Table 2:
Selected Clinical Studies of Cardiovascular Management with Wearable Devices
| Study (year) | Study Design (n) | Wearable Device | Measurement | Major Findings |
|---|---|---|---|---|
| Physical Activity | ||||
| Lee et al. 2019 20 | Prospective cohort study (n = 16,741) | Actigraph GT3X+ Accelerometer (Actigraph Corp) | Daily step counts and step intensity | - As daily steps increased, the mortality rates decreased until it plateaued around 7,500 steps/day in a large cohort of older women. |
| Brickwood et al. 2019 23 | SR/MA of RCTs (n = 3,646) | Variety of wearable activity trackers | Daily step counts and step intensity | - Multifaceted interventions were more effective compared to interventions that relied solely on the wearable device. |
| Hodkinson et al. 202124 | SR/MA of RCTs (n = 4,203) | Variety of wearable activity trackers | Daily step counts and step intensity | - Interventions that combine activity trackers and consultations with health care professionals can significantly improve the PA level in patients with cardiometabolic conditions. |
| ENGAGE study 2021 33 | RCT (n = 500) | Fitbit Alta or Fitbit Inspire (Fitbit Inc) | Daily step counts and step intensity | - There was a greater increase in PA when individuals selected their goals (rather than assigned) with immediate implementation in economically disadvantaged adults. |
| Ferguson et al. 2022 2 | Umbrella review (n = 163,992) | Variety of wearable activity trackers | Daily step counts and step intensity | - Wearables increase activity by an average of 1800 steps/ day, 6 min of MVPA, and promote 1kg of weight loss with sustainable effects for at least 6 months. |
| Atrial Fibrillation | ||||
| REHEARSE-AF Study 2017 111 | RCT (n=1,001) | AliveCor Kardia device | Single-lead iECG | - Twice-weekly iECG screening led to nearly fourfold increase in new AF diagnosis in patients ≥ 65 y.o |
| mSToPS study 2018 13 | RCT and observational cohort study (n=2,659) | Zio Patch (iRhythm Technologies) | Single-lead ECG | - Monitored individuals had higher rates of AF diagnosis, AC use, and healthcare utilization. |
| Apple Heart Study. 2019. 38 | Prospective, multicenter, study. (n=419,297) |
Apple Watch (Apple Inc) | PPG | - Irregular pulse notifications occurred in 0.52% of the population cohort, and the PPV of the notification was 0.84 for atrial fibrillation detection. |
| Huawei Heart Study 201939 | Prospective cohort study (n=187,912) | Honor Band 4, Huawei Watch GT, Honor Watch (Huawei Tech.) | PPG | - PPG identified “suspected AF” in 0.2% of the cohort, and the PPV of the notification was 91.6%. |
| EPACS Study. 2019. 40 | RCT (n=116) | Zio Patch (iRhythm Technologies) | Single-lead ECG | - Continuous ECG monitoring after an index stroke/TIA resulted in significantly higher AF detection and AC use compared to Holter monitor. |
| SEARCH-AF Study. 2021 41 | RCT (n= 336) | SEEQ (Medtronic) or CardioSTAT (Icentia) chest patch | Single-lead ECG | - Continuous ECG monitoring increased the rate of AF detection by 17.9% within 30 days of hospital discharge after cardiac surgery. |
| SCREEN-AF Study 2021 112 | RCT (n = 856) | Zio Patch (iRhythm Technologies) and Watch BP-HomeA Monitor (Microlife) | Single-lead ECG and Oscillometric Screening |
- Continuous ECG monitoring increased AF detection 10-fold and led to AC initiation in 75% of patients ≥ 75 y.o. BP monitor screening was inferior compared to continuous ECG. |
| Heart Failure | ||||
| TIM-HF 2011. 46 | RCT (n=710) | Unspecified ECG and BP monitor | 3-lead ECG and BP | - Telemonitoring with physician interventions did not reduce all-cause mortality compared to usual care in ambulatory patients with stable HFrEF. |
| BEAT-HF study 2016 47 | RCT (n=1,437) | Unspecified BP + HR monitor | Unspecified | - Telemonitoring with health coaching did not reduce readmission or mortality rates after a HF hospitalization. |
| TIM-HF 2 Study 2018 45 | RCT (n= 1,571) | PhysioMem PM 1000 (GETEMED) and UA 767 PBT BP Device (A & D company) | 3-lead ECG and BP | - Telemonitoring reduced number of days lost to CV admissions and all-cause mortality in patients with HFrEF, no depression, and recent HF admission (subgroup of TIM-HF study). |
| LINK-HF study 2020 49 | Prospective multicenter study (n=100) | Multisensor wearable chest patch (Vital Connect) | PA, ECG, skin impedance, temperature | - ML algorithms detected rehospitalization with 76-88% sensitivity and 85% specificity, similar to the accuracy of implanted devices. - Alerts preceded the readmission by 6.5 days. |
| Cardiac Rehabilitation | ||||
| Telerehab II study 2015. 57 | RCT (n=80) | Yorbody Triaxial Accelerometer (Yorbody) | Daily step counts and activity intensity | - The telemonitoring program combined with conventional CR increased the peak VO2 more effectively than the control at 18 weeks in patients with CAD. |
| Maddison et al. 2019 58 | Non-inferiority RCT (n=162) | BioHarness 3 (Zephyr Technology) | HR, RR, single lead ECG, and PA | - Remotely monitored exercise-based cardiac telerehabilitation was similarly effective and had reduced program delivery costs compared to traditional center-based cardiac rehabilitation. |
| SmartCare-CAD study 2021 59, 60 | RCT (n=300) | Mio Alpha HR monitor (Physical Enterprises, Inc) and Actigraph wGT3x-BT triaxial accelerometer (Actigraph Corp) | Physical Activity Intensity and HR | - Cardiac telerehabilitation with on-demand coaching was similarly effective to center-based CR for improvement in PA and QOL. - The intervention was likely to be cost-effective. |
| Nagatomi et al. 2022 61 | RCT (n = 30) | Fitbit Inspire (Fitbit Inc.) | Daily steps | - The home based CR program was a safe and effective approach that improved 6MWD and muscle strength in HF patients with frailty. |
| Peripheral Artery Disease | ||||
| Gardner et al. 2011 63 | RCT. (n = 119) | StepWatch 3 Activity Monitor (Cyma Inc). | Daily step counts and activity intensity | - The home-based exercise program had high adherence and similarly improved claudication measures compared to a standard supervised program. |
| GOALS study 2013 113 | RCT (n = 194) | Caltrac Vertical Accelerometer (Muscle Dynamics Fitness Network) | Activity units | - The home based exercise program with a cognitive behavioral intervention improved objective and subjective measures of PA. |
| HONOR study 2018 64 | RCT (n = 200) | Fitbit Zip (Fitbit Inc) | Daily step counts | - The home-based exercise program without onsite visits did not improve 6MWD compared to usual care. |
| LITE study 2021. 65 | RCT (n=305) | Unspecified Accelerometer | Activity units | - Low-intensity home-based exercise was significantly less effective than the high-intensity group for improving 6MWD. |
| Diabetes: | ||||
| Beck et al. 2017 68 | RCT (n = 158) | Dexcom G4 Platinum | Glucose levels and amount of time in range | - In patients with type 2 DM on basal-bolus insulin, CGM significantly reduced hemoglobin A1c at 24 weeks compared to usual care with an adjusted difference in mean change of −0.3%. - There was high satisfaction and adherence to CGM use. |
| MOBILE study 2021 69 | RCT (n = 175) | Dexcom G6 | Glucose levels and amount of time in range | - In primary care patients with type 2 DM on basal insulin only, the CGM group had significantly improved hemoglobin A1c at 8 months (adjusted difference −0.4%) compared to fingerstick testing. |
| FLASH-UK study 202267 | RCT (n = 156) | Freestyle Libre 2 | Glucose levels and amount of time in range | - In patients with type 1 DM, intermittently scanned CGM with optional alerts improved hemoglobin A1c by 0.5% compared to fingerstick testing. - The CGM group had more time in range and lower burden of hypoglycemia. |
Abbreviations: anticoagulation (AC), atrial fibrillation (AF), blood pressure (BP), cardiovascular (CV), cardiac rehabilitation (CR), continuous glucose monitoring (CGM), coronary artery disease (CAD), diabetes mellitus (DM), electrocardiogram (ECG), ejection fraction (EF), heart failure (HF), heart rate (HR), heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), machine learning (ML), meta-analysis (MA), moderate to vigorous physical activity (MVPA) myocardial infarction (MI), peripheral artery disease (PAD), photoplethysmography (PPG), physical activity (PA), positive predictive value (PPV), quality of life (QOL), randomized controlled trial (RCT), respiratory rate (RR), systematic review (SR), transient ischemic attack (TIA), 6 minute walk distance (6MWD).