Abstract
The broad aims of this thesis were to evaluate safety and efficacy of an open-source automated insulin delivery (AID) system in people affected by type 1 diabetes (T1D), and to cast a health equity lens on the utilisation of advanced diabetes technologies. Accordingly, these areas of investigation are covered in three respective studies and chapters (presented as research publications) within this thesis:
1. Study 1 is presented in Chapter 2 and Chapter 3. Study 1 (called the CREATE trial) represents the first randomised controlled trial evaluating safety and efficacy of an open-source AID system in children and adults with T1D. Chapter 2 presents the 24-week randomised controlled phase entitled ‘Open-Source Automated Insulin Delivery in Type 1 Diabetes,’ and is published in the New England Journal of Medicine. Chapter 3 entitled ‘Extended use of an open-source automated insulin delivery system in children and adults with type 1 diabetes: The 24-week continuation phase following the CREATE randomised controlled trial,’ presents the 24-week continuation phase that follows to assess long-term outcomes. This work is published in Diabetes Technology & Therapeutics. The CREATE trial was conducted across four sites in New Zealand; Christchurch, Dunedin, Hamilton, and Auckland. It is a collaboration between investigators at the University of Otago based at the Department of Paediatrics in Christchurch and the Department of Women’s and Children’s Health in Dunedin, investigators at Auckland and Waikato District Health Boards, and experts on open-source AID systems.
2. Study 2 is presented in Chapter 4. This qualitative sub-study of the CREATE trial explores Māori patients’ (and whānau members) experiences using the open-source AID system. Through the application of Kaupapa Māori Research methodologies, Māori (as experts) identify barriers to health outcome equity and propose solutions to be considered in the redesign of diabetes service provision. This study entitled ‘Interviews with Indigenous Māori with type 1 diabetes using open-source automated insulin delivery in the CREATE randomised trial,’ is published in the Journal of Diabetes & Metabolic Disorders. It was conducted through the Department of Paediatrics and the Department of Māori Indigenous Health Innovation, University of Otago, Christchurch.
3. Study 3 is presented in Chapter 5. This cross-sectional population-based study entitled ‘Inequity in access to continuous glucose monitoring and health outcomes in paediatric diabetes, a case for national continuous glucose monitoring funding: A cross-sectional population study of children with type 1 diabetes in New Zealand,’ is published in The Lancet Regional Health – Western Pacific. This study explores the impact of non-funded continuous glucose monitoring (CGM) on equity of access and associated glycaemic outcomes for children with T1D throughout New Zealand. This study is relevant to Study 1 and Study 2 since CGM devices are an essential hardware component of all AID systems. This was a collaboration between investigators from the University of Otago, University of Auckland, Starship Children’s Health, and the Waikato Regional Diabetes Service, with support from all 20 District Health Boards in New Zealand.