Sufyan Hussain, United Kingdom
Guy's and St Thomas' , King's College London DiabetesPresenter of 1 Presentation
DEVELOPMENT OF AN INTERNATIONAL CONSENSUS STATEMENT AND PRACTICAL GUIDANCE ON OPEN-SOURCE AUTOMATED INSULIN DELIVERY (DO-IT-YOURSELF ARTIFICIAL PANCREAS SYSTEMS) FOR HEALTHCARE PROFESSIONALS
- Katarina Braune, Germany
- Rayhan Lal, United States of America
- Lenka Petruželková, Czech Republic
- Per Winterdijk, Netherlands
- Michael Riddell, Canada
- Gary Scheiner, United States of America
- Signe Schmidt, Denmark
- Linda Raymond, Denmark
- Klemens Raile, Germany
- Korey K. Hood, United States of America
- Sufyan Hussain, United Kingdom
Abstract
Background and Aims
Despite increasing use of Open-Source Automated Insulin Delivery (OS-AID) systems and real-world outcomes demonstrating safety and efficacy, there is no professional guidance available for HCPs to support use or provide clarity on ethical and legal concerns. As a result, a lot of uncertainty remains in care teams around the world on how to support people with diabetes using OS-AID. Therefore, an international professional consensus statement and practical guidance review is urgently needed.
Methods
As part of the OPEN project, a steering committee comprising of HCPs (endocrinologists, educators, exercise physiologists and psychologists) with significant clinical experience in OS-AID and publication track record was formed to develop the guidance. An international group of clinicians across several global regions formed part of a larger HCP network and contributed to the wider consensus of this guidance using an online feedback system. Input was also provided by medico-legal experts.
Results
Since the initial meeting at ATTD 2020, the steering committee has met virtually over 12 times. A review strategy was devised (see figure) and up-to-date best practice guidance and consensus statement were drafted using a real-time collaboration tool. The current final version is being appraised by the wider HCP network and major professional diabetes organisations on a multinational level.
Conclusions
Our detailed consensus finds OS-AID satisfies the principles of medical ethics and there is sufficient observational data supporting its safety and efficacy. It provides best practice recommendations for HCPs. Furthermore, it highlights important recommendations for regulators and industry.