ISO/IEEE 11073-10425:2019 PDF

Overview

ISO/IEEE 11073-10425:2019 - Device specialization: Continuous glucose monitor (CGM) defines a normative, plug-and-play communication profile for personal health continuous glucose monitor (CGM) devices and their managers (for example smartphones, PCs, personal health appliances or set‑top boxes). The standard sits within the ISO/IEEE 11073 family and provides a common core of communication functionality so CGM agents and managers can exchange glucose measurements and device state information reliably in telehealth and personal health environments. In this context, CGM refers to sensors that measure glucose periodically (typically every 5 minutes) while attached to the person.

Key Topics and Requirements

• Normative communication model: Specifies required behaviors to enable interoperability between CGM devices (agents) and managers.
• Term codes and formats: Mandates the use of specific term codes and data formats drawn from ISO/IEEE 11073 terminology and information models to reduce optionality and ambiguity.
• Information profiles: Defines the core information objects and attributes for CGM readings, sensor status, calibration events and related metadata.
• Restricted optionality: Limits optional features in base frameworks to ensure implementers follow consistent, interoperable behaviors.
• Transport and application layering: Leverages existing 11073 transport and application profile standards - the standard prescribes how the CGM specialization maps to those layers.
• Telehealth readiness: Emphasizes predictable behaviors and formats for remote monitoring, data aggregation, and clinical use.

Practical Applications

ISO/IEEE 11073-10425:2019 is used to:

• Enable plug-and-play interoperability between CGM sensors and mobile health apps or home gateways.
• Support remote patient monitoring and telehealth workflows where CGM data is streamed to caregivers or cloud platforms.
• Ensure consistent, machine-readable glucose data for diabetes management systems, analytics platforms and clinical decision support.
• Facilitate device certification, conformance testing and supplier integration by defining a common communication core.

Who Should Use This Standard

• CGM manufacturers (device firmware and hardware designers) implementing agent-side communication.
• App and gateway developers (mobile apps, home hubs, telehealth platforms) building CGM managers.
• System integrators and EHR vendors integrating CGM data into electronic health records and clinical systems.
• Test labs and regulatory bodies assessing interoperability and conformance to device communication profiles.
• Clinical researchers and digital health solution providers seeking standardized CGM data streams.

Related Standards

• ISO/IEEE 11073 family (terminology, information models and application/transport profiles) - the CGM specialization depends on existing 11073 terminology and transport standards.
• Other ISO/IEEE 11073 device specializations and application profile documents that address personal health device interoperability.

Keywords: ISO/IEEE 11073-10425:2019, continuous glucose monitor, CGM, personal health devices, medical device communication, plug-and-play interoperability, telehealth, device terminology.