The “OPEN” project brings together an international and intersectoral consortium of patient innovators, clinicians, social scientists, computer scientists, and patient advocacy organizations in order to investigate various aspects of Do-it-Yourself Artificial Pancreas Systems (DIYAPS) that are used by an increasing number of people with diabetes.
The OPEN project aims to establish the empirical evidence base for the clinical effectiveness and quality-of-life benefits of DIYAPS and identify the challenges and possible solutions to enable their wider diffusion.
Why #WeAreNotWaiting — Motivations and Self-Reported Outcomes among Users of Open-Source Automated Insulin Delivery Systems: A Multinational Survey
The OPEN consortium published their paper in JMIR on June, 6th, 2021. 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.
In a survey in 2018/19, OPEN wanted to find out the reasons why people choose to use an open-source AID system for themselves or their children with diabetes. This is the first study to systematically analyze motivations for using open-source AID systems and also the largest study to present self-reported clinical outcomes of users across multiple continents.
Background: In the last years, medicine and technology have evolved, including the field of diabetes. And yet, most people living with type-1 diabetes do not achieve HbA1c levels below the recommended 7.0 % (58 mmol/mol). Despite all technology, it still applies: every single day, PwD have to think a lot about the best way to manage their diabetes. This can lead to distress and/or depressive symptoms, as reported by 40 % of PwD. Furthermore, the longer the duration of one’s diabetes, the greater the risk of developing long-term complications.
Nowadays, modern diabetes technology combines sensors f or continuous glucose monitoring and insulin pumps with a control algorithm to automatically adjust insulin delivery based on current and predicted glucose levels. The industry is developing several of these automated insulin delivery systems, also known as artificial pancreas or (hybrid) closed-loop. A few systems are already available in some countries. However, not every PwD has access to — or the financial means for — such a system.
A few years before the commercial systems hit the market, patients and their families have filled the gap. Under the hashtag #WeAreNotWaiting they didn’t only develop loop systems, but also made the software code freely available via open-source platforms. They provided instructions and support for anyone willing to take responsibility to build, maintain, and use their individual system. So, at least most of the time, it is not any longer the PwD who has to make the decisions, but — instead — the algorithm has taken over.
Studies with smaller cohorts of open-source AID users of all age groups show significant improvements in glycemic outcomes and fewer hypoglycemic episodes. Besides that, people feel better: they can sleep through the night with stable glucose values instead of being awakened by CGM alarms, feel less burdened with their diabetes management, report fewer mood swings, and feel powerful and more confident in achieving diabetes management goals.
Conclusions: OPEN found significant improvements in HbA1c and TIR. This suggests considerable biomedical benefits when people with diabetes are using an open-source AID system — independent of age or sex.
The results from the additional reports (free text) show that both, users and caregivers had multifaceted and complex reasons for using an open-source system, depending on individual needs and life circumstances.
Open-source AID systems may play an important role to improve the mental and physical health of people with diabetes and their families. This and previous studies have shown that people using an open-source AID system report a significantly better sleep quality for themselves and people living with them. Studies have shown that poor quality of sleep has negative effects on well-being, mental performance skills, and several hormones affecting the appetite, metabolism, and immune system. Furthermore, recent research indicates that sleep is also a form of regeneration and maintenance for our brain and DNA system.
A wider range of features and adjustable settings may be a benefit for people with diabetes of all ages, as one size does not fit all. The majority of participants expressed concern that commercial therapy options may not meet their needs because they are not as customizable as open-source systems. E.g., for caregivers, the most important difference lay in the possibility of remotely managing their child’s diabetes.
The open-source AID initiative challenges the traditional top-down hierarchies in medicine by providing a way for people with diabetes to empower themselves through personalized technology. For many, peer support within the open-source AID movement was a motivation for engaging with the topic in both cases, providing and asking for support. The number of responses to our survey (1,125) shows the enthusiasm and importance of open-source AID, which has previously been described as having the potential to democratize health care.
This study can help academia, the medical device industry, regulators, health care providers, and diabetes care teams to better address some needs of people with diabetes worldwide.