Around 350,000 people live with type 1 diabetes in Germany. Their pancreas no longer produces insulin, so they have to regularly monitor their blood sugar (glucose) levels themselves and either take insulin by injection or by pump. It is important for them to keep their glucose levels as close to the target range as possible, otherwise the diabetes will eventually cause damage to blood vessels and organs.
Automated insulin delivery (AID) systems – also known as closed-loop or artificial pancreas systems – make life easier for people with diabetes. A sensor measures glucose levels in tissue every five minutes, and an algorithm uses both this information and data from the insulin pump to calculate changes in glucose levels and then automatically adjusts the insulin dose. Such systems are seen as the future of personalized and precision diabetes care.
We are not waiting!
“The first commercial AID systems are now available and can be prescribed by a doctor,” explains Dr. Katarina Braune, a pediatrician in the Department of Pediatric Endocrinology and Diabetes at Charité – Universitätsmedizin Berlin and a participant and speaker in the BIH Charité Digital Clinician Scientist Program. “But new medical devices usually take a long time to get approved, so they often lag several years behind current technological capabilities. People with diabetes who program and use open-source solutions for automated insulin delivery (AID), a practice that began in 2014, have therefore made their motto ‘#WeAreNotWaiting.’” Along with colleagues, Braune co-leads the EU-funded OPEN project, which is scientifically examining open systems, and is the first author of the consensus statement now being published. The pediatrician not only cares for children and adolescents with diabetes, but has also been living with type 1 diabetes herself since the age of 12 and currently uses an open-source AID system.
An international community of people with type 1 diabetes and their families have developed what are called open-source AID systems. They have added a self-programmed software control algorithm to their existing insulin pumps and glucose sensors. The software algorithm resides on either a smartphone or mini-computer and communicates with the insulin pump via Bluetooth or radio waves. The developers make the software algorithms available open source and free of charge, and also explain how to set up and customize the them. In addition, a steadily growing online community of diabetes patients and their loved ones offers mutual support. Thanks to the large community of users and developers, the systems are always up to date with the latest technology.
Improved quality of life thanks to artificial pancreas
Well over 10,000 children and adults with diabetes worldwide are already using DIY systems and report that their quality of life has improved since they started using an open-source AID system. They sleep better because they are less likely to be woken up by nighttime alarms; they feel better because they are much less likely to experience severe glucose fluctuations; and they keep their glucose levels within the recommended range much more often, which could reduce the risk of secondary diseases. “Initially these were just personal anecdotal reports in social media,” Braune reports. “Hardly any comprehensive scientific studies had been done. We wanted to change that with the OPEN project, which is led by people with diabetes and investigates the #WeAreNotWaiting phenomenon in an interdisciplinary way.” The EU has been funding the OPEN project (www.open-diabetes.eu) since 2019.
No regulatory approval
Everyone who uses an open-source AID system sets it up at their own risk and according to their personal needs, so regulatory authorities have not given official approval. This may be good for users, but healthcare professionals face the difficult question of how to provide medical care to individuals using these non-approved systems. “That prompted us to prepare an international consensus statement with guidelines for healthcare professionals on how they can best support patients,” Braune reports. Some 48 experts in medicine and law from a total of 25 countries contributed to the OPEN project’s consensus statement. The experts also had practical experience with open-source AID systems. The statement provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective, thus providing an international healthcare consensus supporting the implementation of open-source systems in clinical settings, complete with detailed clinical guidance. The consensus statement has already been officially endorsed by nine national and international diabetes organizations (ADCES, CDS, FSDS, DES, DTN, IDF Global, IDF Europe, ISPAD and VDBD).
“We hope that through our OPEN project and the now published guidelines, we can help to eliminate any uncertainties that may still exist about the use of these systems,” Braune hopes. “Because the study’s results prove we are right.”
The complete consensus statement can be found in the January issue of The Lancet Diabetes & Endocrinology under DOI 10.1016/S2213-8587(21)00267-9.