1431.1 – HbA1c point of care test for the management of diabetes mellitus

New MBS item.

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.

Type: Investigative

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.

• PASC meeting: -
• ESC meeting: 8 February 2019
• MSAC meeting: 
  • 28-29 March 2019
  • 9 December 2019
  • 6 March 2020

Note: for PICO confirmation, refer to application 1431.