Isobornyl acrylate contained in the insulin patch pump OmniPod as the cause of severe allergic contact dermatitis

Oppel, Eva; Högg, Christof; Summer, Burkhard; Ruëff, Franziska; Reichl, Franz‐Xaver; Kamann, Stefanie

doi:10.1111/cod.13017

Cited by 45 publications

(48 citation statements)

References 6 publications

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“…However, the other four patients were sensitized to the allergen IBOA, an allergen that was the culprit allergen in the FreeStyle Libre glucose sensor and also in the insulin patch pump Omnipod, and now also detected by GC‐MS analysis in the Enlite glucose sensor, and likely also in the Paradigm infusion sets. It should be noted that IBOA was also detected in insulin pump infusion sets in 1995 . Our analyses demonstrated the presence of IBOA in the extracts of the Enlite sensors (with the adhesive patches removed) but not in the extracts of the adhesive patches.…”

Section: Discussionmentioning

confidence: 62%

Allergic contact dermatitis caused by isobornyl acrylate in the Enlite glucose sensor and the Paradigm MiniMed Quick‐set insulin infusion set

et al. 2019

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Background: The FreeStyle Libre glucose sensor has caused many cases of allergic contact dermatitis, and isobornyl acrylate (IBOA) in this sensor has been identified as one of the culprit allergens.Objectives: To report on the presence of IBOA in devices produced by Medtronic, namely, the Enlite sensor and the insulin infusion set Paradigm MiniMed Quick-set. Patients and Methods: Five patients reacting to the glucose sensor Enlite and/or the insulin infusion set Paradigm MiniMed Quick-set observed in three clinics (two Belgian and one Swedish) were patch tested with the baseline and other series, as well as with IBOA; four of them also with pieces of adhesive patches from the devices, and two with a thin layer chromatogram of Enlite glucose sensor extracts. Gas chromatography-mass spectrometry (GC-MS) analyses were performed.Results: Four patients reacted to IBOA and one to colophonium, a known allergen in Enlite, and three to the adhesive part of the sensor or the insulin infusion set. IBOA was identified in the sensor by GC-MS, and its presence was indicated in the infusion set.Conclusions: IBOA is a contact allergen in Enlite glucose sensor, and likely also in the infusion set. Therefore, these devices are not suitable alternatives for patients sensitized to the FreeStyle Libre sensor.acrylates, allergic contact dermatitis, delayed hypersensitivity, glucose sensor, insulin pump, isobornyl acrylate, medical device

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Section: Discussionmentioning

confidence: 62%

Allergic contact dermatitis caused by isobornyl acrylate in the Enlite glucose sensor and the Paradigm MiniMed Quick‐set insulin infusion set

et al. 2019

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“…Interestingly, in the case of Freestyle Libre, IBOA seems to be part of the sensor itself, whereas the adhesive and the thin glue layer that attaches the sensor to the adhesive are free from IBOA. IBOA has also been detected in the insulin pump Omnipod from Insulet (Acton, Massachusetts), which is a pump that is attached directly to the skin …”

Section: Discussionmentioning

confidence: 99%

Hydrocolloid blister plaster decreases allergic contact dermatitis caused by Freestyle Libre and isobornyl acrylate

Kamann¹,

Oppel

2019

Contact Dermatitis

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K E Y W O R D S : acrylates, allergic contact dermatitis, case report, Freestyle Libre, hydrocolloid plaster, insulin pump, isobornyl acrylate, patch test CASE REPORTOur patient, a 12-year-old boy with diabetes mellitus type 1 for 6 years, started using a flash glucose monitoring system (iscCGM; Freestyle Libre; Abbott, Chicago, Illinois) in June 2016 ( Figure 1A). In November 2016, he complained for the first time about itching underneath his glucose sensor, which progressively worsened, so that, after some days, the sensor had to be removed. The skin under the plastic case showed erythema, pustules, and small yellowish vesicles ( Figure 1B). The patient's diabetes physician recommended the application of a skin barrier film spray, Cavilon, underneath the sensor.However, this did not prevent his allergic contact dermatitis (ACD).We performed patch tests with allergens from a baseline series and a plastics and glues series, following the recommendations of the German Contact Dermatitis Research Group (Deutsche Kontaktallergie Gruppe; http://dkg.ivdk.org/). Also, we tested isobornyl acrylate (IBOA) 0.1% pet., prepared in the laboratory of the Department of Dermatology and Allergology, Ludwig-Maximilian-University, Munich. Following occlusion for 2 days, all patch test reactions were read, according to guidelines, on day (D) 2 and D3. The patient showed only a ++ positive reaction to IBOA 0.1%.We provided our patient with Hansaplast blister plaster from Beiersdorf (Hamburg, Germany). Two overlapping blister plates were placed between the skin and the sensor, thereby preventing potential allergens from penetrating into the skin ( Figure 1C). In our observation period of 9 months, our patient was almost always able to keep his Freestyle Libre in place for the full application time of 14 days ( Figure 1D). DISCUSSIONSkin irritation caused by modern diabetes devices, as a result of occlusion, sweating under the sensor, or tearing off the adhesive, seems to be very common, but is mostly controllable. However, some patients have developed severe ACD.Only in August 2017 could the major culprit allergen, isobornyl acryate (IBOA), be identified; this was followed by further reports and reviews on patients with Freestyle Libre and IBOA allergy. 1-3

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“…Isobornyl acrylate (IBOA) (CAS no. 5888‐33‐5) has recently been identified as the major culprit allergen in diabetic patients sensitized to the glucose sensor Freestyle Libre (Abbott Diabetes Care, Witney, UK) and similar medical devices . As previously reported, numerous patients allergic to Freestyle Libre also reacted positively to sesquiterpene lactone (SL) mix (SLM) (Chemotechnique Diagnostics, Vellinge, Sweden), which is included in the baseline series, and contains equimolar concentrations of alantolactone (0.033%; CAS no.…”

Section: Introductionmentioning

confidence: 96%

Unexpected positive patch test reactions to sesquiterpene lactones in patients sensitized to the glucose sensor FreeStyle Libre

et al. 2019

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Background: Most diabetic patients sensitized to FreeStyle Libre react to isobornyl acrylate (IBOA), with a considerable number of them also showing unexpected positive patch test reactions to sesquiterpene lactone (SL) mix (SLM) tested in the baseline series. Objectives: To compile patch test results of subjects affected, and provide potential explanations for this association. Patients and Methods: Fifty-three Freestyle Libre-allergic patients were patch tested with IBOA and/or SLM, and several were also patch tested with the components of SLM. Chromatographic analyses were performed on the glucose sensor, IBOA, and the components of SLM. Results: Thirty-three patients reacted positively to the components of SLM, and 11 of 27 patients reacted positively to alantolactone, in particular. Gas chromatography-mass spectrometry (GC-MS) analyses did not detect these chemicals in the different parts of the glucose sensor, or in IBOA. Conclusion: Significant co-sensitizations between SLs on the one hand and the glucose sensor FreeStyle Libre and/or isobornyl acrylate on the other hand exist, without evidence of the presence of SLs via GC-MS analysis. Cross-reactions between them seem improbable. As a possible hypothesis, a common precursor for both, such as camphene, may exist. K E Y W O R D S allergic contact dermatitis, chemical analysis, diabetes mellitus, FreeStyle Libre, GC-MS, glucose sensor, isobornyl acrylate, medical device, sesquiterpene lactones, simultaneous reactions

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Isobornyl acrylate contained in the insulin patch pump OmniPod as the cause of severe allergic contact dermatitis

Cited by 45 publications

References 6 publications

Allergic contact dermatitis caused by isobornyl acrylate in the Enlite glucose sensor and the Paradigm MiniMed Quick‐set insulin infusion set

Allergic contact dermatitis caused by isobornyl acrylate in the Enlite glucose sensor and the Paradigm MiniMed Quick‐set insulin infusion set

Hydrocolloid blister plaster decreases allergic contact dermatitis caused by Freestyle Libre and isobornyl acrylate

Unexpected positive patch test reactions to sesquiterpene lactones in patients sensitized to the glucose sensor FreeStyle Libre

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