Adjunctive vs Non-Adjunctive
Definition
A regulatory classification that determines whether a CGM can be used as the sole basis for treatment decisions. Adjunctive CGMs require the user to confirm readings with a traditional fingerstick blood glucose test before making insulin dosing or treatment decisions. Non-adjunctive (also called iCGM or integrated CGM) devices like the Dexcom G7 and FreeStyle Libre 3 have demonstrated sufficient accuracy to replace fingerstick testing entirely for treatment decisions, including insulin dosing. The FDA's iCGM classification, introduced in 2018, codified the accuracy standards required for non-adjunctive use.
Why “Adjunctive vs Non-Adjunctive” Matters for Glucose Monitoring
Understanding adjunctive vs non-adjunctive is essential for anyone using or evaluating a continuous glucose monitor. This concept directly affects how CGM devices are designed, how glucose data is interpreted, and how clinical decisions about blood sugar management are made. Regulatory classifications determine which CGMs you can buy without a prescription, which devices can be used for insulin dosing, and how insurance coverage is determined.
This term is particularly relevant to 3 CGM products in our database. Understanding adjunctive vs non-adjunctive helps you compare devices more effectively and choose the right continuous glucose monitor for your specific needs.
Related Terms
The regulatory approval pathway for CGM devices in the United States, typically through the FDA's 510(k) process, which requires the manufacturer to demonstrate that a new device is substantially equivalent to an existing legally marketed device.
Mean Absolute Relative Difference, the gold standard metric used to evaluate CGM sensor accuracy.
The process of verifying and adjusting CGM accuracy by comparing a sensor reading against a traditional fingerstick blood glucose measurement.
A wearable medical device that tracks glucose levels in interstitial fluid 24 hours a day through a tiny sensor inserted just under the skin.