Abstract

<h3>Background</h3> Glucose sensors (GS) are increasingly used in children and young people (CYP) with Type 1 diabetes. Improved outcome has been associated with their use. However since their introduction, cutaneous reactions have been reported. Both irritant and allergic contact dermatitis (ACD) can be caused by constituents of these devices. Manufacturers are not under any legal obligation to disclose the constituents of the sensor. This makes identification of the allergen by patch test challenging and selection of an alternative device difficult. Since the introduction of these devices in our paediatric diabetes service, we have seen an increasing number of these reactions. All cases are reported to Medicines and Health Regulatory Agency (MHRA) and referred to the Paediatric dermatologist. The relevant manufacturer is contacted to seek details of the constituents. This information has not been forthcoming. <h3>Objectives</h3> The purpose of this study was to review our local experience of contract dermatitis and determine if our experience was reflected nationally and whether all teams were reporting cases to the MHRA and referring to dermatologists for investigation. <h3>Methods</h3> We reviewed all cases in our service to determine incidence with each device and the results of patch testing if done. In June 2020, we carried out a survey to paediatric diabetes and dermatology teams in England to determine the number of cases of contact dermatitis seen, the devices involved and whether MHRA reporting and referral to dermatology for investigation was routine practice. <h3>Results</h3> By 2019, in our service, 12.5% of Dexcom G5 users had experienced a skin reaction, 0% of Dexcom G6, 30% of Medtronic and 3.5% of Free Style Libre (FSL). Since 2019, the FSL formulation has been IBOA free and we have seen no further reactions. Dexcom G6 had a new formulation in 2019 which is IBOA free. Since 2020, we have noticed reactions in 6/55 (10.9%) of our patients. Dexcom has not disclosed the potential allergens in this new formulation, hindering further investigation. From the national survey, we received responses from 61 out of 173 teams giving data on 10487 CYP. GS were used in 61%(6419). 5% (320) had developed a skin reaction likely to be contact dermatitis. The GS implicated were Dexcom G6 (5% of its users), G5 (7.4%), Medtronic Enlite Sensor(15%), Medtronic Guardian Sensor 3(8.8%),and Freestyle libre (3.7%). Only 5 teams had reported the reaction to MHRA via the Yellow Alert scheme and only 6 teams had referred to dermatology for further investigation and management. <h3>Conclusions</h3> Our survey confirmed the problem is widespread, with under reporting of these cases in England to the MHRA. Dermatology referral is often not sought. It is essential that all cases are reported to raise awareness of this problem which is impacting the care of children with Type 1 diabetes. Working closely with dermatology team can help to find ways to manage these patients. Manufacturers must be more transparent in their labelling and modify their formulation if an increased rate of reaction occurs.

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