Evidence map›Paper›PMID 22996144›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2012

Continuous glucose monitoring after islet transplantation in type 1 diabetes: an excellent graft function (β-score greater than 7) Is required to abrogate hyperglycemia, whereas a minimal function is necessary to suppress severe hypoglycemia (β-score greater than 3).

Marie-Christine Vantyghem, Violeta Raverdy, Anne-Sophie Balavoine, Frédérique Defrance, Robert Caiazzo, Laurent Arnalsteen, Valéry Gmyr, Marc Hazzan, Christian Noël, Julie Kerr-Conte and 1 more

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT00446264 phase2completednot on this map

Sequential Islet Transplantation With Steroid Free Immunosuppression for Type 1 Diabetes

TypeinterventionalSponsorUniversity Hospital, LilleRan2003 to 2009Enrolled14ConditionsType 1 Diabetes, Hypoglycemia, Metabolic DiseasesArmsislet transplantation, daclizumab - sirolimus - tacrolimus
NCT01123187 nacompletednot on this map

Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression

TypeinterventionalSponsorUniversity Hospital, LilleRan2003 to 2016Enrolled14ConditionsType 1 Diabetes, Organ Transplantation, ImmunosuppressionArmsislet transplantation
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Allogeneic Islet Transplantation: Chronicle of a Death Foretold?Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Article
  13. Article
  14. Review
  15. Article
  16. 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
  17. Article
  18. Article
  19. The impact of islet mass, number of transplants, and time between transplants on graft function in a national islet transplant program.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022
    Article
  20. 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

11 authors.

Marie-Christine VantyghemEndocrinologie et Métabolisme, hôpital Huriez, Institut National de la Santé et de la Recherche Médicale Unité 859, Centre Hospitalier et Universitaire de Lille, 1 rue Polonovski, F-59045 Lille, France. mc-vantyghem@chru-lille.fr
Violeta Raverdy
Anne-Sophie Balavoine
Frédérique Defrance
Robert Caiazzo
Laurent Arnalsteen
Valéry Gmyr
Marc Hazzan
Christian Noël
Julie Kerr-Conte
Francois Pattou

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextFor the last 10 yr, continuous glucose monitoring (CGM) has brought up new insights into the accuracy of blood glucose analysis.

objectiveOur objective was to determine how islet graft function was able to influence the various components of dysglycemia after islet transplantation (IT). DESIGN AND

settingWe conducted a single-arm open-labeled study with a 3-yr follow-up in a referral center (ClinicalTrial.gov identifiers NCT00446264 and NCT01123187). PATIENTS: Twenty-three consecutive patients with type 1 diabetes (14 islet alone, nine islet after kidney) received IT within 3 months using the Edmonton protocol.

interventionINTERVENTION included 72-h CGM before and 3, 6, 9, 12, 24, and 36 months after transplantation.

main outcome measureGraft function was estimated via β-score, a previously validated index (range 0-8) based on treatment requirements, C-peptide, blood glucose, and glycated hemoglobin.

resultsAt the 3-yr visit, graft function persisted in 19 patients (82%), and 10 (43%) remained insulin independent. Glycated hemoglobin decreased in the whole cohort from 8.3% (7.3-9.0%) at baseline to 6.7% (5.9-7.7%) at 3 yr [median (interquartile range), P < 0.01]. Mean glucose, glucose sd, and time spent with glycemia above 10 mmol/liter (hyperglycemia) and below 3 mmol/liter (hypoglycemia) were significantly lower after IT (P < 0.05 vs. baseline). The four CGM outcomes were related to β-score (P < 0.001). However, partial function (β-score >3) was sufficient to abrogate hypoglycemia; suboptimal function (β-score >5) was necessary to significantly improve mean glucose, glucose sd, and hyperglycemia; and optimal function (β score >7) was necessary to normalize them.

conclusionThe four components of dysglycemia were not equally affected by the degree of islet graft function, which could have important implications for future development of β-cell replacement. A β-score above 3 dramatically reduced the occurrence of hypoglycemia.

Indexed as

Blood Glucose Self-MonitoringAdultBlood GlucoseC-PeptideDiabetes Mellitus, Type 1FemaleFollow-Up StudiesGlycated HemoglobinHumansHyperglycemiaHypoglycemiaIslets of Langerhans TransplantationMaleMiddle AgedTreatment OutcomeBlood GlucoseC-PeptideGlycated Hemoglobin

Identifiers

PMID22996144
PMCPMC3485599

What Socratic holds

Textmetadata
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 Socratic graph.