IEEE 11073-10425-2023

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IEEE Standard – Health informatics–Device Interoperability Part 10425: Personal Health Device Communication–Device Specialization–Continuous Glucose Monitor (CGM) (Approved Draft)

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IEEE	2023

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Description

Revision Standard – Active. Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between continuous glucose monitor (CGM) devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

PDF Catalog

PDF Pages	PDF Title
1	IEEE Std 11073-10425-2023 Front Cover
2	Title page
4	Important Notices and Disclaimers Concerning IEEE Standards Documents Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents Translations
5	Official statements Comments on standards Laws and regulations Data privacy Copyrights
6	Photocopies Updating of IEEE Standards documents Errata Patents
7	IMPORTANT NOTICE
8	Participants
11	Introduction
12	Contents
14	1. Overview 1.1 Scope 1.2 Purpose
15	1.3 Word usage 1.4 Context
16	2. Normative references 3. Definitions, acronyms, and abbreviations 3.1 Definitions
17	3.2 Acronyms and abbreviations 4. Introduction to ISO/IEEE 11073 personal health devices (PHDs) 4.1 General
18	4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs 4.2.1 General 4.2.2 Domain information model (DIM) 4.2.3 Service model 4.2.4 Communication model 4.2.5 Implementing the models
19	4.3 Compliance with other standards 5. Glucose monitoring concepts and modalities 5.1 General
20	5.2 Device types
21	5.3 CGM agent-to-manager communication
22	5.4 Collected data 5.4.1 General 5.4.2 Glucose 5.4.3 Sensor calibration 5.4.4 Sensor run-time 5.4.5 Glucose sampling interval 5.4.6 Glucose trend 5.4.7 Patient low/high thresholds
23	5.4.8 Device hypo/hyper thresholds 5.4.9 Glucose rate-of-change thresholds 5.4.10 PHD DM status 5.4.11 CGM status 5.5 Stored data 6. Continuous glucose monitor (CGM) domain information model (DIM) 6.1 Overview 6.2 Class extensions
24	6.3 Object instance diagram
25	6.4 Types of configuration 6.4.1 General 6.4.2 Standard configuration
26	6.4.3 Extended configuration 6.5 Profiles 6.5.1 General 6.6 MDS object 6.6.1 MDS object attributes
27	6.6.2 MDS object methods
28	6.6.3 MDS object events
29	6.6.4 Other MDS services 6.6.4.1 GET service 6.6.4.2 SET service 6.7 Numeric objects 6.7.1 General
30	6.7.2 Glucose
34	6.7.2.1 Measurement-confidence-95 attribute 6.7.2.2 Glucose threshold and status attributes
35	6.7.3 Sensor calibration 6.7.4 Sensor run-time
36	6.7.5 Glucose sampling interval 6.7.6 Glucose trend
37	6.7.6.1 Glucose trend threshold and status attributes
38	6.7.7 Patient low/high threshold 6.7.8 Device hypo/hyper thresholds
39	6.7.9 Glucose rate-of-change thresholds 6.8 Real-time sample array objects 6.9 Enumeration objects 6.9.1 General
40	6.9.2 PHD DM status
42	6.9.3 CGM status
43	6.10 PM-store objects 6.10.1 General
44	6.10.2 Persistent store model
45	6.10.3 PM-store object attributes 6.10.4 PM-store object methods
46	6.10.5 PM-store object events 6.10.6 PM-store object services 6.10.6.1 GET service 6.10.6.2 SET service 6.10.7 PM-segment objects
47	6.11 Scanner objects 6.12 Class extension objects 6.13 CGM information model extensibility rules
48	7. CGM service model 7.1 General 7.2 Object access services
50	7.3 Object access event report services 8. CGM communication model 8.1 Overview 8.2 Communication characteristics
51	8.3 Association procedure 8.3.1 General 8.3.2 Agent procedure—association request
52	8.3.3 Manager procedure—association response 8.4 Configuring procedure 8.4.1 General
53	8.4.2 CGM—standard configuration (0x09C4) 8.4.2.1 Agent procedure
54	8.4.2.2 Manager procedure 8.5 Operating procedure 8.5.1 General 8.5.2 GET CGM MDS attributes 8.5.3 Measurement data transmission
55	8.6 Time synchronization 9. Test associations 9.1 Behavior with standard configuration 9.2 Behavior with extended configurations 10. Conformance 10.1 Applicability
56	10.2 Conformance specification 10.3 Levels of conformance 10.3.1 General 10.3.2 Conformance level 1: Base conformance 10.3.3 Conformance level 2: Extended nomenclature (ASN.1 and/or ISO/IEEE 11073-10101) 10.4 Implementation conformance statements (ICSs) 10.4.1 General format
57	10.4.2 General ICS
60	10.4.3 DIM MOC ICS 10.4.4 MOC attribute ICS
61	10.4.5 MOC notification ICS 10.4.6 MOC nomenclature ICS
62	Annex A (informative) Bibliography
63	Annex B (normative) Any additional ASN.1 definitions B.1 PHD DM status, CGM status, and measurement status bit mappings
64	B.2 Numeric extension for measurement confidence
65	B.3 Capability-mask B.4 State-flag
67	Annex C (normative) Allocation of identifiers C.1 General C.2 Definitions of terms and codes
69	C.3 Systematic derivations of terms and codes
72	Annex D (informative) Message sequence examples
74	Annex E (informative) Protocol data unit examples E.1 General E.2 Association information exchange E.2.1 General E.2.2 Extended configuration E.2.2.1 General E.2.2.2 Association request
75	E.2.2.3 Association response E.2.3 Previously known extended configuration E.2.3.1 General E.2.3.2 Association request
76	E.2.3.3 Association response E.2.4 Standard configuration E.2.4.1 General E.2.4.2 Association request
77	E.2.4.3 Association response E.3 Configuration information exchange E.3.1 General E.3.2 Extended configuration E.3.2.1 General E.3.2.2 Remote operation invoke event report configuration
79	E.3.2.3 Remote operation response event report configuration E.3.3 Known configuration E.3.3.1 General
80	E.3.3.2 Remote operation invoke event report configuration E.3.3.3 Remote operation response event report configuration E.3.4 Standard configuration E.3.4.1 General E.3.4.2 Remote operation invoke event report configuration E.3.4.3 Remote operation response event report configuration E.4 GET MDS attributes service E.4.1 General E.4.2 Get all MDS attributes request
81	E.4.3 Get response with all MDS attributes
82	E.5 Data reporting E.5.1 Unconfirmed measurement data transmission E.6 Disassociation E.6.1 Association release request E.6.2 Association release response
83	Annex F (informative) Revision history
85	Back Cover

Additional information

Standard Title	IEEE Standard – Health informatics–Device Interoperability Part 10425: Personal Health Device Communication–Device Specialization–Continuous Glucose Monitor (CGM) (Approved Draft)
Published Code	IEEE
Publication Date	2023

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