Open-source innovation benefits people living with diabetes
Type 1 diabetes is a chronic condition whereby the body stops producing insulin – a key hormone in the regulation of glucose. Treatments typically involve replacing insulin through multiple daily injections, or insulin pump therapy. “Dosage requirements vary depending on a range of factors, including food, physical activity, stress and hormone levels,” explains OPEN project coordinator Shane O’Donnell from University College Dublin in Ireland, who also lives with type 1 diabetes. “Dozens – if not hundreds – of treatment decisions need to be made on a daily basis. There are no breaks – it is absolutely relentless.”
Potential of open-source automated insulin delivery
A promising treatment for managing diabetes is automated insulin delivery (AID). In these systems, an algorithm takes over decision-making from the user, calculating predicted glucose levels every five minutes and adjusting insulin delivery accordingly. “Commercial development and regulatory approval of such technologies have been piecemeal and slow,” notes O’Donnell. “This is why tech-savvy people with diabetes and their families started the grassroots movement ‘#WeAreNotWaiting’ and built their own AID systems through open-source collaboration.” However, open-source AID systems, as they came to be known, have been the subject of scepticism among some within the medical establishment. To address this issue, the OPEN project, undertaken with the support of the Marie Skłodowska-Curie Actions programme, was launched to build an evidence base on the outcomes experienced by users of open-source AID, and the implications for more widespread use among people with diabetes. “We undertook a survey to investigate the benefits for health and well-being,” adds O’Donnell. “This generated responses from over 1 500 people from over 40 different countries, helping to illuminate the benefits of life with open-source AID.” What made OPEN especially innovative was that it was almost entirely patient led. Over half of the project team live with diabetes (or a family member or friend of a person with diabetes).
Safe and ethical use of open-source AID systems
The project also teamed up with 44 medical experts and four legal experts across 25 countries to create a consensus statement on the safe and ethical use of open-source AID systems. This is the first time that international guidance on open-source AID has been provided to healthcare professionals. “These guidelines will be particularly important in providing both education and reassurance to healthcare providers who are increasingly encountering open-source AID in their clinical practice,” says O’Donnell. “This can also support policymakers in dealing with the legal and regulatory dilemmas that open-source innovation presents to formal healthcare systems, now and in the future.”
Keywords
OPEN, insulin, diabetes, glucose, hormone, clinical, healthcare, AID
