NCT Number: NCT05969665
The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
Location status: Recruiting
Jan Gerrit van der Stouwe, Dr. med.
CONTACT
Jan Gerrit van der Stouwe, Dr. med.
PRINCIPAL_INVESTIGATOR
Otmar Pfister, Prof. Dr. med.
SUB_INVESTIGATOR
Patrick Badertscher, Dr. med.
CONTACT
Patrick Badertscher, Dr. med.
SUB_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A smartwatch (Fitbit Inspire 2) with its respective app will be worn by the patients in the intervention group for 3 months.
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.
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
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
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 %
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
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
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
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
Contact information is provided by the study sponsor or research team.
Jan Gerrit van der Stouwe, Dr. med.
CONTACT
Patrick Badertscher, Dr. med.
CONTACT
University Hospital, Basel, Switzerland
Other
Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors After Cardiac Rehabilitation - A Randomised Controlled Trial: MITIGATE-RF
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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