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

Abstract

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 chromatographymass 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 0 -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.2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate, allergic contact dermatitis, contact allergy, diabetes type I, gas chromatography-mass spectrometry glucose monitoring (CGM) systems, isobornyl acrylate medical device | INTRODUCTIONInvestigating patients with suspected allergic contact dermatitis to medical devices (MDs), such as continuous glucose monitoring (CGM) systems, intermittently scanned glucose monitoring (isCGM)/flash glucose monitoring systems, and insulin pumps, is complicated. 1 The diagnosis has to be suspected and the patient must be patch tested with the right substances. The investigation should also include patch testing with the patient's own material. This testing may, however, result in false negative reactions since the concentration of allergens

Products for Monitoring Glucose Levels in the Human Body With Noninvasive Optical, Noninvasive Fluid Sampling, or Minimally Invasive Technologies

“…72 Acrylates being in the adhesives (and also in the plastic material of the sensor housing) are known to induce skin reactions. 73,74 Short term studies with MI-GMs that use transcutaneous microneedles to sample ISF have demonstrated minor edema and erythema skin irritation that resolve without treatment. 75,76 The use of a powerful laser for NIO-GM measurements poses a risk of pronounced skin damage.…”

Advances in Insulin Pump Infusion Sets Symposium Report

“…7 2,2′-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate, which is used as an ingredient in adhesive for some pumps, has also been implicated as a potential cause of contact allergy. 8…”

“…7 2,2′-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate, which is used as an ingredient in adhesive for some pumps, has also been implicated as a potential cause of contact allergy. 8 There is a need for new ideas, new technologies, and new products for IISs. This three-part report characterizes (1) the patient burden associated with using current IISs, (2) new developments in extended wear technology, and (3) future directions for IIS developments that would be well received.…”

In Response to the Letter to the Editor on Minimizing Adverse Skin Reactions to Wearable Continuous Glucose Monitoring Sensors

“…However, alterations in device content risk introducing new potential allergens, which in turn can cause even more contact allergies among users. 4 Isobornyl acrylate (IBOA) was the first main sensitizer in CGM systems, but by no means the last one. The allergen was identified and cases of CA confirmed in university clinics -without aid from the industry.…”

“…5 Today, IBOA is just one of several allergens found in MD. 2,4,5,6 Unfortunately, it has been found in various MD from different manufacturers.…”