Dermatitis to medical devices in diabetic children: update in 2020.

Since the introduction of medical devices like glucose sensors and insulin pumps into the market, the management of Type 1 diabetes has been significantly improved. Nevertheless, since their introduction, several cutaneous undesirable events have been reported, such as infections, hematomas, and irritant contact dermatitis (ICD). Allergic contact dermatitis (ACD) has been also recently described, not only in adults but also in diabetic children.

In the past few years, the first case of ACD caused by glucose sensor in children was due to Dexcom G4â Platinum sensor (Dexcom, San Diego, United States). Ethyl cyanoacrylate has been reported to be the culprit allergen (1). Since 2016, the manufacturer has been using a heatstaking thermal process that eliminates the ethyl cyanoacrylate from this sensor (2).

Later, another sensor FreeStyleâ Libre (Abbott Diabetes Care, Winey, Oxford-Shire, UK) was also responsible of an “epidemic” of allergies. Isobornyl acrylate (IBOA) (3), an acrylate derivative, was highlighted as a relevant allergen. However, N-N-dimethylacrylamide (DMAA) has also been implicated (4). This sensor was the first sensor to be reimbursed on the Belgian market. So a large number of patients were wearing this device due to the patients’ preference because of the ease of its use, but in addition, due to the clinicians’ prescribing habits.
In a recent study, it was estimated that 4.2% of all diabetes children wearing a glucose sensor FreeStyle® Libre were sensitized to IBOA and 83.3% of children (with adverse cutaneous reactions to FreeStyle® Libre)  patch testes were sensitized to IBOA (5).

Moreover, to date, no observation suggests cross-reaction between IBOA and others acrylates. Possible cross-reactions between IBOA and plant derivatives like sesquiterpene lactones have been reported (6). Indeed, 41.7% of children sensitized to IBOA tested positively to sesquiterpene lactone mix (SLM) (5).

It has been also demonstrated that the sensor Enlite® (Medtronic Minimed, Northridge, CA, USA), proposed as second-line sensors in Belgium, contain IBOA, DMAA (7) and colophonium (8). The same with the insulin infusion set Paradigm® MiniMed Quick-Set® (Medtronic, Minneapolis, Minnesota) which contain also IBOA and DMAA (7).

It has been observed that some patients, notably children, presented acquired leukoderma following ACD to FreeStyle® Libre and IBOA, with the possible potential role of hydroquinone monomethyl ether (HMME) which acts as inhibitor to prevent the inadvertent IBOA polymerization.

Sensitization to diabetes medical devices is still a current problem in contact allergology. At this time, there is no specific European recommendation for diabetes children with dermatitis caused by medical devices. We recommended to test with IBOA 0.1%, DMAA 0.1%, colophonium, an adhesive patch piece of the sensor, and the acrylate series in all children presenting a reaction caused by diabetic medical devices.

However, note that several patients with reactions suspected of ACD do not test positively nor with the commercialised or above mentioned allergens, nor with pieces of the adhesive parts of the sensors. Either other allergens have not yet been identified, either it is more likely irritant contact dermatitis. This highlight the importance and very urgent need of European legislation over full labelling of medical devices ‘ingredients. 

References

  1. Schwensen JF, Friis UF, Zachariae C, Johansen JD. Sensitization to cyanoacrylates caused by prolonged exposure to a glucose sensor set in a diabetic child. Contact Dermatitis. 2016;74:124-5.
  2. Gisin V, Chan A, Welsh JB. Manufacturing Process Changes and Reduced Skin Irritations of an Adhesive Patch Used for Continuous Glucose Monitoring Devices. J Diabetes Sci Technol. 2018;12:725-6.
  3. Herman A, Aerts O, Baeck M, et al. Allergic contact dermatitis caused by isobornyl acrylate in Freestyle(R) Libre, a newly introduced glucose sensor. Contact Dermatitis. 2017;77:367-73.
  4. Mowitz M, Herman A, Baeck M, et al. N,N-dimethylacrylamide-A new sensitizer in the FreeStyle Libre glucose sensor. Contact Dermatitis 2019 Jul; 81:27-31.
  5. Herman A, Darrigade AS, de Montjoye L, Baeck M. Contact dermatitis caused by glucose sensors in diabetic children. Contact Dermatitis. 2019. DOI: 10.1111/cod.13429 [Epub ahead of print].
  6. Herman A, Mowitz M, Aerts O, et al. Unexpected positive patch test reactions to sesquiterpene lactones in patients sensitized to th glucose sensor FreeStyle Libre Contact Dermatitis. 2019;81:354-67.
  7. Herman A, Baeck M, de Montjoye L, et al. Allergic contact dermatitis caused by isobornyl acrylate in the Enlite® glucose sensor and the Paradigm® MiniMed Quick-Set® insulin infusion set. . Contact Dermatitis. 2019;81:432-7.
  8. Passanisi S, Lombardo F, Barbalace A, et al. Allergic contact dermatitis and diabetes medical devices: 2 clinical cases. Contact Dermatitis. 2018 Apr 30. doi: 10.1111/cod.13012.


Anne Herman1
1Department of Dermatology, Cliniques universitaires Saint-Luc, 1200 Brussels, Belgium.