Background
Isobornyl acrylate (IBOA) has recently been identified as one sensitizer in the FreeStyle Libre glucose sensor. Analyses with gas chromatography‐mass spectrometry (GC‐MS) have indicated the presence of N,N‐dimethylacrylamide (DMAA) in the sensor.
Material and methods
Seven patients were referred for patch testing after developing skin reactions when using FreeStyle Libre. All patients were patch tested with IBOA and DMAA. Two patients were tested with adhesive patches that had been removed from the sensors “as is,” and two patients were tested with acetone extracts of materials from the sensor. The extracts were analysed with GC‐MS.
Results
Six patients reacted to both IBOA and DMAA, and one patient reacted only to DMAA. Positive reactions were also observed in both patients tested with the adhesive patch "as is". One patient reacted to both an extract of the adhesive patch and an extract of the sensor itself. When analysed with GC‐MS, IBOA was found in both extracts and DMAA was found in the extract of the sensor.
Conclusion
Both IBOA and DMAA may be present in adhesives used in medical devices such as glucose sensors or insulin pumps, and should be patch tested when suspected contact allergic reactions to these products are investigated.
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.
Isobornyl acrylate may play a role as hidden allergen, in the form of an impurity collected during the industrial process, explaining some cases of allergic reaction to alkyl glucosides.
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