Ten-Year Outcome of Islet Alone or Islet After Kidney Transplantation in Type 1 Diabetes: A Prospective Parallel-Arm Cohort Study.
Adult
Blood Glucose
/ metabolism
Combined Modality Therapy
Diabetes Mellitus, Type 1
/ blood
Female
Glycated Hemoglobin
/ analysis
Humans
Hypoglycemia
/ epidemiology
Hypoglycemic Agents
/ administration & dosage
Immunosuppression Therapy
/ methods
Insulin
/ administration & dosage
Islets of Langerhans Transplantation
/ adverse effects
Kidney Transplantation
/ adverse effects
Male
Middle Aged
Postoperative Complications
/ epidemiology
Prospective Studies
Treatment Outcome
Journal
Diabetes care
ISSN: 1935-5548
Titre abrégé: Diabetes Care
Pays: United States
ID NLM: 7805975
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
25
02
2019
accepted:
03
08
2019
pubmed:
17
10
2019
medline:
9
7
2020
entrez:
17
10
2019
Statut:
ppublish
Résumé
The long-term outcome of allogenic islet transplantation is unknown. The aim of this study was to evaluate the 10-year outcome of islet transplantation in patients with type 1 diabetes and hypoglycemia unawareness and/or a functioning kidney graft. We enrolled in this prospective parallel-arm cohort study 28 subjects with type 1 diabetes who received islet transplantation either alone (ITA) or after a kidney graft (IAK). Islet transplantation consisted of two or three intraportal infusions of allogenic islets administered within (median [interquartile range]) 68 days (43-92). Immunosuppression was induced with interleukin-2 receptor antibodies and maintained with sirolimus and tacrolimus. The primary outcome was insulin independence with A1C ≤6.5% (48 mmol/mol). Secondary outcomes were patient and graft survival, severe hypoglycemic events (SHEs), metabolic control, and renal function. The primary outcome was met by (Kaplan-Meier estimates [95% CI]) 39% (22-57) and 28% (13-45) of patients 5 and 10 years after islet transplantation, respectively. Graft function persisted in 82% (62-92) and 78% (57-89) of case subjects after 5 and 10 years, respectively, and was associated with improved glucose control, reduced need for exogenous insulin, and a marked decrease of SHEs. ITA and IAK had similar outcomes. Primary graft function, evaluated 1 month after the last islet infusion, was significantly associated with the duration of graft function and insulin independence. Islet transplantation with the Edmonton protocol can provide 10-year markedly improved metabolic control without SHEs in three-quarters of patients with type 1 diabetes, kidney transplanted or not.
Identifiants
pubmed: 31615852
pii: dc19-0401
doi: 10.2337/dc19-0401
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin
0
hemoglobin A1c protein, human
0
Banques de données
ClinicalTrials.gov
['NCT01123187', 'NCT00446264']
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2042-2049Investigateurs
V Averous
(V)
A S Balavoine
(AS)
C Cope
(C)
F Defrance
(F)
F Devemy
(F)
A Derveaux
(A)
C Fermon
(C)
P Fontaine
(P)
C Gillot
(C)
H Hoth Guechot
(H)
L Humbert
(L)
C Lemaire
(C)
C Lepage
(C)
M Lepeut
(M)
R Leroy
(R)
C Loyer
(C)
S Marcelli
(S)
B Mycinski
(B)
F Kohler
(F)
M Kwapich
(M)
M Prudhomme
(M)
A Ryndak
(A)
F Toullet
(F)
A Vambergue
(A)
E Verlet
(E)
D Bertrand
(D)
G Choukroun
(G)
C Colosio
(C)
R Desailloud
(R)
A Durrbach
(A)
M Joubert
(M)
J D Lalau
(JD)
C Lucas-Croisier
(C)
G Prévost
(G)
Y Reznik
(Y)
P Rieu
(P)
B Lukowiak
(B)
S Belaich
(S)
R Ezzouaoui
(R)
Isanga Aluka
(I)
G Pasquetti
(G)
R Hakem
(R)
C Bonner
(C)
E Moerman
(E)
A Coddeville
(A)
A Elledge
(A)
J Thevenet
(J)
A Quenon
(A)
A Lobez
(A)
J Noulette
(J)
E Wasylikow
(E)
S Balik
(S)
D Thuillier
(D)
M Daoudi
(M)
R Connynck
(R)
A S Paranthoen
(AS)
G Lavergne
(G)
Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2019 by the American Diabetes Association.