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Cited by 200Pancreatic function and diabetesDiabetes Management and ResearchDiabetes and associated disorders

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Islet transplantation versus insulin therapy in patients with type 1 diabetes with severe hypoglycaemia or poorly controlled glycaemia after kidney transplantation (TRIMECO): a multicentre, randomised controlled trial

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Lablanche, Sandrine, Vantyghem, Marie-Christine, Kessler, Laurence, Wojtusciszyn, Anne, Borot, Sophie, Thivolet, Charles, Girerd, Sophie, Bosco, Domenico, Bosson, Jean-Luc, Colin, Cyrille, Tetaz, Rachel, Logerot, Sophie, Kerr-Conte, Julie, Renard, Eric, Penfornis, Alfred, Morelon, Emmanuel, Buron, Fanny, Skaare, Kristina, Grguric, Gwen, Camillo-Brault, Coralie, Egelhofer, Harald, Benomar, Kanza, Badet, Lionel, Berney, Thierry, Pattou, François, Benhamou, Pierre-Yves, Malvezzi, Paolo, Tauveron, Igor, Roche, Béatrice, Noel, Christian, Frimat, Luc, Guerci, Bruno, Pernin, Nadine, Moisan, Anaick, Persoons, Virginie, Ezzouaoui, Rimed, Gmyr, Valery, Thony, Frédéric, Bricault, Yvan, Rodière, Mathieu, Sengel, Christian, Greget, Michel, Enescu, Iulian, Noel, Christian, Hazzan, Marc, Caiazzo, Robert, Torres, Fanelly, Le Mapihan, Kristel, Raverdy, Violetta, Pierredon, Marie-Ange, Valette, Pierre-Jean, Muller, Arnaud, Champagnac, Jean, Chaillous, Lucy, Dantal, Jacques, Cattan, Pierre, Riveline, Jean-Pierre, Moreau, François, Baltzinger, Philippe, Bahoune, Thibault·2018·The Lancet Diabetes & Endocrinology
DOI 10.1016/s2213-8587(18)30078-0
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Abstract

Background Islet transplantation is indicated for patients with type 1 diabetes with severe hypoglycaemia or after kidney transplantation. We did a randomised trial to assess the efficacy and safety of islet transplantation compared with insulin therapy in these patients. Methods In this multicentre, open-label, randomised controlled trial, we randomly assigned (1:1) patients with type 1 diabetes at 15 university hospitals to receive immediate islet transplantation or intensive insulin therapy (followed by delayed islet transplantation). Eligible patients were aged 18-65 years and had severe hypoglycaemia or hypoglycaemia unawareness, or kidney grafts with poor glycaemic control. We used computer-generated randomisation, stratified by centre and type of patient. Islet recipients were scheduled to receive 11 000 islet equivalents per kg bodyweight in one to three infusions. The primary outcome was proportion of patients with a modified β-score (in which an overall score of 0 was not allocated when stimulated C-peptide was negative) of 6 or higher at 6 months after first islet infusion in the immediate transplantation group or 6 months after randomisation in the insulin group. The primary analysis included all patients who received the allocated intervention; safety was assessed in all patients who received islet infusions. This trial is registered with ClinicalTrials.gov, number NCT01148680, and is completed. Findings Between July 8, 2010, and July 29, 2013, 50 patients were r…

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  • Islet and pancreas transplants have not been compared with hybrid closed-loop technology in large long-term studies.

    “However, these approaches have not been compared with the newer systems of hybrid closed-loop technology, which might render immunosuppression requiring therapies less necessary, in large long-term studies (243).”

    From The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021) · cites this paper as [243]

  • Controlled trials and follow-up of recipients in major centres showed that high rates of insulin independence can be reached, and long duration of graft function is also seen.

    “Controlled trials 62,63 and followup of recipients 64,65 in major centres showed that high rates of insulin independence can be reached, and long duration of graft function is also seen; however,”

    From The future of type 1 diabetes therapy (2025) · cites this paper as [63]

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References 29 · Cited by 200

Research works printed but not linked: 25

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Metadata

Authors
Lablanche, S., Vantyghem, M.-C., Kessler, L., Wojtusciszyn, A., Borot, S., Thivolet, C., Girerd, S., Bosco, D., Bosson, J.-L., Colin, C., Tetaz, R., Logerot, S., Kerr-Conte, J., Renard, E., Penfornis, A., Morelon, E., Buron, F., Skaare, K., Grguric, G., Camillo-Brault, C., Egelhofer, H., Benomar, K., Badet, L., Berney, T., Pattou, F., Benhamou, P.-Y., Malvezzi, P., Tauveron, I., Roche, B., Noel, C., Frimat, L., Guerci, B., Pernin, N., Moisan, A., Persoons, V., Ezzouaoui, R., Gmyr, V., Thony, F., Bricault, Y., Rodière, M., Sengel, C., Greget, M., Enescu, I., Noel, C., Hazzan, M., Caiazzo, R., Torres, F., Le Mapihan, K., Raverdy, V., Pierredon, M.-A., Valette, P.-J., Muller, A., Champagnac, J., Chaillous, L., Dantal, J., Cattan, P., Riveline, J.-P., Moreau, F., Baltzinger, P., & Bahoune, T.
Affiliations
  • Inserm (FR)
  • Hôpitaux Universitaires de Strasbourg (FR)
  • Centre National de la Recherche Scientifique (FR)
  • Centre Hospitalier Universitaire de Besançon (FR)
  • Université de Lyon (FR)
  • Centre Hospitalier Régional et Universitaire de Nancy (FR)
  • University Hospital of Geneva (CH)
  • Lyon 1 Université (FR)
  • Université Grenoble Alpes (FR)
  • Université Paris-Sud (FR)
  • Centre Hospitalier Universitaire de Grenoble (FR)
Corresponding author
Lablanche, Sandrine
ORCID
Venue
The Lancet Diabetes & Endocrinology
Publisher
Elsevier BV
Published
2018-07
Volume
6
Issue
7
Pages
527-537
ISSN
2213-8587 (ISSN-L)
DOI
10.1016/s2213-8587(18)30078-0
OpenAlex
W2804796774
Cited by
200
References
29
Citations by year
2026: 13 · 2025: 32 · 2024: 19 · 2023: 23 · 2022: 23 · 2021: 34 · 2020: 21 · 2019: 28 · 2018: 5
FWCI
22.86
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet Diabetes & Endocrinology (publishedVersion)
  • PubMed (publishedVersion)
  • Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
  • HAL (submittedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pancreatic function and diabetes
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
type 1 diabetes, kidney transplantation, hypoglycemia, hypoglycemia unawareness, intensive insulin therapy, glycemic control, beta-cell function, C-peptide, post-transplant diabetes mellitus
MeSH terms
Adult, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Quality of Life, Kidney Transplantation, Islets of Langerhans Transplantation, Treatment Outcome

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