It's no secret that we're big fans of diabetes technology, from new meters to insulin pumps and real-time data devices and apps. But so often, this D-tech is missing a key piece: the human side, that takes into account how we might feel about that particular device.
One researcher in the United Kingdom has honed in on that, exploring the psychosocial aspect of diabetes and how we need our device-makers to keep our real lives in mind when designing new systems.
Her name is Dr. Katharine Barnard from the University of Southampton, and she's part of a global working group focusing on the "human factors" surrounding closed-loop technology. She was a featured panelist at the Advanced Technologies and Treatments of Diabetes (ATTD) conference in February, talking about this working group made up of leading experts in the psychosocial arena, that's received funding from the Helmsley Charitable Trust.
We had a chance to connect with Dr. Barnard recently by email, and she shared some insights into how the group hopes to help infuse the human side into D-tech more effectively in the future:
DM) Dr. Barnard, can you start by telling us a little about yourself and your research?
KB) I am a health psychologist and I work in different areas of chronic disease management. My research has focused on quality of life aspects of diabetes for children, adolescents, adults and family members. I have a specific interest in the impact of diabetes technologies on people’s everyday experience and how we can minimize the burden of diabetes and maximize quality of life.
To this end, I am an active researcher and alongside leading my own research projects, I collaborate with other experts providing advice on how to incorporate psychosocial assessment into their clinical trials. Also, I am a strong patient advocate and try to influence healthcare and research at different levels, so I am an Expert Adviser to NICE (the National Institute for Health Excellence), I work with various charities, and I also chaired the Diabetes UK Annual Professional Conference last year with over 3,000 delegates from all areas of healthcare, and I provide postgraduate training and education to diabetes specialists in the psychosocial aspects of diabetes management.
What has your research uncovered?
There has been a growing recognition of the importance of the psychosocial side of diabetes management over recent years and it’s exciting to be part of that. My research has shown that if we robustly assess the psychosocial impact of devices and interventions, and use that information to provide appropriate best-practice support and education, we will help people to achieve better medical and quality of life outcomes.
To this end, I have worked a lot with insulin pump therapy, with continuous glucose monitoring and increasingly with Artificial Pancreas systems. By understanding the barriers and facilitators to using devices effectively, we can really support people in using them to meet their needs in the context of their own life.
Tell us more about the formal working group on this topic?
We have established the PsychDT Working Group, which focuses specifically on the psychosocial aspects of diabetes technology, with a specific interest in Artificial Pancreas systems. Professor Korey Hood from Stanford, Professor Lori Laffel from Joslin Diabetes Center and Professor Jill Weissberg-Benchell from Chicago are my co-investigators on the project and we are working with research teams, industry, funders and regulatory approvals bodies.
We held our first workshop at the ATTD conference in Paris in February and will hold our second workshop on the first day of the ADA conference in Boston on June 5th. In Paris, we presented psychosocial and medical perspectives, however in Boston we will be presenting the perspectives of other key stakeholders, including industry, payers and FDA.
What's your mission in adding a psychosocial perspective to the development of AP systems and other diabetes tech?
We know that it is not only disease, but also disease management that has a direct and often negative impact on quality of life. We think it is important to always consider the psychosocial impact of technologies alongside the engineering and biomedical excellence. This really helps us to understand more how easy or otherwise it will be for people to live with the technology and the impact it will have on their everyday living. If the burden is too onerous, then people will simply stop using it. It’s important to know this so that we can ensure devices are developed in a way that minimizes the burden, and that support and education are provided in a way that maximizes the benefits.
But, how exactly? Are we talking about tangible changes like personalizing alarms or offering “fun” designs, to address possible burnout of using a particular device?
Unfortunately it’s not possible for me to comment on those specific features because there are so many factors that impact psychosocial aspects; I have to stick to the evidence base of what we've observed.
OK, how about the concept of adding psychosocial measures as endpoints in clinical trials?
We often add psychosocial measures as secondary endpoints in clinical trials, so for example we will add a validated, reliable quality of life measure alongside the primary endpoint of HbA1c, or we will add a treatment satisfaction or psychosocial functioning measure to gauge how patients feel about the technology.
Why do clinical trials seem to so often focus almost exclusively on A1c results?
It’s not that A1c as a primary outcome is a problem in clinical trials, it is often the most important outcome. The challenge comes when we are specifically focusing on a psychosocial intervention when it would not necessarily be expected that A1c would improve or change, but that quality of life would improve. In that instance, A1c is not the best primary outcome. What is required is a validated, reliable psychosocial measure as primary outcome.
For example, we are developing 5 new questionnaires on AP tech -- one each for children, adolescents, parents, adults and significant others/partners. These measures will really focus in on the experience of users and their expectations, needs and concerns associated with Artificial Pancreas designs.
How receptive have other researchers and industry been to this change?
We have been very impressed. There is a real willingness to collaborate and work together to achieve our common goal of ensuring that devices that are ultimately available for people with diabetes really meet their needs. We are working closely with regulators such as the FDA, funders, industry and the wider research community.
What can we patients do to further this important issue?
We will be holding focus groups, one-on-one interviews and surveys over the next 12 months as we develop the new measures so it would be fantastic if people could get involved in those and give us your views. Ultimately, the purpose of the project is to ensure that Artificial Pancreas systems meet the needs of users in terms of psychosocial outcomes as well as medical. To do that we really need your help to tell us what you need and how we can deliver it. You can reach out to me at @DrKathBarnard or by email here.
Sounds intriguing! We're eager to hear how this moves forward, hopefully getting some more detail at the ADA Scientific Sessions meeting coming up in June.