Summary

Millions of people around the world have type 1 diabetes, which can lead to life-threatening physical complications, distress, anxiety, and depression. To help, tech-savvy people with diabetes (and their families) have developed open-source software to automatically adjust insulin dosing in response to glucose levels – in order to stay within a healthy range and reduce the psychological burden of the condition. These software programmes are sometimes known as do-it-yourself "artificial pancreases". 

OPEN is a patient-led research project that is gathering evidence on the safety and effectiveness of these open-source automated insulin delivery (AID) systems, to better understand the impact they have on the lives of people with diabetes. Through this research, OPEN has established an international consensus statement with practical guidance for healthcare professionals on open-source AID; received funding and awards from various organisations; and hosted public engagement events to foster dialogue between key stakeholders.

This research may help overcome clinical and regulatory hurdles so that open-source AID can be used more widely and safely, while also highlighting some of the inequalities in access to diabetes technology that prevent wider uptake.

Research description

Diabetes management is a relentless 24/7 job. In addition to life-threatening physical complications, the burden of diabetes can lead to psychological distress, anxiety and depression for people with diabetes (PwD) and their families.

The concept of an AID system (software that automatically adjusts insulin dosage with a pump according to predicted blood-sugar levels) is a promising approach to managing diabetes. It improves glucose levels while reducing the emotional and cognitive burden of living with diabetes. An algorithm takes over decision-making from the user, calculating predicted glucose levels every 5 minutes and adjusting insulin delivery accordingly — similarly to the pancreas of a person without diabetes. 

However, the research, commercial development and regulatory approval of such technologies have been piecemeal and slow. So tech-savvy patients started the grass-root movement “#WeAreNotWaiting” and built their own AID systems. Based on the principles of open-source sharing and the mantra of ‘paying it forward’, this online community has helped over ten thousand people worldwide to build their own system for automated insulin delivery, and the uptake continues to grow.

Until recently, evidence on the safety and effectiveness of these systems has been lacking, as has evidence on the lived experiences of people using them. To address this gap, an international team of interdisciplinary researchers co-founded the OPEN project in 2019, with the aim of examining the outcomes experienced by users of open-source AID, and the implications for more widespread use among people with diabetes.

The team found significant improvements across all participants (in terms of self-reported clinical outcomes), regardless of age and gender. The most significant transformation was in relation to quality of life. There was almost universal consensus among participants that these systems were life-changing and brought with them improvements in sleep quality that had been previously unimaginable.

This is highlighted by a parent of a 12-year-old boy from the UK, who was three when diagnosed: “If I could give my pancreas to my son, I would. This is the next best available option.”

However, participants also highlighted the multiple challenges of building AID systems. Major barriers include sourcing the necessary components, lack of confidence in one's own technological knowledge and skills, perceived time and energy required to build a system, and fear of losing support from healthcare providers. The support of the wider diabetes community was seen as crucial for overcoming some of these hurdles.

Brilliant leaders hastening our opportunities to live healthier, more productive, happier lives! Thank you!

—Paul Madden, Managing Director Diabetes & Behavioral Medicine, American Diabetes Association

Research impact

Research and engagement in numbers (metrics at a glance)

• EU Horizon 2020 RISE funding of around €1 million
• 1,092 participants in the OPEN surveys
• 6 papers/protocols published in best-in-field medical journals (72 citations, 370 tweeters, 16 news outlets, 4 FB pages)
• 3 solicited articles in medical journals
• 25 oral presentations at international conferences
• 30 invited talks and keynotes at medical conferences, local and virtual
• 3 public engagement events organised by the OPEN project
• 698 subscriptions to OPEN newsletter, 793 Twitter followers, 950 Facebook subscribers, 10,150 website visitors
• 13 out of 38 researchers recruited are people with diabetes, and active users of artificial pancreases
• Creation of an extensive AID diabetes dataset with an estimated 140 individuals and 500,000 hours of data

Political and technological impact

The OPEN project is establishing a scientific evidence base around open-source AID. It is helping patients, healthcare professionals, researchers, industry and regulators to recognise the value and importance of user-led, open-source innovation and the real-world evidence emerging from it.

In 2020, OPEN teamed up with 48 medical experts and 4 legal experts across 25 countries to create a consensus statement on the safe and ethical use of these systems, which currently have no regulatory approval in clinical practice. The consensus statement, which has been endorsed by several international professional diabetes organisations—including the International Diabetes Federation and International Society for Pediatric and Adolescent Diabetes—is published in the Lancet Diabetes & Endocrinology.

This is the first time that international guidance on open-source AID has been provided to healthcare professionals. The guidelines will be particularly important in providing education and reassurance to healthcare providers who are increasingly encountering these systems in their clinical practice. Alongside other guidance that will likely emerge in the future, it is expected to help policymakers deal with the legal and regulatory dilemmas that open-source innovation presents to formal healthcare systems.

Health impact

Around the world, there are roughly 10,000 people using an open-source AID. However, based on membership of DIY social media groups, the team estimate that the number of people interested in building one of these systems is several times that figure.

Through the work of OPEN, those interested in DIY solutions can make an informed decision about whether an open-source AID system would help them to manage their diabetes. As a result, uptake will likely increase, improving patients’ clinical outcomes and their quality of life. Research by the OPEN team also provides evidence of the impact of growing inequalities in access to these life-enhancing technologies, supporting the work of those advocating for increased affordability and access for all.

Social impact

Importantly, OPEN has also sparked significant interest within the diabetes community and the wider public. For example, a public engagement event aimed at promoting awareness of the initial findings of the OPEN project held at UCD in May 2019 attracted over 150 people, including healthcare professionals, medical device manufacturers and people living with diabetes. Similar public engagement events have been staged in Copenhagen and Barcelona. This continued during COVID-19 when the OPEN team presented at the Loop and Learn session, a regular online workshop for people with diabetes who want to learn more about open-source AID systems.

A special shout-out to OPEN Project Diabetes for being a truly patient-driven initiative with results.

—Denise Silber, Founder of Doctors 2.0

Academic impact

The team has published open-access articles in several prestigious journals on clinical outcomes of people using these systems, as well as their motivations for building them. Two senior researchers from the OPEN team are currently guest-editing a special issue of Diabetic Medicine on user-led diabetes technology.

OPEN has gained recognition for its uniquely user-centred and patient-driven approach, both within the scientific community and beyond. For example, in 2020 it was awarded the Berlin Institute for Health QUEST Patient and Stakeholder Engagement Award, and in 2021 the BIH QUEST Patient & Stakeholder Engagement Grant for a follow-up project that facilitates direct patient engagement in academic teaching of future doctors, clinical researchers and healthcare providers.