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

Primary Purpose

Coronary Heart Disease, Physical Activity, Cardiovascular Risk Factors

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Fitbit Inspire 2
Abbott Freestyle Libre 3
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Heart Disease focused on measuring blood pressure, lipids, glucose level, smoking, weight, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wearing a smartwatch and glucose measuring device

Standard care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
July 24, 2023
Last Updated
August 2, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT05969665
Brief Title
Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Physical Activity, Cardiovascular Risk Factors
Keywords
blood pressure, lipids, glucose level, smoking, weight, diet

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-centre, randomized controlled, open-label trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wearing a smartwatch and glucose measuring device
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The control group will be given the standard recommendations that all patients completing cardiac rehabilitation receive.
Intervention Type
Device
Intervention Name(s)
Fitbit Inspire 2
Intervention Description
A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months.
Intervention Type
Device
Intervention Name(s)
Abbott Freestyle Libre 3
Intervention Description
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 Outcome Measure Information:
Title
Change in cardiovascular risk factor score blood pressure
Description
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
Title
Change in cardiovascular risk factor score LDL
Description
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
Title
Change in cardiovascular risk factor score HbA1c
Description
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
Title
Change in cardiovascular risk factor score BMI
Description
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
Title
Change in cardiovascular risk factor score physical activity
Description
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
Time Frame
at baseline and after 3 month
Title
Change in cardiovascular risk factor score nutrition
Description
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
Time Frame
at baseline and after 3 month
Title
Change in cardiovascular risk factor score smoking
Description
For the risk factor smoking 0 or 3 points will be awarded. Points according to goals: Smoking (yes/no) 3 = no 0 = yes
Time Frame
at baseline and after 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Gerrit van der Stouwe, Dr. med.
Phone
+41 61 265 44 44
Email
jangerrit.vanderstouwe@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Badertscher, Dr. med.
Phone
+41 61 265 52 14
Email
patrick.badertscher@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Gerrit van der Stouwe, Dr. med.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Gerrit van der Stouwe, Dr. med.
Phone
+41 61 265 44 44
Email
jangerrit.vanderstouwe@usb.ch
First Name & Middle Initial & Last Name & Degree
Patrick Badertscher, Dr. med.
Phone
+41 61 265 52 14
Email
patrick.badertscher@usb.ch
First Name & Middle Initial & Last Name & Degree
Jan Gerrit van der Stouwe, Dr. med.
First Name & Middle Initial & Last Name & Degree
Patrick Badertscher, Dr. med.
First Name & Middle Initial & Last Name & Degree
Otmar Pfister, Prof. Dr. med.

12. IPD Sharing Statement

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

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