“Evidence on User-Led Innovation in Diabetes Technology
(The OPEN Project): Protocol for a Mixed Method Study”
The OPEN consortium published their paper in JMIR Res Protoc on November, 19th, 2019. The JMIR (Journal of Medical Internet Research) is the top #1 journal in digital health. Scientific articles are published online and openly accessible to all free of charge.
The main points are:
Type 1 diabetes (T1D) is a chronic condition that is hard to manage. Only 17 / 21% (youth/adults) of people with type 1 diabetes (PwD) achieve the recommended HbA1c level below 7,0%.
Closed-loop insulin delivery systems / artificial pancreas systems (APS) / automated insulin delivery systems (AID) combine insulin pumps and sensors for continuous glucose monitoring (CGM) with an automated control algorithm.
The algorithm predicts future glucose values, uses the predictions for calculating and then automatically doses the amount of insulin needed to keep the glucose values within a certain healthy range. Commercially developed closed-loop systems have indicated to be safe and effective and have shown further improvements, they are considered the gold standard of future diabetes therapy. But commercial closed-loop systems are not universally available, accessible or affordable.
So far, patients had a passive role in digital innovations in healthcare. But more and more patients are not willing to wait until manufactures went through long regulatory processes. Under the hashtag #WeAreNotWaiting, people with diabetes and their families have co-created new tools and systems to help PwD benefit better from their devices and data. Instructions and code for the tools and systems are freely accessible on open-source platforms (software code is publicly available) and anybody can use them at their own risk.
The DIYAPS or “Open-Source Artificial Pancreas System” (OpenAPS) is “the most spectacular example of empowered patients”. Every user, and their number is increasing, has to build their own system and adjust the wide range of the parameter set to fit the personal needs.
(picture: Nightscout Loopalyzer)
First studies on DIYAPS based on self-reported outcomes of smaller cohorts have described significant improvements for the PwD, but so far, evidence of usage of DIYAPS is limited. There is an estimated 15+ million hours of real-world DIYAPS data (20+ million as of January 2020) and most of it not yet been fully analysed. A global investigation is of interest in regard to the benefits and challenges of using the systems, clinical and quality-of-life outcomes considering different groups of DIYAPS users, and will identify the mechanisms by which these results are achieved.
Getting prepared, establishing and continuously maintaining and updating an effective DIYAPS, all this currently is challenging and too complicated for many PwD. So, another fundamental question is who might get left behind in this user-driven technological innovation. Consequently, investigation also needs an ethical, sociological and political view on the subject, and this is why an interdisciplinary and intersectoral approach will be more effective.
Moreover, cooperating and benefitting from the expertise, knowledge and experience of the DIYAPS community will be the formula for success when it comes to some of the new research opportunities and new challenges arising from the DIY solutions.
The OPEN project (Outcomes of Patients´ Evidence with Novel, Do-It-Yourself Artificial Pancreas Technology) aims to investigate different aspects of the DIY systems with the goal of making artificial pancreas technology of all kinds available to everyone. Since the majority of the OPEN team members live with type 1 diabetes and are active DIYAPS users, this research project is a unique user-driven one. Hereby, OPEN acts as a role model for a new type of cooperation by bringing together an international, interdisciplinary and intersectoral group composed of healthcare professionals, technical developers and data scientists, biomedical and social scientists, and patient advocates.
This project has received funding from the European Commission’s Horizon 2020 Research and Innovation Program, under the Marie Skłodowska-Curie Action Research and Innovation Staff Exchange grant agreement number 823902.
Staff has been and will be exchanged between high-profile nonacademic organisations dedicated to patient-driven approaches (Steno Diabetes Center Copenhagen, Denmark; Dedoc Labs, Germany) and leading research organisations in the field of diabetes research and connected health (Charité – Universitätsmedizin Berlin, Germany; University College Dublin, Ireland). Furthermore, the project will make use of the expertise of the DIYAPS community via staff secondments and further collaborations.
Methods: Within five work packages (WP) OPEN will examine the clinical outcomes, quality of life and psychosocial benefits of these DIYAPS solutions, identify and reduce the technical barriers to DIYAPS and disseminate the research findings to the diabetes community. This will include engaging the community in sharing data, as well as self-reporting on their experience of living with DIYAPS.
Work Package 1 – Clinical outcomes and Guidelines:
WP1 is led by Katarina Braune and Klemens Raile, PwD and medical doctors at the Department of Paediatric Endocrinology and Diabetes at Charité University Medicine Berlin, and will:
(1) evaluate the clinical outcomes of DIYAPS users of all age groups,
(2) create a draft for future guidelines for closed-loop technology in clinical routine.
Users of any of the DIYAPS can anonymously donate and consent to share their data via the nonprofit citizen science platform Open Humans to the OpenAPS Data Commons project, which includes use in research projects such as OPEN. After getting access, OPEN will utilize data, for pre-post DIYAPS evaluations, from the OpenAPS Data Commons, such as glycaemic outcomes and CGM sensor data for calculating Time below/in/above Range. This data is considered pseudonymized for the purposes of the OPEN project. In addition, OPEN will ask for self-reported parameters, for basic demographic and health data, such as gender, age, etc. This will enable an analysis of clinical outcomes for different user groups.
Work Package 2 – Patient-Reported Outcomes:
WP2 is led by Ingrid Willaing, Bryan Cleal and Timothy Skinner, diabetes management researchers at Steno Diabetes Center Copenhagen, and will:
(1) evaluate the quality of life and lived experiences of DIYAPS users,
(2) investigate motivations, barriers and retention factors,
(3) explore effects on individuals´ sense of self-efficacy, social support and the benefits from joining a wider network of PwD.
A suitable T1D-specific quality-of-life questionnaire does not exist. Therefore, the project will take a facet approach to evaluating the quality-of-life outcomes, such as emotional well-being, sleep quality, hypoglycaemia-related anxiety and fears, the burden of diabetes and flexibility of lifestyle. Also, WP2 will examine how the lived experiences of DIYAPS users vary across gender, age, ethnicity and socioeconomic status.
Furthermore, WP2 will investigate motivations, barriers and retention factors to building and maintaining DIYAPS or additional benefits from setting up their own closed-loop system. Also, the effects on individuals´ sense of self-efficacy, social support and the benefits from a wider network of PwD will be explored.
Work Package 3 – Technical development:
WP3 is led by Dana Lewis, PwD and founder of OpenAPS, and Adrian Tappe, PwD and developer of AndroidAPS, and aims to:
(1) make data donation easier for DIYAPS users to support further research and evaluation,
(2) evaluate existing DIYAPS platforms and implications for APS improvement.
WP3 will enable DIYAPS users to choose automatic, regular data uploads from Nightscout (remote monitoring of CGM data and retrospective data analysis and report, widely spread among DIYAPS users) into Open Humans. Especially for AndroidAPS (one of the commonly used DIYAPS) users, this WP plans to add direct upload capabilities. As a result, the OPEN team expects available datasets to increase from 115 users to an estimated 300 or more users.
With several hundred pseudonymized datasets, OPEN expects to be able to sort outcome data into subcohorts to better quantify the impact of different algorithm choices and settings. In this way, less optimal usage patterns or specific needs of varying subcohorts will be identified and recommendations for improvements in the development of DIYAPS can be given. Eventually, this can also be adapted into the use of commercially developed APS.
Work package 4 – Barriers to Scale-Up:
WP4 is led by Shane O´Donnell, PwD and sociologist at the School of Sociology, University College Dublin and it will explore the potential economic, social, cultural, legal, and political barriers to the scale-up of DIYAPS technology.
This WP aims to examine why PwD have decided not to build their DIYAPS or gave up after not being successful in building their own system, or why they discontinued using DIYAPS. This will be achieved by questionnaires about possible reasons, such as time and effort, lack of confidence in own IT skills and other, through the findings from WP2 and through interviews. The results of this investigation will help researchers to develop ways to make it easier for PwD to access AP systems.
WP4 will also conduct a series of one-to-one and focus group interviews to capture what needs to be changed for DIYAPS users with lower IT skills. The result will be a set of use cases that will be made available for the benefit of APS developers, both DIY and commercial.
Additionally, this WP will examine whether any social inequalities currently exist in regard to access the required technologies and how these inequalities could be minimised. For this, data from the T1International Out-of-Pocket Expenses survey will be used.
Work Package 5 – Communication and Dissemination:
WP5 is led by Bastian Hauck, PwD and CEO of Dedoc Labs and it will:
(1) spread the word about OPEN to different audiences,
(2) promote the project concept and vision,
(3) ensure technical and scientific dissemination of the project´s results,
(4) raise public awareness of the project’s objectives.
This WP will provide various target groups with information carefully adjusted to their needs. All academic results from this project will be published in open-access journals and on the project´s public dissemination channels. The project and its findings will be presented at various conferences and industry events. A dialogue between the proponents and the critics of DIYAPS is intended at face-to-face interactions. This consortium will ensure that the patient voice remains in the focus.
Any technical innovations emerging or evolving from this project will be shared with the public, including DIYAPS developers. OPEN, focused solely on research, will remain separated from any direct DIYAPS development.
Initial results on clinical and patient-reported outcomes have been presented at several conferences (ATTD 2019, ADA 2019). A study on self-reported clinical outcomes of the paediatric population using DIYAPS has been recently published in JMIR mHealth and uHealth, showing improved glycaemic outcomes across all paediatric age groups.
The OPEN consortium aims to influence decisions in public policy and professional practise. It is planned to have a constant information flow throughout the duration of the project.
DIYAPS represents an important case study in how increasingly informed and connected patients are shaping the direction of technological innovation in diabetes care and, potentially, for other areas of health care. As outlined above, researching this global movement presents unique challenges and opportunities that require moving away from the traditional, top-down scientific investigations and adopt a more cooperative and interactive approach, which is largely driven by PwD themselves.
The OPEN project addresses these challenges, as it is a patient- and user-led research project that brings together an international, interdisciplinary and intersectoral research group combining health care professionals, technical developers, biomedical and social scientists, many of whom live with diabetes and are active DIYAPS users. The OPEN consortium is ready to use their variety of expertise in combination with prioritization and knowledge of patients´ needs within this project, which, to the best of our knowledge, has not yet been investigated by other research projects.
The OPEN consortium is aware of potential limitations and challenges of this project, for example using user-provided data may be seen as a problematic approach. But it is precisely this aspect of our methodological approach that has the potential to make a significant contribution to the existing literature on the effectiveness of APS technology. This is the first study based on reliable, user-provided data from all three DIYAPS (OpenAPS, AndroidAPS and Loop) in real-world settings, and it will be an important extension to the clinically led research studies on this subject.
Moreover, the OPEN team will evaluate and openly share both, positive and negative forms of evidence related to DIYAPS.
(If you want to read the full article, please find the original publication at JMIR Res Protoc here.)