The OPEN team invites you to take part in a global study that examines the impact of Do-It-Yourself Artificial Pancreas Systems (DIYAPS) on the health and well-being of users. The following information explains what to expect if you choose to take part in the research. Please read it carefully. If you do not understand some of the information and/or would like to discuss anything related to the project, feel free to contact a member of our research team (see below).
Name of Study
OPEN (Outcomes of Patients’ Evidence with Novel, Do-it-Yourself Artificial Pancreas Technology)
Name of Principal Investigator
Dr Shane O’Donnell
What is this research about?
A growing number of people living with diabetes are choosing to build DIYAPS to help with the management of their condition. However, more research is needed to understand if and how people living with diabetes benefit from using these systems. This study has three main aims:
- to examine the clinical and quality of life outcomes of DIYAPS users
- to identify potential technical improvements that could be made to artificial pancreas technology of all kinds
- to investigate how more people can benefit from the innovations being developed by the DIY community
Why is OPEN doing this research?
Through our research, we are building evidence concerning the effectiveness of DIYAPS as well as investigating potential technological improvements. Our aim is to spread awareness and improve the quality of DIYAPS.
Why am I being invited to take part?
You are being invited to take part because you are a DIYAPS user.
What will happen if I decide to take part in this research study?
If you agree to take part, you will be first given a unique participant ID which will guarantee your anonymity in the survey. The ID allows you to take a break and come back where you have left off at a later stage or login on another device and continue from there. Therefore, please keep it safe by noting it down, e-mailing it to yourself or taking a picture of it as you may need it later.
You will then be asked to complete some questionnaires. Altogether, it should not take you more than 15 minutes. These questionnaires will focus on:
- your demographic information
- information about your health and diabetes
- your general experiences of building and maintaining a DIYAPS
To further assist our research, we invite you to become a member of a data repository site called ‘Open Humans’. Open Humans allows people to anonymously donate their health-related data (including device data, e.g. from their glucose monitoring, or Nightscout, etc.) for research purposes. Once you sign up to Open Humans, we invite you to also join our project on the Open Humans platform called ‘OPEN’ (by Shane O'Donnell). This should take you no longer than 2–3 minutes.
Choosing to sign up to Open Humans and joining ‘OPEN’ on Open Humans is optional. You decide what data you would like to share with us (if at all), and whether you would like to participate in any further follow-up studies. Bear in mind that your participation in the OPEN project and future studies will greatly assist us to enhance the existing scientific evidence on DIYAPS.
If you are happy to sign up to the Open Humans platform, instructions on how to connect your existing Open Humans account — or create a new one and connect this — are provided on the OPEN website.
How will the data be used?
The pseudonymized responses to the survey will be analyzed by our team of researchers. If you choose to give OPEN (on Open Humans) access to the device data you can upload to the Open Humans site, we will combine them with your responses to the survey described above to create a more complete picture of the impact of DIYAPS on the lives of people with diabetes. It will also help us to (anonymously) stay “in touch” and inform you about any follow-up studies in the future.
Once the OPEN project is completed your anonymized data will be available to researchers upon request. To protect your privacy, any information that might lead to your identity will be removed from your data set before being accessed by any researchers.
The organizations in the OPEN consortium involved in accessing your data will include:
- University College Dublin, Ireland
- Charité – Universitätsmedizin Berlin, Germany
- Dedoc Labs GmbH, Germany
- Steno Diabetes Center Copenhagen, Denmark
- Copenhagen University, Denmark
- The Australian Centre for Behavioural Research in Diabetes (ACBRD), Australia
How is your privacy protected?
The design of this study is in line with all EU (GDPR), Irish (Data Protection Act, 2018) and UCD (UCD ethics Committee) ethical and data protection regulations. Every precaution will be taken to respect your privacy, in line with the General Data Protection Regulations (GDPR).
As stated above, any information that you share that may potentially inadvertently make you identifiable will be removed — this process is called pseudonymization.
Please note that only adults (aged 18+) who are able to provide consent are allowed to participate.
What are the benefits of taking part in this research study?
There are no direct, material benefits expected from taking part in this study. However, you will be helping to improve the overall scientific knowledge about DIYAPS and its use. As a consequence, your participation and experience may help the diabetes community.
What are the risks of taking part in this research study?
There are no anticipated risks expected from taking part in this study. However, if you do experience any aspect of the study as distressing, you are free to stop participating at any time, without personal consequence. In such circumstances, we recommend contacting your diabetes team, GP/primary care physician or local diabetes organizations who may be able to provide you with psychological and practical support. However, if they are not in a position to provide support, you may find information on the following webpages helpful:
If you choose to provide detailed personal information in a free text field, there is a small chance that you may identify yourself within the questionnaire to OPEN researchers. However, this information will be removed before the data set is shared with the rest of the OPEN research team.
Can I change my mind at any stage and withdraw from the study?
Yes! If you decide to participate and subsequently change your mind, you may withdraw from the study at any time. You may also choose to remove your data from future analyses of the OPEN project. To do so, please contact our research team through the details provided below. You can also have the option to leave the OPEN project on Open Humans at any time and remove any data that you have uploaded to the platform. Please note that in both instances we can only delete your data if you provide your Participant ID from the survey.
How will I find out what happens with this project?
The OPEN team would like you to engage with this project as much as possible. That is why we have developed a website for the OPEN project. On this website, we provide regular updates on the findings of our project, and you may also sign up to our newsletter to receive regular email updates. All the results of our research will be published in a way which will be accessible and free of charge to the public.
If any participant would like to contact a member of the research team for any research-related reason, they can do so via the contact information below. If any questions are not answered in a satisfactory manner, then contact can be made with a Data Protection Officer at UCD, the details of which are also provided below. For general data protection inquiries, please contact the UCD Data Protection office. Finally, if none of the UCD contacts have given a satisfactory response, details on the Data Protection Commission are provided below.
Thank you very much for your time and willingness to help us to research this subject!
The OPEN team
PARTICIPANT CONSENT FORM
I have read this consent form. I understand that I can refuse to participate in this project. I have taken time to think carefully about my decision to participate. I freely consent to share my data with this research project.
By clicking "agree" below, you are e-signing this form and agree to the following:
- I understand the uncertainty and risk of research as stated in this consent form.
- I understand that data I choose to share may be used for any purpose, including research purposes.
- I understand that once I authorize data sharing, data privacy laws might not apply or no longer protect my information.
- I understand that I can withdraw data from the study at any time, but copies of that data that have already been made by other people may remain.