Dexcom G6

The Dexcom G6 has a small needle that, when inserted beneath the skin, measures glucose levels in the body continuously. The Dexcom G6 sensor and transmitter connect to an app (Dexcom Clarity) on a compatible smart device (Apple or Android device) or Dexcom G6 Receiver.

Follow all directions given to you by your doctor and read all documents provided in the User Guide, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Dexcom G6. However, the following is a synopsis of the general guidelines for the use of Dexcom G6:

1. There is no need for calibration with this device.

2. Before inserting the sensor, get started on the Dexcom G6 app or display device. You will need a stable internet connection for the setup. After making an account, follow the app instructions as described below.

3. Check the sensor to make sure it is not expired and that the sterile package is not damaged or open.

4. Next, choose your sensor site. Those 17 years of age or older should use the back of the upper arm or stomach, and those 2-17 years old should use the upper buttocks or stomach. Avoid areas with loose skin, lots of hair, scarring, or irritation. Do not use a spot within 3 inches of an insulin pump.

5. Wash and dry your hands, then clean the chosen site with an alcohol wipe, allowing it to air-dry completely.

6. Next, remove the labels from the sensor and applicator. Place the sensor applicator on the skin, remove the safeguard, and press down to insert the sensor. Each sensor can be worn for up to 10 days.

7. Next, take the Dexcom G6 transmitter from the box and insert it on top of the sensor, pressing down to insert. Rub around the patch 3 times. The transmitter can be used for up to 3 months.

8. You should rotate sites for injection each week.

9. Next, go back to your phone to continue the setup. Press “start sensor” to start the warmup time (about 2 hours), and have a timer counting down.

10. The app will provide you with glucose numbers, glucose data, and customizable alerts and notifications, including low alerts (hypoglycemia), high alerts, urgent low soon alert, and rising fast or falling fast.

11. The app can also connect to compatible insulin pumps to aid with insulin delivery.

The side effects of Dexcom G6 seen in clinical trials as compared to placebo include:

• In rare cases, inserting the sensor can cause infection, bleeding, or pain.
• Adhesive reactions (slight redness/ swelling) are rare, mild, and typically resolve within a week.

Some individuals may experience serious side effects while using Dexcom G6. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• There is a chance a sensor wire could break or detach and remain under your skin; however, these usually don't pose a significant medical risk. If this occurs and shows signs of infection or inflammation, contact your healthcare provider and technical support (dexcom.com/contact).

These are not all of the possible side effects of Dexcom G6. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Dexcom G6, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Any upcoming imaging by magnetic resonance imaging (MRI), computerized tomography (CT), or high-frequency electrical heat (diathermy) - this could damage the Dexcom G6 CGM System and make you miss an important warning. The Dexcom G6 (including sensor, transmitter, receiver, or smart device) should not be worn for these procedures.

• Those who cannot or will not use fingersticks to test their blood glucose, if their symptoms don’t match their sensor readings.
• Those who cannot or will not keep in touch with their healthcare provider regarding diabetes management.
• Pregnancy, dialysis, or critical illness - readings may be inaccurate for you.

After application, the system has a 2-hour warm-up period before you start to receive glucose alerts.

When Dexcom G6 is used with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Taking higher than the recommended doses of acetaminophen (> 1 gram every 6 hours in adults) may falsely elevate your glucose readings.
• Use of hydroxyurea while using the Dexcom G6 may falsely elevate your glucose readings. Treatment decisions should not be made based on these readings.

The Dexcom G6 CGM system is available in 10-day sensors.

The sensors, transmitter, and receiver should be kept at room temperature away from the reach of children or pets. The sensor can be kept in the fridge, but not the freezer.

It is manufactured by Dexcom Inc.

No, but there are similar continuous glucose monitoring systems from FreeStyle Libre, or others by Dexcom, such as the Dexcom G7.

If you stop using your Dexcom G6 and are meant to continue monitoring your blood sugar daily, be sure to continue using a blood glucose meter (glucometer), and let your doctor know

Dexcom G6 is not approved for use in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.