What is the CREATE Trial?
The CREATE (Community deRivEd AutomaTEd insulin delivery) Trial is a ground-breaking study in the treatment of type one diabetes. It is a randomised controlled trial of an open-source, community-built algorithm for automated insulin delivery. This technology allows for automation of insulin delivery, improving control of blood glucose and reducing the burden of care for people with type one diabetes.
The study will examine the safety and efficacy of the algorithm for both children and adults. The algorithm and app interface being tested is based on AndroidAPS, one of the two implementations of the OpenAPS algorithm. The study is funded by the Health Research Council of New Zealand.
The initial study will compare blood glucose control over 6 months of CREATE system use compared to sensor augmented pump therapy (SAPT). A nine month continuation phase will follow.
Who is on the CREATE Trial study team?
Dr Martin de Bock
Dr de Bock, a paediatric endocrinologist, is the primary investigator for the study. He has extensive experience running large, multi-site diabetes technology studies.
Ms Lewis is the co-investigator for the study and is the founder of the do-it-yourself artificial pancreas system movement. She has collaborated extensively to develop a range of research projects in relation to do-it-yourself diabetes technologies, and wrote the first book on closed loop automated insulin delivery.
Dr Hamish Crocket
Dr Crocket is a social scientist, whose research focuses on learning and self-management practices in relation to diabetes technologies. He is a person with diabetes and an AndroidAPS user.
Associate Professor Ben Wheeler
Associate Professor Ben Wheeler, a paediatric endocrinologist, is responsible for the Dunedin study site.
Associate Professor Craig Jefferies
Associate Professor Craig Jefferies, a paediatric endocrinologist is responsible for the Auckland study site.
Dr Ryan Paul
Dr Ryan Paul, an endocrinologist, is responsible for the Hamilton study site.
What stage is the study in?
The protocol for the study is currently being finalized, and initial recruitment for the study is planned for early 2020.
Can I participate in the CREATE Trial?
We appreciate your interest in the study, however, we are not yet ready to recruit participants. Enrolment in the study will take place in Christchurch (paediatrics and adults), Dunedin (paediatrics only), Auckland (paediatrics only) and Hamilton (adults only). Recruitment will be via DHBs diabetes services and potential participants will have to meet specific criteria. Recruitment will begin in early 2020.
What is automated insulin delivery?
Automated insulin delivery, another name for the technology used in an ‘artificial pancreas system’, integrates an insulin pump and a continuous glucose monitor with an algorithm to automatically adjust insulin delivery in real time.
What is DIY APS?
A do-it-yourself artificial pancreas system. These have been created by people affected by type one diabetes and made available, via open-source software and online support groups.
What is OpenAPS?
The first DIY APS to have been developed. It has been written by people affected by diabetes with the aim of improving safety, glycaemic control and quality of life. See https://openaps.org/
What is AndroidAPS?
AndroidAPS is an Android-specific app that deploys the OpenAPS algorithm. See https://androidaps.readthedocs.io/en/latest/EN/index.html
What is sensor-augmented pump therapy?
Sensor-augmented pump therapy is the use of a continuous glucose monitor alongside an insulin pump for managing type one diabetes. It is the current standard of care that outcomes from automated insulin delivery trials are most commonly compared to. The main difference is that in SAPT there is no algorithm driving adjustments of insulin delivery; the person with type 1 diabetes does all insulin dosing adjustments manually.
Where can I learn more about automated insulin delivery?
If you’re not eligible for the study but want to learn more about automated insulin delivery, https://www.ArtificialPancreasBook.com/ is a good resource to introduce you to commercial and do-it-yourself artificial pancreas system options.