A clinical trial to improve glucose control with a next generation insulin pump system in adults with diabetes and advanced kidney disease
About this study
The purpose of the study is to investigate the efficacy, safety and acceptance of new insulin pump technology with automated insulin delivery in people with type 1 and type 2 diabetes with chronic kidney disease who are already managed with traditional insulin therapy. This trial involves a 6-week run-in period before randomisation where the new insulin pump technology will be compared with usual insulin therapy care over 16 weeks (8 weeks of pump with automated insulin delivery and 8 weeks with usual insulin pump care, randomised in a cross over study). Continuous glucose monitoring will also assess glucose levels in the bloodstream.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.