Omnipod® System Podder™ Resource Guide

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 your 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
• Glucagon emergency kit and written instructions for giving an injection if you are unconscious
• Additional blood glucose meter
• Phone numbers for your healthcare provider and/or doctor in case of an emergency

Reorder Tips

• It is a good idea to call your Omnipod^® System supplier (Insulet or other vendor) when you open your last box of 10 Pods. This helps ensure you will have enough supplies in the event additional authorizations are needed from your insurance.
• If your reorder is coming direct from Insulet, you may be eligible for our Autoship program which automatically ships your Pods approximately every 90 days. You can call Customer Care to inquire about enrollment.
• If your reorder is coming from an Insulet authorized distributor, please call them direct to inquire about shipping schedules and options.
• Be sure to inform your distributor of any changes in your insurance coverage.
• If you have forgotten where your reorder is coming from, you can find out in the following ways:
  • Check the shipping label on your last Pod shipment
  • Call your insurance and ask who submitted the most recent claim for Pods
  • Call Customer Care

Important Reorder Contacts:

• Insulet Customer Care: 800-591-3455 ext. 2

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

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

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

What is a basal rate?

Your body needs a small amount of insulin that’s constantly delivered throughout the day, called basal insulin. The exact amount of insulin your body needs changes often depending on:

• What you’re doing throughout the day
• How stressed you are
• When you eat
• When you’re sick

Omnipod^® System lets you personalize your basal rates.

When you first set up your Omnipod^® System, a Certified Pod Trainer will assist you in programming your PDM to deliver the basal rates that are determined by your healthcare provider. If you need to adjust your settings, you have up to 24 time intervals per basal program. You can have up to 7 basal programs.*

What is a bolus dose?

A bolus is an extra dose of insulin, delivered when needed to: match the carbohydrates in a meal or snack and/or to lower your blood glucose when it gets too high. There are two types of bolus doses:

• Meal bolus: With the Omnipod^® System, you can deliver either a normal or an extended meal bolus.
  • A normal meal bolus usually delivers enough insulin for a meal or snack you are about to eat
  • An extended meal bolus delivers insulin over a longer period of time. When you eat foods high in fat and/or protein or are eating over a long period of time, such as at a party, you might need an extended meal bolus.
• Correction bolus: A correction bolus can be delivered with or without a meal bolus if you need to lower your blood glucose level.

Omnipod^® System will help to deliver your bolus doses.

A Certified Pod Trainer will assist you in programming your PDM to deliver the bolus doses that are determined by your healthcare provider when you first set up your Omnipod^® System. As your insulin needs change, you can later adjust these settings.

Calculate bolus insulin doses.

Omnipod^® System also features a Suggested Bolus Calculator to help you deliver an accurate bolus dose. The calculator uses your current blood glucose, carbs entered, and your insulin on board (IOB) to determine a suggested bolus dose.

Caution: Consult User Guide.

For more information about the Suggested Bolus Calculator, see Chapter 4, Understanding and Delivering Bolus Doses, in your Omnipod^® Insulin Management System User Guide.

It is always a good idea to keep a copy of your Pod settings handy in the event you have to set up another PDM. Your healthcare provider will provide you with your initial start rates as well as any future changes. Please download the PDF of the Podder™ Resource Guide and refer to page 9 for a chart where you can record your Pod settings.

Why carbohydrates matter

Carbohydrates are important because they provide us with energy and essential vitamins and minerals. Proteins and fats also contain calories, vitamins, and minerals, but do not contain carbohydrates unless the food is a mixed item like a casserole. Carbohydrates are the primary foods that affect glucose levels. Nearly 100% of digestible starches and sugars become glucose soon after eating. Glucose is then released into the blood stream to provide immediate energy needs, or stored in the muscle or liver as glycogen. Excess glucose is converted to fat for storage.

Impact on blood glucose levels.

Proteins and fats take longer to digest and are slower to affect your blood. Higher consumption of protein or fat at meals can delay glucose absorption and create higher blood glucose levels later. The section “Omnipod^® System Advanced Features” will teach you more about bolusing for certain meals with the Omnipod^® Insulin Management System.

1. Complex carbohydrates include starchy foods and foods with fiber like whole grain pasta, beans, brown rice, or whole wheat bread. Choosing less processed, whole grain products is not only more nutritious, but the fiber can have a favorable effect on your blood glucose and digestive health.
2. Simple carbohydrates include table sugar, honey, syrups, regular soda, fruit juice, jellies and candies. These foods are digested easier and are absorbed into your blood stream faster than complex carbohydrates.

Making Healthy Food Choices. American Diabetes Association website. http://www.diabetes.org/food-and-fitness/food/what-can-i-eat/understanding-carbohydrates/types-of-carbohydrates.html. Updated March 9, 2015. Accessed June 21, 2017
Beaser RS. Joslin's Diabetes Deskbook: A guide for primary care providers. 3rd ed. Boston, MA. Joslin Diabetes Center; 2014
Making Healthy Food Choices. American Diabetes Association website. http://www.diabetes.org/food-and-fitness/food/what-can-i-eat/making-healthy-food-choices/. Accessed June 21, 2017.

Check the label

The two key pieces of information on the nutrition facts label for carb counting are the serving size and total carbohydrates. For more detailed label information, visit the Taking a Closer Look at Labels Labels at http://www.diabetes.org/food-and-fitness/food/what-can-i-eat/food-tips/taking-a-closer-look-at-labels.html. For a more extensive list, visit the USDA Food Composition Databases https://ndb.nal.usda.gov/ndb/search/list.

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 you have a blood glucose reading of 250 mg/dL or more and ketones are present
• If you experience unexpected elevated blood glucose levels
• As directed by your healthcare provider
• If a Pod is active and fails to beep

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 Podders™ 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 on pages 11 and 12 in this guide 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.

Before activating a new Pod, wash your hands and assemble the following supplies

• Vial of insulin at room temperature (U-100, rapid-acting), See Omnipod^® System User Guide for insulins tested and found to be safe for use with the Omnipod^® Insulin Management System
• One sealed Pod
• PDM
• Alcohol prep swab

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 your 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 determined with your healthcare provider; 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 Omnipod^® 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. Place the PDM next to the Pod so they are touching.
   1. Press Next.
   2. The PDM establishes a one-to-one relationship with the Pod, which will prevent it from communicating with any other Pod while this Pod is active. Once the Pod successfully completes its priming and safety checks, the PDM will beep.

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 interrupted insulin delivery

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

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 figures on page 14 of the Podder™ Resource Guide PDF for sites your healthcare provider may recommend 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 Pod’s the needle cap.
4. Carefully remove white paper backing from the adhesive, ensuring the adhesive is clean and intact.
5. Remove and discard the white paper backing from the adhesive.
6. Apply the Pod to the selected site. + Run your finger around the adhesive to secure it.
   1. Press Next on the PDM.
   2. 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.

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

Press Start

1. 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. Look through the Pod’s viewing window, if properly inserted, press Yes. Press No if you see a problem with the cannula.
3. The PDM will generate an automatic reminder to check your blood glucose 1.5 hours after each Pod change.

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

WARNING:

The PDM will generate an automatic reminder to check your 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.

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

Verify cannula does not extend beyond adhesive backing once needle cap is removed. If the PDM screen times out during the process, press and hold the Home/Power button to continue.

It’s easy to find a place for your Pod. And your Pod is tubeless and lightweight, so you can wear it with freedom.

Where to wear your Pod

It’s important to choose a new area every time when placing your Pod to avoid site overuse, which could result in variable absorption. The new area should be at least 1 inch away from the previous one, 2 inches away from the navel and not over a mole, scar, or tattoo, where insulin absorption may be reduced. Be sure to put your Pod somewhere you’ll be comfortable—avoid sites where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the Pod.

How to place your Pod

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.

Pinching up: This step is important if your Pod location is very lean or doesn’t have much fatty tissue. Place your hand over the Pod and make a wide pinch around your skin surrounding the viewing window. Then press the Start button on the PDM. You can let go when the cannula inserts.

WARNING:

Occlusions may result in lean areas if you do not use this technique.

How to secure and remove your Pod

Below are more ways to help secure and remove your Pod.* These tips from Podders™, nurses, and doctors can help you stay tube and worry-free.

Prepping for your Pod

Remember to stay cool and be cool (dry and not sweating) when it’s time to change your Pod. Here are more potential sticking points:

Helpful Products

Experienced Podders™ have reported using the following products to help with comfortable Pod wear.

Preparing your skin

• BD Alcohol Swab - www.bd.com
• Hibiclens - www.amazon.com

Helping the Pod stick: Adhesives and more.

• Bard^® Protective Barrier Film: www.bardmedical.com
• Torbot Skin Tac™: www.torbot.com
• AllKare^® Wipe: www.convatec.com
• Mastisol^®: www.amazon.com
• Hollister Medical Adhesive: www.amazon.com

Protecting your skin: Prevent irritation with barriers and banners.

• Bard^® Protective Barrier Film: www.bardmedical.com
• Torbot Skin Tac™: www.torbot.com^®
• AllKare^® Wipe: www.convatec.com
• Hollister Skin Gel Protective Dressing Wipes: www.amazon.com
• 3M™ Cavilon™ No String Barrier Film: www.3m.com

Holding the Pod in place: Keep your Pod even more secure with tapes and bands.

• Mefix^® 2" Tape: www.amazon.com
• 3MTM Coban™ Self-Adherent Wrap: www.3m.com
• Bands 4 Life Arm and Thigh Bands: www.bands4life.net

Removing your Pod gently : Use a soft touch with moisturizers and removers.

• Baby Oil/Baby Oil Gel: www.johnsonsbaby.com
• UNI-SOLVE◊ Adhesive Remover: www.amazon.com
• Detachol^®: www.amazon.com
• Torbot TacAway Adhesive Remover: www.amazon.com

(After removing your Pod, clean area with warm, soapy water and rinse well to remove any residue still on your skin.)

*Insulet has not tested any of these products to work with the Pod and does not endorse the use of these products with the Pod. These recommendations have been shared with Insulet by other Insulet Podders™ whose needs, preferences and situations may differ from yours. Consult with your healthcare provider prior to the use of any of these products with the Pod. All trademarks are the property of their respective owners.

How often do I need to check my glucose?

You can use the built-in FreeStyle blood glucose meter to check your blood glucose levels as often as you need to. However, you may want to check your blood glucose levels at least a few times a day, in particular:

• When you feel symptoms likeweakness, sweating, nervousness, headaches, or confusion
• When you have delayed a meal after taking insulin
• When your healthcare provider advises you to do so

How do I check my glucose levels with FreeStyle and Omnipod^® System?

Checking your blood glucose levels with the FreeStyle meter requires just a small amount of blood—only 0.3 microliters. However, the first step involves knowing the anatomy of your lancing device. NOTE: to make sure your results are accurate, be sure to wash your hands and the test site with soap and water. Make sure all cream and lotion is removed and dry thoroughly.

WARNING:

Measurements obtained from alternate site testing should not be used to calculate insulin doses with Omnipod^® Insulin Management System.

Caution: Consult User Guide.

Prepare your lancing device in 3 easy steps

1. Snap off the cap of the lancing device at an angle, and insert a new lancet firmly into the white holder cup. This action may cock the device, which is fine.
2. With one hand, hold the lancet in place while twisting off the rounded top with your other hand. Then replace the cap until it snaps back into place. Make sure you do not touch the exposed needle.
3. Set the Depth Setting; the lancing device offers 9 different settings (including half settings). Level 1 is the shallowest depth; Level 5 is the deepest. Use a lower number to lance. Pull back the grey slider until it clicks. (You may have already cocked the device in step 1)
4. You’re now ready to test!

Lancing device depicted is representative only. Please follow the instructions included with your specific lancing device.

Testing your blood glucose level

1. Insert your test strip and set the code.
   1. Insert a new test strip into the test strip port at the bottom of the PDM until it stops. Make sure you insert only the top end of the strip.
      1. To help you see the test strip port in reduced lighting, press the middle soft key labeled Light. To turn the light off, press Light again.
   2. The PDM will display a code number once you insert the strip. This code must match the code on the side of the vial to ensure test accuracy. To change this code, just press the Up/Down Controller to change the numbers until they match.
   3. From some PDM screens, you cannot access the FreeStyle blood glucose meter. For example, you cannot use the meter while you are activating a Pod or when an alert, alarm, or communication error screen is displayed. In these cases, if you insert a test strip, the PDM beeps to alert you.
      1. If you do not start the test within 2 minutes, the PDM powers off. To restart the PDM, take out the unused strip and reinsert it, or simply press and hold the Power button to turn on the PDM.
      2. If you need to adjust the code number after the PDM has moved to the next screen, just press Up/Down Controller buttons. The code screen reappears and you can adjust the number. The code number remains on the PDM screen for your reference until you have completed the BG test.
2. Get your sample and fill the test strip
   1. Tip: Before you lance, you’ll want to stimulate the blood flow by lowering your hand to waist level and gently massaging your finger.
3. Lance the site
   1. Hold the lancing device firmly against the side of your fingertip.
   2. Press the lancing button.
   3. Squeeze your finger, if needed, until a blood drop forms.
4. Return to your PDM, make sure the strip is in the PDM and your screen reads “Apply a blood sample to the strip.” Bring the strip to the blood at a slight angle.

What if my levels are too low or high?

“LOW” or “HIGH” blood glucose readings can indicate a potentially serious condition requiring immediate medical attention. If you get either a “LOW treat your low BG” reading or a “HIGH check for ketones” reading, first check and see if you feel hypoglycemic or hyperglycemic symptoms. If you do not, retest and perform a control solution test to ensure the Omnipod^® System is working properly. If not, or if you feel any symptoms related to hypoglycemia or hyperglycemia, follow your healthcare provider’s recommendation.

Test Strip Do’s and Don’ts

DO:

• Only use FreeStyle test strips and FreeStyle Control Solution with the PDM (Other brands may produce inaccurate results)
• Match the code on the PDM to the side of the vial
• Use a slight angle to bring the test strip to the blood
• Use only one edge of the strip per test
• Add more blood to the strip if the PDM doesn’t display “Checking”
• Only use each strip once
• Throw away the used lancet in a puncture-resistant container and wash hands thoroughly 

DON’T:

• Test your blood glucose while your PDM is connected via USB to a computer. This could result in a shock.
• Press the strip against the test site
• Scrape the blood onto the strip
• Apply blood to the at side of the strip
• Apply blood to the strip when it is out of the meter
• Put blood or other foreign objects into the test strip port
• Pull strip away before you hear 1 beep or see “Checking” on the screen
• Use strips beyond the expiration date printed on the package, as this may cause inaccurate results.

WARNING:

Measurements obtained from alternate site testing should not be used to calculate insulin doses with Omnipod Insulin Management System.

Caution: Consult User Guide.

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.

1. 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.
2. When blood glucose reading appears, press Next to continue.
3. If eating now, press Yes. OR If not eating, press No.
4. If eating, press the Up/Down Controller button to enter the correct number of carbs, then press Enter.
5. Review the BG and carb values to make sure they are correct, then press Confirm.
6. Press the User Info/Support button to view how the suggested bolus is calculated. Then press Close.
7. 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.
   1. Only use the Extend option when directed by your healthcare provider. If extended boluses are not part of your Diabetes Management Plan, the Extend option will not appear on the screen.
8. Press Confirm to start the bolus.
9. 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. You do 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.

Sometimes you may need to briefly stop insulin delivery (for example, when editing an active basal program or changing the time or date).

1. Turn on the PDM. Press the Home/Power button, then select Suspend.
2. Enter the length of time the suspension should last(minimum 0.5 hour, maximum 2.0 hours), then press Enter.
3. Press Confirm.
4. The Status screen indicates that insulin delivery has been suspended.
5. 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).

Important reminder: During the activation and priming of the Pod, the PDM and the Pod should be adjacent and touching. Please refer to the Omnipod^® Insulin Management System User Guide for a full set of instructions.

Important PDM Tips and Reminders

These tips are intended for use only with the PDM UST400 model. The PDM model number is found on the back of the PDM next to the REF symbol.

How to view insulin records

1. On home screen, select My records.
2. Select Insulin delivery.
3. PDM provides summary of today’s information including total boluses, total basal, and total daily doses. Use Up/Down Controller buttons to view the summary for previous days.

How to view multiple-day BG trends

1. On home screen, select My records.
2. Select BG history
3. Press Trends to show BG data for past 7 days.
4. Continue pressing the Middle Soft Key to show trends for previous 14, 30, 60, and 90 days.

How to change existing basal rate

NOTE: Insulin delivery must be suspended before changing basal rates.

1. On home screen, select Settings.
2. Select Basal Programs.
3. Select basal program to be edited.On next screen, select segment to be edited, then press Edit.
4. Enter start time, then press Next and repeat for end time.
5. Enter basal rate for edited segment, then press Enter.
6. Review the settings on the confirmation screen carefully. If the settings are correct, press Confirm.
7. Press Save.
8. Press Save. For additional edits, repeat steps 3-8.

How to change correction factors

1. On home screen, select Settings.
2. Select System setup.
3. Select Bolus/basal/calcs.
4. Select Ratios/factors/ targets. NOTE: Bolus calcs must be “on.”
5. Select Correction factor.
6. Select Add New or Choose Segment and hit Edit. On next screen, enter start time, then press Next and repeat for end time.
7. Enter the correction factor, then press Next.
8. Review the settings on the confirmation screen carefully. If the settings are correct, press Confirm. Repeat steps 6-8 to add or edit segments (up to 8 total segments), then press Done, then Save.

How to change IC ratio or insulin action (duration)

1. On home screen, select Settings.
2. On home screen, select Settings.
3. Select Bolus/basal/calcs.
4. Select Ratios/factors/ targets. NOTE: Bolus calcs must be “on.”
5. To Change IC Ratio
   1. Select IC ratio.
   2. Select Add New or Choose Segment and hit Edit. On next screen, enter start time then press Next and repeat for end time.
   3. Enter IC ratio, then press Next.
   4. Review the settings on the confirmation screen carefully. If the settings are correct, press Con rm. On following screens, press Done, then press Save.
6. To Change Insulin Action
   1. Select Insulin action.
   2. Use Up/Down Controller buttons to change duration of insulin action, then press Enter.

When to use:

This feature is most commonly used for high-fat and/or high-protein meals such as pizza, cheeseburgers, or fried chicken when the digestion of carbohydrates could be delayed.

1. From the home screen, select Bolus.
2. Check or manually enter your current blood glucose, then press Yes.
3. Press Yes. (Only meal boluses can be extended.)
4. Enter the grams of carbs you are about to eat, then press Enter.
5. Review the values on the confirmation screen carefully. If values are correct, press Confirm.
6. A suggested bolus will appear on the screen. Press Extend.
7. Enter amount of meal bolus to deliver now, then press Enter.
8. Enter the duration of time to extend your bolus, then press Enter.
9. A final confirmation will show the entire breakdown of the extended bolus. Press Confirm.
   1. Correction boluses will always be delivered “Now” and cannot be extended with the meal bolus.

WARNING:

When using the extended bolus function the user should check their blood glucose levels more frequently to avoid hypoglycemia or hyperglycemia.

The values shown here are for illustrative purposes only. Actual screens may vary based on user settings. Consult with your healthcare provider before using advanced features. Your healthcare provider can also provide you with your own personalized recommendations.

Important Reminders:

Extended Bolus and Temporary Basal must be selected in% or U/h in System Setup>Bolus/basal/cals Each example is shown with the PDM set to %

Once you have set an Extended Bolus orTemp Basal you can cancel it from the Home Screen>Suspend/Cancel

When to use:

A temporary basal rate lets you adjust your background insulin for a predetermined period of time. This feature is best used to account for a temporary change in a daily routine, such as physical activity or times of illness. Temporary basal rates can be set for durations of 30 minutes to 12 hours; once the time limit is reached, the Pod returns to the active basal program.

1. From the home screen, select Temp basal.
2. Based on your situation, select increase or decrease, then press Next.
3. Enter the % or U/h change for the temp basal, press Enter.
4. Enter the duration for the temporary basal in increments of 30 minutes, press Enter.
5. A summary of your temporary basal details will appear on the screen for review. Press Confirm.

When to use:

Please consult with your healthcare provider prior to creating additional basal programs. Different basal programs are commonly used for entire days out of your common routine (e.g., weekends vs. work days.)

1. From the home screen, select Settings.
2. Select Basal Programs.
3. Select [add new], then press New.
4. You may rename your selection or keep the default name (for example, “basal 2”). Press Next.
5. Enter the first new basal rate provided by your healthcare provider, then press Next.
6. Review the settings on the confirmation screen carefully. If the settings are correct, press Confirm.
7. Press New if you have more basal segments; otherwise press Done.
8. Press Save.

Important Reminders:

To enable your new basal program you must first suspend your pump. Then go to Settings>Basal Programs. Select the new program that you just created, Press Enable to view and confirm the new program, then press Enable to send the program to the Pod.

When to use:

Best used for “temporary” routine activities, such as an exercise class that occurs twice a week. The PDM can store up to 7 temporary basal presets. You will be able to access your temp basal presets when you select Temp Basal from your home screen.

1. From the home screen, select Settings.
2. Select Presets.
3. Select Temp basal presets.
4. Select [add new] press New.
5. Keep default name, or rename. Press Save.
6. Indicate whether you want to increase or decrease your basal rate, then press Next.
7. Enter the % or U/h change for the temp basal preset, then press Next.
8. Enter duration for the temp basal preset, then press Next
9. A summary of the temp basal preset you just created will appear on the screen, then press Save.

Important Reminders:

Presets are a quick way to get many of your Pod actions complete. If you and yourself eating the same foods, or setting the same temp basal rates, Presets can be a real time-saver.

On any preset, you will have the option to rename your entry for even more personalization.

When to use:

Best used for easy access to favorite food items, snacks, or meals that you eat frequently. You will be able to access your carb preset during the bolus calculator process.

1. From the home screen, select Settings.
2. Select Presets.
3. Select Carb presets.
4. Select Favorites, Snacks, or Meals.
5. Keep default name, or rename. Press Next.
6. Enter the amount of carbs in grams, additional nutrition info is optional, then press Next.

When to use:

Bolus presets can only be used if your bolus calculator is OFF. This feature is best for those utilizing set bolus amounts at their meals. You will be able to access your bolus preset when you select Bolus from the home screen.

1. From the home screen, select Settings.
2. Select Presets.
3. Select Bolus presets.
4. Select [add new], then press New.
5. Keep default name, or rename. Press Next.
6. Enter bolus preset amount, then press Next.
7. A summary of the bolus preset you just created will appear on the screen, then press Save.

Blood Glucose (BG) less than 70 mg/dL or ≤ 80 mg/dL with symptoms

Always follow your healthcare provider’s guidelines. The below guidelines are derived from The Joslin Diabetes Center’s recommendations and may differ from your own healthcare providers guidelines.

Never ignore the signs of low blood glucose, no matter how mild. If left untreated, severe hypoglycemia may cause seizures or lead to unconsciousness. If loss of consciousness, inability to swallow glucose treatment or seizures are experienced or observed take the following action immediately:

• Give glucagon as instructed by healthcare provider
• Notify healthcare provider
• Call 911
• Suspend insulin delivery

Never leave a person who is hypoglycemic unattended!

Mild to Moderate Hypoglycemia Symptoms

• Shakiness
• Weakness
• Tingling
• Fatigue
• Blurred vision
• Anxiety
• Hunger
• Headache
• Drowsiness
• Unexplained sweating
• Rapid heartbeat
• Dizziness
• Cold, clammy skin
• Confusion
• Personality change

Action Plan

Verify and check BG level.

1. If BG less than 50 mg/dL
   1. Treat with 30 grams of carbohydrate*
   2. Recheck BG in 15 – 20 mins
2. If BG less than 70 mg/dL
   1. Treat with 15 grams of carbohydrate*
   2. Recheck BG in 15 mins
3. If BG is less than 80 mg/dL or symptoms persist
   1. Repeat above steps†
4. If BG is greater than 80 mg/dL
   1. Follow with a meal or snack
   2. If next meal/snack is 30 mins away, take additional 15 grams of carbohydrate
   3. If next meal/snack is 60 mins away, take an additional 30 grams of carbohydrate

*Rapid-acting carbohydrates such as glucose tabs, glucose gel, juice, regular soda, honey and corn syrup are ideal.

†If BG remains low after repeated treatments, notify your healthcare provider immediately and/or go to the nearest emergency room.

IMPORTANT NOTES: Make sure your blood glucose is at least 100mg/dL before driving or working with dangerous machinery or equipment. Even if you cannot check BG, do not wait to treat symptoms of hypoglycemia. Avoid hypoglycemia unawareness by checking your BG more frequently.

The above general guidelines are drawn from Joslin Diabetes Center. For further guidance please consult with your healthcare provider for individualized advice.

Troubleshooting

Check PDM Settings

• Is the correct basal program active?
• Is the PDM time set correctly? 
• Is the temp basal (if active) correct? 
• Are target blood glucose levels correct? 
• Is the insulin sensitivity factor (or correction factor) correct?
• Is the insulin-to-carb ratio correct?

Consult your healthcare provider for guidance about adjusting settings on your PDM. 

Review Recent Activity

Physical activity:

• Has your exercise been unusually long or strenuous?
• Have you been unusually physically active? (e.g., extra walking, housework, heavy or repetitive tasks, lifting or carrying?)
• Did you use a decreased temp basal during this activity?
• Did you consume carbs before, during and/or after activity?

Meals/Snacks:

• Did you count the carbs correctly—including subtracting significant fiber? 
• Did you bolus with food? 
• Did you consume alcohol?

Consult your Omnipod^® Insulin Management System User Guide for additional information.

Discuss Sick Day Management with your healthcare provider as part of your routine of office visit. Always follow your healthcare provider’s guidelines for your individual needs. Below are only general guidelines.

Emergency situations

• For BG of 250 mg/dL or more see: Hyperglycemia Action Plan
• For BG of 70 mg/dL or less (and/or symptoms) see: Hypoglycemia Action Plan

Throughout an illness

If you have a cold, stomach virus, toothache or other minor illness: 

• Check blood glucose more often (every 2-4 hours or at least 4 times a day)
• Check ketones—any time BG is 250 mg/dL or more
• Use temp basal as directed by your healthcare provider
• Stay hydrated
• Monitor urine output
• Keep a record of information (BG, ketone checks, fluids, and time/amount of urine, vomiting, diarrhea, temperature)

Call your healthcare provider immediately if you have:

• Persistent nausea and/or if you are vomiting/or have diarrhea over two hours
• Difficulty breathing
• Unusual behavior (such as confusion, slurred speech, double vision, inability to move, jerking movements)
• Persistent high BG and/or positive ketones after treating with extra insulin and drinking fluids
• Persistent low BG that is not responsive to decreasing insulin and drinking carbohydrate-containing fluids
• A fever above 100.5°F
• Moderate to large urine ketones or ≥ 1.0 mmol/L blood ketones

IMPORTANT NOTE:

The symptoms of DKA (diabetic ketoacidosis) are much like those of the flu. Before assuming you have the flu, check your BG to rule out DKA. Consult your healthcare provider for further information. Always consult with your healthcare provider when experiencing hyperglycemia and sick days. Always follow your healthcare provider’s guidelines first. 

Caution: Consult User Guide.

Always follow your healthcare provider’s guidelines. The below guidelines are derived from The Joslin Diabetes Center’s recommendations and may differ from your own healthcare providers guidelines.

There are several factors that can cause hyperglycemia. Common causes include illness, stress, infection, and missed insulin doses. As a Podder™, only rapid-acting insulin is used in your Pod, so you have no long-acting insulin in your body. If an occlusion or other interruption of insulin delivery occurs, your blood glucose may rise rapidly. It is important you do not ignore the signs and symptoms of hyperglycemia.

If you are experiencing persistent nausea and/or vomiting, or have diarrhea over two hours, contact your healthcare provider immediately.

Mild to Moderate Hyperglycemia Symptoms

• Fatigue
• Unexplained weight loss
• Frequent urination (i.e. at night)
• Blurred vision
• Unusual thirst or hunger
• Slow healing of cuts or sores

Action Plan

Verify and Check BG level. If BG is over 250 mg/dL Check Urine/Blood for ketones.

Trace or Negative:

1. Take a bolus using PDM*
   1. Address possible causes.
   2. Recheck BG in 2 hours.
2. If BG unchanged or higher: Recheck for Ketones
   1. If neg ketones take a bolus with a syringe*. Perform a Pod change.
   2. If ketones small /0.6-0.9 mmol/L, or mod/large/>1.0 mmol/L, follow steps B or C above. 
3. If BG decreased, return to normal dosing schedule and continue to monitor BGs frequently.

Small urine or 0.6-0.9 mmol/L blood ketones:

1. Take bolus with syringe* Perform a Pod change.
   1. Address possible causes.
   2. Recheck urine ketones in 2 hours or blood ketones in 1 hour and BG in 2-3 hours.
2. If BG unchanged or higher: Recheck for Ketones
   1. If neg ketones take a bolus using your PDM*
   2. If ketones small /0.6-0.9 mmol/L, or mod/large/>1.0 mmol/L, follow steps B or C above. 
3. If BG remains >250 mg/dL after 2 correction boluses by syringe, contact your healthcare provider.

Moderate – large urine or ≥ 1.0 mmol/L blood ketones:

1. Take bolus using syringe* Perform a Pod change.
   1. Address possible causes.
   2. Recheck urine ketones in 2 hours or blood ketones in 1 hour and BG in 2-3 hours.
2. If BG unchanged or higher, contact your healthcare provider.

If BG decreased, return to normal dosing schedule and continue to check BGs every 3-4 hours and monitor ketones if BG is >250 mg/dL

*Follow the dosing guidelines provided to you by your healthcare provider.

The above general guidelines are drawn from Joslin Diabetes Center. For further guidance please consult with your healthcare provider for individualized advice.

Troubleshooting

Check PDM Settings

Check status screen:

• Last bolus: was the bolus too small?
  • Was the bolus timing correct?
  • Did you account for high-protein or high-fat meal?
• Basal program: Is the proper basal program running?
• Temp basal: Do you have a temp basal running that you should have turned off?

Check my records:

1. Alarm history: Did you ignore or not hear alarms that should have been addressed?

Check Pod

Check your cannula through the viewing window:

• Did the cannula slip out from under your skin?
• Is there blood in the cannula?
• Is there redness, drainage, or other signs of infection around the cannula?
• If YES, change your Pod. If you suspect an infection, then call your healthcare provider.

Check your infusion site:

• Is there redness or swelling around the Pod and adhesive?
• Is insulin leaking from your infusion site or is there odor of insulin?
• If YES, change your Pod. If you suspect an infection, then call your healthcare provider.

Check your adhesive dressing:

• Is the adhesive dressing coming loose from your skin?
• Is the Pod becoming detached from the adhesive dressing?
• If YES, and if cannula is still inserted properly, you may tape down the Pod or adhesive to prevent further detachment.
• If cannula is no longer under your skin, change your Pod.

Check your insulin:

• Is the insulin used expired? 
• Has the insulin used been exposed to extreme temperatures?
• If YES, change Pod using a new vial of insulin. 

WARNING:

Hyperglycemia symptoms can be confusing. Always check your BG before treating your hyperglycemia. Consult with your healthcare provider.

Caution: Consult User Guide.

Get to know your Omnipod^® System reminders

A reminder is a notification you can turn on or off at any time and customize to fit your needs. Your Omnipod^® System has a number of different reminders:

• Blood glucose (BG) reminders: Program your Personal Diabetes Manager (PDM) to remind you to check your blood sugar levels every time you deliver a bolus dose.
• Bolus reminders: Your PDM can remind you if you haven’t delivered a meal bolus within a specific time frame.
• Program reminders: Your Pod will automatically beep to let you know that a temporary basal and/or extended bolus program is in process.
• Confidence reminders: Your PDM is preset to beep so you can know when certain programs have started and finished, including:
  • Bolus delivery
  • Extended bolus
  • Temporary basal
• Custom reminders: Enter text reminders into your PDM to be delivered when you choose.

Get to know your Omnipod^® System alerts

An alert is a notification you can adjust based on your needs. There are 4 different kinds of alerts on your Omnipod^® Sytem:

• Pod expiration alerts: When your Pod is about to expire (nearing the 72 hour expiration time), you’ll hear 2 sets of beeps every minute for 3 minutes. This pattern will repeat every 15 minutes until you press OK on your PDM.
• Low reservoir alerts: So you can plan ahead to change your Pod and make sure you have enough insulin, your Pod will alert you when your insulin reaches a certain level.
• Auto-off alerts: Program your PDM to alert you if it hasn’t received a Pod status within 1 to 24 hours.
• Blood glucose meter alerts: If there is an error with your blood glucose meter, test strip, sample, or results, your PDM will beep and display an error message number. To learn more about addressing specific error messages, Alerts and Alarms, refer to your Omnipod^® Insulin Management System User Guide.

WARNING:

The Low reservoir alert will escalate to an Empty reservoir hazard alarm when insulin is depleted. Be sure to respond to alert when it first occurs. The Auto-off alert will escalate to a hazard alarm if ignored, and will result in the deactivation of your active Pod. Be sure to respond to the alert when it occurs.

Programming reminders and alerts

To program all reminders and alerts except Bolus reminders and Custom reminders, follow these simple steps. For more information about programming Bolus reminders and Custom reminders, see Chapter 6, Using the Personal Diabetes Manager, in your Omnipod^® Insulin Management System User Guide.

1. On home screen, choose Settings. Then press Select.
2. Choose System setup, then press Select.
3. Choose Alerts/reminders, then press Select.
4. Choose the option you want to set, then press Select.
5. Choose the desired option or set the desired value, then press Select or Enter.

Understanding your Omnipod^® System alarms

An alarm is a notification to make you aware of serious, or possibly serious, conditions.

When an alarm goes off, your PDM will display a message with instructions on what to do. If you ignore an alarm, your Pod could be deactivated— so be sure to respond to alarms promptly.

There are 2 types of alarms: advisory alarms and hazard alarms.

• Advisory alarms
  • Advisory alarms beep intermittently to let you know about a condition that requires your attention.
  • When you hear an advisory alarm, turn on your PDM to see the Status screen. A message will appear describing the alarm and telling you what to do next.
  • It’s important to resolve an advisory alarm as quickly as possible. If you wait too long to address the alarm, it can escalate to a hazard alarm.
• Hazard alarms
  • Hazard alarms are a continuous tone to let you know when the Pod is in a very serious condition or something is wrong with the PDM.
  • When a hazard alarm goes off, all insulin delivery stops. To avoid hyperglycemia, it’s very important to follow the instructions on your PDM to resolve the issue quickly:
    • Step 1: Press OK on your PDM to silence the alarm
    • Step 2: Deactivate and remove your current Pod
    • Step 3: Activate and apply a new Pod

Caution: Consult User Guide.

To learn more about alarms and how to handle them, see Chapter 10, Alerts and Alarms, in your Omnipod^® Insulin Management System User Guide.

What happens if….?

You already know that your PDM enables you to live a tubeless life, delivering basal and bolus insulin doses remotely to your Pod.** However, from time to time you may find yourself asking the question “Why does my PDM do that?” The Customer Care team has heard it all, and we’ve compiled the top 3 areas our Podders™ ask or comment about the most. Read on to understand how to use your PDM to its maximum potential.

Your PDM Battery

The PDM requires two AAA alkaline batteries to perform at optimal level. If you are using another type of battery, your battery life could suffer and ultimately damage the PDM. AAA alkaline batteries are readily available at most pharmacy, grocery, or hardware stores. Your PDM automatically takes steps to maximize battery life when running low. You’ll first see the Low PDM battery alert and then your PDM will:

• Turn off your vibration alert (if set)
• Disable the bright mode
• Disable the test strip port light

Once you replace your battery these functions resume.

PDM Communication

One of the key benefits of the Omnipod^® Insulin Management System is the wireless, tubeless communication between PDM and Pod.** This means that you don’t have to keep your PDM next to you all the time. However, there are a few actions that require your PDM and Pod to be in close proximity to communicate. Here are a few ways you can help that “conversation”:

• When you deactivate a Pod, it can take a few moments for the Pod to fully deactivate. Often you’ll see the “Please Wait” screen while your Pod and PDM communicate. Make sure you wait until the Pod is fully deactivated before you attempt to activate a new Pod.
• Remember if you are helping deliver a bolus to someone in your care (or changing the basal rate), remember that the PDM and Pod need to keep communicating until the Bolus is confirmed. Make sure you keep both the Pod and PDM in close proximity to each other—within 5 feet—until you see the confirmation screen. 

Your PDM’s Environment

Your Pod can go anywhere you go, but your PDM requires a bit more protection. Following the below guidelines will help you keep your PDM functioning at peak performance!

• Your Pod is waterproof* but your PDM isn’t—make sure to keep it dry.
• Like all electronics, your PDM needs to be maintained at a moderate temperature. Avoid storing it in extreme heat or cold (such as a hot car or cooler).
• While your PDM has a 4-year warranty, years of wear and tear can take a toll on your PDM screen in the way of nicks and small scratches. You can help save the integrity of your screen and overall body of your PDM by keeping it stored in your storage bag.

Helpful Tips from Omnipod^® System Podders™

As the Omnipod^® Team, we pride ourselves on helping our customers navigate the Omnipod^® Insulin Management System and use it successfully to live life on their terms. However, occasionally we find ourselves taking notes from our Podders™, who have discovered ways to bring their Pod success to the next level. Check out these helpful tips: 

• From time to time we hear that the 90-minute alert, after you perform a Pod change, can be disruptive to everyday life. Did you know that putting your PDM on vibrate will quiet this alert?
• Try taking a picture of your program settings with your smartphone and keeping it. This way if you don’t download your PDM regularly at home, you always have a record of your settings.
• What happens if you misplace your PDM? Put your phone number as your ID, so that anyone who may find it can easily return it to you.

Caution: Consult User Guide.

*The Pod has a waterproof IPX8 rating for up to 25 feet for 60 minutes.
**At start up the PDM and Pod should be adjacent and touching, either in or out of the tray to ensure proper communication during priming. At least 5 feet (1.5 meters) during normal operation

1. For frequently asked questions, please visit Glooko support at: https://support.glooko.com/hc/en-us
2. For Glooko privacy policy please visit https://www.glooko.com/privacy/
3. For full upload instructions, please visit: http://myomnipod.com/glooko.php and select User Guide under the Sync Data section.

Step 1: Get an Insulet Provided Glooko account

• In the iTunes App Store (Apple^® devices) or Google Play (Android™ devices) on your mobile phone, search for and install the free Glooko app. 
• Open the Glooko app and create an account: fill out the form and click Sign Up (or log in if you already have a Glooko account). Remember your username and password. 
• Click Profile and then click Personal.
  • Click ProConnect and then Add Code. Follow the steps to enter in your clinic’s ProConnect code.
• Your Omnipod^® System PDM (Personal Diabetes Manager) data will be automatically uploaded to your clinic’s Glooko account.

Step 2: Upload Omnipod^® System PDM data

Data can currently be uploaded from Omnipod^® System PDMs directly to Android™ mobile devices and PC or Mac computers. If you are an Apple^® user, once you upload your Omnipod^® System PDM data to your computer, you will be able to view the data on your Apple^® device and also use your device to add additional context to your day such as notes about carbs, insulin and exercise.

To upload glucose readings, insulin and carb data from your Omnipod^® System PDM to your Android™ mobile device, you will need a Micro-to-Mini USB OTG Cable. Order the cable here: http://shop.glooko.com/products/insulet-provided-glooko-subscription. This cable is at no charge to Omnipod^® System users (standard S&H rates apply).

1. Log into the Glooko app. 
2. From the Home screen, click Sync. 
3. Click Add Device and then click Pumps.
4. Select Omnipod^® System from the list of devices and then click Done. 
5. Select Insulet Omnipod^® System and then follow the illustrative tutorial to connect your Omnipod^® System PDM to your Android™ device using a Micro-to-Mini USB OTG Cable. 
6. After your Omnipod^® System PDM is connected to your Android™ device, click Sync in the Glooko app.
7. The data stored in your Omnipod System PDM will now download to the Glooko app.

To upload glucose readings, insulin and carb data from your Omnipod^® System PDM to your PC or Mac Computer, you will need an Omnipod^® System USB Cable, which was included in your Omnipod^® System Starter Kit. If you need a new cable, order it here: http://shop.glooko.com/ products/insulet-provided-glooko-subscription. This cable is at no charge to Omnipod^® System users (standard S&H rates apply).

1. On your computer, open your Internet browser and go to: my.glooko.com.
2. Log into your Glooko account by entering in your Email and Password. Click Sign in.
3. Use the top navigation bar to open Settings.
4. Scroll down to a section called Apps & Devices. Click Upload Omnipod^® System Data.
5. Connect your Omnipod^® System PDM to your computer using the Omnipod^® System USB Cable:
   • Plug the USB side of the cable into your computer.
   • Plug the Mini-USB side into your Omnipod^® System PDM.
   • Note: To upload data from your Omnipod^® System PDM to Mac computers manufactured before mid-2012 utilizing Apple^®’s OS X El Capitan (version 10.11) and macOS Sierra (version 10.12) software, it is recommended to use a USB Hub:
     • Plug the USB Hub into your computer
     • Plug the USB side of the Omnipod^® System USB Cable into the USB Hub.
     • Plug the other end of the Omnipod^® System USB Cable into your Omnipod^® System PDM.
6. After connecting the Omnipod^® System PDM to your computer, wait for the Omnipod^® System PDM to prepare your data file. Your Omnipod^® System PDM display will say “USB device ready.”
7. On your computer, click Upload.
8. Your Omnipod^® System will appear as a mounted drive on the left-hand side of the file system pop-up. It will be labeled as a NO NAME, Removable Disk or USB Drive. Select the Omnipod^® System drive and the .ibf le will be visible within it.
9. Highlight the file ending in .ibf and then click Open in the Finder winder.
10. Click Done to stay on the Settings page or click View Data to see your Daily Overview.