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Insulin allergy: A diagnostic and therapeutic strategy based on a retrospective cohort and a case–control study.
Diabetologia 65, 1278-1290 (2022)
Aims/hypothesis: Insulin allergy is a rare but significant clinical challenge. We aimed to develop a management workflow by (1) validating clinical criteria to guide diagnosis, based on a retrospective cohort, and (2) assessing the diagnostic performance of confirmatory tests, based on a case–control study. Methods: In the retrospective cohort, patients with suspected insulin allergy were classified into three likelihood categories according to the presence of all (likely insulin allergy; 26/52, 50%), some (possible insulin allergy; 9/52, 17%) or none (unlikely insulin allergy; 17/52, 33%) of four clinical criteria: (1) recurrent local or systemic immediate or delayed hypersensitivity reactions; (2) reactions elicited by each injection; (3) reactions centred on the injection sites; and (4) reactions observed by the investigator (i.e. in response to an insulin challenge test). All underwent intradermal reaction (IDR) tests. A subsequent case–control study assessed the diagnostic performance of IDR, skin prick and serum anti-insulin IgE tests in ten clinically diagnosed insulin allergy patients, 24 insulin-treated non-allergic patients and 21 insulin-naive patients. Results: In the retrospective cohort, an IDR test validated the clinical diagnosis in 24/26 (92%), 3/9 (33%) and 0/14 (0%) likely, possible and unlikely insulin allergy patients, respectively. In the case–control study, an IDR test was 80% sensitive and 100% specific and identified the index insulin(s). The skin prick and IgE tests had a marginal diagnostic value. Patients with IDR-confirmed insulin allergy were treated using a stepwise strategy. Conclusions/interpretation: Subject to validation, clinical likelihood criteria can effectively guide diabetologists towards an insulin allergy diagnosis before undertaking allergology tests. An IDR test shows the best diagnostic performance. A progressive management strategy can subsequently be implemented. Continuous subcutaneous insulin infusion is ultimately required in most patients. ClinicalTrials.gov: NCT01407640. Graphical abstract: [Figure not available: see fulltext.]
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Publikationstyp
Artikel: Journalartikel
Dokumenttyp
Wissenschaftlicher Artikel
Schlagwörter
Anaphylaxis ; Ige ; Immune Tolerance ; Intradermal Reaction ; Prick Test ; Skin Test
ISSN (print) / ISBN
0012-186X
e-ISSN
1432-0428
Zeitschrift
Diabetologia
Quellenangaben
Band: 65,
Heft: 8,
Seiten: 1278-1290
Verlag
Springer
Verlagsort
Berlin ; Heidelberg [u.a.]
Nichtpatentliteratur
Publikationen
Begutachtungsstatus
Peer reviewed
Institut(e)
Institute of Diabetes Research (IDF)
Förderungen
Hôpitaux de Paris
Fondation Francophone pour la Recherche sur le Diabète
Fondation Francophone pour la Recherche sur le Diabète