Improvement in outcomes of clinical islet transplantation: 1999-2010.
OBJECTIVE
To describe trends of primary efficacy and safety outcomes of islet transplantation in type 1 diabetes recipients with severe hypoglycemia from the Collaborative Islet Transplant Registry (CITR) from 1999 to 2010.


METHODS
A total of 677 islet transplant-alone or islet-after-kidney recipients with type 1 diabetes in the CITR were analyzed for five primary efficacy outcomes and overall safety to identify any differences by early (1999-2002), mid (2003-2006), or recent (2007-2010) transplant era based on annual follow-up to 5 years.


RESULTS
Insulin independence at 3 years after transplant improved from 27% in the early era (1999-2002, n = 214) to 37% in the mid (2003-2006, n = 255) and to 44% in the most recent era (2007-2010, n = 208; P = 0.006 for years-by-era; P = 0.01 for era alone). C-peptide ≥0.3 ng/mL, indicative of islet graft function, was retained longer in the most recent era (P < 0.001). Reduction of HbA(1c) and resolution of severe hypoglycemia exhibited enduring long-term effects. Fasting blood glucose stabilization also showed improvements in the most recent era. There were also modest reductions in the occurrence of adverse events. The islet reinfusion rate was lower: 48% by 1 year in 2007-2010 vs. 60-65% in 1999-2006 (P < 0.01). Recipients that ever achieved insulin-independence experienced longer duration of islet graft function (P < 0.001).


CONCLUSIONS
The CITR shows improvement in primary efficacy and safety outcomes of islet transplantation in recipients who received transplants in 2007-2010 compared with those in 1999-2006, with fewer islet infusions and adverse events per recipient.
The EMMES Corporation, Rockville, MD, USA. fbarton@emmes.com
Franca B
FB
Barton
Michael R
MR
Rickels
Rodolfo
R
Alejandro
Bernhard J
BJ
Hering
Stephen
S
Wease
Bashoo
B
Naziruddin
Jose
J
Oberholzer
Jon S
JS
Odorico
Marc R
MR
Garfinkel
Marlon
M
Levy
Francois
F
Pattou
Thierry
T
Berney
Antonio
A
Secchi
Shari
S
Messinger
Peter A
PA
Senior
Paola
P
Maffi
Andrew
A
Posselt
Peter G
PG
Stock
Dixon B
DB
Kaufman
Xunrong
X
Luo
Fouad
F
Kandeel
Enrico
E
Cagliero
Nicole A
NA
Turgeon
Piotr
P
Witkowski
Ali
A
Naji
Philip J
PJ
O'Connell
Carla
C
Greenbaum
Yogish C
YC
Kudva
Kenneth L
KL
Brayman
Meredith J
MJ
Aull
Christian
C
Larsen
Tom W H
TW
Kay
Luis A
LA
Fernandez
Marie-Christine
MC
Vantyghem
Melena
M
Bellin
A M James
AM
Shapiro
D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D002096:C-Peptide / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D016381:Islets of Langerhans Transplantation / Q000009:adverse effects; D008875:Middle Aged; D012042:Registries; D016896:Treatment Outcome
D001786:Blood Glucose; D002096:C-Peptide; D006442:Glycated Hemoglobin