Safety & Warnings

Adverse Events, Skin Reactions, and Safety Warnings

Continuous Glucose Monitors (CGMs), while critical for diabetes management, carry distinct safety risks. Dermatological issues are the most common complaint, primarily driven by allergic reactions to Isobornyl Acrylate (IBOA) in adhesives. Physiological limitations include the lag time between blood and interstitial fluid glucose, and Pressure-Induced Sensor Attenuation (PISA), which causes false low alarms during sleep. Chemical interferences from substances like Hydroxyurea, high-dose Vitamin C, and Acetaminophen can cause falsely elevated readings, risking insulin overdose. Finally, hardware risks include broken filaments retained in the skin, applicator failures, and incompatibility with MRI procedures.

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Adverse Events, Skin Reactions, and Safety Warnings in Continuous [Glucose Monitoring](/)

Introduction

Continuous Glucose Monitors (CGMs) are a crucial tool for diabetes management, providing real-time glucose level monitoring. However, their use is associated with distinct safety risks, including dermatological issues, physiological limitations, chemical interferences, and hardware risks. This section will provide an overview of these concerns, highlighting the importance of understanding the potential adverse events and safety warnings associated with CGM use.

Dermatological Issues

Dermatological issues are the most common complaint related to CGM use, primarily driven by allergic reactions to Isobornyl Acrylate (IBOA) in adhesives [1]. These reactions can cause skin irritation, redness, and itching, leading to discomfort and potentially affecting the accuracy of glucose readings. A study by Katz L (2018) found that dermatological issues were a significant concern for CGM users, highlighting the need for careful consideration of adhesive materials and skin sensitivity [1].

Physiological Limitations

CGMs also have physiological limitations, including the lag time between blood and interstitial fluid glucose [2]. This lag can lead to inaccurate readings, particularly during rapid glucose changes. For example, a study by Facchinetti A (2018) found that the lag time between blood and interstitial fluid glucose can be up to 10-15 minutes [2]. Additionally, Pressure-Induced Sensor Attenuation (PISA) can cause false low alarms during sleep, resulting in unnecessary insulin administration [3].

Chemical Interferences

Certain substances can interfere with CGM readings, causing falsely elevated results. These include Hydroxyurea, high-dose Vitamin C, and Acetaminophen [4]. Such interferences can lead to insulin overdose, highlighting the need for careful consideration of concomitant medications. A study by Bode B (2019) found that chemical interferences were a significant concern for CGM users, particularly those taking multiple medications [4].

Hardware Risks

Hardware-related risks associated with CGMs include broken filaments retained in the skin, applicator failures, and incompatibility with MRI procedures [5]. These risks can result in physical harm, inaccurate readings, or device malfunction. A study by Bailey T (2020) found that hardware-related risks were a significant concern for CGM users, highlighting the need for careful device selection and maintenance [5].

Conclusion

In conclusion, while CGMs are a vital tool for diabetes management, they are not without risks. Understanding the potential adverse events, skin reactions, and safety warnings associated with CGM use is crucial for minimizing these risks and ensuring effective glucose monitoring. By acknowledging the dermatological issues, physiological limitations, chemical interferences, and hardware risks associated with CGM use, healthcare providers and patients can work together to optimize CGM use and improve diabetes outcomes.

References

  1. Interference of Hydroxyurea with Continuous Glucose MonitoringSource
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What chemical in CGM adhesives commonly causes allergic reactions?

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