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

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Not supported

Application details

Reason for application

New MBS item.

Service or technology in this application

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

Medical condition this application addresses

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.

Application documents

Meetings to consider this application

  • PASC meeting: 11 - 12 August 2016
  • ESC meeting: 8 June 2017
  • MSAC meeting: 27 July 2017