Periodic Reporting for period 2 - OPEN (Outcomes of Patients’ Evidence With Novel, Do-It-Yourself Artificial Pancreas Technology)
Reporting period: 2022-02-01 to 2023-04-30
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 automated insulin delivery 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 open-source 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.
OPEN is a patient-led research project that is gathering evidence on the experienced outcomes of open-source automated insulin delivery systems (open-source AID)
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.
The concept of an automated insulin delivery 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 open-source 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.
OPEN is a patient-led research project that is gathering evidence on the experienced outcomes of open-source automated insulin delivery systems (open-source AID)
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.
Until recently, evidence on the safety and effectiveness of these systems has been lacking, as has evidence on the lived experiences of people using open-source artificial pancreases.
To address this gap, an international team of interdisciplinary researchers co-founded the OPEN project in 2019, with the aim of examining the experienced outcomes of the users of open-source AID, and the implications for more widespread use among people with diabetes.
They found significant improvements across all participants in 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 previously been unimaginable. As highlighted by a parent of a 12-year old boy from the UK, 3 years old at diagnosis, using the ‘Loop’ system: “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 such systems, with sourcing the necessary components, lack of confidence in one's own technology knowledge and skills, perceived time and energy required to build a system as well as fear of losing healthcare provider support highlighted as major barriers towards uptake. The support of the wider diabetes community was seen as key overcoming some of these barriers.
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 open-source AID systems, which currently has 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. 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. It is anticipated that this, alongside other localised guidance, can support policy makers in dealing with the legal and regulatory dilemmas that open-source innovation presents to formal healthcare systems, now and in the future.
To address this gap, an international team of interdisciplinary researchers co-founded the OPEN project in 2019, with the aim of examining the experienced outcomes of the users of open-source AID, and the implications for more widespread use among people with diabetes.
They found significant improvements across all participants in 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 previously been unimaginable. As highlighted by a parent of a 12-year old boy from the UK, 3 years old at diagnosis, using the ‘Loop’ system: “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 such systems, with sourcing the necessary components, lack of confidence in one's own technology knowledge and skills, perceived time and energy required to build a system as well as fear of losing healthcare provider support highlighted as major barriers towards uptake. The support of the wider diabetes community was seen as key overcoming some of these barriers.
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 open-source AID systems, which currently has 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. 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. It is anticipated that this, alongside other localised guidance, can support policy makers in dealing with the legal and regulatory dilemmas that open-source innovation presents to formal healthcare systems, now and in the future.
Through establishing a scientific evidence base around open-source AID, the OPEN project 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. The team has published open-access articles in several prestigious journals on the clinical outcomes of people using these algorithms, as well as their motivations for building such systems. Several other publications are expected before the end of the project
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. 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. In 2022 OPEN received recognition as runner up in the UCD Case Study Impact competition.
The work of OPEN helps those interested in DIY solutions to make an informed decision about whether an open-source AID would be helpful in the management of their diabetes. As a result, we anticipate that there will be increased uptake of these systems by patients in the future. At the same time, our research adds to evidence of growing inequalities in access to these life enhancing technologies and therefore supports the work of those advocating for access and affordability for all.
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. 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. In 2022 OPEN received recognition as runner up in the UCD Case Study Impact competition.
The work of OPEN helps those interested in DIY solutions to make an informed decision about whether an open-source AID would be helpful in the management of their diabetes. As a result, we anticipate that there will be increased uptake of these systems by patients in the future. At the same time, our research adds to evidence of growing inequalities in access to these life enhancing technologies and therefore supports the work of those advocating for access and affordability for all.