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Disease/health condition -
Diabetes mellitus
Glucose
Assay format
Self-testing
Information History
First added in 2022
Purpose type
Monitoring
Purpose
To self-monitor type 1 and type 2 diabetes mellitus at home.
Specimen types
Capillary whole blood
WHO prequalified or recommended products
N/A
GMDN
62537
Glucose monitoring system IVD, home-use
A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024EMDN
W0201060102
BLOOD GLUCOSE METERS
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdnWHO supporting publications
World Health Organization. (2020). HEARTS D: diagnosis and management of type 2 diabetes. World Health Organization. https://iris.who.int/handle/10665/331710 ; The Spanish version is published by PAHO: https://iris.paho.org/handle/10665.2/53007 ; The Portuguese version is published by PAHO: https://iris.paho.org/handle/10665.2/57457
Technical specifications
This tool presents technical specifications for the glucose meter, to review it download the file and scroll down.
Related Medical Devices in MeDevIS
SAGE IVD recommended including the proposed edits to the test purpose of the glucose IVD test, for the glucose meter assay format in EDL 4
• as a disease-specific IVD for use in community settings (EDL 4, Section I.b);
• using a glucose meter format;
• using capillary whole blood as specimen type;
• to self-monitor type 1 and type 2 diabetes mellitus at home.
• as a disease-specific IVD for use in community settings (EDL 4, Section I.b);
• using a glucose meter format;
• using capillary whole blood as specimen type;
• to self-monitor type 1 and type 2 diabetes mellitus at home.
This edit would add a new test purpose for self-monitoring diabetes at home to the already existing glucose meter non-laboratory-based assay in the EDL.
SAGE IVD considered the submission to be generally good and aligned with WHO guidelines, in particular for diabetes, for primary health care interventions and for self-health care. One expert observed that promoting self-monitoring of glucose at home with test strips will result in better control of diabetes and will also help to make support for the technology a priority at the government level. In this regard, including the test in the EDL constitutes a step towards reducing inequities.
It was also noted that this application was the only one to receive considerable attention during the call for public comments phase, including two comments from people living with diabetes who provided evidence. SAGE IVD also commented on the role of the EDL in highlighting what is available and useful in the field even when it is not yet in the guidelines, especially in settings where access to clinical laboratories is limited.
One point of confusion concerned a footnote included in the proposed edit to the test purpose provided by the applicant appearing to say that the test was for self-monitoring type 2 diabetes when indicated or recommended but not for type 1. SAGE IVD suggested removing the footnote to avoid misunderstanding, as the test is clearly meant for self-monitoring of both type 1 and type 2 diabetes.
Evidence of the effectiveness of self-monitoring, relative to no self-monitoring or other alternatives, is scarce and of questionable validity (one case series) and applicability (association between monitoring frequency and outcomes). Available evidence, while of very low certainty, suggests that higher frequencies of self-monitoring might improve HbA1c control. Despite this lack of good quality evidence, self-monitoring appears to be widely recommended as part of routine care in diabetic patients using insulin therapy.
World Health Organization. (2023). The selection and use of essential in vitro diagnostics: report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/373322