The OPEN Project
Outcomes of Patient’s Evidence with Novel,
Do-it-Yourself Artificial Pancreas Technology
About OPEN
The OPEN Project was a patient-led, EU-funded 4-year research project on open-source “DIY” Artificial Pancreas Solutions, managed by #dedoc°. It concluded in 2013.
Inquiries: mail@dedoc.org
This project has received funding from the European Commission's Horizon 2020 Research and Innovation Programme under the Marie Sklodowska–Curie Action Research and Innovation Staff Exchange (RISE) grant agreement number 823902.
About DIYAPS
Digital innovations in healthcare up until recently have typically followed a ‘top-down’ pathway, with device manufacturers leading the design and production of technology-enabled solutions, and patients involved only as users of the end product. However, this is now being disrupted by the increasing influence and popularity of more ‘bottom-up’ and patient-led open-source initiatives. A leading example is the growing movement of people with diabetes who create their own “Do-it-yourself Artificial Pancreas Systems” (‘DIYAPS’) through remote control of medical devices with an open-source algorithm. The DIYAPS community has created a safety-focused reference algorithm and an implementation of a hybrid closed-loop system. Based on the prediction of glucose levels, the system constantly and automatically adjusts basal insulin levels, in order to keep glucose levels inside a safe range, night and day.
DIYAP systems are not CE-marked or FDA-approved systems or devices. They are not being manufactured or sold anywhere in the world. However, the algorithm and source code are made open-source and are publicly available.
Further information is available here:
OpenAPS: www.openaps.org
AndroidAPS: www.androidaps.org
Loop: www.loopdocs.org
Project logbook - Day 1532: Mission complete.
In 2019, this patient-led research project set out to gather real-world evidence on the clinical and quality of life outcomes of open-source automated insulin delivery (AID) systems to better understand their impact on the lives of people with diabetes.
Over 40 researchers joined us on this mission with a consortium consisting of 8 international members, including University College Dublin, Charité - Universitätsmedizin Berlin, #dedoc° Diabetes Community, The Australian Centre for Behavioural Research in Diabetes, University of Copenhagen, Steno Diabetes Center Copenhagen, Stanford University, Diabetes Center Berne and King's College London.
We are grateful to everyone who contributed to the success of The OPEN Project.
Watch the entire recording of the conference with it an in-depth summary of our work.
4 Years of OPEN: A Recap
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Work Package 1
Clinical Outcomes and Professional Guidance
Work Package 1 explored physical health-related changes that open-source AID users experience, such as the changes in hemoglobin A1c (HbA1c) and time of glucose spent “in range”, and on practical guidance for healthcare professionals who want to support people with diabetes using open-source AID.
In the DIWHY survey, we found that after people started using open-source AID, HbA1c levels were significantly reduced, and time in range was increased. These changes were found in people of different genders and ages, ranging from 2 to 77 years, and users of all types of open-source AID systems (OpenAPS, AndroidAPS, and Loop).
In an international consensus statement, the OPEN team worked with a group of 44 medical and legal experts on the topic of open-source AID from around the world. In the statement, we provided an overview of the state-of-the-art research on open-source AID, a description of the different technologies, discussed safety aspects, but also availability and access issues of diabetes technology, and the ethical and legal considerations for these systems from an international perspective. Furthermore, we provided much-needed guidance for healthcare professionals that will enable them to support people with diabetes who choose open-source AID for their treatment. Lastly, we provided recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, with respect to interoperability, transparency, and data ownership.
The consensus was published by Lancet Diabetes & Endocrinology as part of the “100 Years of Insulin” special issue on World Diabetes Day 2021. The full-text version of the article is available here upon free registration or on PubMed Central).
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Work Package 2
Person-Reported Outcomes & Lived Experience
With the OPEN survey, the project has collected the largest and most exhaustive dataset of Quality of Life (QoL) outcomes for people using open-source AID systems (see Knoll et al and Schipp et al). Open-source AID users indicate high quality of life scores measured in the survey, particularly in relation to well-being, treatment satisfaction, and diabetes distress.
The qualitative analysis of data acquired in WP2 in the form of photo-elicitation and autoethnography (“a diabetes diary”) provides deep insights into the impact that open-source AID has on the user. It illustrates the transformative potential of open-source AID while highlighting the many daily challenges and successes that are part of life with open-source AID. It also spotlights the motivations for people using open-source AID, and the resources they have drawn on to do so.
Aside from underlining the massive transformative potential of open-source AID for the individual user, the data also point to the importance, both practically and emotionally, of the #WeAreNotWaiting community. Many open-source AID users say that becoming part of that community has had a profound impact on their lives with diabetes and beyond. In many ways, it is as important as the open-source AID technology itself.
Finally, our findings point to the challenges that people using open-source AID may confront in their interactions with healthcare providers and services. Although many users report positive experiences and how using open-source AID has changed the dynamic of their interactions with HCPs in a constructive way, there are still more who highlight the scepticism and lack of support by healthcare stakeholders as negative experiences resulting from their opting to use open-source AID.
Although we could not find any significant differences in average HbA1c and time in range between people of different genders, the many testimonials of users highlighting the menstrual cycle and other female health-related implications led us to further look into the topic. In a series of interviews, 12 users of open-source AID shared their observations, thoughts, and strategies with us on how they manage diabetes throughout the menstrual cycle and menopause. Many of them stated that the differences in insulin needs only become obvious to them after they started using AID, and that professional guidance both from diabetes and OBGYN specialists is limited. We highly recommend future research to address these topics, in data analytics as well as in user experience research. The full-text version of this article is available here.
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Work Package 3
Technical Aspects and Improvements
Work Package 3 made extensive use of two of the now-largest diabetes datasets in the world: the OpenAPS Data Commons and the data contributed to the OPEN project, which could be paired with the survey data. We sought to make it possible to pair survey data with donated device data via a pseudonymous user ID, which is something that is not commonly done, and created an open-source research tool called the “Gateway” (available open-source here for other researchers to use). More details about the Gateway are in this paper.
We also developed methods for de-duplicating data from participants who contributed to the two datasets anonymously, to avoid replicating analyses on individuals who had already been analyzed as part of previous work. This enables us and other researchers to leverage diabetes data from multiple datasets. This method can also be used to enable researchers to use diabetes data from clinical research and real-world datasets. We are excited to see these methods used in the future to expand the amount of open data that is used for research, particularly for training machine learning and deep learning algorithms to further improve AID algorithms.
Ultimately, the goal of our work was to address how machine learning might be used to learn from and then propose improvements to open-source AID. We used several machine learning and deep learning models (methods and results available here) to extend glucose prediction or forecast horizons up to 48 hours in the future, whilst maintaining accuracy and evaluating the ‘cost’ of computing power to do so. In the future, we are excited to see others build on this work to evaluate new prediction models alongside computing costs to better evaluate the trade-offs of using these models in real-world systems; possibly test and apply these additional forecast methods to open-source AID; and continue to leverage the open source code for glycemic variability analysis to continue to improve “edge cases” like hypoglycemia reduction during and after exercise, improving individual mealtime outcomes, reduce the work involved in everyday diabetes, and more.
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Work Package 4
Barriers to Uptake
The main aim of WP4 was to examine the barriers to the wider diffusion of open-source AID technology. With this in mind, we conducted a survey of members of the DIY community who were not (yet) users to examine what they perceived as the most common barriers to building a system. The main barriers identified towards uptake included: sourcing the necessary components, such as loopable insulin pumps or continuous glucose monitoring sensors, lack of confidence in one's own technology-related knowledge and skills, perceived time and energy required to build a system, and fear of losing healthcare. Some of these barriers may be overcome over time through the peer support of the community as well as greater acceptance of open-source innovation among healthcare professionals. However, other barriers, such as sourcing components, are more structural in nature and reflect long-standing inequalities in access to diabetes technology.
These findings also echoed in another study conducted by WP4 that examined the costs associated with diabetes supplies across different counties. For this, we were fortunate to collaborate with the patient-led NGO ‘T1International’ on their global Out-of-Pocket Cost Survey. Worldwide, one out of every four respondents reported having underused their insulin at least once within the last year due to high cost. In Ghana, for example, the majority reported rationing test strips every week.
OPEN | Consortium
#dedoc° Diabetes Online Community
Berlin, Germany
#dedoc° runs the world’s largest scholarship program for diabetes advocates. We believe in the value that lived experience brings to scientific conferences. This is why we empower hundreds of #dedoc° voices every year to attend ATTD, EASD, ADA and other congresses where they speak at scientific sessions and symposia, engage with HCPs, researchers, policy makers and key stakeholders and report back to their communities around the globe.
Our #dedoc° academy builds capacity for impactful advocacy. It provides a safe space for members of our community to meet, mentor and support each other, learn from experts and collaborate with partners. Our #dedoc° blog, #docdays° and social media channels provide a platform to share projects, opinions, research, campaigns and policy initiatives with the wider public.
On 14 November, #dedoc° collaborates with IDF Global for Virtual World Diabetes Day, our annual signature event. This year, we will also send #dedoc° voices to join the IDF’s World Diabetes Congress in Bangkok, Thailand. In Germany, we collaborate with DIE ZEIT to run in-person WDD events throughout the country as well as ZEIT für [Forschung], Germany’s largest conference on health, nutrition, obesity and diabetes.
University College Dublin, School of Sociology
Dublin, Ireland
The UCD team is based in the School of Sociology. It is Ireland’s leading center for education and research in sociology. The School has an international research reputation and strong research links with multiple academic schools in related disciplines within UCD and external to the University. The School’s staff, post-doctoral and PhD researchers have numerous research interests from historical, comparative, and quantitative research to social complexity and arising changes in the modern world. Currently, research activities address issues of health and illness, health inequality, new technologies, cybernetics, human rights and global inequalities, social network analyses, the media, migration and diversity, national identity, criminology, globalization, and more.
Charité – Universitätsmedizin Berlin
Berlin, Germany
Charité – Universitätsmedizin Berlin is one of the largest European university hospitals. Clinical care, research, and teaching are delivered by physicians and researchers of the highest international standard. CUB proudly lays claim to more than half of all German Nobel Prize winners in Physiology or Medicine, including Emil von Behring, Robert Koch, and Paul Ehrlich. La CUB is internationally renowned for its excellence in teaching and training. CUB represents a single medical faculty, which serves both Humboldt-Universität zu Berlin and Freie Universität Berlin. Innovative capacity and responsible governance, for the benefit of patients and society, are the central tenets behind all of Charité’s research endeavors. Approximately 3,700 researchers are actively engaged in the development of pioneering innovations in the field of medicine. Committed to the highest standards of quality and sustainability, they work across 1,000 projects, working groups and collaborative projects. There is a particular focus on the interface between basic and patient-oriented research, which seeks to foster interdisciplinary collaborations with both national and international partners. Harnessing the potential of this approach is of particular importance to Charité, given that the most significant scientific developments are likely to arise from interdisciplinary cooperation. While committed to both national and international research, and growing its reputation on both the national and international stage, Charité remains true to its roots. Charité is very much the heart of Berlin-based health care research as well as its driving force. Developed in cooperation with the Max Delbrück Center for Molecular Medicine (MDC), the Berlin Institute of Health (BIH) continues to expand, offering a systems medicine approach that is unique in Germany.
Steno Diabetes Center
Copenhagen, Denmark
Steno Diabetes Center Copenhagen (SDCC) is the largest diabetes clinic in Scandinavia and treats each year more than 9000 people with diabetes from the Capital Region. SDCC is a hospital specialized in patient care, research, and prevention of diabetes and in the education of healthcare professionals within diabetes. SDCC is one of few centers globally that focus on diabetes only and has research, education, and health promotion closely connected to the clinical care of patients. From the earliest stages of risk for diabetes to patients with longstanding diabetes and the development of complications, the Center ensures that research results are directly implemented to improve patient care and management as well as targeting new approaches to disease prevention.
University of Copenhagen
Copenhagen, Denmark
The University of Copenhagen (UCPH), the oldest one in Denmark, is highly ranked among the world’s best universities. The university provides an international research and study environment for approximately 5000 researchers and 37,500 students, where they have the chance to develop their talents for contributing to solutions for the challenges and needs of society. Nine Nobel Prizes have been awarded to researchers at the university.
The research activities focus on free basic research, but the University of Copenhagen also encourages inter-organizational cooperation and interdisciplinary initiatives, maintains close contact with the business community, and helps students find programs and projects in the field of sustainability.
More than 200 research centers and the diversity of scientific approaches are the distinguishing feature and strength of the University. Together, the Faculty of Health and Medical Science and the Faculty of Science are one of the largest Health and Life Sciences centers in Northern Europe.
The Centre for Medical Science and Technology Studies is part of the Department of Public Health, which itself is part of the Faculty of Health and Medical Science. The aim of the Centre is to support research that looks at medical and health-related topics from the perspective of science and technology studies.
The Australian Centre for Behavioural Research in Diabetes
Melbourne, Australia
The Australian Centre for Behavioural Research in Diabetes (ACBRD) is a partnership between Diabetes Victoria and Deakin University. The ACBRD is the first national research center for the investigation of psychological, behavioral and social aspects of diabetes. The Centre aims to be a national resource for clinicians, researchers, and policymakers. It aims to raise awareness and influence policy and practice at local and national levels. The ACBRD focuses on improving the quality of life of Australian people with diabetes and their families with research that includes social stigma surrounding diabetes, emotional well-being, self-management education and peer support, experiences of new treatments, insulin delivery and monitoring technologies, the role of beliefs, attitudes, and emotions in diabetes outcomes and more.
Diabetes Center Berne
Berne, Switzerland
Diabetes Center Berne (DCB) is a private, independent Swiss foundation established in 2017. DCB aims to identify unmet needs in diabetes technology and to translate ideas into tangible solutions, helping research projects and business ideas to grow. Based in Switzerland, DCB provides expertise, access to clinical research facilities and its own laboratories and workspaces, as well as funding to projects around the world. DCB works in close scientific partnership with the Department of Diabetology, Endocrinology, Nutritional Medicine and Metabolism of the Inselspital Bern (UDEM), a university hospital with a stellar international reputation in the field of diabetes technology. DCB is a growing international community and interdisciplinary network of innovators, experts, researchers and patients that join forces to achieve a common goal: Making life with diabetes easier.
King’s College London
London, UK
The King’s College London is an internationally renowned university delivering exceptional education and world-leading research. Being one of the top 35 universities in the world (Times Higher Education World Rankings 2022) and among the oldest in England, King’s hosts more than 33,000 students from over 150 countries. The university has a world-class range of research facilities, technical services and technology platforms. Staff and students, as well as external researchers and collaborators, benefit from facilities for imaging, biological and medical sciences, physical and materials sciences and digital technologies. The King’s community includes 14 Nobel Prize laureates and the university was ranked 3rd amongst multi-faculty universities for research impact in the 2021 Research Excellence Framework (REF).
Stanford University
Stanford, United States of America
Stanford University is a private US university in Stanford, California and one the most research-intensive and prestigious universities in the world. Since its founding in 1885, 30 faculty members have been awarded the Nobel Prize and the university regularly achieves top positions in various ratings for academic institutions. Stanford’s areas of excellence span seven schools along with research institutes, the arts and athletics. Students, faculty and staff work to improve the health and well-being of people around the world through the discovery and application of knowledge. Stanford University emphasises interdisciplinary research, fostering innovative research with programs that reflect the expertise, creativity and initiative of the faculty who set the research agenda. There are 19 independent laboratories, centers and institutes that provide physical and intellectual intersections between schools and disciplines.
OpenAPS
The Open Artificial Pancreas System project (#OpenAPS) is an open and transparent effort to make safe and effective basic Artificial Pancreas System technology widely available to more quickly improve and save as many lives as possible and reduce the burden of type 1 diabetes. Dana M. Lewis is the founder and developer of OpenAPS.
AndroidAPS
AndroidAPS is a free and open-source research tool-kit with which patients can build their own closed-loop artificial pancreas system controlling a Sooil Dana R/RS, an Accu-Chek Spirit Combo, or an Accu-Chek Insight insulin pump.
OPEN | Publications
Hussain S, Lal R, Braune K. Open-source Automated Insulin Delivery in Type 1 Diabetes – the evidence is out there. Lancet Diabetes Endocrinol. 2022 Oct 13:S2213-8587(22)00283-2. doi: 10.1016/S2213-8587(22)00283-2. PMID: 36244346
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Huhndt A, Chen Y, O’Donnell S, Cooper D, Ballhausen H, Gajewska KA, Froment T, Wäldchen M, Lewis DM, Raile K, Skinner TC, Braune K. Barriers to Uptake of Open- Source Automated Insulin Delivery Systems: Analysis of Socioeconomic Factors and Perceived Challenges of Caregivers of Children and Adolescents With Type 1 Diabetes from the OPEN Survey. Front Clin Diabetes Healthc. 2022 3:876511. doi: 10.3389/fcdhc.2022.876511
Braune K, Krug N, Knoll C, Ballhausen H, Thieffry A, Chen Y, O’Donnell S, Raile K, Cleal B. Emotional and Physical Health Impact in Children and Adolescents and Their Caregivers Using Open-source Automated Insulin Delivery: Qualitative Analysis of Lived Experiences. J Med Internet Res. 2022 Jul 14;24(7):e37120. doi: 10.2196/37120. PMID: 35834298; PMCID: PMC9335170
Shahid A, Lewis DM. Large-Scale Data Analysis for Glucose Variability Outcomes with Open-Source Automated Insulin Delivery Systems. Nutrients. 2022 May 2;14(9):1906. doi: 10.3390/nu14091906. PMID: 35565875; PMCID: PMC9101219
Cooper D, Ubben T, Knoll C, Ballhausen H, O’Donnell S, Braune K, Lewis D. Open-source Web Portal for Managing Self-reported Data and Real-world Data Donation in Diabetes Research: Platform Feasibility Study. JMIR Diabetes. 2022 Mar 31;7(1):e33213. doi: 10.2196/33213. PMID: 35357312
Mewes D, Wäldchen M, Knoll C, Raile K, Braune K. Variability of Glycemic Outcomes and Insulin Requirements Throughout the Menstrual Cycle: A Qualitative Study on Women With Type 1 Diabetes Using an Open-Source Automated Insulin Delivery System. J Diabetes Sci Technol. 2022 Mar 7:19322968221080199. doi: 10.1177/19322968221080199. PMID: 35254146
Knoll C, Peacock S, Wäldchen M, Cooper D, Aulakh SK, Raile K, Hussain S, Braune K. Real-world Evidence on Clinical Outcomes of People with Type 1 Diabetes Using Open-Source and Commercial Automated Insulin Dosing Systems: A Systematic Review. Diabet Med. 2021 Nov 12:e14741. doi: 10.1111/dme.14741. PMID: 34773301
Braune K, Lal RA, Petruželková L, Scheiner G, Winterdijk P, Schmidt S, Raimond L, Hood KK, Riddell MC, Skinner TC, Raile K, Hussain S; 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. 2021 Nov 12:S2213-8587(21)00267-9. doi: 10.1016/S2213-8587(21)00267-9. PMID: 34785000
Braune K, Gajewska KA, Thieffry A, Lewis DM, Froment T, O’Donnell S, Speight J, Hendrieckx C, Schipp J, Skinner T, Langstrup H, Tappe A, Raile K, Cleal B. 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. doi: 10.2196/25409. PMID: 34096874
Schipp J, Skinner TC, Holloway EE, Scibilia R, Langstrup H, Speight J, Hendrieckx C. 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. doi: 10.1089/dia.2020.0652. PMID: 33720767
O’Donnell S, Lewis D, Marchante Fernández M, Wäldchen M, Cleal B, Skinner T, Raile K, Tappe A, Ubben T, Willaing I, Hauck B, Wolf S, Braune K. Evidence on User-Led Innovation in Diabetes Technology (The OPEN Project): Protocol for a Mixed Methods Study. JMIR Res Protoc. 2019 Nov 19;8(11):e15368. doi: 10.2196/15368. PMID: 31742563; PMCID: PMC6891827
Braune K, May A, Thurm U. Safe and Successful Completion of a Half Marathon by an Adult With Type 1 Diabetes Using a Personalized Open Source Artificial Pancreas System. J Diabetes Sci Technol. 2020 Nov;14(6):1137-1138. doi: 10.1177/1932296819884922. PMID: 31709805; PMCID: PMC7645146
Braune K, O’Donnell S, Cleal B, Lewis D, Tappe A, Willaing I, Hauck B, Raile K. 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 Jul 30;7(7):e14087. doi: 10.2196/14087. PMID: 31364599; PMCID: PMC6691673
Knoll C, Schipp J, O’Donnell S, Wäldchen M, Ballhausen H, Cleal B, Gajewska KA, Raile K, Skinner T, Braune K. Quality of life and psychological well-being among children and adolescents with diabetes and their caregivers using open-source automated insulin delivery systems: Findings from a multinational survey. Diabetes Res Clin Pract. 2023 Feb;196:110153. doi: 10.1016/j.diabres.2022.110153. PMID: 36423699
O’Donnell S, Cooper D, Chen Y, Ballhausen H, Lewis DM, Froment T, Anna Gajewska K, Tappe A, Skinner T, Cleal B, Braune K. Barriers to uptake of Open-Source automated insulin delivery Systems: Analysis of socioeconomic factors and perceived challenges of adults with type 1 diabetes from the OPEN survey. Diabetes Res Clin Pract. 2023 Mar;197:110235. doi: 10.1016/j.diabres.2022.110235. PMID: 36581143
Braune K, Hussain S, Lal R. The First Regulatory Clearance of an Open-Source Automated Insulin Delivery Algorithm. J Diabetes Sci Technol. 2023 Apr 13:19322968231164166. doi: 10.1177/19322968231164166. PMID: 37051947