Health Economic Analysis of Islet Cell Transplantation for the Stabilization of the Severe Forms of Type 1 Diabetes
NCT ID: NCT02854696
Last Updated: 2022-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
42 participants
INTERVENTIONAL
2016-07-07
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Islet graft
Patients who receive islet graft Intervention : Procedure/Surgery
Islet graft
Patients will be transplanted with pancreatic islet cells
Best medical care
Patients who continue their optimal medical treatment (insulin pump therapy coupled with real time continuous glucose monitoring) Intervention : insulin treatment
best medical care
Patients will continue their insulin treatment
Interventions
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Islet graft
Patients will be transplanted with pancreatic islet cells
best medical care
Patients will continue their insulin treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with brittle type 1 diabetes despite an optimized insulin treatment and educational training will be included. A patient will be considered as experiencing a brittle type 1 diabetes if at least two criteria are present among: persistence of severe hypoglycemia, occurrence of ketoacidosis events without obvious etiology, diagnosis of unaware hypoglycemic episodes \< 3 mmol/l based on CGM or self-monitoring blood glucose data, a mean blood glucose standard deviation\>50%, MAGE index (Mean amplitude of glucose excursions)\>60 mg/dl, LBGI index (low blood glucose index)\>5, Clarke score≥4 or HYPOSCORE\>800.
* Insulin needs \< 0,85 U/kg/day
* HbA1c \< 12% ;
* No residual insulin secretion (plasmatic basal and stimulated C-peptide \< 0.3 ng/ml)
* Social Security membership or benefit from Social Security
* Patients who signed the consent form
Exclusion Criteria
* Evolutive proliferative retinopathy, evolutive nephropathy (Glomerular filtration rate \<30 ml/min/1.73m2 and/or proteinuria \>0.5g/day), evolutive cardiopathy or obliterative arteriopathy with trophic cutaneous lesions.
* Hemoglobin \< 110mg/dL in women and \< 120 mg/dL in men, leuconeutropenia, thrombopenia, systemic infection including chronic hepatitis B, C and VIH, neoplasia disease and hypertension\>160/100 mmHg.
* Corticoid treatment (except for patient that benefited from a kidney graft with maintenance steroid therapy)
* Presence of anti-HLA antibody directed against the donor
* Positive B or T cells crossmatch
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Pierre-Yves BENHAMOU, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital of Besançon
Besançon, , France
university hospital of Clermont Ferrand
Clermont-Ferrand, , France
Grenoble University Hospital
Grenoble, , France
University hospital of Lille
Lille, , France
University Hospital of Lyon
Lyon, , France
University Hospital of Montpellier
Montpellier, , France
University hospital of Nancy
Nancy, , France
university hospital of Nantes
Nantes, , France
APHP
Paris, , France
University hospital of Strasbourg
Strasbourg, , France
University Hospital of Geneva
Geneva, , Switzerland
Countries
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References
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Barton FB, Rickels MR, Alejandro R, Hering BJ, Wease S, Naziruddin B, Oberholzer J, Odorico JS, Garfinkel MR, Levy M, Pattou F, Berney T, Secchi A, Messinger S, Senior PA, Maffi P, Posselt A, Stock PG, Kaufman DB, Luo X, Kandeel F, Cagliero E, Turgeon NA, Witkowski P, Naji A, O'Connell PJ, Greenbaum C, Kudva YC, Brayman KL, Aull MJ, Larsen C, Kay TW, Fernandez LA, Vantyghem MC, Bellin M, Shapiro AM. Improvement in outcomes of clinical islet transplantation: 1999-2010. Diabetes Care. 2012 Jul;35(7):1436-45. doi: 10.2337/dc12-0063.
Beckwith J, Nyman JA, Flanagan B, Schrover R, Schuurman HJ. A health economic analysis of clinical islet transplantation. Clin Transplant. 2012 Jan-Feb;26(1):23-33. doi: 10.1111/j.1399-0012.2011.01411.x. Epub 2011 Feb 16.
Bellin MD, Kandaswamy R, Parkey J, Zhang HJ, Liu B, Ihm SH, Ansite JD, Witson J, Bansal-Pakala P, Balamurugan AN, Papas KK, Sutherland DE, Moran A, Hering BJ. Prolonged insulin independence after islet allotransplants in recipients with type 1 diabetes. Am J Transplant. 2008 Nov;8(11):2463-70. doi: 10.1111/j.1600-6143.2008.02404.x. Epub 2008 Sep 19.
Badet L, Benhamou PY, Wojtusciszyn A, Baertschiger R, Milliat-Guittard L, Kessler L, Penfornis A, Thivolet C, Renard E, Bosco D, Morel P, Morelon E, Bayle F, Colin C, Berney T; GRAGIL Group. Expectations and strategies regarding islet transplantation: metabolic data from the GRAGIL 2 trial. Transplantation. 2007 Jul 15;84(1):89-96. doi: 10.1097/01.tp.0000268511.64428.d8.
Lablanche S, David-Tchouda S, Margier J, Schir E, Wojtusciszyn A, Borot S, Kessler L, Morelon E, Thivolet C, Pattou F, Vantyghem MC, Berney T, Benhamou PY. Randomised, prospective, medico-economic nationwide French study of islet transplantation in patients with severely unstable type 1 diabetes: the STABILOT study protocol. BMJ Open. 2017 Feb 20;7(2):e013434. doi: 10.1136/bmjopen-2016-013434.
Other Identifiers
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38RC14.453
Identifier Type: -
Identifier Source: org_study_id
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