Safety & Warnings

Non-Invasive Glucose Monitoring Technologies

Non-Invasive Glucose Monitoring (NIGM) aims to measure glucose without skin penetration, utilizing technologies like Near-Infrared (NIR) spectroscopy, Raman spectroscopy, and Radio Frequency (RF) sensing. Key players include Apple (silicon photonics), Samsung, and specialized startups like Know Labs (Bio-RFID) and Afon Technology.

Despite heavy investment, no non-invasive device is currently FDA-cleared for diabetes management. In February 2024, the FDA issued a safety communication warning against smartwatches and rings claiming to measure glucose, citing serious risks of inaccurate dosing. Current non-invasive prototypes struggle with MARD scores above 15%, physiological interference (sweat, motion, skin pigmentation), and signal specificity, failing to match the ~8% accuracy of minimally invasive CGMs like Dexcom or Libre.

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Introduction to Non-Invasive [Glucose Monitoring](/) Technologies

Non-Invasive Glucose Monitoring (NIGM) technologies have emerged as a promising approach for measuring glucose levels without penetrating the skin. These technologies utilize various methods, including Near-Infrared (NIR) spectroscopy, Raman spectroscopy, and Radio Frequency (RF) sensing [1]. Several key players, such as Apple, Samsung, and specialized startups like Know Labs and Afon Technology, are actively involved in the development of NIGM technologies.

Current Status of NIGM Technologies

Despite significant investment in NIGM research and development, no non-invasive device is currently FDA-cleared for diabetes management [2]. In fact, the FDA has issued a safety communication warning against the use of smartwatches and rings that claim to measure glucose levels, citing serious risks associated with inaccurate dosing [3]. The current status of NIGM technologies is characterized by several challenges, including:

  • High MARD scores: Current prototypes have MARD scores above 15%, which is significantly higher than the ~8% accuracy of minimally invasive Continuous Glucose Monitors (CGMs) like Dexcom or Libre [4].
  • Physiological interference: Factors such as sweat, motion, and skin pigmentation can interfere with the accuracy of NIGM devices [5].
  • Signal specificity: NIGM devices often struggle to specifically detect glucose signals, leading to inaccurate readings [6].

Technical Challenges and Future Directions

To overcome the current limitations of NIGM technologies, researchers and developers must address the technical challenges associated with these devices. This includes improving the accuracy and reliability of NIGM devices, as well as reducing the impact of physiological interference and signal specificity issues. Further research and development are needed to advance the field of NIGM and to bring these technologies to market.

Conclusion

In conclusion, NIGM technologies hold promise for convenient and pain-free glucose monitoring, but significant technical challenges must be overcome before these devices can be widely adopted. By addressing the current limitations and challenges associated with NIGM technologies, researchers and developers can work towards creating accurate, reliable, and safe devices for diabetes management.

References

  1. FDA Safety Communication: Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose LevelsSource
  2. Know Labs: Bio-RFID Technology ExplanationSource
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Why have non-invasive glucose monitors struggled to reach market approval?

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