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

NCT05969665 | Recruiting

• 1 other identifier: 2023-D0040; kt23vanderstouwe
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Heart Disease; Physical Activity; Cardiovascular Risk Factors

Keywords

blood pressure; lipids; glucose level; smoking; weight; diet

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Wearing a smartwatch and glucose measuring device

EXPERIMENTAL

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.

Device: Fitbit Inspire 2; Device: Abbott Freestyle Libre 3

Standard care

NO INTERVENTION

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

Interventions

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.

Wearing a smartwatch and glucose measuring device

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.

Wearing a smartwatch and glucose measuring device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older on the date of consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Motor Activity; Smoking; Body Weight

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Gerrit van der Stouwe, Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Gerrit van der Stouwe, Dr. med.

CONTACT

+41 61 265 44 44; jangerrit.vanderstouwe@usb.ch

Patrick Badertscher, Dr. med.

CONTACT

+41 61 265 52 14; patrick.badertscher@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-centre, randomized controlled, open-label trial

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: February 7, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CH (1)