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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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Insulin allergy (IA) is still observed even with recombinant human insulin and insulin analogs.
Obviously, the usual attitude facing an allergy, i. e. exclusion of the allergen, poses problems in face of IA because insulin is often vital for the patient. IA is thus a complex situation in which a rigorous diagnostic procedure to identify the exact allergen is necessary to propose a therapeutic answer; the purpose of the study is 1/ to validate a diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA.
Phenotype of the patient Investigation of allergy per intradermal testing using a wide range of insulin preparations Determination of immunologic and immunogenetic profile particularly CD4 + T cells and mast cells
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Allergy tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergy tests | Procedure | 1/ to validate a diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of cutaneous insulin tests | Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion. | after 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenetic of patients with IA (Insulin Allergy) | Immunogenetic of patients with IA (Insulin Allergy) at study completion Determination of insulin epitopes that are involved in IA at study completion Determination of isotypes of anti insulin antibodies and whether specific isotypes are associated with susceptibility / protection at study completion | after 36 months |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Sola-Gazagnes, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Paris | 75005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14514615 | Background | Sola-Gazagnes A, Pecquet C, Radermecker R, Pietri L, Elgrably F, Slama G, Selam JL. Successful treatment of insulin allergy in a type 1 diabetic patient by means of constant subcutaneous pump infusion of insulin. Diabetes Care. 2003 Oct;26(10):2961-2. doi: 10.2337/diacare.26.10.2961. No abstract available. | |
| 15259314 | Background |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D006967 | Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Sola-Gazagnes A, Pecquet C. [Allergy to insulin in 2003]. Journ Annu Diabetol Hotel Dieu. 2004:161-79. No abstract available. French. |
| 17321300 | Background | Sola-Gazagnes A, Pecquet C, M'Bemba J, Larger E, Slama G. Type I and type IV allergy to the insulin analogue detemir. Lancet. 2007 Feb 24;369(9562):637-8. doi: 10.1016/S0140-6736(07)60301-8. No abstract available. |
| 35505238 | Result | Sola-Gazagnes A, Pecquet C, Berre S, Achenbach P, Pierson LA, Virmoux-Buisson I, M'Bemba J, Elgrably F, Moguelet P, Boitard C, Caillat-Zucman S, Laanani M, Coste J, Larger E, Mallone R. Insulin allergy: a diagnostic and therapeutic strategy based on a retrospective cohort and a case-control study. Diabetologia. 2022 Aug;65(8):1278-1290. doi: 10.1007/s00125-022-05710-9. Epub 2022 May 4. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |