Continuous glucose monitoring systems give contact dermatitis in children and adults despite efforts of providing less ‘allergy‐ prone’ devices: investigation and advice hampered by insufficient material for optimized patch test investigations

Abstract

Background Medical devices are increasingly being reported to cause contact allergic dermatitis reactions. Objective Review of patients with diabetes type I referred for suspected allergic contact dermatitis to insulin pump or glucose sensor systems. Method: We have reviewed 11 referred diabetes mellitus patients investigated for allergic contact dermatitis reactions to medical devices and specifically Dexcom G6®. Extracts from the medical devices were analysed. Results The majority of patients was children, the majority had relevant allergies and particularly allergy to isobornyl acrylate which was also found in the glucose sensor system Dexcom G6®. Conclusions The following case reports bring in focus the fact that patients sensitized through use of one medical device and being advised the use of another, or find another product for a while useful, are not by necessity free from future episodes of allergic contact dermatitis. The case reports emphasize the need for collaboration since it is impossible for even well‐equipped laboratories to properly investigate the medical devices when information on the substances used in production is not uniform and complete and material to investigate are scarce. The importance of adequate patch test series and testing with own material and furthermore the importance to re‐analyse medical devices and re‐analyse test data are emphasized.

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

“…Figure 3 shows chromatograms and mass spectra of an adhesive patch extract and a 2,2 0 -methylenebis(6-tert-butyl-4-methylphenol) monoacrylate reference sample. All extracts also contained isobornyl acrylate (IBOA) at estimated concentrations in the same order of magnitude as those found in previously analyzed sensors from older batches, 2 corresponding to a total IBOA content of ≤1 μg/patch and ≤1 μg/sensor housing. Furthermore, all sensors were also found to contain 2,2 0methylenebis(6-tert-butyl-4-methylphenol).…”

“…in the material may actually be too low to elicit a positive reaction at ordinary patch testing, even if an extract of the product is made. 2 Producing an extract can in itself be difficult because of the lack of material, especially if extraction solvents with different physico-chemical properties are desired. 1 The culprit contact allergens found have mainly been used in attachment areas, ie, where different materials must adhere to each other, but not necessarily primarily in the adhesive patch in direct contact with the skin.…”

“…Therefore, identifying and finding the optimal patch test substance and dose has been complex, as the final dose on skin exposure is not necessarily the same as where the substance is identified used. The need for collaboration with the manufacturers of the devices has been emphasized, 2,3 especially as the number of patients being sensitized to several allergens found in different MDs is increasing. As product ingredients may be changed without a change of brand name or notification to the clinicians or the users, helping the user find a reliable product is made even more difficult.…”

“…The identification of the allergen was simplified by the fact that previous analyses of Dexcom G6 existed for comparison at our laboratory in Malmö. 2…”

Allergic contact dermatitis from a disposable blood pressure cuff containing isobornyl acrylate and 2‐phenoxyethyl acrylate

“…The presence of IBOA in some medical devices might be underestimated, as recent investigations have shown that some devices, even those once deemed to be free from IBOA, 6 might still contain this sensitizer, depending, among other things, on the specific chemical analytical tools used. 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.…”