IMPACT CASE STUDY
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.
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
Dr O’Donnell is co-founder and coordinator of the Horizon 2020 OPEN project. He leads the ‘barriers to uptake’ work package, using his background as a sociologist to understand the barriers and enablers to increasing the global footprint of DIY solutions in diabetes care.
OPEN has its roots in the International Diabetes Federation Young Leaders in Diabetes initiative—an advocacy training programme for young PwD from all over the world—where many of the OPEN team members first met. A list of researchers is available here.
The OPEN team brings together an international and intersectoral consortium of patient innovators, clinicians, social scientists, legal experts, computer scientists and data scientists. Consortium members include UCD, Charité – Universitätsmedizin Berlin, Dedoc Labs GmbH, the Australian Centre for Behavioural Research in Diabetes, the University of Copenhagen, Stanford School of Medicine, King’s College London and Diabetes Center Berne.
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.
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.
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
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.
“It is a wonderful project and I look forward to hearing about how it progresses. I would consider it a landmark project in terms of PPI in Ireland.”
—Dr Geraldine Canny, Head of the Irish Marie Skłodowska-Curie Office
“This was one of the most inspiring stories of patients taking charge of their own fate! [@OPENDiabetesEU] we were all blown away in @UCDDCRC best of luck on this amazing project!”
—Dr Fiona McGillicuddy, Lecturer in UCD school of medicine [link]
“Brilliant leaders hastening our opportunities to live healthier, more productive, happier lives! Thank you! Living a bold life that has included T1 diabetes for 58 years!”
—Paul Madden, Managing Director Diabetes & Behavioral Medicine, American Diabetes Association
“A special shout-out to Open Project Diabetes for being a truly patient-driven initiative with results. Thank you Saskia Wolf for leading the way for us at this session.”
—Denise Silber, Founder of Doctors 2.0 & You [link]
“At every medical conference, there is one scientific session that was worth travelling for. This was this session.”
—IDF World Diabetes Congress 2019, Busan, South Korea
“This is stakeholder engagement on steroids!”
—Professor Ulrich Dirnagl, Director of the Berlin Institute of Health (BIH) QUEST Center
“And this was — no exception — one of the highly emotional and motivated meetings.”
—Professor Roman Hovorka, University of Cambridge, developer of CamAPS FX [link]
“These are **great** people doing great work :)"
—Weston Nordgren, Vice President of the Nightscout Foundation
Braune K, et al. OPEN International Healthcare Professional Network and OPEN Legal Advisory Group. Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals. Lancet Diabetes Endocrinol. 2022 Jan;10(1):58-74.
Pfiester E, et al. Costs and underuse of insulin and diabetes supplies: Findings from the 2020 T1International cross-sectional web-based survey. Diabetes Res Clin Pract. 2021 Sep;179:108996.
Braune K, et al. Why #WeAreNotWaiting-Motivations and Self-Reported Outcomes Among Users of Open-source Automated Insulin Delivery Systems: Multinational Survey. J Med Internet Res. 2021 Jun 7;23(6):e25409.
Schipp J, et al. How adults with type 1 diabetes are navigating the challenges of open-source artificial pancreas systems: a qualitative study. Diabetes Technol Ther. 2021 Mar 15.
Raile K, Boss K, Braune K, Heinrich-Rohr M. Children and Adolescents with Type 1 Diabetes: a Technological and Psychosocial Challenge. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020 Jul;63(7):856-863. German.
O’Donnell S, et al. Evidence on User-Led Innovation in Diabetes Technology (The OPEN Project): Protocol for a Mixed Methods Study. JMIR Res Protoc 2019;8(11):e15368.
Braune K & O’Donnell S et al. Real-World Use of Do-It-Yourself Artificial Pancreas Systems in Children and Adolescents With Type 1 Diabetes: Online Survey and Analysis of Self-Reported Clinical Outcomes. JMIR Mhealth Uhealth 2019;7(7):e14087.