Diagnosis and Physiopathology of Insulin Allergy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Diagnosis and Physiopathology of Insulin Allergy (IA)

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Hypersensitivity, Immediate Hypersensitivity, Allergy

Intervention / Treatment
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* Procedure: Allergy tests


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Patients aged 18 years old and more with a written informed consent Experimental group : type 1 or type 2 diabetic patients with insulin allergy based on clinical criteria Active Comparator group: type 1 or type 2 diabetic patients insulin treated without insulin allergy Exclusion criteria : Not willing participate Pregnancy Age below 18 years Severe Renal failure Severe Anaphylactic shock only for the experimental group No social security overture

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Allergy tests | Procedure: Allergy tests<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin allergy, adverse drug reaction, diabetes, type 1 hypersensitivity, immediate hypersensitivity, type 4 hypersensitivity, insulin analogs, intradermal testing, insulin antibody, mast cell, CD+ TCELL