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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05969665

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Physical Activity Cardiovascular Risk Factors	Device: Fitbit Inspire 2 Device: Abbott Freestyle Libre 3	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

single-centre, randomized controlled, open-label trialsingle-centre, randomized controlled, open-label trial

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Fitbit Inspire 2 A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months. Device: Abbott Freestyle Libre 3 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.
No Intervention: Standard care The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive.

Arm

Intervention/Treatment

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.

Device: Fitbit Inspire 2

A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months.

Device: Abbott Freestyle Libre 3

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.

No Intervention: Standard care

The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive.

Outcome Measures

Primary Outcome Measures

Change in cardiovascular risk factor score blood pressure [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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