Evidence map›Paper›PMID 37105208›Full record

Observational studyThe lancet. Diabetes & endocrinology2023

Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry.

Mikaël Chetboun, Elodie Drumez, Cassandra Ballou, Mehdi Maanaoui, Elizabeth Payne, Franca Barton, Julie Kerr-Conte, Marie-Christine Vantyghem, Lorenzo Piemonti, Michael R Rickels and 3 more

Registry-linked trialOpen access · greenAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in The lancet. Diabetes & endocrinology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07666789 (Efficacy and Safety of Islet Re-transplantation After Failure of Beta-cell Replacement), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
18.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07666789 recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy and Safety of Islet Re-transplantation After Failure of Beta-cell Replacement

TypeobservationalSponsorUniversity Hospital, MontpellierRan2025 to 2026Enrolled20ConditionsType 1 Diabetes (T1D), Islets of Langerhans Transplantation
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 57 citations in OpenAlex.

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  14. Cell Therapy for T1D Beyond BLA: Gearing Up Toward Clinical Practice.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 3 countries.

Mikaël ChetbounUniversité Lille, U1190 Translational Research for Diabetes, INSERM, Institut Pasteur de Lille, Lille, France; CHU Lille, Department of General and Endocrine Surgery, Lille, France.
Elodie DrumezCHU Lille, ULR 2694 Évaluation des technologies de santé et des pratiques médicales (METRICS), Lille, France.
Cassandra BallouCollaborative Islet Transplant Registry, The EMMES Company, Rockville, MD, USA.
Mehdi MaanaouiUniversité Lille, U1190 Translational Research for Diabetes, INSERM, Institut Pasteur de Lille, Lille, France; CHU Lille, Department of Nephrology, Lille, France.
Elizabeth PayneCollaborative Islet Transplant Registry, The EMMES Company, Rockville, MD, USA.
Franca BartonCollaborative Islet Transplant Registry, The EMMES Company, Rockville, MD, USA.
Julie Kerr-ConteUniversité Lille, U1190 Translational Research for Diabetes, INSERM, Institut Pasteur de Lille, Lille, France.
Marie-Christine VantyghemUniversité Lille, U1190 Translational Research for Diabetes, INSERM, Institut Pasteur de Lille, Lille, France; CHU Lille, Department of Endocrinology, Diabetology, and Metabolism, Lille, France.
Lorenzo PiemontiDiabetes Research Institute, IRCCS, Ospedale San Raffaele, 20132 Milan, Italy.
Michael R RickelsDivision of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA; Institute for Diabetes, Obesity, and Metabolism, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Julien LabreucheCHU Lille, ULR 2694 Évaluation des technologies de santé et des pratiques médicales (METRICS), Lille, France.
François PattouUniversité Lille, U1190 Translational Research for Diabetes, INSERM, Institut Pasteur de Lille, Lille, France; CHU Lille, Department of General and Endocrine Surgery, Lille, France. Electronic address: francois.pattou@univ-lille.fr.
Collaborative Islet Transplant Registry (CITR) Investigators study group
Centre Hospitalier Universitaire de Lille · FRHospital of the University of Pennsylvania · USInstitut Pasteur de Lille · FRInserm · FREmmes (United States) · USIRCCS Ospedale San Raffaele · ITEvaluation des technologies de santé et des pratiques médicales

Funding

Glucose Counterregulation in Long Standing Type 1 DiabetesR01DK091331 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI RICKELS, MICHAEL R · 2011 to 2020
$3.8M
Data and Statistical Coordinating Center (DSCC) for the Collaborative Islet TransUC4DK098086 · NIDDK · THE EMMES COMPANY, LLC · PI BARTON, FRANCA B · 2012 to 2012
$3.3M
Continuation of The Collaborative Islet Transplantation Registry (CITR)U01DK133709 · NIDDK · THE EMMES COMPANY, LLC · PI Elizabeth Holly Payne · 2022 to 2026
$3.0M
Data and Statistical Coordinating Center (DSCC) for the Collaborative Islet Transplant Registry (CITR)UC4DK114839 · NIDDK · THE EMMES COMPANY, LLC · PI PAYNE, ELIZABETH HOLLY · 2017 to 2017
$2.7M
NIDDK NIH HHS R01 DK091331NIDDK NIH HHS U01 DK133709NIDDK NIH HHS UC4 DK098086NIDDK NIH HHS UC4 DK114839
6 · The paper itself

Abstract

backgroundAllogeneic islet transplantation is a validated therapy in type 1 diabetes; however, there is decline of transplanted islet graft function over time and the mechanisms underlying this decline are unclear. We evaluated the distinct association between primary graft function (PGF) and 5-year islet transplantation outcomes.

methodsIn this retrospective, multicentre, observational cohort study, we enrolled all patients from the Collaborative Islet Transplant Registry who received islet transplantation alone (ITA recipients) or islet-after-kidney transplantation (IAK recipients) between Jan 19, 1999, and July 17, 2020, with a calculable PGF (exposure of interest), measured 28 days after last islet infusion with a validated composite index of islet graft function (BETA-2 score). The primary outcome was cumulative incidence of unsuccessful islet transplantation, defined as an HbA

findingsIn 39 centres worldwide, we enrolled 1210 patients with a calculable PGF (of those without missing data, mean age 47 years [SD 10], 712 [59·5%] were female, and 865 (97·9%) were White), who received a median of 10·8 thousand islet-equivalents per kg of bodyweight (IQR 7·4-13·5). 986 (82·4%) were ITA recipients and 211 (17·6%) were IAK recipients. Of 1210 patients, 452 (37·4%) received a single islet infusion and 758 (62·6%) received multiple islet infusions. Mean PGF was 14·3 (SD 8·8). The 5-year cumulative incidence of unsuccessful islet transplantation was 70·7% (95% CI 67·2-73·9), and was inversely and linearly related to PGF, with an adjusted subhazard ratio (sHR) of 0·77 (95% CI 0·72-0·82) per 5-unit increase of BETA-2 score (p<0·0001). Secondary endpoints were similarly related to PGF. The model-adjusted median C-statistic values of PGF for predicting 5-year cumulative incidences of unsuccessful islet transplantation, graft exhaustion, inadequate glucose control, and exogenous insulin therapy were 0·70 (range 0·69-0·71), 0·76 (0·74-0·77), 0·65 (0·64-0·66), and 0·72 (0·71-0·73), respectively.

interpretationThis global multicentre study reports a linear and independent association between PGF and 5-year clinical outcomes of islet transplantation. The main study limitations are its retrospective design and the absence of analysis of complications.

fundingPublic Health Service Research, National Institutes of Health, Juvenile Diabetes Research Foundation International, Agence National de la Recherche, Fondation de l'Avenir, and Fonds de Dotation Line Renaud-Loulou Gasté.

Indexed as

Diabetes Mellitus, Type 1HypoglycemiaIslets of Langerhans TransplantationBlood GlucoseC-PeptideFemaleGlycated HemoglobinHumansInsulinMaleMiddle AgedRegistriesRetrospective StudiesTransplantation, HomologousTreatment OutcomeBlood GlucoseC-PeptideGlycated HemoglobinInsulin

Identifiers

PMID37105208
PMCPMC10388704
OpenAlexW4366817838

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.