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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Wearing a smartwatch and glucose measuring deviceExperimental treatment 2 interventions
Group B: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
at baseline and after 3 month
2

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

Time frame
at baseline and after 3 month
3

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 %

Time frame
at baseline and after 3 month
4

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

Time frame
at baseline and after 3 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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