Omnipod® System Parent & Caregiver Guide

The Omnipod^® System provides up to 3 days¹ of nonstop insulin delivery* so kids with diabetes can run, play, and move, all while staying in control of their insulin. The system is simply 2 parts—the tubeless Pod and the handheld Personal Diabetes Manager (PDM) that your child keeps nearby so you can both wirelessly program insulin delivery. The Pod is waterproof², lightweight, and discreet, and can be worn anywhere you would give an injection. The Omnipod^® System helps simplify insulin delivery, so kids can be kids and you can worry less. That’s just part of what makes people so passionate about the Pod.

Preparing your child to start on Omnipod^®

Whether you’re a school nurse, daycare provider, parent, grandparent, or other secondary caregiver for a child using the Omnipod^® System, this guide will lead you through some of the key functions you may need to perform. In an emergency, you should call the child’s healthcare provider, as well as the parent or emergency contact.

Have questions? We’re here to help with our 24/7 comprehensive customer support 

Customer Care: 800-591-3455
From outside the US: 978-600-7850

A small, lightweight Pod that’s easy to apply and wear daily.

A wireless Personal Diabetes Manager (PDM) that’s easy to use.

Main Menu Items

Bolus: Deliver bolus doses to cover carbohydrates and/or correct high blood glucose (BG) levels.

More actions:

• Change the Pod
• Add BG readings
• Assign/edit BG tags
• Food library

Temp basal: Adjust insulin delivery for exercise or illness according to your Diabetes Management Plan. This menu item is present only if the Temp basal option is turned on.

My records: Review insulin delivery, blood glucose history, alarm history, carbohydrate history, and personal user information.

Settings:

• Enter, edit, and name basal programs
• Program temp basal, carbohydrate, and bolus presets
• Customize system settings

Suspend: Temporarily suspend, cancel, or resume insulin delivery programs

A bolus is an extra dose of insulin that helps manage the rapid natural rise in blood glucose (also known as blood sugar) that results when you eat carbohydrates (sugar or starch). A correction bolus delivers insulin to counteract high blood glucose levels. Follow the steps below to check the child’s blood glucose level, determine the appropriate bolus and deliver the bolus. These steps assume that the suggested bolus calculator has been turned on as part of the child’s Diabetes Management Plan. Because children’s food intake is often unpredictable, consult the child’s Diabetes Management Plan or healthcare provider to determine the appropriate timing of insulin delivery.

Step 1.

• Insert FreeStyle^® test strip into strip port.
• Check that the code on the vial of test strips matches the code on the PDM screen.
• If the codes do not match, use the Up/down controller button to match the code on the PDM to the code on the vial.

Step 2.

• Wash the finger with soap and water or an alcohol wipe and dry it completely.
• Prick finger with the lancing device.
• Press Light to illuminate the test strip in low-light situations.
• Apply blood sample to test strip.

Step 3.

• When blood glucose reading appears, press Next to continue.


Step 4.

• If eating now, press Yes OR
• If not eating, press No

Step 5.

• If eating, press the Up/down controller button to enter the correct number of carbs, then press Enter.

Step 6.

• Review the BG and carb values to make sure they are correct, then press Confirm.

Step 7.

• Press the User info/support button to view how the suggested bolus is calculated. Then press Close.

Step 8.

• Press Enter to accept the suggested bolus OR
• Press Extend and follow on-screen instructions to deliver a portion/percentage of the bolus immediately and the rest over a set period of time. Only use the Extend option when required by the child’s Diabetes Management Plan.
• If extended boluses are not part of the child’s Diabetes Management Plan, the Extend option will not appear on the screen.

Step 9.

• Press Confirm to start the bolus

Step 10.

• The PDM screen will indicate when bolus delivery has begun. If necessary, you may press Cancel to stop a bolus while it is being delivered.
• The child does not need to remain near the PDM during delivery. Delivery time varies based on the size of the bolus dose.
• Once bolus delivery begins, you may press and hold the Home/power button to turn off the PDM screen.

Warning

Measurements obtained from alternate site testing should not be used to calculate insulin doses with Omnipod Insulin Management System. For more information about blood glucose testing, control solution testing, manual blood glucose test entry and the Suggested Bolus Calculator, see Chapter 7, Checking Your Blood Glucose, in your Omnipod^® Insulin Management System User Guide.

Caution: Consult User Guide.

You may need to change the Pod:

• When the reservoir is low or empty, or the Pod is nearing expiration
• In response to an alarm
• If the Pod/cannula has become dislodged
• If the child has a blood glucose reading of 250 mg/dL or more and ketones are present
• If the child experiences unexpected elevated blood glucose levels
• As directed by the child’s healthcare provider

How to change the Pod:

1. Turn on the PDM. Press the Home/ Power button, then select More actions.
2. Select Change Pod.
3. Press Confirm to deactivate the Pod. Gently remove the deactivated Pod by slowly peeling back the adhesive. (Our users have reported commercial solvent or baby oil can be helpful to soften the adhesive if necessary.)
4. Press Yes to activate a new Pod. Follow the steps to Activate a New Pod on this page to fill a new Pod with insulin. As you proceed, if the PDM screen times out, press and hold the Home/Power button to turn it back on.

Caution: Consult User Guide.

Pod placement options

The Pod may be placed over any subcutaneous tissue in most places one would deliver an insulin injection. Please note the recommended positioning for each body area. The child’s Diabetes Management Plan or healthcare provider should indicate any preferred sites.

Pod Positioning

Arm and Leg: position the Pod vertically or at a slight angle.

Back, Abdomen, and Buttocks: position the Pod horizontally or at a slight angle.

Site Selection

Change the site location each time you apply a new Pod; improper site rotation can reduce insulin absorption. The new site should be at least 1 inch away from the previous site, 2 inches away from the navel, and not over a mole or scar.

Optimal Adhesion

Always clean the site thoroughly with an alcohol swab to remove all body oils and lotions, which may loosen the Pod’s adhesive Let the site air-dry completely; do not blow on the site to dry it.

See the Pod Placement Guide for more information.

Activate a New Pod:

Wash your hands and assemble the following supplies:

• Vial of insulin at room temperature (U-100, rapid-acting). See User Guide for insulins that are safe for use with the Omnipod^® System.
• One sealed Pod 
• PDM
• Alcohol prep swab

If the PDM screen times out during the process, press and hold the Home/power button to continue.

Step 1. Fill the Pod

1. Remove the Pod from its sterile packaging.
   1. Use the alcohol prep swab to clean the top of the insulin vial.
   2. Assemble the fill syringe by twisting the needle onto the syringe.
2. Remove the protective cap.
3. Draw air into the fill syringe equal to the amount of insulin indicated in the child’s Diabetes Management Plan.
   1. Depress air into the vial of insulin.
   2. Turn the vial and syringe upside down.
   3. Withdraw insulin from the vial and fill the syringe with the amount of insulin indicated in the child’s Diabetes Management Plan; fill at least to the MIN line.
   4. Remove any air bubbles from the syringe.
4. Insert the needle straight down into the fill port on the underside of the Pod. To ensure proper fill, do not insert fill syringe at an angle into the fill port.
   1. Completely empty the syringe into the Pod.
   2. The Pod will beep twice, indicating that the System is ready to proceed.
5. Return to the PDM. If the PDM screen times out, press and hold the Home/power button to turn it back on.
   1. Press Next.
   2. The PDM establishes a one-to-one relationship with the Pod, which will not allow it to communicate with any other Pod while this Pod is active. Once the Pod successfully completes its priming and safety checks, the PDM will beep.

Step 2. Apply the Pod

1. Select the infusion site, being careful to avoid areas where the Pod will be affected by folds of skin. Refer to the section above for recommended sites and placement tips.
2. For optimal adhesion, always clean the site thoroughly with an alcohol swab to remove all body oils and lotions, which may loosen the Pod’s adhesive. Let the site air-dry completely; do not blow on the site to dry it.
3. Remove the needle cap.
4. Remove and discard the white paper backing from the adhesive.
5. Apply the Pod to the selected site.
   1. Run your finger around the adhesive to secure it.
   2. Press Next on the PDM.
   3. To facilitate insertion, place one hand over the Pod and make a wide pinch around the skin surrounding the viewing window; this step is critical if the insertion site does not have much fatty tissue.

Step 3. Press Start

1. Press Start. The Pod automatically inserts the cannula and delivers a prime bolus to fill the cannula with insulin. It takes a few seconds to complete this process. Release the skin after the cannula inserts.
2. Once complete, the PDM indicates that the Pod is active and asks you to check the infusion site.
   1. Look through the Pod’s viewing window to check that the cannula is properly inserted, then press Yes.

Caution and Warnings

CAUTION: Do not use any other type of needle or filing device besides the syringe provided with each Pod.

WARNING:

NEVER inject air into the fill port. Doing so may result in unintended or interrupted insulin delivery.

NEVER use a Pod if you hear a crackling noise or feel resistance when you depress the plunger. These conditions can result in under-delivery of insulin.

NEVER inject insulin (or anything else) into the fill port while the Pod is on the child’s body. Doing so may result in unintended or interrupted insulin delivery.

The PDM will generate an automatic reminder to check the child’s blood glucose 1.5 hours after each Pod change. If the cannula is not properly inserted, hyperglycemia may result. Verify there is no wetness or scent of insulin, which may indicate the cannula has dislodged.

The basal rate refers to the steady dose of insulin the child receives at all times. You may need to:

• Temporarily increase the basal rate in response to high blood sugar if, for instance, the child is ill.
• Temporarily decrease the basal rate prior to increased physical activity (physical education or organized sports) or in response to low blood sugar that does not respond to oral carbohydrates or other efforts.

The child’s Diabetes Management Plan or healthcare provider should provide the appropriate temp basal rates.

Step 1.

1. Turn on the PDM.
2. Press the Home/power button, then select Temp basal.
3. If temporary basal rates are not part of the child’s Diabetes Management Plan, the Temp basal option will not appear on the screen.

Step 2.

1. Choose Increase or Decrease basal rate, then press Next.
2. + Enter % change (or temp basal rate), then press Enter. (Shown here is an example of a temporary basal increase. In this example, 25% MORE insulin will be delivered).

Caution: Consult User Guide.

If the child has severe low blood sugar you may need to suspend insulin delivery.

Step 1.

1. Turn on the PDM.
2. Press the Home/power button, then select Suspend.

Step 2.

1. Enter the length of time the suspension should last, then press Enter.

Step 3.

1. Press Confirm.

Step 4.

1. The Status screen indicates that insulin delivery has been suspended.

Step 5.

1. The Pod will beep every 15 minutes until the end of the suspension period. At the end of the suspension period, a Pod advisory alarm will occur. At this time, turn the PDM on and press OK to resume the active basal program.

WARNING: Insulin delivery will not resume until you press OK. If you do not press OK to resume insulin delivery, you could develop hyperglycemia (high blood glucose).

You should have the following supplies on hand at all times:

• Several new, sealed Pods
• Extra new PDM batteries (at least two AAA alkaline)
• A vial of rapid-acting U-100 insulin
• Syringes or pens/needles for injecting insulin
• Instructions from the child’s healthcare provider about how much insulin to inject if delivery from the Pod is interrupted
• Blood glucose test strips
• Ketone test strips
• Lancing device and lancets
• Glucose tablets or another fast-acting source of carbohydrate
• Alcohol prep swabs
• If traveling, a copy of a letter from the child’s healthcare provider for airline security
• Phone numbers for the child’s parents, healthcare provider, and emergency contact
• Glucagon emergency kit and written instructions for giving an injection