Trial reportDiabetes care2009
Primary graft function, metabolic control, and graft survival after islet transplantation.
Trial report in Diabetes care, 2009. 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 51 papers, 2 of them syntheses that pooled 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.
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.
Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression
Randomized Controlled Trial Comparing the Metabolic Efficiency of Allogeneic Pancreatic Islet Transplantation to Intensive Insulin Therapy for the Treatment of Type 1 Diabetes
Who cites it
51 citing papers in PubMed, 2 syntheses or guidelines pooled it, 157 citations in OpenAlex.
- 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.Transplantation · 2018Guideline
- Pancreas Islet Transplantation for Patients With Type 1 Diabetes Mellitus: A Clinical Evidence Review.Ontario health technology assessment series · 2015Pooled it
- Targeting CXCR1/2 Does Not Improve Insulin Secretion After Pancreatic Islet Transplantation: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial in Type 1 Diabetes.Diabetes care · 2020Trial
- 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).The Journal of clinical endocrinology and metabolism · 2012Trial
- March5-mediated Trim28 degradation preserves islet β-cell function in mice.Nature communications · 2025Article
- Tacrolimus and diabetic rodent models.Pharmacological reports : PR · 2025Review
- Current Challenges in Pancreas and Islet Transplantation: A Scoping Review.Biomedicines · 2024Article
- Paired box 6 gene delivery preserves beta cells and improves islet transplantation efficacy.EMBO molecular medicine · 2023Article
- 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.The lancet. Diabetes & endocrinology · 2023Observational
- Extracellular Vesicles: The Future of Diagnosis in Solid Organ Transplantation?International journal of molecular sciences · 2023Review
- Impact of GAD65 and IA2 autoantibodies on islet allograft survival.Frontiers in clinical diabetes and healthcare · 2023Article
- Primary Graft Function and 5 Year Insulin Independence After Pancreas and Islet Transplantation for Type 1 Diabetes: A Retrospective Parallel Cohort Study.Transplant international : official journal of the European Society for Organ Transplantation · 2023Article
- The challenge of HLA donor specific antibodies in the management of pancreatic islet transplantation: an illustrative case-series.Scientific reports · 2022Observational
- 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 · 2022Article
- Estimation of Early Graft Function Using the BETA-2 Score Following Clinical Islet Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022Article
- Restoring normal islet mass and function in type 1 diabetes through regenerative medicine and tissue engineering.The lancet. Diabetes & endocrinology · 2021Review
- The Map3k12 (Dlk)/JNK3 signaling pathway is required for pancreatic beta-cell proliferation during postnatal development.Cellular and molecular life sciences : CMLS · 2021Article
- Amniotic Membrane Extract Protects Islets From Serum-Deprivation Induced Impairments and Improves Islet Transplantation Outcome.Frontiers in endocrinology · 2020Article
- Advances in β-cell replacement therapy for the treatment of type 1 diabetes.Lancet (London, England) · 2019Review
- Islet Transplantation Alone Versus Solitary Pancreas Transplantation: an Outcome-Driven Choice?Current diabetes reports · 2019Review
Corrections and comments
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Authors and funding
12 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
OBJECTIVE To investigate the influence of primary graft function (PGF) on graft survival and metabolic control after islet transplantation with the Edmonton protocol. RESEARCH DESIGN AND METHODS A total of 14 consecutive patients with brittle type 1 diabetes were enrolled in this phase 2 study and received median 12,479 islet equivalents per kilogram of body weight (interquartile range 11,072-15,755) in two or three sequential infusions within 67 days (44-95). PGF was estimated 1 month after the last infusion by the beta-score, a previously validated index (range 0-8) based on insulin or oral treatment requirements, plasma C-peptide, blood glucose, and A1C. Primary outcome was graft survival, defined as insulin independence with A1C < or =6.5%. RESULTS All patients gained insulin independence within 12 days (6-23) after the last infusion. PGF was optimal (beta-score > or =7) in nine patients and suboptimal (beta-score < or =6) in five. At last follow-up, 3.3 years (2.8-4.0) after islet transplantation, eight patients (57%) remained insulin independent with A1C < or =6.5%, including seven patients with optimal PGF (78%) and one with suboptimal PGF (20%) (P = 0.01, log-rank test). Graft survival was not significantly influenced by HLA mismatches or by preexisting islet autoantibodies. A1C, mean glucose, glucose variability (assessed with continuous glucose monitoring system), and glucose tolerance (using an oral glucose tolerance test) were markedly improved when compared with baseline values and were significantly lower in patients with optimal PGF than in those with suboptimal PGF. CONCLUSIONS Optimal PGF was associated with prolonged graft survival and better metabolic control after islet transplantation. This early outcome may represent a valuable end point in future clinical trials.
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What Socratic holds
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.