Preferences of Type 1 Diabetic Patients on Devices for Islet Transplantation

Abstract

Transplantation of pancreatic islets within a biomaterial device is currently under investigation in clinical trials for the treatment of patients with type 1 diabetes (T1D). Patients’ preferences on such implants could guide the designs of next-generation implantable devices; however, such information is not currently available. We surveyed the preferences of 482 patients with T1D on the size, shape, visibility, and transplantation site of islet containing implants. More than 83% of participants were willing to receive autologous stem cells, and there was no significant association between implant fabricated by one’s own stem cell with gender ( χ 2 (1, n = 468) = 0.28; P = 0.6) or with age ( χ 2 (4, n = 468) = 2.92; P = 0.6). Preferred location for islet transplantation within devices was under the skin (52.7%). 48.3% preferred microscopic disks, and 32.3% preferred a thin device (like a credit card). Moreover, 58.4% preferred the implant to be as small as possible, 25.4% did not care about visibility, and 16.2% preferred their implants not to be visible. Among female participants, 81% cared about the implant visibility, whereas this number was 64% for male respondents ( χ 2 test (1, n = 468) = 16.34; P < 0.0001). 22% of those younger than 50 years of age and 30% of those older than 50 did not care about the visibility of implant ( χ 2 test (4, n = 468) = 23.69; P < 0.0001). These results suggest that subcutaneous sites and micron-sized devices are preferred choices among patients with T1D who participated in our survey.

Preferred Islet Delivery Device Characteristics and Implantation Strategies of Patients With Type 1 Diabetes

“…The response rate of 43.1% from the diabetes outpatient clinic similar to that of a different survey study amongst patients with diabetes [ 18 ]. The outcomes of our survey will allow researchers to incorporate device preferences of potential recipients at an early stage during device design and development [ 14 ].…”

“…Generating insights in the preferences of future recipients may support a smooth transition from IDD development to acceptance in the clinic. In a previous report, Mohammadi et al were the first to describe patient perspectives on implants for treatment of diabetes [14]. The results from their study indicated that patients with T1D prefer a device to be as small as possible and that a majority of the patients favored subcutaneous implantation.…”

Clinical Translation of Bio-Artificial Pancreas Therapies: Ethical, Legal and Psychosocial Interdisciplinary Considerations and Key Recommendations

“…An online survey study investigated the willingness of Type 1 Diabetes patients in the US to receive a personalized beta-cell replacement therapy as well as their preferences regarding the size, shape, visibility and transplantation site of the therapy. Findings suggested that the aesthetics are of importance to the majority of the patients surveyed [ 46 ]. There is also the implicit relationship between the human donors and recipients to be considered.…”

Developing a morphomics framework to optimize implant site-specific design parameters for islet macroencapsulation devices

“…Device shape significantly affects the distribution of the interfacial forces where higher stress concentrates at sharp angles, curves and edges, have been shown to induce a strong foreign body response [ 13 , 32 ]. A survey of 482 people with T1D investigating their preferences on the size, shape, visibility and transplantation site of islet containing implants showed that 52.7% of people preferred the location to be under the skin and 58.4% preferred the implant to be as small as possible [ 33 ]. Macroencapsulation devices have emerged in various sizes and shapes, with some reaching clinical trials including β-Air by Beta-O 2 Technologies Ltd and PEC-Encap (VC-01) by ViaCyte.…”