CentrePoint Insight Watch
FDA Cleared, Medical-Grade Actigraphy Monitoring
The compact and unobtrusive CentrePoint Insight Watch (CPIW) captures continuous, high-resolution motion data for up to 30 days on a single battery charge. These high quality digital measures provide sponsors with clinical insights into how trial participants feel and function in their natural environments.
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U.S. federal law restricts this device to sale by or on the order of a physician.
ActiGraph Digital Measures
The CPIW, in conjunction with the CentrePoint remote monitoring platform, provides objective, real-world digital measures of physical activity, mobility, and sleep behavior in clinical trial participants. Raw acceleration data, sampled at up to 256 Hz, is converted into meaningful clinical measures using transparent algorithms developed and validated by members of the life science research community. Available measures include:
- Raw Acceleration (G's)
- Activity Intensity
- MVPA
- Steps
- Calories
- MET Rates
- Locomotion
- Total Movement
- Total Sleep Time (TST)
- Sleep Efficiency
- Wake After Sleep Onset (WASO)
- Sleep Fragmentation
CentrePoint Insight Watch Key Features
Real-Time Data Access
The CPIW passively transmits collected data, via mobile app or home data hub, to the cloud for near real-time detection of wear adherence and potential data trends. The rearchitected raw data system provides infinite scalability with 2x improved performance.
Patient-Centric Design
The CPIW looks and feels like a consumer smart watch. The single push button interface activates the backlight, making it easy to read date and time. Standard interchangeable wristbands can be customized to improve participant satisfaction, comfort, and compliance.
Optimized User Experience
Single push button interface, passive data capture and transfer, and a long* battery life help to simplify and enhance the patient experience.
30-Day Battery Life*
An extended 30-day battery life minimizes participant burden and the potential for missing data associated with frequent device charging, even during long periods of data collection.
Customizable Wristband
Standard interchangeable wristbands can be customized to improve patient satisfaction, comfort, and compliance.
Near Body Temperature Sensor
The CPIW now comes with an enabled near body temperature sensor, which has the potential to provide richer data insights, such as improved wear time monitoring and sleep scoring.**
** Temperature data is for investigational use only
CentrePoint Ecosystem
The cloud-based CentrePoint technology system includes an ecosystem of hardware and software tools that capture and manage real-world patient data collected during a clinical trial or research study.
CentrePoint Insight Watch
The stylish and comfortable Insight Watch captures and records continuous, high resolution raw acceleration data.
CentrePoint Web Portal
This secure, permissions-based web portal provides instant access to near real-time patient outcomes and raw data files, site performance details, and overall study progress.
CentrePoint Data Hub
This communication gateway securely transmits data collected by the CentrePoint Insight Watch from the patient’s home to the CentrePoint cloud.
CentrePoint API
An available API makes it possible to integrate ActiGraph outcomes directly into our clients’ proprietary or third party EDC platforms.
CentrePoint Insight Watch Specifications
Dimensions
1.97 x 1.35 x 0.41 in
Sample Rate
32Hz-256Hz
Battery Life
30 Days
Data Storage
30 Days*/512MB
Dynamic Range
+/- 8G
Communication
USB/Bluetooth® LE 5
Water Resistance
IP57 1 meter, 30 minutes
Wear location
Wrist
Warranty
1 year
The CentrePoint Insight Watch is fully backward compatible with previous device models to ensure data comparability for our existing clients.
Regulatory Requirements
The CentrePoint Insight Watch is an FDA cleared Class II medical device within the United States and a Class I non-measuring medical device within the European Union that abides by the regulatory requirements listed below:
EU Directives Compliant:
- Medical Devices Directive 93/42/EEC
- Radio Equipment Directive 2014/53/EU
- RoHS Directive 2011/65/EU Compliant
- FCC Federal Register CFR 47, Part 15, Subpart B: 2017
- FCC Part 15, Subpart C, Section 15.249
- ICES-003 Interference Causing Equipment Standards for a Digital Apparatus
- RSS-210 Certification of Radio Apparatus
IP57
The CentrePoint Insight Watch is dust protected and water resistant up to 1 meter of water for 30 minutes in accordance with IEC 60529.
All ActiGraph products are manufactured Lead Free and are RoHS Compliant.
510(k) Cleared Class II Medical Device K181077
IEC 60601-1-2 General requirements for basic safety and essential performance
