Our Artificial Pancreas Meetup in Barcelona supported by Hacking Health, Nightscout Foundation, Hospital Universitari Parc Tauli and Stiftung Charité has been a great success! Some people took a long ride just to attend our event and many people hopped over from the EASD (European Association for the Study of Diabetes) Annual Meeting 2019 occupying the room up to the last seat.
Well-chosen speakers and members of the panel with very different backgrounds and thus a variety of presentations, talks and ideas kept the audience focused for six hours. They listened to people with diabetes (PwD) and their friends and families, developers, health care professionals (HCPs), mathematicians, sociologists and more. The audience was very interested and had a very intense dialogue followed up by a panel discussion with different stakeholders from the DIY community, industry and research.
Dana Lewis, founder of OpenAPS, who traveled the long way from the USA, told the fascinating history of the DIYAPS movement. She looked for a way to make her CGM alarms louder, but then, as a non-tech person, dived into the open source community and ended up with OpenAPS, the first DIYAPS, and finally, with plenty of people who all work together sharing the same idea. The OpenAPS algorithm automates what PwD would usually do by themselves, so it helps especially when the person is tired, sleeping, sick, distracted, or simply just busy with everyday life. You only need a tiny computer to utilize the pump's ability to set temporary basal rate in order to keep the glucose values where they belong: in range! Dana´s pictures before and after loop showed the amazing outcome: Before, she had a lot of highs and lows, afterwards, the values were perfectly stable and in range.
Whereas industry has to wait until the product is as perfect as possible, so it can be tested in studies and finally get approved by regulatory bodies, the DIY community came up with a small solution and makes it bigger step by step. Intendedly for safety, the officially approved way unfortunately slows down the process of innovation on the commercial markets in our technically fast-moving society and software supported healthcare. Though, Dana emphasized that the focus at the DIY solutions also is on safety as users have the highest interest in being safe at all times. However, one great advantage of the DIY solutions, is the interoperability and flexibility. PwD do have individual wishes and needs. But Dana made clear that the people of the #WeAreNotWaiting movement are filling a gap at the moment but on the other hand, they are willing to share their knowledge with industry, and already did so, in order to get a variety of commercial closed loops.
Adrian Tappe from Austria, co-developer of AndroidAPS, explained to the attentively listening audience how he, coming from a technical background, got in contact with the DIY community and finally became one of the core developers, first of xDrip (which is an mobile app working as a receiver for several different CGM systems). Later he joined Milos Kozak's work of transferring the OpenAPS algorithm to an Android smartphone in order to use this for calculating the needed amount of insulin. This system, AndroidAPS, makes the open source loop more practicable for many people and, due to the pumps, more available in several countries. Adrian explains how they developed a learning programme for the system which guides users through several steps first to help them get familiar with it and get a stable individualized system. Adrian perfectly visualized his words for the audience's better understanding of the components and user interface of AndroidAPS. Also, he showed how you can use a smartwatch to give a bolus - discreetly. And, the work never ends: The DIY community is constantly working on improvements to automate even more (e.g. during exercise or meals).
Ulrike Thurm, a certified diabetes educator from Germany, intended to be the party pooper (her own expression!), but actually, she emphasized the importance of starting a closed loop with a good knowledge of your diabetes. You should know how to handle your pump and your CGM, you should have tested your basal rate and your - also during the day varying - carb ratios and insulin sensitivity factors, you should know what to do in case one part of the system does not work at the moment, you should know how to adjust your loop during sports or illness. A loop is only as good as the knowledge of its user! She also reminded HCPs not to forget what Michael Berger said 30 years ago, even if it was about glucose measuring and insulin adjustments back then, it's still up-to-date: Every PwD has to be trained so well that they become their own best diabetologist. Nowadays, the best method for some PwD to manage their diabetes is DIYAPS and again, we need brave and open HCPs to step into the future now - together with their patients!
Dr Shane O´Donnell, Ireland, sociologist and post-doctoral researcher, introduced our OPEN project. As you already know our project brings together different people of academic and non-academic institutions. This is in order to share knowledge and give new impulses for the examination of DIY Artificial Pancreas Systems, such as their impact on PwD or challenges of the systems. Also, we have an advisory board with experienced people in diabetic concerns who are willing to help us with their knowledge, especially when it comes to publications in journals. And about our ongoing work: The DIWHY questionnaire reached 1058 PwD from 34 countries at different ages, genders, levels of education and much more. Our data analysts found out about the why, who and how of a DIY system and also, further surveys are planned.
Dr Katarina Braune from Germany, a medical doctor and research fellow, explained on the one hand her personal view on DIYAPS as a user of Loop (for iOS) and on the other hand her view as a doctor: She supports DIYAPS users because the systems are evidence-based, efficient, personalized, free for all, ethical and improving “Patient-Reported Outcomes”. Katarina went into the details of each point and stressed that the systems are designed for safety, but nevertheless, PwD use it at their own risk as a highly experimental way of treating their diabetes. As the systems are not build by companies, users should take in account that there will be no warranty and no customer service. There is a support by other members of the DIY community but it is 100% volunteer work. Also, there are no safety studies - so far, but they are under way:
- for AndroidAPS with DanaRS pump and Dexcom CGM in Prague, CZ, led by Lenka Petruzelkova, and in Europe (CE mark), New Zealand and Korea, and
- for Loop with OmniPod Dash and Dexcom CGM in order to get approval through FDA Fast Track Programme, led by Tidepool, Palo Alto, USA.
Besides that, Katarina showed results of the DIWHY survey where people have been asked why they came up with their own solution. One thing really caught the eye: Open source artificial pancreas systems improve sleep quality. Studies and self-reports show that there is much more: The HbA1c and the time in (target glucose) range improve significantly, people have less hypo- or hyperglycemia, less mood swings, more confidence and more energy. Thus, medical industry and HCPs should learn from the DIY community - for the patients' benefit.
Prof Roman Hovorka, UK, mathematician and professor of metabolic technology, presented his work at the University of Cambridge - an Artificial Pancreas System called CamAPS FX - which he has developed and has been being tested for several years now. It uses a mobile phone to control a pump's insulin delivery in order to keep the glucose levels in range. People in challenging situations, e.g. pregnancy, HbA1c above 8.5%, children using regularly food banks, children from minorities such as refugees, adolescents missing meal boluses, are involved in his study. The results are amazing with a TIR of 95%. He also noted that PwD should not forget that money is needed for the development of medical devices and algorithms if this is your main job.
Prof Klemens Raile, Germany, head of the department of paediatric endocrinology and diabetes Charité university medicine Berlin , raised the question of ethical behaviour for endocrinologists supporting their patients who use a DIYAPS. Klemens reminded that the rape of medical ethics during the times of Nazism led to the WMA Declaration of Geneva. He picked out some parts of the Physician's Pledge and discussed them:
The health and well-being of my patient will be my first consideration.
From a doctor's perspective it is important do ask and evaluate the following questions: Does the used DIYAPS impair and endanger or improve and secure my patient's health, does my patient endanger himself or his child, how could I support my extremely motivated patient?
I will respect the autonomy and dignity of patient.
Is it the patient's own decision to use a DIYAPS? If the patient is a child: Do both parents agree? Does the child understand and follow the parents´ decision? Does the DIY Loop reflect the child's health interests?
I will respect the secrets that are confided in me.
I am not allowed to indicate a looper to any authority, I need to keep any information on the patient´s alternative use of sensors or pumps secret, but critical review is needed in looping of children.
What is needed from Klemens point of view, is a training around new technologies for HCPs but also their protection (legal and reputational) in order to continue to care for those patients who choose to use DIY systems for their personal diabetes management.
And one important note to physicians: The doctor is not allowed to withdraw or restrict access to medical supplies that are needed to use a DIY system if they are required for usual treatment and covered by health insurance. This might destabilize and harm the patient's health.
Before the panel got together to discuss the topics there were three presentations of people with diabetes talking about their life towards and with DIYAPS:
Susana Feans Ponte, Spain, coming from a background in data science, explained how her life differs with Loop. Her HbA1c did not improve very much but the TIR did, she gets more hours of uninterrupted sleep, feels less frustrated to manage her diabetes and she finds it very satisfying to help others in the DIY community. Diabetes is variable at each moment and the DIY systems can cope with that, being individually configurable for different situations. Also, Susana gave an overview about what might encounter you as a DIYAPS user besides learning a lot, running into technical issues and having to ask others for help such as the moments when you want to tell your HCPs about it, when you meet, personally or in social media, professionals who are opposed to DIY, or the scary moment when you are forced to stop looping for whatever reason. She ensured that people with DIYAPS are strong enough to manage all these moments.
Saskia Wolf, Germany, not being a tech-person, talked about her struggle to become an early adopter of OpenAPS and hereby, she showed what people are able to achieve when they really want to. Before she switched to AndroidAPS two years later she had already founded #LooperInBerlin, organized and initiated meetups in many other German cities and spread the word amongst HCPs. Saskia also showed the improvement of her HbA1c, her TIR of > 90% and how the loop works nicely at night preventing her from severe lows. She stressed how diabetes management became more fun because “now it works”, and how she doesn't feel like a burden to family and friends anymore. She said Open Source Looping has changed her life from a depressed couch potato to an energetic patient advocate and - brand new - proud member of the OPEN team. And last but not least she asked her usual question: #We are not waiting - What are you waiting for?
Linzi Knock and her son Jacob, UK, showed how teenage life as a PwD is even more difficult and how Jacob can finally lead a normal life with various sports and huge amounts of carbohydrates or even forgetting a bolus for food - using his DIYAPS. But most important to him is that, since loop, others forget that he is a PwD. Linzi and Jacob showed a video of the moment when he got his loopable pump as a birthday present and many people in the audience were not ashamed of getting tears in their eyes. Standing ovations for this young man and his supportive mother!
Paul Madden, talking out of the audience, stressed the importance of first findings from our DIWHY survey on TIR like sleep, safety and more. And Bastian Hauck, also from the back, reminded that diabetes has always been and always will be DIY.
At the end of our event we had a panel discussion with Dana Lewis, Erik Huneker, CEO at diabeloop, Prof Roman Hovorka, Kyle Rose, Healthcare Innovator, and Renza Scibilia, Diabetes Australia, as moderator. Different stakeholders are getting in touch, discussing or even working together on making life better for PwD. But more efforts are needed to be done, especially the regulatories have to be adapted to a faster progress of technological development. So, think about Katarina´s last question to the panel: What would you wish if a fairy came and granted you one free wish?
The bottom line
Diabetes is a fulltime job - and a hard one. It can interrupt your sleep and give you a hard time during the day. It can be exhausting and make you sick: long-term complications, depressions. - Any help is appreciated!
Automated diabetes works so much better. The outcomes of Open Source Loop System users are amazing. Closed Loops work!
PwD have different needs, ideas and lifestyles, different issues to solve. The reason why DIY APS works so perfectly for so many people is the fact that every single individual can customize and individualize its own system just as it is needed. PwD want and need interoperability and flexibility. Diabetes devices should be made with or even from PwD as they are the ones dealing with the disease all day and night for the rest of their lives and they know exactly what they need.