In the meantime, we have several newcomers to our OPEN team. First of all, Timothée will introduce himself to you.
Hello, hello, my name is Timothée, I am 28 years old and I have been living with diabetes since more than 14 years.
Together with Katarina Braune I was the European Chair of the Young Leaders in Diabetes Program. This program has been an incredible personal and professional incubator where I also had the chance to meet Shane O’Donnell and Bastian Hauck. All three members… well, roots of the OPEN project.
Until I know if I´m going to choose a loop, I am one of the people with type 1 diabetes that still use pens with different types of insulin and multiple injections per day. I have never been able to solve my internal conflict between the freedom of not constantly wearing a pump versus being without injections. The injections have won so far, let’s see if participating in this team will change my mind or not??!!
Aside from my diabetes-related
story, I grew up in sub-Saharan Africa (Gabon, Congo, Cameroon and others)
until the age of 14, before landing in my ‘country of origin’, Belgium. I have
a BA in Social Care Studies and worked as an educator in an association that
sailed with young people facing different kinds of difficulties – including
T1D. Then, I studied in the UK for my MA in Education (International Education)
and even though this topic is not directly linked to the aims of OPEN, I became
familiar with qualitative methods and research – which OPENed the door to OPEN.
Therefore, I am mainly working on work package 4 – barriers to scale-up.
Nevertheless, after my MA I really wanted to go back and LIVE in Africa. It took me some time to figure out how I wanted to do that. So, I went from internships to small jobs – between Chad, Belgium and Benin – trying to figure out what to do and where to do it. At the beginning of 2018 I decided to quit my job in Belgium and try to build my own project. This led me to try and set up an eco-lodge in northern Benin – and offer motorbike tours in the mountains. I created a company, had the land to start with, but, sadly, there was an attack that resulted in a guide being murdered and two tourists being abducted. The foreseeable consequences of this is a slowdown (massive slowdown) of activities in the touristic sector. I had to put my hopes and dreams in my pocket for a while.
So, I returned to Belgium with a bag full of questions. Research has always been something that I particularly enjoyed doing. Katarina talked to me about the project and secondment. I saw that I could join in two things that I feel passionate about, diabetes and research. In addition, I felt that I could really help and that the working methodology would suit mine. Also, I always kept the idea of a PhD in mind, and coming back to research could be a nice step towards this – even if the topic is still a bit blurry.
I like to travel, read, wander about in unknown places, and comfort myself by telling others that I like running. On some days I am highly social and on others I can be a real hermit. I like deep talking under the sun on a terrace with a beer in my hand. Get lost trying to find my way. The rhythm of the sea.
Finally, please be sure
that I am both honoured and excited to be working in such a project with such
objectives, such methodology, such incredible people AND such a fantastic
Thank you, Tim! We are very happy that with you we have another passionate, skilled, pleasant and humorous person in our team!
People with diabetes (PwD) have the same disease, but they are different, they do different things, they feel differently: Everyone is an individual and that is what makes the world so colourful and bright. Diabetes is only one part of it. But Diabetes is hard to handle because it feels like there is another individual living with us – different, doing different things and feeling differently, even from one day to the next. PwD can use all the help they can get to manage what they did not ask for. Some of them tried to get help from others and from the idea to create something of their own: a DIYAPS, also known as open source loop system, such as OpenAPS, AndroidAPS or Loop (for iOS).
How do people approach these new experiences and how do they deal with them? The stories that reached us via the DIWHY survey were interesting, short, long, funny, heartbreaking, technical – and absolutely unique and inspiring.
Read the first stories we have chosen to give you an idea of why we are looking for more.
Hard to believe that I finally have normal blood glucose levels!
“I always thought that I would never make it, and now I am happy to have my own loop – my own project !! In my 35 years with diabetes, I have never achieved an HbA1c value even close to 6, not even within three pregnancies! For years I suffered from diabulimia* – a vicious cycle I never thought I could break! I did break it – but since I have been looping, I feel that maybe I will not relapse. I guess that is because I do not have these enormous blood sugar fluctuations anymore! To me loop is a miracle – after 35 years I can hardly believe that I finally have normal blood glucose levels – I already have congenital diseases and the fear has been huge. For now, I look forward to the future with ease, and from the bottom of my heart I wish that all people with diabetes have access to and can use this technology. I am currently working as a consultant in an endocrinology department and I feel very sorry for some patients because I cannot simply tell them – look, this is how it could work …. Long story short – I never want to be without a loop again!!!”
female, 49 years old, Germany
* diabulimia, also known as insulin purging, is a severe eating disorder. People with type 1 diabetes reduce the amount of insulin needed, blood sugars rise and calories are released through the urine. This can lead to weight loss, mostly due to loss of water because of dehydration. But without the correct amount of insulin, PwD put themselves at risk for severe hyperglycaemia, diabetic ketoacidosis, long-term complications of diabetes or even death.
Why are commercial solutions not as good as DIY?
“For me Facebook had played a key role in my beloved AndroidAPS*. I have been a person with diabetes for almost 19 years and had been “isolated” in this disease. I had no contact with other people with diabetes and I was managing and controlling my diabetes quite well. A couple of years ago, when I was quite low carb, I developed an interest in this way of managing the disease. This is why I joined a Facebook group for low carb people with diabetes. I learned (and still do) lots and lots of things, including the existence of Nightscout.
Sometime later, after setting up my Nightscout** page and asking in a Nightscout group how to get my pump information in it, I found out about “looping”. I was curious, but I heard something about old pumps and so I didn’t think about it anymore. Not long after that, and also thanks to Facebook, I was invited to an event at a hospital where they were talking about closed loop systems. I was truly impressed, and the best thing was to find out that MY pump, which I had been wearing for years and which was covered by my health care system, was now also loopable.
I went back home, and the first thing I said to my family was: “I am going to set up a DIY artificial pancreas”. And so I did. I was hoping that AndroidAPS would give me a bit of peace of mind and would ease the mental burden and reduce the amount of energy required to manage this disease, and it certainly did.
I have been looping for only 4 months now and I am really grateful to all the people that have worked so hard to develop this amazing technology. Also, I still don’t understand why there are no commercial options as good as DIY. And I don’t want to finish without mentioning the importance that the support groups are having to me – both, in helping to understand and set up the system and in managing everyday life with it. It is absolutely amazing to be connected to so many people who are also looping and to give and get support.”
female, 40 years old, Spain
*AndroidAPS – one of the commonly used DIYAPS **Nightscout – remote monitoring of CGM data and retrospective data analysis and report, widely spread among DIYAPS users
The girl from the field and her spaceship
“November 2015, in some field in Germany 12 years ago I was given the assignment to take care of a sensitive, baby-like thing that is only doing well at temperatures between 19 and 21 degrees Celsius. All the doctors gave me was an umbrella, a flashlight and firewood. Snow is blowing around the baby’s nose, and in the spotlight I can see that the fire has burned it slightly on its feet. Too bad that I cannot use air conditioning. Suddenly the whole field is flooded by the light of a UFO. The UFO lands, like in some silly science fiction movie. Right next to me, doors open, effect fog, and Rainer* comes out in his space suit. “Wanna come along? You can build a UFO yourself. Do-it-yourself. Hashtag: We are not waiting.”
November 2018, just before diving into the atmosphere of reality Everything is quiet, a few lights are blinking softly. 20 degrees Celsius. I’ve been up half the night making my UFO, which I will soon be able to control with my phone. Soon I will have to go to work on Earth. I managed to build my first UFO by myself. Yes, me, the girl from the field. Of course, Rainer*, who works down in the engine room of the UFO fleet, always sent me the right links. Apart from Olaf* from the next deck, I have never met anyone in person on this big spaceship in the last two years, but knowing that Scotty* and Nana* are in the cockpit would always give me security. Neither can I solder nor read this “white cryptic on black ground” language, and my spaceship isn’t that beautiful, but it manages to fly. Automatically. With lighting …. better than air conditioning.
Yesterday, in the canteen I looked around: We have become a very colourful bunch: international developers and girls like me, fathers with toddlers, brothers and husbands, real heroines, invisible warriors and a whole support group. All cyborgs. Everyone with a homemade little spaceship. An amazing fleet. Just before I immerse into the atmosphere of reality, I look through the curtains back to earth. Everywhere I see people with small umbrellas, matches and lighters waving their flags in the fields. We turn on the lights.”
female, 40 years old, Germany
*fictitious names given by the author
Why not use only one device to manage my BG?
Handling a variety of devices for therapy has given me the desire to handle everything on one device that I always have with me anyway: my phone. The technology had been able to make connections between all possible devices via Bluetooth, Zigbee or other protocols for at least 5 years and my pump is also able to communicate via Bluetooth with the control device. So I wondered why it was necessary to walk around with so many devices, if all this could be done by one. The reason for that is clear to me: manufacturers are not interested in whether their equipment can be combined with that of other manufacturers because that reduces their profit.
I’ve searched the market for a long time to see if there’s anything useful, but I found absolutely nothing. My diabetes educator then gave me a hint that there are groups that deal with such a thing. It was a very vague clue because she had to protect herself for legal reasons. But she knew me long and well enough to know that I’m not technically inexperienced and that I can look at new techniques, procedures and tests relatively impartially. In addition, she had already seen that I had written my own evaluation software for my data and the preparation of the required reports.
I’m really grateful for that. Because of this little hint, I found #WeAreNotWaiting instructions on how to bring my diabetes data in the cloud and transform a FGM into a real CGM. It was still associated with various difficulties, because I had to try different things and also made some investments. I needed a new smartphone because my old one could not handle the continuous load of the Bluetooth connection. I needed a smartwatch that I had to attach to the sensor to constantly read the values. I needed something to protect the sensor from being accidentally pulled out, but holding it tight enough to reliably receive the values. Also I “needed” a smartwatch for the wrist, so I didn’t have to take my phone out of my pocket every time. “Needed” is quoted in this case because I could have done without it, but I like to make life as easy as possible – even if that costs me a lot. I worked pretty well with this system for a while, but that was only the first step.
After a few weeks, I received another hint that the connection to my pump had already been reached via the mobile phone. I researched the internet again and found AndroidAPS, which was suitable for it. After some initial difficulties, I managed to play this application on the phone, connect to the pump and the sensor, and in the course of a few weeks to achieve a closed loop.
My sensor´s data now is retrieved every 5 minutes from the AndroidAPS app and according to these values, the pump is controlled so that my sugar level is approximately at the set target value. This system works very well as long as all parts cooperate. It may be natural that the pump disconnects, the mobile phone or the sensor dies – such a system has a lot of interfaces and interfaces always hold the possibility of problems. But it’s a system that I trust a lot because I know how it works. That is not the case with a commercial system of which I am a customer. Because these devices are black boxes, whose innermost is a corporate secret and in which one relies on the fact that everything comes from one source. And this hand collects according to its monopoly position.
However, DIYAPS is completely open, the calculation bases can (and sometimes even have to) be understood by the user and the setting is completely in the hand in which it belongs: the hand of the person with diabetes. People with diabetes are responsible for their lives. They always have been. This does not change with open source loop systems. It only becomes clearer to many. The diabetologist, the diabetes educator and the medical professionals are not crucial for people with diabetes in everyday life. It only matters what they know by themselves, what they use and how they can help themselves. DIYAPS requires people with diabetes to do exactly the same: take self-responsibility for their therapy. And I think that’s a very good thing.
The attention for the important factors (basal rate, carb ratios, ISF) is trained very strongly in the course of setting up a DIY APS. And not from the outside, but from the inside. You have it in your own hands. I always find that very important. Also from the psychological point of view, because then you are safer in everyday life. There is a lot of discussion in the forums. And there are always requests for help, and to that I always reply: read the documentation (usually with list of sources) and understand what you do. That too, I find very positive.
“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 effectiveand 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 itnot 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 theexpertise, 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 groupswith 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.)