Abstract
Objectives Islet transplantation is an accepted transplantation method in type I Diabetes Mellitus, yet islet survival is hampered due to an insufficient transplantation site and severe immunological and inflammatory responses. The development of a bio-artificial pancreas (BAP) may contribute to transplanted islet functionality and survival. The objective of this study is to identify the most important transplantation characteristics and to asses patients’ and endocrinologists´ preferences for three potential BAP scenarios in order to guide further development. Methods The current standard of care and characteristics that determine clinical decisions for a particular transplantation method were analysed based on a literature search, semi-structured interviews and focus groups. A decision tree was constructed covering the main attributes effectiveness, patient safety, impact of the treatment for the patient and the required amount of donor material. The analytic hierarchy process was used to obtain the relative weights for each defined attribute in type I DM patients (n=21) and endocrinologists (n=12). Based on these weights, overall preferences for three potential BAP scenarios were calculated and compared to conventional pancreas and islets transplantation. Results The three most important treatment attributes are the effectiveness of the transplant for glucose control, patient safety and the surgical procedure. However, there were considerable differences between patients and endocrinologists in the importance of effectiveness of the transplant (weights were 0.471 and 0.257 respectively) and patient safety (0.331 and 0.423). While considering both endocrinologists’ and patients’ preferences, all three BAP scenarios assessed gained a higher overall preference in comparison to conventional islet transplantation. Conclusions This study indicates the prospects of BAP development. Nevertheless, the study also highlights the discrepancies between endocrinologists’ and type 1 diabetes patients’ preferences. In the future, BAP developers can benefit from this multidisciplinary approach by critically reviewing their BAP design, in view of patient safety and clinical performance
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