Aims: Open-source automated insulin delivery (AID) is perceived to be technologically complex, and data to date has limited generalisability due to reporting in self-selected populations. This sub-study investigated participants’ experiences in the CREATE study, a multi-site randomised controlled trial of an open-source AID algorithm.
Methods: The CREATE study compared an open-source AID system—consisting of an app on an Android phone, with CGM and a Bluetooth enabled insulin pump—versus sensor-augmented pump therapy. Study participants completed age appropriate psychosocial surveys (HFS-II, DTSQs, PSQI, EQ-5D) at the beginning and end of the 24 week trial. Survey data were summarised by treatment group, and differences estimated using analysis of covariance. A representative sample of adults, children, and parents of children from the intervention group were selected for in-depth, semi-structured interviews. Interviews were recorded and transcribed. Thematic analysis was undertaken using Nvivo. The sample was completed at the point of thematic saturation.
Results: 97 participants completed surveys. Survey data are presented in table 1. Treatment satisfaction improved for children. Most other scales favoured AID but differences were not statistically significant. 8 Adults (4f, mean age 41.6), 6 children (2f, mean age 10.1y) and 8 parents (5f) participated in interviews. All interview participants reported improvements with AID, including improved quality of life and glycaemic control, reduced diabetes burden and, for parents, improved family dynamics. Most participants found the phone-based system convenient; technical problems were present but manageable with study team support; participants were able to use the system to fit their lifestyle needs.
Conclusion: Use of open-source AID improves quality of life in multiple domains and reduces treatment burden.