Abstract：
BACKGROUND: Allergic contact dermatitis (ACD) has been reported as an adverse effect from the use of several glucose sensors and insulin pumps from different manufacturers. Isobornyl acrylate (IBOA) has been identified as a major culprit sensitizer, but also other acrylates and (modified) colophonium have been reported as causes of ACD.
OBJECTIVE: To report the two first cases diagnosed with ACD caused by the Dexcom G7 (DG7) glucose sensor.
METHODS: Two children with suspected ACD from DG7 were patch tested with our medical device series with an addition of selected test preparations including two variants of modified colophonium - methyl hydrogenated rosinate (MHR) and glyceryl hydrogenated rosinate (GHR). Both patients were also tested with acetone extracts made from different parts of the DG7 sensor. The extracts were analysed by gas chromatography-mass spectrometry (GC-MS).
RESULTS: Both patients tested positive to IBOA, hydroabietyl alcohol and GHR. In addition, patient 1 had a positive reaction to MHR and patient 2 had a positive reaction to colophonium. The GC-MS analyses showed the presence of IBOA and colophonium-related substances in the DG7 extracts.
CONCLUSIONS: Both patients were diagnosed with contact allergy to well-known medical device-related sensitizers. The presence of IBOA and (modified) colophonium in a newly introduced (on the Swedish market in 2023) glucose sensor is remarkable and indicates an inadequate toxicological assessment of the materials used in the sensor.
OBJECTIVE: To report the two first cases diagnosed with ACD caused by the Dexcom G7 (DG7) glucose sensor.
METHODS: Two children with suspected ACD from DG7 were patch tested with our medical device series with an addition of selected test preparations including two variants of modified colophonium - methyl hydrogenated rosinate (MHR) and glyceryl hydrogenated rosinate (GHR). Both patients were also tested with acetone extracts made from different parts of the DG7 sensor. The extracts were analysed by gas chromatography-mass spectrometry (GC-MS).
RESULTS: Both patients tested positive to IBOA, hydroabietyl alcohol and GHR. In addition, patient 1 had a positive reaction to MHR and patient 2 had a positive reaction to colophonium. The GC-MS analyses showed the presence of IBOA and colophonium-related substances in the DG7 extracts.
CONCLUSIONS: Both patients were diagnosed with contact allergy to well-known medical device-related sensitizers. The presence of IBOA and (modified) colophonium in a newly introduced (on the Swedish market in 2023) glucose sensor is remarkable and indicates an inadequate toxicological assessment of the materials used in the sensor.
摘要：
背景：据报道，过敏性接触性皮炎（ACD）是使用不同制造商的几种葡萄糖传感器和胰岛素泵产生的不利影响。丙烯酸异冰片酯（IBOA）已被确定为主要的致敏剂，还有其他丙烯酸酯和（改性的）松香被报道为ACD的原因。
目的：报告由DexcomG7（DG7）葡萄糖传感器引起的2例诊断为ACD的首例病例。
方法：使用我们的医疗设备系列对两名疑似来自DG7的ACD儿童进行了贴片测试，并添加了选定的测试制剂，包括两种变体的改性松香-甲基氢化松脂酸盐（MHR）和甘油基氢化松脂酸盐（GHR）。还用从DG7传感器的不同部分制成的丙酮提取物对两名患者进行了测试。通过气相色谱-质谱(GC-MS)分析提取物。
结果：两名患者的IBOA检测呈阳性，氢松香醇和GHR。此外,患者1对MHR呈阳性反应,患者2对松香呈阳性反应.GC-MS分析显示DG7提取物中存在IBOA和松香相关物质。
结论：两名患者均被诊断为对众所周知的医疗器械相关致敏剂的接触过敏。在新推出的（2023年在瑞典市场上）葡萄糖传感器中存在IBOA和（改性的）松香是显着的，表明对传感器中使用的材料的毒理学评估不足。
目的：报告由DexcomG7（DG7）葡萄糖传感器引起的2例诊断为ACD的首例病例。
方法：使用我们的医疗设备系列对两名疑似来自DG7的ACD儿童进行了贴片测试，并添加了选定的测试制剂，包括两种变体的改性松香-甲基氢化松脂酸盐（MHR）和甘油基氢化松脂酸盐（GHR）。还用从DG7传感器的不同部分制成的丙酮提取物对两名患者进行了测试。通过气相色谱-质谱(GC-MS)分析提取物。
结果：两名患者的IBOA检测呈阳性，氢松香醇和GHR。此外,患者1对MHR呈阳性反应,患者2对松香呈阳性反应.GC-MS分析显示DG7提取物中存在IBOA和松香相关物质。
结论：两名患者均被诊断为对众所周知的医疗器械相关致敏剂的接触过敏。在新推出的（2023年在瑞典市场上）葡萄糖传感器中存在IBOA和（改性的）松香是显着的，表明对传感器中使用的材料的毒理学评估不足。
