Solution using Stomahesive® wafers for allergic contact dermatitis caused by isobornyl acrylate in glucose monitoring sensors.

Isobornyl acrylate (IBOA) has recently caused a number of cases of allergic contact dermatitis (ACD) from its use in medical devices. We would like to enhance the awareness of this issue with the reporting of three Australian cases, involving two adults and a child. We also report a successful solution by using hydrocolloid wafer (Stomahesive®) as a barrier. As IBOA is not usually found on baseline patch test series and does not cross-react with other acrylic monomers, ACD to IBOA may be missed by clinicians.

Contact dermatitis from glucose sensors in Spain: A multicentric approach.

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.

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

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 chromatography-mass 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'-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.

Contact dermatitis caused by glucose sensors, insulin pumps, and tapes: Results from a 5-year period.

BACKGROUND: The number of patients with contact dermatitis from glucose sensors and insulin infusion sets is increasing. Patch testing is challenging because of a lack of information concerning the constituent materials of medical devices. OBJECTIVES: To report on products and causes of allergic reactions to glucose sensors or insulin infusion sets over a 5-year period and suggest a short screening series. METHODS: Analysis of patch test data from consecutive patients suspected of allergic contact dermatitis (ACD) to glucose sensors and/or insulin infusion sets from 2015-2019. RESULTS: Patient numbers increased from 4 to 15 per year; 30/38 (78.9%) were children. In 29 (76.3%), a diagnosis of allergic/probable ACD was established, mostly due to the tapes of the device or allergens in these tapes (n = 23) followed by allergens in the device housing (n = 10). Isobornyl acrylate, abitol, and colophonium were the most common allergens. Information from manufacturers was often difficult to obtain and, if accessible, inadequate. For this reason, the diagnosis was delayed for more than 1.5 years in 12 (31%) patients. CONCLUSIONS: The increasing number of patients, mostly children, with ACD from devices used in treatment of type 1 diabetes demonstrates the importance of this problem. Allergies can easily be overlooked, due to the lack of mandatory labeling of the constituent materials of the devices.

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

BACKGROUND: Concomitant positive patch test reactions in patients sensitized to isobornyl acrylate (IBOA) have rarely been documented. OBJECTIVES: To report concomitant sensitizations in patients with allergic contact dermatitis (ACD) from the glucose sensor FreeStyle Libre and sensitized to IBOA. METHODS: In 2019, 26 patients with suspected ACD from FreeStyle Libre were patch tested to a baseline series and to a (meth) acrylate series containing IBOA and 2-phenoxyethyl acrylate (PEA) 0.1% pet. Diabetes devices and patch test preparations were analyzed with gas chromatography - mass spectrometry (GC-MS) for the presence of IBOA and PEA. RESULTS: Of the 26 patients, 18 (69%) were sensitized to IBOA, and eight (44%) and 11 (61%) of these were co-sensitized to sesquiterpene lactones and fragrances, respectively. Ten patients (56%) were co-sensitized to PEA, which, contrary to IBOA, could not be detected in any device. The PEA test material was shown to be contaminated with IBOA. CONCLUSIONS: Contact allergy to IBOA appears to be declining and IBOA-sensitized patients are most often co-sensitized to sesquiterpene lactones and fragrances. Vigilance is required when patch testing (acrylate) materials obtained from industry, as these might be contaminated and, hence, alter the results and their interpretation.

Contact dermatitis caused by glucose sensors-15 adult patients tested with a medical device patch test series.

BACKGROUND: Several cases of allergic contact dermatitis (ACD) to the glucose sensor FreeStyle Libre have been reported. Isobornyl acrylate (IBOA) and N,N-dimethylacrylamide (DMAA) are known culprit allergens. OBJECTIVES: To evaluate patients with suspected ACD to FreeStyle Libre in a standardized manner, present causative allergens, and assess patient-reported implications. METHODS: A total of 15 patients with suspected ACD to FreeStyle Libre were patch tested with the Swedish baseline series and a new medical device series. IBOA and DMAA were tested at 0.1% and 0.3% in petrolatum (pet.). Readings were performed on day (D) 3 and D7. Background data, details on skin reactions, and associated implications were assessed using a questionnaire. RESULTS: Thirteen patients were sensitized to IBOA and four to DMAA. Two positive reactions to IBOA and one to DMAA were seen only at 0.3% concentration on D7. Median duration of sensor use before dermatitis onset was 6 months. Half the number of the patients took precautions in everyday life due to sensor-related skin reactions. Six patients discontinued sensor usage. CONCLUSIONS: Patients with suspected ACD to glucose sensors should be evaluated with a relevant patch test series containing IBOA and DMAA. Adding the 0.3% pet. concentration is recommended. The reading on D7 is necessary.

Adverse cutaneous reaction to diabetic glucose sensors and insulin pumps: Irritant contact dermatitis or allergic contact dermatitis?

BACKGROUND: Adverse cutaneous reactions to diabetes medical devices (glucose sensors and insulin pumps) are described, notably allergic contact dermatitis (ACD) with isobornyl acrylate (IBOA) and N,N dimethylacrylamide (DMAA) as the main allergen. OBJECTIVES: To determine if all cases of adverse cutaneous reactions observed with diabetes medical devices (ie FreeStyle Libre, Enlite sensors or insulin pumps), referred to our department with suspected allergies are confirmed as ACD. PATIENTS AND METHODS: Fifty-two patients who presented skin reactions to diabetes medical devices were patch tested with the European baseline series, a plastic and glues series, a (meth) acrylates series, a piece of the adhesive part of the device, as well as IBOA 0.1% and DMAA 0.1% pet. RESULTS: Seventeen patients had no positive reaction to IBOA nor to the adhesive part of the device; 11 of these also tested with DMAA with negative result. No other relevant allergen was identified. CONCLUSION: Some cutaneous reactions, otherwise very similar to those of patients sensitized to IBOA, can be explained either by the presence of an untested allergen not yet discovered, or by irritant contact dermatitis. Therefore, European legislation on the full labelling of ingredients by manufacturers, in order to facilitate the identification of allergens and irritants, is imperative.