What is Omnipod: Uses, Warnings & Interactions

The Omnipod system consists of a pod, controller, smartphone app, and, in some cases, a continuous glucose monitoring (CGM) system.

• The pod delivers insulin, receives commands from the controller or smartphone app, and can give manual insulin boluses.

• The controller or smartphone app programs the insulin pump, receives glucose levels from the CGM sensor, displays glucose and insulin information, and can be used to tell the pump to give manual insulin boluses.

• The CGM sensors (Dexcom 6 or Dexcom 7) monitor tissue glucose and sends those values in real time to the pump and the controller or app.

Setting up and using the system is complex and involves many steps. Space does not allow for all these instructions to be reproduced or even summarized here. Instead, here are a few general principles and tips:

Insulin:

• The Omnipod system only uses rapid-acting insulin—U-100 NovoLog (insulin aspart), Humalog (insulin lispro), and Admelog (insulin lispro). Do not use any other kind of insulin.

• The Omnipod system continuously delivers basal doses throughout the day (rather than one or two doses of longer-acting insulin) and bolus doses as meal doses or correction doses.

General tips:

• You should be familiar with the operation of all the parts of the system.

• Avoid placing the pod in any location where it might easily be dislodged such as under a waistband or near skin folds.

• Avoid extreme temperatures when wearing the pod. The pod can operate safely between 41°F and 104°F.

• Do not use sunscreen, bug spray, body oils, or skincare products on the skin around the pod.

• Keep the controller, PDM, or smartphone app on and near you at all times so that you can respond to any alarms.

Be familiar with the system and the instructions:

• You must receive training in all the device components, set-up, and use of the Omnipod before you can start using the device.

• The Omnipod systems come with a Quick Start Guide and User Guide. Please read this guide completely before the system is prescribed or started.

• Dexcom 6 and Dexcom 7 sensors come with Instructions for Use. Please read these instructions before using the sensors and the app.

Set up the apps:

• The Omnipod Dash comes with a Personal Diabetes Manager controller and a pod. The Ominpod Dash is not controlled through a smartphone.

• The Omnipod 5 can be administered by the controller or your smartphone. 

• The Omnipod app only works on Android phones.

• No matter what you choose, you must first power up and set up the controller or PDM using the setup screens.

• If using your smartphone, download the app. Always keep the phone and the device’s Bluetooth on.

• If you decide to switch from the controller to a smartphone, you must remove any active pod and repeat the entire setup procedure.

Setting up the Dexcom sensor:

• If using a Dexcom CGM sensor, setting it up is a good second step after setting up the controller or the app. 

• You cannot use the Dexcom receiver that pairs with the sensor if you are also connecting the sensor to Omnipod. Keep the Dexcom receiver turned off.

• The sensor has to be set up using the Dexcom app on the smartphone.

• You must then select the sensor in the Omnipod 5 app. Follow the guide or the onscreen instructions.

• If you want to switch sensors, you will have to do that the next time you change the pod.

Set up the Omnipod 5 pod:

• Set up the pod in the app or controller. 

• You will need to fill the pod with insulin. Follow the instructions in the Quick Start Guide.

• When it is filled, the final steps and activation are completed by the app or controller. Place the pod near the controller or smartphone with the app open to complete these steps.

Set up the Omnipod Dash pod:

• Set up the PDM by using the Quick Start Guide or the User Guide. The User Guide has more detailed instructions.

• Connect the PDM to your Contour Next One blood glucose readings if appropriate.

• Fill the pod by following the instructions in the User Guide.

• Touch the pod to the controller to pair the pod and the PDM.

• The PDM will complete the pod’s setup.

• Immediately apply the pod to the skin. The pod will beep every five minutes until it’s applied to the skin. If the pod Is not applied within 60 minutes of activation, the pod will be unusable.

Place the pod:

• Read the Pod Placement Guide before starting.

• The Quick Start instructions (Omnipod 5) or User Guide (Omnipod Dash) will show you the appropriate locations on the body where the pod can be placed. Read the instructions for details.

• If using a Dexcom sensor, the sensor must be on the same side as the pod so that the devices can communicate. The sensor and the pod must be at least three inches apart.

• For both the Omnipod 5 and Omnipod Dash, the app will display all the instructions for applying the sensor. You can also use the Quick Start Guide (Omnipod 5) or User Guide (Omnipod Dash), but you will still have to proceed through the app’s screens.

• The Pod Placement Guide lists recommended products that can be used to keep the pod securely attached to the skin or keep the skin protected from the adhesive.

Change the pod when:

• It’s low on insulin or out of insulin

• It’s expired or nearing expiration

• An alarm tells you to remove the pod

• The pod or cannula is dislodged

• Glucose levels are higher than 250 mg/dL or ketones are present

• Symptoms of high blood sugar are experienced

• An activated pod does not beep during a diagnostic test

• Encountering any other situation the prescriber has indicated necessitates a pod change

• Three days have passed after an Omnipod Dash pod has been activated and applied to the skin

Change the pod:

• To change the pod, you must first deactivate the old pod in the controller, PDM, or app. Follow the instructions in the Quick Start Guide (Omnipod 5), User Guide (Omnipod Dash), or the app.

• After deactivation, the pod can be removed from the skin.

• The new pod can be activated and placed on the skin.

• Always choose a new infusion site when changing pods.

Using the pod and app:

• The Technical User Guide (Omnipod 5) and User Guide (Omnipod Dash) have a full set of instructions for using all the functions of the app to control and monitor the pod.

• When the pod and the controller, PDM, or smartphone are not in communication, the pod will continue in its automated mode to deliver doses. To monitor or change the program and to receive alarms, the devices must be brought close together to re-establish communication.

• When wearing the pod, regularly check to make sure the cannula is properly inserted. Regularly check the skin around the pod and cannula to check for signs of infection.

• The pod is waterproof and can be cleaned gently with a washcloth. Do not use chemicals, detergents, or solvents. You MUST hold the pod securely when washing or drying it so that the cannula does not dislodge. 

• If the pod gets wet (swimming, shower, or bath), gently dry it with a towel.

If a pod needs changing, it must be removed and the new pod placed and activated.

If it is not, you must resume insulin injections until a new pod is placed and activated.

If you forget to replace a Dexcom sensor, the pod will continue following its automated programs. 

Any changes in blood sugar must be managed with the controller. PDM, or app.

The sensor can be replaced at any time and paired with the controller or app.

As a medical device, the Omnipod pump is not contraindicated in anyone who can take insulin shots.

All the device components must be removed before any MRI scan, CAT scan, or high-frequency electrical heat treatment (diathermy). All Omnipod components including the controller, PDM, or smartphone should not even be in the same room as the procedure.

The Omnipod is not recommended for people who:

• Cannot monitor their blood glucose levels

• Cannot contact their healthcare provider

• Cannot use the Omnipod system

• Have hearing or vision problems that interfere with their ability to use or recognize all the functions of the system

Read all the warnings and precautions in the Omnipod 5 Technical User Guide or the Omnipod Dash User Guide.

To be safe, ALWAYS carry insulin and be ready to inject it if something happens to the pod.

Always be ready to treat hypoglycemia.

Do not use any part of the system including the pod if you suspect that it is damaged. Immediately remove and replace the pod if you notice it has any problems.

Exposing the pod to certain environments can cause serious problems including mistakes in insulin delivery. Remove the device or completely avoid:

• Very high or very low temperatures

• Hot tubs, pools, or saunas

• Low air pressure below 700hPA (altitudes greater than 10,000 feet or an airplane flight)

• High air pressure (such as a hyperbaric chamber)

• Rich oxygen environments (such as some surgical areas)

Do not expose the pod to direct sunlight for extended periods.

Take care of the controller, PDM, or smartphone.

• Keep the battery charged.

• Protect the device from extreme heat.

• Protect the device from water (the controller and PDM are not waterproof). 

• Keep the device away from children and pets.

• Keep the device near you at all times so that you can respond to alarms.

• Do not share your PIN or allow children to play on the smartphone running the app.

• Only caregivers or parents should operate the Omnipod 5 controller/app or the Omnipod Dash PDM when the pod is used on a child.

If using the smartphone app:

• Keep the phone on.

• Keep Bluetooth on and enabled.

• Keep the app running in the background. Never close the app.

• Do not delete the app while wearing an active pod.

• Never install other apps from untrusted sources. Malware could cause the app to run incorrectly.

• Do not enable any app development settings on the phone.

If you believe the phone has been compromised:

• Delete any suspect app

• Remove the pod and begin regular insulin injections

• Restore the phone to factory settings

To avoid high blood sugar, always respond to hazard alarms as soon as they go off.

• If you do not respond to the shut-off alarm, the pod will automatically shut down and stop insulin injections 15 minutes after it has sounded.

Monitor your blood glucose levels as instructed by your doctor.

Do not enter any blood glucose reading into the app if it is older than 10 minutes.

Do not wear the Dexcom sensor for longer than 10 days or try to reuse an old sensor. When paired with an Omnipod, inaccurate sensor readings can cause the system to deliver the wrong insulin doses.

Be careful when changing time zones. You must update the app with the time zone change or it will use the wrong schedule to deliver insulin doses.

• To avoid this problem, do not turn off Automatic Time Zone on the controller or app.

The Omnipod can cause skin infections. Regularly check the skin around the pod. If you spot signs of an infection, immediately remove the pod and put it on a different area of the body. 

Tell any doctor or other healthcare provider who treats you that you are using an Ominpod device. 

The prescriber will need to schedule regular visits and blood tests for critical monitoring. Do not miss any follow-up appointments.

People taking fast-acting insulin will already be familiar with insulin drug interactions. All of these drug interactions apply to the fast-acting insulins used in the Omnipod. 

The Omnipod system itself also has significant drug interactions:

The Omnipod system cannot be used in anyone taking the cancer drug hydroxyurea.

Avoid taking insulin by injection or inhalation when wearing an active Omnipod. The Omnipod cannot track insulin that is not delivered directly through the device.