Doyle et al. (1) eloquently set out minimum common requirements for artificial pancreas (AP) trials to accelerate progress in this important field. The authors focus on engineering aspects and glucose outcomes critical to the success of AP technology, but we would like to draw attention to the importance of psychosocial aspects of AP technology. A greater understanding of the “lived experience” is crucial to ensure that technologies develop successfully and are fit to meet the demands of living with diabetes in addition to glycemic control.
Only people with type 1 diabetes know whether they are able to meet the demands of AP technologies long term. Continuous glucose monitors have received mixed reviews from people with diabetes with strong views both for and against (2). Loss of connection, short durability of sensors (particularly during physical activity when there is a tendency for them to fall out), and frequent alarms are all commonly reported downsides. Wearing and interacting with an AP device may appear a reasonable trade-off for euglycemia and reduced risk of diabetes complications, but the visibility of the disease state has already been demonstrated to be a challenge for many insulin pump users, and the addition of a sensor and controller will only add to this burden. It will be especially important during the development of AP systems to understand and manage patient expectations to aid user engagement.
American Diabetes Association clinical practice recommendations emphasize that emotional well-being is an important part of diabetes care and self-management and that psychological and social problems can impair ability to carry out diabetes care tasks and compromise health status, while treatment decisions should be timely and tailored to individual patient preferences (3). The U.K. National Institute for Health and Care Excellence (NICE) guidelines recommend collaborative, patient-centered, individualized care and state that patients value sensitivity to their individuality and the unique way in which each person experiences a condition and its impact on his or her life. NICE further recommends recognition of the individual and for services to be tailored and responsive to his or her specific needs, preferences, and values (4). The National Service Framework aimed to ensure people with diabetes are empowered to enhance their personal control of diabetes management to enable the best possible quality of life (5).
To effectively develop future diabetes technologies that meet these standards, robust and standardized assessment of patient-centered outcomes should be carefully considered in addition to metabolic and engineering outcomes. There are a number of validated, reliable measures to assess psychosocial functioning, well-being, functional health status, and quality of life. Qualitative interviews can elicit more detailed accounts of participants’ experiences and their hopes, expectations, concerns, and fears around living with AP technology.
By focusing on glycemia, we are in danger of developing devices that are not tailored to everyday living for people with diabetes. One size generally fits nobody well. Identifying, assessing, and respecting the experiences of participants in closed-loop clinical trials ensure that the end product provides optimal diabetes control, both in glycemic and quality-of-life terms.
Duality of Interest. N.S.O. has served on advisory panels for Abbott Diabetes Care. M.L.E. has sat on advisory panels for Roche, Medtronic, Cellnovo, and Abbott Diabetes Care; has received speaker fees from Animas, Eli Lilly, Roche, Abbott Diabetes Care, and Novo Nordisk; has stock options in Cellnovo research; and has collaborated with Medtronic, Roche, and Abbott Diabetes Care. R.H. has received speaker honoraria from MiniMed Medtronic, LifeScan, Eli Lilly, B. Braun, and Novo Nordisk; has served on advisory panels for Animas, MiniMed Medtronic, and Eli Lilly; has received license fees from B. Braun and Becton Dickinson, patent applications; and has served as a consultant to Becton Dickinson, B. Braun, Sanofi, and Profil. S.H. has received consultancy fees from Sanofi Aventis, Eli Lilly, and Novo Nordisk and has received speaker fees from Novo Nordisk and Eli Lilly. K.B. sits on the global advisory board for Roche Diagnostics, Roche Insulin Delivery Systems Advisory Board, and LifeScan CHOICE Advisory Board and has received honoraria for presentations and expert advice from Roche, Janssen, Animas, LifeScan, Sanofi, AbbVie, and Novo Nordisk. No other potential conflicts of interest relevant to this article were reported.