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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05969665
Other study ID # 2023-D0040; kt23vanderstouwe
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2024
Est. completion date June 2024

Study information

Verified date March 2024
Source University Hospital, Basel, Switzerland
Contact Jan Gerrit van der Stouwe, Dr. med.
Phone +41 61 265 44 44
Email jangerrit.vanderstouwe@usb.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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