Concomitant positive patch test reactions in FreeStyle‐allergic patients sensitized to isobornyl acrylate

Dendooven, Ella; Foubert, Kenn; Goossens, An; Gilles, Philippe; Borggraeve, Wim M. De; Pieters, Luc; Lambert, Julien; Aerts, Olivier

doi:10.1111/cod.13706

Cited by 25 publications

(43 citation statements)

References 27 publications

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“…In published case series of ACD from glucose sensors, IBOA was the most common allergen involved. Interestingly, in our series, the frequency of sensitisation to IBOA (30.8%), was similar to previously reported rates by other Spanish authors (35.7%), 15 however, much lower than the frequency detected by authors in other European countries, such as Belgium (69.2% currently and ~80% in the past), 16 Portugal (80.0%), 17 and Finland (80.9%) 18 …”

Section: Discussionsupporting

confidence: 91%

Contact dermatitis from glucose sensors in Spain: A multicentric approach

et al. 2021

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Background Allergic contact dermatitis from glucose sensors may interfere with their ongoing application. Objective To evaluate a series of Spanish patients with contact dermatitis to glucose sensors regarding former sources of contact allergens, patch test results, and outcomes from the ongoing use of the device. Methods A series of patients with contact dermatitis from glucose sensors was investigated in eight dermatology departments across Spain (epidemiological features, brands, latency time to develop dermatitis, the ability to continue using the devices as well as the patch test results). Results Thirty patients were evaluated (mean age 20.9 years). A total of 66.7% were children and 66.7% female. Ninety per cent used Freestyle Libre (FSL). Eight of 26 (30.8%) reacted to isobornyl acrylate (IBOA) and two of 20 (10.0%) to N,N dimethylacrylamide (DMAA). The mean latency time to develop dermatitis was 9 months. Sixteen of 29 (55.2%) patients continued using the same sensor causing the reaction. Thirteen of 29 (44.8%) patients were unable to continue using the sensor because of severe reactions. Of these, five were positive to IBOA, one to IBOA and DMAA, one to DMAA, one to colophony, and one to isopropyl alcohol wipes. In one patient, the outcome was unknown. Conclusion The frequency of sensitisation to IBOA and DMAA, was lower than in other European series, but similar to a previously published Spanish article. Legislation requiring manufacturers to provide information regarding the composition of medical devices and cooperate with the investigations into contact dermatitis is urgently needed.

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Section: Discussionsupporting

confidence: 91%

Contact dermatitis from glucose sensors in Spain: A multicentric approach

et al. 2021

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“…They had as a mean nine contact allergies. Multiple allergies have been discussed previously with regard to patients using the medical device Freestyle Libre, 11 but that using a medical device, ie a glucose sensor or insulin pump, should be a risk factor for polysensitization can, of course, not be argued from case reports. The patients had been patch tested in an targetted manner with substances that also might be found in the same products.…”

Section: Discussionmentioning

confidence: 99%

Changes in adhesive ingredients in continuous glucose monitoring systems may induce new contact allergy pattern

et al. 2021

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Background: Medical devices (MD) in close skin-contact for a prolonged time, such as glucose monitoring (CGM) systems, are a risk factor for contact allergy, and there has been an increase in patients using these. Correct diagnosis demands targetted testing.Objectives: We report a new allergen in a continuous CGM system in which the adhesive was changed. The allergy pattern of the patients diagnosed is reported. Methods:The three patients reported were patch tested with an MD series, own material, and possible allergens found through analysis with gas chromatographymass spectrometry, comparing analysis from the CGM system before and after change.Results: The patients were sensitized to isobornyl acrylate (IBOA), found in previously used devices and the present CGM. Apart from IBOA, the culprit allergen was found to be 2,2 0 -methylenebis(6-tert-butyl-4-methylphenol) monoacrylate. Conclusion:Allergic contact dermatitis due to CGM systems and insulin pumps are difficult to investigate and require chemical analysis. Because of the lack of information on substances used in the production, and when changes with MDs are initiated, it is difficult to advise patients, especially since they risk sensitization to several allergens. The use of MDs has increased and, thus, the need for collaboration between manufacturers, clinicians, and patient organizations.2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate, allergic contact dermatitis, contact allergy, diabetes type I, gas chromatography-mass spectrometry glucose monitoring (CGM) systems, isobornyl acrylate medical device | INTRODUCTIONInvestigating patients with suspected allergic contact dermatitis to medical devices (MDs), such as continuous glucose monitoring (CGM) systems, intermittently scanned glucose monitoring (isCGM)/flash glucose monitoring systems, and insulin pumps, is complicated. 1 The diagnosis has to be suspected and the patient must be patch tested with the right substances. The investigation should also include patch testing with the patient's own material. This testing may, however, result in false negative reactions since the concentration of allergens

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“…7 The FreeStyle sensor also contains other potential contact allergens but, as recently demonstrated, no PEA. 3 For the observed coreactivity to the PEA-containing patch test preparation and to the other acrylates, possible explanations include: (a) concomitant sensitization from other sources: given that the boy had already been hospitalized several times, he was potentially at increased risk for cutaneous sensitization to (meth)acrylates from various medical devices and adhesives, including the blood pressure cuff that had been repeatedly applied during previous hospitalizations; (b) crossreactivity between IBOA and PEA, and other acrylates, although IBOA has rarely shown any clear cross-reactivity to other acrylates so far; 3,8 and (c) the positive patch test reaction to PEA may actually have been provoked by IBOA, as recent analyses showed that raw materials of PEA obtained from the industry, as in the present case, may contain acrylate contaminants, which include IBOA. Unfortunately, the particular PEA patch test preparation could no longer be analyzed and we were not able to re-test another preparation containing PEA in our patient.…”

Section: Discussionmentioning

confidence: 99%

“…Readings on day (D)2 and D4 showed positive reactions to many meth(acrylates)(Figure S2 nor to fragrances. 2,3 The blood pressure cuff was sent to the Antwerp laboratory for chemical analysis, based on a previous protocol. 4 These analyses showed the presence of IBOA (10-20 ppm) in the part of the device where the tube is glued to the cuff, the cuff itself, and the velcro adhesive.…”

Section: Case Reportmentioning

confidence: 99%