Clinical trial NCT01407640: Diagnosis and Physiopathology of Insulin Allergy
Official title: Diagnosis and Physiopathology of Insulin Allergy (IA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Hypersensitivity
Immediate Hypersensitivity
Allergy
Keywords: Insulin allergy
adverse drug reaction
diabetes
type 1 hypersensitivity
immediate hypersensitivity
type 4 hypersensitivity
insulin analogs
intradermal testing
insulin antibody
mast cell
CD+ TCELL
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2011-08-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Validation of cutaneous insulin tests
timeFrame: after 36 months
Secondary outcomes:
measure: Immunogenetic of patients with IA (Insulin Allergy)
timeFrame: after 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Agnes Sola-Gazagnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sola-Gazagnes A, Pecquet C. [Allergy to insulin in 2003]. Journ Annu Diabetol Hotel Dieu. 2004:161-79. No abstract available. French.
citation: 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.
citation: 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.