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When using the Omnipod 5 Automated Insulin Delivery System and Dexcom G6 or G7 Continuous Glucose Monitoring (CGM) systems, it's crucial to be aware of specific risks to ensure safe and effective diabetes management.

Device Compatibility and Usage

The Omnipod 5 System is designed for individuals aged 2 years and older who require rapid-acting U-100 insulin. It is not recommended for those unable to monitor glucose levels as advised by their healthcare provider, maintain regular contact with their provider, or use the system according to instructions. Additionally, individuals taking hydroxyurea—a medication for certain cancers and sickle cell anemia—should avoid using the system, as it may cause falsely elevated CGM readings, potentially leading to excessive insulin delivery and severe hypoglycemia. Adequate vision and hearing are essential to recognize system alerts, alarms, and reminders.

Environmental Considerations

Avoid exposing the Omnipod 5 System to environments with low atmospheric pressure (below 700 hPa), such as high elevations above 10,000 feet or during air travel, as this can lead to unintended insulin delivery and hypoglycemia. Similarly, do not use the system in oxygen-rich environments (greater than 25% oxygen), like areas with supplementary oxygen or hyperbaric chambers, due to the risk of combustion, which can cause severe burns. High atmospheric pressure environments (above 1060 hPa), such as hyperbaric chambers, can damage system components, leading to insulin delivery issues and hyperglycemia.

Medical Procedures

Before undergoing medical procedures involving strong radiation or magnetic fields, such as X-rays, MRIs, or CT scans, remove and dispose of the Pod and CGM sensor. Place the Controller outside the procedure room to prevent damage to the components.

Potential Device Malfunctions

Be vigilant for signs of device malfunction. For instance, the Omnipod 5 Controller's charging port and cable have been reported to overheat, potentially leading to melting, deformation, or discoloration. If you notice these issues, disconnect the charger immediately and contact Customer Care. Similarly, certain Dexcom G6 and G7 receivers have experienced speaker malfunctions, which may prevent critical alerts for dangerous blood sugar levels. Regularly test your receiver's speaker and contact Dexcom for a replacement if necessary. (, )

General Precautions

Always carry an emergency kit to address diabetes-related emergencies or potential system failures. Ensure you have supplies for a Pod change if needed. Dispose of used Pods according to local waste disposal guidelines, as they are considered biohazardous and can transmit infectious diseases.

By adhering to these guidelines and maintaining open communication with your healthcare provider, you can effectively manage your diabetes while minimizing potential risks associated with these devices.

When using the Omnipod 5 Automated Insulin Delivery System and Dexcom G7 Continuous Glucose Monitoring (CGM) System, it's important to be aware of potential side effects and safety considerations to ensure effective diabetes management. Omnipod 5 System:

• Insulin Delivery Issues: The Omnipod 5 System relies on accurate sensor glucose readings to adjust insulin delivery. Inaccurate readings can lead to inappropriate insulin dosing, resulting in either hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).
• Skin Reactions: Some users may experience skin irritation at the infusion site, including redness, swelling, or itching. If such reactions occur, consult your healthcare provider.
• Device Malfunctions: There have been reports of the Omnipod 5 Controller's charging port and cable overheating, potentially causing melting or discoloration. Users should monitor the device during charging and discontinue use if overheating is observed. Dexcom G7 CGM System:
• Skin Irritation: The adhesive used in the Dexcom G7 sensor may cause skin reactions such as redness, itching, or rash. If you experience skin irritation, consult your healthcare provider for guidance.
• Medication Interference: Certain medications, like hydroxyurea, can interfere with Dexcom G7 sensor readings, leading to falsely elevated glucose values. This may result in inappropriate insulin dosing. If you're taking hydroxyurea, discuss alternative glucose monitoring methods with your healthcare provider.
• Acetaminophen Use: High doses of acetaminophen (exceeding 1 gram every 6 hours) may affect sensor readings, making glucose levels appear higher than they actually are. It's advisable to adhere to recommended acetaminophen dosages to maintain accurate sensor readings. General Recommendations:
• Regular Monitoring: Consistently monitor your blood glucose levels and be attentive to any unusual symptoms.
• Device Inspection: Regularly check your devices for signs of wear, damage, or malfunction.
• Consult Healthcare Providers: If you encounter any issues or have concerns about your diabetes management devices, seek advice from your healthcare provider promptly. Being informed about these potential side effects and safety considerations can help you use the Omnipod 5 and Dexcom G7 systems more effectively and safely.

The Omnipod 5 Automated Insulin Delivery (AID) System now integrates with both the Dexcom G6 and G7 Continuous Glucose Monitoring (CGM) systems, offering enhanced flexibility for diabetes management. This integration allows users to choose between the two CGM options based on their preferences and needs.

For Android users, the Omnipod 5 App is compatible with both Dexcom G6 and G7 sensors. This compatibility enables full control of the Omnipod 5 system, including insulin delivery adjustments and monitoring, directly from a compatible Android smartphone.

iPhone users can now also control their Omnipod 5 system integrated with Dexcom G7 through the Omnipod 5 App for iPhone. This development provides iPhone users with the convenience of managing their diabetes care seamlessly from their device.

The integration of Omnipod 5 with Dexcom G7 brings several benefits, including a shorter CGM warm-up period of approximately 30 minutes, allowing users to spend more time in automated mode. Additionally, the system features an intuitive QR code scanning option for easy sensor pairing.

It's important to note that the Omnipod 5 Pods compatible with both Dexcom G6 and G7 sensors use the same prescription code as previous Omnipod 5 Pods. This means that users won't need a new prescription, and insurance coverage remains similar to what they have with Omnipod 5 today.

For those considering switching between Dexcom G6 and G7 sensors, it's advisable to consult with a healthcare professional to discuss the change. They can provide guidance on obtaining a prescription for the new sensor and offer training on its use.

In summary, the integration of Omnipod 5 with Dexcom G6 and G7 CGM systems offers users enhanced flexibility and convenience in managing their diabetes, with options for both Android and iPhone users to control their system directly from their smartphones.