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NCT Number: NCT05969665

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

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

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Key information

Conditions

Coronary Heart Disease Behavior Body Weight Cardiovascular Diseases Cardiovascular Risk Factors Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Smoking Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in cardiovascular risk factor score blood pressure

    Time frame: 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

  2. Change in cardiovascular risk factor score LDL

    Time frame: 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

  3. Change in cardiovascular risk factor score HbA1c

    Time frame: 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 %

  4. Change in cardiovascular risk factor score BMI

    Time frame: 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

  5. Change in cardiovascular risk factor score physical activity

    Time frame: 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

  6. Change in cardiovascular risk factor score nutrition

    Time frame: 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

  7. Change in cardiovascular risk factor score smoking

    Time frame: 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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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