Name of the Procedure:

Transmitter; external, for use with interstitial continuous glucose monitoring system (A9277)

Summary

In laymen's terms, this procedure involves attaching an external transmitter that works with a glucose monitoring system. The system continuously measures glucose levels in the interstitial fluid (the fluid between cells) and sends that information to a receiver or a compatible device.

Purpose

This transmitter is used to help manage diabetes by continuously monitoring glucose levels. The aim is to provide real-time glucose readings, thereby assisting in better glycemic control and reducing the risk of complications associated with diabetes.

Indications

• Individuals diagnosed with diabetes (Type 1 or Type 2).
• Patients who experience frequent hypoglycemia or hyperglycemia.
• Patients who have difficulty managing their blood glucose levels with traditional finger-prick tests.
• Those who require continuous glucose monitoring as preferred by their healthcare provider.

Preparation

• Clean the skin area where the sensor will be attached.
• Ensure that the compatible continuous glucose monitoring (CGM) sensor is functioning properly.
• No fasting or specific medication adjustments are typically required, but follow any specific instructions provided by your healthcare provider.

Procedure Description

1. Preparation: The skin area is cleaned and possibly disinfected.
2. Attachment of Sensor: A compatible interstitial glucose sensor is inserted into the skin.
3. Connecting the Transmitter: The external transmitter is then connected to the sensor.
4. Syncing: The transmitter is synced with the receiver or a compatible device to start transmitting glucose data.

Tools and equipment involved include the CGM sensor, the external transmitter, and a receiver/device for data display. There is no need for anesthesia or sedation.

Duration

The entire setup process typically takes about 15 to 30 minutes.

Setting

The procedure can be performed at home, in a doctor’s office, or in an outpatient clinic.

Personnel

• The procedure can be carried out by the patient themselves or with the assistance of a healthcare provider, such as a nurse or diabetes educator.

Risks and Complications

• Common Risks: Skin irritation or allergic reaction at the site of sensor insertion.
• Rare Risks: Infection at the insertion site, transmitter malfunction or signal loss.
• Management: Issues can usually be managed at home (e.g., applying creams for irritation) or by contacting a healthcare provider if serious complications arise.

Benefits

• Continuous Monitoring: Real-time tracking of glucose levels.
• Improved Glycemic Control: Helps in maintaining targeted glucose levels.
• Alert System: Provides alerts for high or low glucose levels, allowing for immediate action. Benefits are typically realized almost immediately upon proper setup.

Recovery

• Post-Procedure Care: Regularly check the sensor and transmitter for proper function and skin for signs of irritation.
• Expected Recovery: There is no recovery time needed beyond regular monitoring and maintenance of the device.

Alternatives

• Finger-Prick Tests: Traditional method of blood glucose testing.

  • Pros: Tried and tested, widely available, and cost-effective.
  • Cons: Provides only momentary glucose levels, not continuous monitoring.

• Implantable CGM Systems: Systems with sensors that are implanted under the skin.

  • Pros: Longer-term monitoring without frequent sensor changes.
  • Cons: More invasive, possible need for minor surgical insertion.

Patient Experience

• During the Procedure: Mild discomfort or a pricking sensation when attaching the sensor.
• After the Procedure: Slightly aware of the device presence, but minimal discomfort. Glucose levels are monitored painlessly and continuously. Any discomfort is generally manageable and subsides quickly.
• Pain Management: Over-the-counter pain relief can be used if necessary, but typically no pain management is required.