OPEN

Outcomes of Patients’ Evidence with Novel, Do-it-Yourself Artificial Pancreas Technology

The OPEN project is funded by the European Commision's Horizon 2020 programme and the Berlin Institute of Health (BIH), and investigates "Do-it-Yourself"-/"Open-source" technology for automated insulin delivery in diabetes. OPEN is an international, multidisciplinary consortium led by people with diabetes. Aim of the OPEN project is to translate experienced-based evidence from the patient community to industry and academia, and vice versa.

Motivation

For people with diabetes, modern therapy methods such as sensors for continuous glucose monitoring and insulin pump therapy are available today. However, only a small percentage of people with diabetes actually achieve a glycated hemoglobin (HbA1c) level of <7.0%, as recommended by clinical guidelines.

In closed-loop systems, also called “artificial pancreas systems” (APS) or “automated insulin delivery” (AID) systems, a control algorithm continuously calculates the predicted glucose levels and required insulin needs, and constantly adapts insulin dosing via an insulin pump. The goal of these automated systems is to regulate glucose profiles and insulin needs, that depend on a multitude of factors, more safely, precisely and reliably than with conventional systems, and to facilitate diabetes management in everyday life. However, the commercial development, clinical trials and approval process for AID systems is often complex and time-consuming. Although a large number of AID systems are under development in academic and industrial research, and the first commercial AID systems have recently become available in select countries, they are not universally available, accessible, affordable or individually suitable for all people with diabetes.

Behind the hashtag #WeAreNotWaiting, an online community of people with diabetes and their families has developed their own solution for automated insulin dosing (OpenAPS, AndroidAPS, FreeAPS, Loop). Each user has to build his or her own individual system and use at their own risk. Instructions and code for these systems are freely available via open-source platforms. First observational studies on open-source AID showed significant improvements in glycemic outcomes, quality of life, and sleep quality in users of all age groups, including children and adolescents.

Objectives and approach

The “OPEN” project brings together an international and intersectoral consortium of patient innovators, clinicians, social scientists, computer scientists and patient advocacy organisations in order to investigate various aspects of Do-it-Yourself Artificial Pancreas Systems (DIY APS) that are used by an increasing number of people with diabetes:

Do open-source AID systems have an effect on health and quality of life of the users?
What experiences do users have with this technology, and can these experiences be used to improve future developments in AID technologies?
Can we further improve the predictions and dosing of the algorithms?
Are there any barriers for a further dissemination and use of AID systems (e.g. age, gender, socio-economic status)?
How can diabetes care teams support individuals that choose to use open-source AID?
And, finally, what can industry, academia and other stakeholders learn from the #WeAreNotWaiting movement?

Innovations and perspectives

The OPEN project is the first patient-led interdisciplinary project that is funded by the EU, and the first international research project on open-source technologies in diabetes.

In February 2020, OPEN was awarded the QUEST Award for Patient & Stakeholder Engagement.