Introduction and Overview
The DexCom STS Sensor is part of the DexCom STS Continuous Glucose Monitoring System, which is designed for tracking glucose levels in adults aged 18 and older with diabetes. This system is used to detect significant fluctuations in blood sugar levels, assisting in both immediate and long-term management of diabetes. The product is intended for patient use at home as well as in clinical settings and requires a prescription.
Indication for Use
The DexCom STS System is an adjunctive tool meant to supplement rather than replace traditional home glucose monitoring methods. It enables users to recognize patterns and trends in glucose levels, foresee hyperglycemia and hypoglycemia events, and make appropriate therapeutic adjustments.
Contraindications and Warnings
It’s crucial to remove the STS System before undergoing MRI procedures. Additionally, taking acetaminophen while using the STS Sensor could impact the system’s performance. The STS System is not a replacement for blood glucose meters. It should be used alongside such devices, with blood glucose meters being the primary reference for making treatment-related decisions.
Precautions for Effective Use
Precautions include hand hygiene before handling the device, avoiding contact with the Sensor’s adhesive side, and skin cleaning prior to Sensor insertion. Users are advised to adhere to a Sensor rotation schedule to avoid skin irritation and other complications related to Sensor placement. Insulin injections should be kept separate from the Sensor area. Also, the Sensor must be protected with a suitable bandage during exposure to water.
Principle of Operation
The STS Sensor operates through an electrochemical reaction facilitated by glucose oxidase, an enzyme that transforms glucose concentration into electronic signals. These signals, transmitted by the STS Transmitter, are then processed by the STS Receiver, which in turn provides the user with glucose readings.
Reagents, Storage, and Handling
The enzyme glucose oxidase is sourced from Aspergillus niger and is handled under specific production guidelines to minimize tissue reaction risks. As for storage, the STS Sensors should be maintained within a specified temperature range and used before their expiration date. Sensors exposed to inappropriate conditions or with compromised packaging should be discarded and not used.
The manual emphasizes that results from the DexCom STS System must be cross-verified with a standard blood glucose meter and clarifies that the device’s performance when calibrated less frequently than every 12 hours has not been studied, hence the importance of regular calibration is stressed for consistent device accuracy.
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