Personalised Closed Loop Systems for Childhood Diabetes

A case study of how internet of things technologies are being used in childhood diabetes management.

Under the banner #WeAreNotWaiting parents of children with type 1 diabetes are building their own closed loop systems which provide continuous glucose monitoring and automated insulin dosage delivery. Nightscout provides free open source software enabling users to access their real-time blood sugar data via any web-connected device.

The Therapeutic Goods Administration imposes a regulatory structure for approval of medical devices but acknowledges that such software creates ‘regulatory dilemmas.’ Data from closed loop systems are stored on the Cloud. Data on closed loop devices can be changed, so cybersecurity and data privacy are key concerns, alongside safety.

This project will scope the range and availability of hybrid closed loop systems, their regulatory status both in Australia and in other countries such as the UK, USA, and Scandinavian countries. The research team will use qualitative research methods to engage with regulators, policymakers, healthcare practitioners and patients/consumers. It will cultivate a relationship with the Therapeutic Goods Administration and develop key concepts for framing regulation.

Through interviews with parents and consumer groups, the project will explore why parents use open source software to create their own looping systems, their expectations of using such devices, issues of hacking and cybersecurity and the relationship with the clinical team looking after their child.

Internet of Things (IoT) challenges the existing framework of medical practice. The project will address the concerns of clinicians through interviews and workshop discussion. It will consider the shift in the doctor-patient relationship, legal and moral duties to respond to parents’ reporting of data, how clinicians feel about and respond to the use of devices that do not conform to TGA requirements, and their ongoing duty to provide care.

The project will:

  • provide an understanding of parents’ and clinicians’ experiences using hybrid closed loop systems, the impact on the doctor- patient relationship ánd the ethical and legal obligations on paediatric endocrinologists to provide care to patients using unregulated devices.
  • identify data security and privacy concerns.
  • create an ongoing research collaboration. Project outcomes include two worked up clinical case scenarios to be developed into training materials, a workshop for stakeholders to meet and discuss key themes, academic publications and a proposal for a ARC Linkage grant/ NHMRC partnership grant.

The interdisciplinary research team brings together experts in legal regulation and ethics, researchers in information systems and communication, and practitioners working at the forefront of diabetes. Members of the team also have expertise in qualitative research.

Research Team

External Collaborators

Fergus Cameron, Royal Children's Hospital

Renza Scibilia, Diabetes Australia

Funding

Seed Funding 2018

Presented at the Health Data Analytics conference: 'The utility and security of data from wearable devices in the management of T1 diabetes in children' on Tuesday 23 October 2018. [Slide deck]

Presented at the 10th National Bioethics Paediatric Conference: ‘Who has responsibility for emerging technologies in diabetes management’ on Wednesday 5 September 2018. [Slide deck]