Islet Transplantation vs. Standard of Care for Type 1 Diabetes Complicated by Severe Hypoglycemia from the Collaborative Islet Transplant Registry (CITR) and the T1D Exchange (T1DX) Registry
Year: 2025
Type: other
Abstract: Objective Islet transplantation is recently FDA-approved for adults with type 1 diabetes complicated by recurrent severe hypoglycemia events (SHE). We sought to understand the long-term benefit for glycemic control and risk of immunosuppression to kidney function associated with islet transplantation compared to ongoing standard-of-care. Research Design and Methods We performed a case-control analysis of prospectively collected data from patients in the Collaborative Islet Transplant Registry (CITR) with at least one SHE in the year (2000-2014) prior to transplant (cases) and compared them to patients in the T1D Exchange (T1DX) Registry with at least one SHE in the year (2010-2012) prior to enrollment (controls), with both cohorts followed over 5-years. SHEs were restricted to those resulting in seizure or loss-of-consciousness. Results Cases from CITR (n=71) compared to controls from T1DX (n=213) more often achieved the primary outcome of HbA1c <7.0% and absence of SHE (71–80 vs. 21–33% over 5-years; P <0.001), and the outcome of HbA1c ≤6.5% and absence of SHE (60–75% vs. 10–20%; P <0.001) while requiring significantly less insulin (majority in CITR insulin-independent). Kidney function, measured by estimated glomerular filtration rate, declined from baseline to a greater extent in CITR than in T1DX (-8.8 to -20 vs. -1.3 to -6.5 mL·min-1·1.73 m-2 over 5-years; P <0.001). Conclusions Islet transplantation for adults with type 1 diabetes complicated by SHE results in near-normal glycemic control in the absence of SHE more often than that observed with standard-of-care, but at the cost of greater reduction in kidney function.
Authors: Michael R. Rickels, Cassandra M. Ballou, Nicole C. Foster, Rodolfo Alejandro, David A. Baidal, Melena D. Bellin, Thomas L. Eggerman, Bernhard J. Hering, Fouad Kandeel, Adam Brand, Kellee M. Miller, Franca B. Barton, Elizabeth H. Payne
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4407564898