 2<br>* A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months.<br>Device: Abbott Freestyle Libre 3<br>* 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.<br>|
| No Intervention: Standard care<br>The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure, lipids, glucose level, smoking, weight, diet