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.
Anticipated date enrolment will close: December 2023
Who can take part
You may be eligible to participate in this study because you have type 1 diabetes. To be eligible you must meet the following criteria:
- be aged 18 years or over
- have Type 1 diabetes (T1D) of at least 1-year duration or insulin requiring Type 2 diabetes
- be managed with multiple daily insulin injections or pump therapy
- have advanced kidney disease
The study involves a run in period of 4-6 weeks during which you will be taught how to measure the amount of carbohydrates (sugars) in the food you eat, receive diabetes education on how to use this new insulin pump technology with automated insulin delivery, as well as be seen by a doctor who will ask you questions about your medical history and details of all medications you are currently using. During that visit, the tests performed will include blood pressure, pulse, height, weight, waist circumference and hip measurement. A blood sample will be taken and tested for diabetes, blood fats and biochemistry tests. You will also be asked to completed some questionnaires and test your muscle strength and walking speed. After this, you will be randomised to receive treatment with either the new insulin pump technology with automated insulin delivery or continue with your usual insulin therapy for 8 weeks. Then your treatment will be crossed over for a further 8 weeks. Over these 16 weeks, you will be asked to wear a blood glucose sensor to that your blood glucose levels can be measured. The run-in period tests and questionnaires will be repeated at the end of the study.
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.