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Disease/health condition - Diabetes mellitus
Discipline - Clinical chemistry
Glucose
Setting:
1. Non-laboratory
Tiered Testing Service:
Primary health care center without laboratory District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Point-of-care test
Information History
First added in 2018
Changed in 2024
Purpose type
Screening, Diagnosis, Monitoring, Determination of physiological status
Purpose
To detect hypoglycaemia and hyperglycaemia. To diagnose and monitor type 1 and type 2 diabetes mellitus if HbA1c testing is not available. To screen for type 2 diabetes mellitus and impaired fasting glucose. To diagnose impaired fasting glucose.
Specimen types
Capillary whole blood
WHO prequalified or recommended products
N/A
GMDN

62538

Glucose monitoring system IVD, point-of-care

A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. 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 2005-2024
EMDN

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/emdn
WHO 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.
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Related Medical Devices in MeDevIS
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
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The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
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