Draft Report – Post-market Review of Products Used in the Management of Diabetes on Stage Two: Insulin Pumps (Closed)

Page last updated: 15 July 2014

Draft Report – Post-market Review of Products Used in the Management of Diabetes Stage Two: Insulin Pumps - (Word 611 KB) - (PDF 62 KB)

Date: July 2014

Report Prepared by:

Department of Health

University of South Australia

Quality Use of Medicines and Pharmacy Research Centre


The objective of this review is to systematically evaluate the body of clinical evidence regarding diabetes interventions. This will help to ensure that patients are using the most appropriate medicines and products, effectively, and safely, to achieve optimal health outcomes and support quality use of medicines.

Diabetes is a major health issue, as recognised by its status as a National Health Priority Area (NHPA).  As such, the current review will take time to properly assess all relevant components.

Given the scope of the Review and the significant health issue that diabetes represents, the review is being progressed in a staged approach to ensure all aspects of diabetes management are considered comprehensively. The first component under consideration focused on blood glucose test strips given that they are a precursor to other medicines and aspects of diabetes management. That is, testing is intended to be used to achieve stability and better inform the best therapeutic approach.

This Report contains the findings of the second component of the Review focussing on the clinical outcomes and cost-effectiveness of insulin pump therapy for people with type 1 diabetes, and the clinical and financial eligibility criteria for the Insulin Pump Programme. This includes terms of reference 8 - 10 to the Review:

8. Determine the clinical outcomes (e.g. HbA1c, health-related quality of life), and other potential benefits and harms for people with type 1 diabetes of insulin pump therapy. In this, consideration should be given to different age groups, with a particular reference to those under 18 who may be eligible for the Insulin Pump Programme, which is funded by the Australian Government.

9. Investigate the cost-effective use of different insulin pumps available under the Insulin Pump Programme.

10. Consider the clinical criteria and eligibility under the Insulin Pump Programme, to ensure those who would most benefit from insulin pump therapy receive support to assist in their care.

This review has been informed by relevant research and evidence, including:

  • Relevant guidelines;
  • International experience;
  • Public consultation;
  • Literature reviews;
  • Input by the Reference Group.

The Report is comprised of seven parts:

  • Executive Summary – This part of the Report is designed to be read as a stand-alone document that summarises the process and results of the Insulin Pumps Review.
  • Part 1 – Review background and context.
  • Part 2 – Diabetes background including prevalence, impact in Australia, complications, and treatment options. This section also contains information on the Insulin Pump Programme and the regulation of insulin pumps in Australia.
  • Part 3 – Outcomes of Stakeholder consultation and input.
  • Part 4 – Benefits and safety of insulin pump therapy (Terms of Reference 8).
  • Part 5 – Costs and comparative effectiveness of insulin pump therapy (Terms of Reference 9).
  • Part 6 – Examination of the Insulin Pump Programme eligibility criteria (Terms of Reference 10).

Comments on the draft Report of Stage 2 of the Review focusing on Insulin Pumps were open between 4 and 21 July 2014.

This Report, stakeholder submissions, and comments will be provided to Government for consideration.