Status:

COMPLETED

Diagnosis and Physiopathology of Insulin Allergy

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

Institut National de la Santé Et de la Recherche Médicale, France

URC-CIC Paris Descartes Necker Cochin

Conditions:

Diabetes Mellitus, Type 1

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

NA

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 fac...

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 a...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 6 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 27 2016

    Estimated Enrollment :

    55 Patients enrolled

    Trial Details

    Trial ID

    NCT01407640

    Start Date

    February 6 2012

    End Date

    July 27 2016

    Last Update

    September 12 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Cochin Hospital

    Paris, France, 75005