Evidence map›Paper›PMID 29528967›Full record

GuidelineTransplantation2018

Defining Outcomes for β-cell Replacement Therapy in the Treatment of Diabetes: A Consensus Report on the Igls Criteria From the IPITA/EPITA Opinion Leaders Workshop.

Michael R Rickels, Peter G Stock, Eelco J P de Koning, Lorenzo Piemonti, Johann Pratschke, Rodolfo Alejandro, Melena D Bellin, Thierry Berney, Pratik Choudhary, Paul R Johnson and 16 more

Registry-linked trialOpen access · greenAbstract readConsensus StatementPractice GuidelineReview
In one paragraph

Guideline in Transplantation, 2018. 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, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
11.4field-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, 1 synthesis or guideline pooled it, 93 citations in OpenAlex.

  1. First world consensus conference on pancreas transplantation: Part I-Methods and results of literature search.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Comparative Analysis of Islet Auto-Transplantation Outcome Classification Systems: Evaluating Concordance, Feasibility, and a Data-Driven Approach.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Article
  11. Article
  12. Article
  13. Observational
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Observational
  20. Islets-on-Chip: A Tool for Real-Time Assessment of Islet Function Prior to Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 16 institutions in 8 countries.

Michael R RickelsDivision of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Institute for Diabetes, Obesity and Metabolism, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Peter G StockDivision of Transplantation, Department of Surgery, University of California at San Francisco, San Francisco, CA.
Eelco J P de KoningDepartment of Medicine, Leiden University Medical Center, Leiden, The Netherlands.
Lorenzo PiemontiDiabetes Research Institute, San Raffaele Scientific Institute, Milan, Italy.
Johann PratschkeDepartment of Surgery, Charité Medical School Berlin, Berlin, Germany.
Rodolfo AlejandroDivision of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.
Melena D BellinDivision of Endocrinology, Department of Pediatrics, and the Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
Thierry BerneyDivision of Transplantation and Visceral Surgery, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Pratik ChoudharyDiabetes Research Group, King's College London, London, United Kingdom.
Paul R JohnsonNuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
Raja KandaswamyDivision of Transplantation, Department of Surgery, and the Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
Thomas W H KayDepartment of Medicine, St. Vincent's Hospital, and St. Vincent's Institute of Medical Research, University of Melbourne, Melbourne, Victoria, Australia.
Bart KeymeulenDiabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium.
Yogish C KudvaDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
Esther LatresJuvenile Diabetes Research Foundation International, New York, NY.
Robert M LangerOrdensklinikum Elisabethinin Hospital, Linz, Austria.
Roger LehmannDepartment of Endocrinology and Diabetology, University Hospital Zurich, Zurich, Switzerland.
Barbara LudwigDivision of Endocrinology and Diabetes, Department of Medicine III, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany.
James F MarkmannDivision of Transplantation, Department of Surgery, Massachusetts General Hospital, Boston, MA.
Marjana MarinacJuvenile Diabetes Research Foundation International, New York, NY.
Jon S OdoricoDivision of Transplantation, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI.
François PattouDepartment of General and Endocrine Surgery, Centre Hospitalier Universitaire de Lille, and Inserm, Université de Lille, Lille, France.
Peter A SeniorDivision of Endocrinology and Metabolism, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
James A M ShawInstitute of Transplantation, The Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom.
Marie-Christine VantyghemDepartment of Endocrinology, Diabetology and Metabolism, Centre Hospitalier Universitaire de Lille, and Inserm, Université de Lille, Lille, France.
Steven WhiteInstitute of Transplantation, The Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom.
Breakthrough T1D · USFreeman Hospital · GBKing's College London · GBKrankenhaus der Elisabethinen · ATLeiden University Medical Center · NLMassachusetts General Hospital · USMayo Clinic in Arizona · USNewcastle University · GBSt Vincents Institute of Medical Research · AUUniversity Hospital of Geneva · CHUniversity Hospital of Zurich · CHUniversity of Alberta · CAUniversity of California, San Francisco · USUniversity of Oxford · GBUniversity of Wisconsin–Madison · USVrije Universiteit Brussel · BE

Funding

Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) TrialUC4DK108483 · NIDDK · UNIVERSITY OF VIRGINIA · PI ANDERSON, STACEY, DOYLE, FRANCIS J · 2016 to 2016
$12.7M
B-Lymphocyte Immunotherapy in Islet TransplantationU01DK070430 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI NAJI, ALI · 2004 to 2011
$10.1M
Evaluation of the entero-insular (incretin) axis in cystic fibrosis-competitive renewal.R01DK097830 · NIDDK · CHILDREN'S HOSP OF PHILADELPHIA · PI KELLY, ANDREA BRIDGET, RICKELS, MICHAEL R · 2012 to 2024
$5.7M
Glucose Counterregulation in Long Standing Type 1 DiabetesR01DK091331 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI RICKELS, MICHAEL R · 2011 to 2020
$3.8M
NIDDK NIH HHS R01 DK091331NIDDK NIH HHS R01 DK097830NIDDK NIH HHS U01 DK070430NIDDK NIH HHS UC4 DK108483
6 · The paper itself

Abstract

β-cell replacement therapy, available currently as pancreas or islet transplantation, has developed without a clear definition of graft functional and clinical outcomes. The International Pancreas and Islet Transplant Association and European Pancreas and Islet Transplantation Association held a workshop to develop consensus for an International Pancreas and Islet Transplant Association and European Pancreas and Islet Transplant Association Statement on the definition of function and failure of current and future forms of β-cell replacement therapy. There was consensus that β-cell replacement therapy could be considered as a treatment for β-cell failure, regardless of etiology and without requiring undetectable C-peptide, accompanied by glycemic instability with either problematic hypoglycemia or hyperglycemia. Glycemic control should be assessed at a minimum by glycated hemoglobin (HbA1c) and the occurrence of severe hypoglycemia. Optimal β-cell graft function is defined by near-normal glycemic control (HbA1c ≤6.5% [48 mmol/mol]) without severe hypoglycemia or requirement for insulin or other antihyperglycemic therapy, and with an increase over pretransplant measurement of C-peptide. Good β-cell graft function requires HbA1c less than 7.0% (53 mmol/mol) without severe hypoglycemia and with a significant (>50%) reduction in insulin requirements and restoration of clinically significant C-peptide production. Marginal β-cell graft function is defined by failure to achieve HbA1c less than 7.0% (53 mmol/mol), the occurrence of any severe hypoglycemia, or less than 50% reduction in insulin requirements when there is restoration of clinically significant C-peptide production documented by improvement in hypoglycemia awareness/severity, or glycemic variability/lability. A failed β-cell graft is defined by the absence of any evidence for clinically significant C-peptide production. Optimal and good function are considered successful clinical outcomes.

Indexed as

BiomarkersBlood GlucoseConsensusC-PeptideDiabetes MellitusGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin-Secreting CellsIslets of Langerhans TransplantationRisk FactorsTreatment OutcomeBiomarkersBlood GlucoseC-PeptideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic Agents

Identifiers

PMID29528967
PMCPMC6408213
OpenAlexW2794349436

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.