1431 - HbA1c point of care test for the diagnosis and management of diabetes mellitus

Page last updated: 25 January 2019

Application Detail



Description of Medical Service

The proposed medical service is for the use of in vitro diagnostic test instrument that meets defined acceptable performance criteria comparable to laboratory based testing being performed at or near the site of patient care (e.g. within GP consulting rooms) for the quantification of HbA1c (glycated haemoglobin) in human whole blood.

Description of Medical Condition

Diabetes mellitus is a group of metabolic disorders characterised by hyperglycaemia resulting from defects in insulin secretion, action or both. Several pathogenic processes are involved in its development ranging from autoimmune destruction of the β-cells of the pancreas to abnormalities resulting in insulin action resistance. For patients with diabetes, chronic hyperglycaemia is associated with long-term damage, dysfunction and failure of various organs including eyes, kidneys, nerves, heart and blood vessels. The symptoms of hyperglycaemia include polyuria, polydipsia, weight loss and blurred vision. Long-term complications involve loss of vision due to retinopathy, renal failure, peripheral and autonomic neuropathy. The incidence of atherosclerotic cardiovascular, peripheral arterial and cerebrovascular disease, as well as hypertension and lipoprotein abnormalities in patients with diabetes is increased. Early detection and effective therapy providing good metabolic control, can delay the onset and progression of diabetes late complications, resulting in better outcomes for patients.

Reason for Application

New MBS item

Medical Service Type


Previous Application Number

Not Applicable

Associated Documentation

Application Form


PICO Confirmation

Final Protocol (PDF 503 KB)
Final Protocol (Word 367 KB)

Assessment Report


Public Summary Document

Public Summary Document (PDF 745 KB)
Public Summary Document (Word 444 KB)

Meetings for this Application


11 - 12 August 2016


8 June 2017


27 July 2017