Insulet Omnipod 5 User manual

CAREGIVER GUIDE

OMNIPOD®5

Table of contents

SECTION 1: Basics

What is type 1 diabetes?..............................4

What is the Omnipod®5 System?...............6

Omnipod 5 Home screen ............................7

How to deliver a bolus.................................8

SECTION 2: Response

Managing glucose levels............................10

How to change a Pod.................................12

Managing activity and exercise.................16

SECTION 3: Troubleshooting

Alerts/alarms..............................................18

Viewing history...........................................19

System states .............................................20

SECTION 1 | BASICS SECTION 1 | BASICS

This guide will help you feel comfortable taking care of someone with

diabetes using the Omnipod®5 Automated Insulin Delivery System.

Let’s start with the basics!

What is type 1 diabetes?

Type 1 diabetes is a chronic disease where the pancreas produces little

to no insulin. People with diabetes need to replace the insulin their

pancreas cannot make, either through injections or an insulin pump

(standard or automated).

How do insulin pumps work?

Insulin pumps deliver insulin in two dierent ways, with basal and bolus doses.

Basal insulin covers background insulin needed to keep glucose levels in

range between meals and overnight.

Bolus insulin is an additional dose of insulin needed for food (meal bolus)

and/or to lower high glucose levels (correction bolus).

Insulin delivery in standard insulin pump therapy

Insulin delivery in Automated Insulin Delivery (AID) Systems

In AID systems like Omnipod®5, automated insulin delivery is adjusted

automatically based on continuous glucose monitor (CGM) values. With

Omnipod 5, the system automatically increases, decreases or pauses

insulin delivery every 5 minutes based on where glucose is predicted

to be 60 minutes into the future.

How Omnipod 5 works

Insulin Delivered From Pod

100

150

200

250

300

TIME 7 AM 1 PM

mg/dL

HELPS PROTECT AGAINST LOWS1,2

When your levels are dropping, SmartAdjust™

technology automatically decreases or

pauses insulin delivery.

HELPS PROTECT AGAINST HIGHS1,2

When your levels are rising, SmartAdjust™

technology automatically increases

insulin delivery.

CUSTOMIZABLE TARGET GLUCOSE LEVEL

GLUCOSE VALUES

GLUCOSE

LEVELS

INSULIN

DELIVERY

HOW IT WORKS

1. Study in 240 people with T1D aged 6 -70 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average time in Target

Glucose range (from CGM) for standard therapy vs Omnipod 5 in adults/adolescents = 64.7% vs. 73.9% and children = 52.5% vs. 68.0%. Brown et al. Diabetes Care (2021).

2. Study in 80 people with T1D aged 2 –5.9 yrs involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average time in Target

Glucose range (from CGM) for standard therapy vs Omnipod 5 = 57.2% vs. 68.1%. SherrJL, et al. Diabetes Care (2022).

Document #: INS-OHS-09-2021-00002 V2.0

Bolus Insulin

Basal Insulin

1. Study in 240 people with T1D aged 6 -70 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average

time in Target Glucose range (from CGM) for standard therapy vs Omnipod 5 in adults/adolescents = 64.7% vs. 73.9% and children = 52.5% vs. 68.0%. Brown

et al. Diabetes Care (2021).

2. Study in 80 people with T1D aged 2 –5.9 yrs involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average

time in Target Glucose range (from CGM) for standard therapy vs Omnipod 5 = 57.2% vs. 68.1%. SherrJL, et al. Diabetes Care (2022).

NOTE!

The Omnipod 5 System

will always pause insulin

delivery when glucose

is below 60 mg/dL.

4 5

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations. Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

SECTION 1 | BASICS SECTION 1 | BASICS

Omnipod®5 Home screen

What is the Omnipod®5

Automated Insulin Delivery System?

The Omnipod 5 System automatically adjusts insulin delivery every

5 minutes to manage glucose levels. The system will increase, decrease

or pause insulin based on the CGM value and trend.

The Omnipod 5 App

Control the Pod’s operations from a compatible smartphone* or the

Insulet-provided Controller. Always keep the Omnipod 5 App or Controller

close to hear any alerts and alarms.

The Omnipod 5 Pod

Tubeless, wearable and waterproof,†the Pod with SmartAdjust™ technology,

automatically adjusts and delivers insulin for up to 3 days or 72 hours.

Dexcom G6 CGM

Continuously sends glucose values to the Pod so the SmartAdjust™

technology can automatically adjust insulin delivery.

Dexcom G6 CGM

Controller or smartphone*

Omnipod 5 Pod

* Please go to omnipod.com/compatibility for a list of compatible smartphones

†IP28 Rating, up to 25 ft. for 60 minutes

CGM Graph

CGM Glucose

Value and

Trend Arrow

Current

System Mode

Tab Views:

• DASHBOARD

• INSULIN

• POD INFO

Alarms and

Notications

Button

Insulin

on Board

(IOB)

Last

Bolus

Button

6 7

SECTION 1 | BASICS SECTION 1 | BASICS

How to deliver a bolus

With the Omnipod®5 System, it is still important and necessary to bolus (deliver

an insulin dose) for both meals and high glucose levels. It is ideal to start a

meal bolus at least 15-20 minutes before eating to prevent hyperglycemia.1

To start a bolus, tap

the Bolus button

Tap on the Carbs eld

to enter the amount

of carbohydrates to

be eaten

Tap USE CGM to use

CGM value and trend

for a correction bolus*

Tap CONFIRM Review the entries to

ensure they are correct,

then tap START

Conrm the screen

says Delivering Bolus

and shows a green

progress bar before

moving away from

the Omnipod 5 App

* Tap Glucose eld to manually enter your BG

1. Berget C, Sherr JL, DeSalvo DJ, Kingman R, Stone S, Brown SA, Nguyen A, Barrett L, Ly T, Forlenza GP. Clinical Implementation of the Omnipod 5 Automated Insulin

Delivery System: Key Considerations for Training and Onboarding People with Diabetes. Clin Diabetes. 2022;40(2):168-184.

TIP!

If snacking or having a second helping, do

not re-enter the glucose value. Enter only the

carbohydrates to keep from adding too much

insulin at once. If glucose is still high a few

hours after the snack or second helping,

you can give a correction bolus then.

TIP!

The SmartBolus Calculator suggests

insulin amounts based on glucose

value, trend and active insulin.

Tap CALCULATIONS to see

additional information.

8 9

SECTION 2 | RESPONSE SECTION 2 | RESPONSE

Hungry Sweaty

Confused

Thirsty

Feeling Tired

Irritable

Frequent Urination

Blurry Vision

Weight Loss Weak

Hungry

Sweaty

Confused

Thirsty

Feeling Tired

Irritable Frequent Urination

Blurry Vision

Weight Loss Weak

Hungry Sweaty

Confused

Thirsty

Feeling Tired

Irritable Frequent Urination

Blurry Vision

Weight Loss

Weak

Hungry Sweaty

Confused

Thirsty

Feeling Tired

Irritable Frequent Urination

Blurry Vision

Weight Loss Weak

Hungry

Sweaty

Confused

Thirsty

Feeling Tired

Irritable Frequent Urination

Blurry Vision

Weight Loss Weak

1. Check glucose level if you think or they

feel that they have a low glucose level.

2. Treat the low glucose level with 5-15

grams of fast-acting carbohydrates.3

3. Check again in 15 minutes to make

sure the glucose is going up.

4. If still under 80 mg/dL, treat again.

SOURCES OF

15 GRAMS OF

CARBS

• 3-4 glucose

tabs

• 1 tablespoon

of sugar

• ½ cup (4oz)

juice or

regular soda

(not diet)

High glucose (hyperglycemia)

High glucose is when there is too much glucose in their blood, usually over

250 mg/dL. If you notice any of the symptoms below or they feel them,

check glucose to conrm.

Hungry Sweaty

Confused

Thirsty

Feeling Tired

Irritable

Frequent Urination

Blurry Vision

Weight Loss Weak

Hungry Sweaty

Confused

Thirsty

Feeling Tired

Irritable Frequent Urination

Blurry Vision

Weight Loss Weak

Hungry Sweaty

Confused

Thirsty

Feeling Tired

Irritable Frequent Urination

Blurry Vision

Weight Loss Weak

Hungry Sweaty

Confused

Thirsty

Feeling Tired

Irritable Frequent Urination

Blurry Vision

Weight Loss

Weak

Hungry Sweaty

Confused

Thirsty

Feeling Tired

Irritable Frequent Urination

Blurry Vision

Weight Loss Weak

TIP!

These are the most

common symptoms

to look for:

Low:____________________

_________________________

High: ___________________

_________________________

Potential causes of a low glucose:

Food

• Did they eat as many carbohydrates as planned?

• Did they delay eating after taking their insulin or medication?

Activity

• Were they more active than usual?

Medication

• Did they take more insulin or medication than usual?

Potential causes of a high glucose:

Food

• Did they increase their portion size

of carbohydrates without accounting

for it?

• Did they correctly calculate how

much insulin to take?

Activity

• Were they less active than usual?

Wellness

• Are they feeling stressed

or scared?

• Do they have a cold, u or other illness?

• Are they taking any new medications?

1. Check glucose.

2. If glucose is higher than 250mg/dL follow their healthcare provider’s

instructions for checking for ketones.

3. If ketones are not present, take a correction bolus from Pod

as prescribed.

4. Continue to monitor glucose and treat as instructed by their

healthcare provider.

Managing glucose levels

Managing and responding to glucose levels can be challenging. The Omnipod 5

System automates insulin delivery, helping to protect against highs and lows.

1,2

Sometimes though, you may still need to respond to highs and lows. Always

follow the treatment plan provided by the primary caregiver and/or

healthcare provider.

Low glucose (hypoglycemia)

Low glucose is when the amount of glucose drops below 70 mg/dL. If the

person with diabetes has any of the symptoms below, check glucose to conrm.

If symptoms do not match CGM readings, test glucose levels with BG meter.

1. Study in 240 people with T1D aged 6 -70 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average

time in Target Glucose range (from CGM) for standard therapy vs Omnipod 5 in adults/adolescents = 64.7% vs. 73.9% and children = 52.5% vs. 68.0%. Brown

et al. Diabetes Care (2021).

2. Study in 80 people with T1D aged 2 –5.9 yrs involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average

time in Target Glucose range (from CGM) for standard therapy vs Omnipod 5 = 57.2% vs. 68.1%. SherrJL, et al. Diabetes Care (2022).

3. Boughton CK, Hartnell S, Allen JM, Fuchs J, Hovorka R. Training and Support for Hybrid Closed-Loop Therapy. J Diabetes Sci Technol. 2022 Jan;16(1):218-223.

10 11

SECTION 2 | RESPONSE SECTION 2 | RESPONSE

To deactivate and

change Pod, tap

POD INFO

Tap VIEW

POD DETAILS

Tap CHANGE

POD, and then tap

DEACTIVATE POD. If

the pod has already

been deactivated, tap

SET UP NEW POD on

the home screen

How to change a Pod

The Pod should be changed every 72 hours or when it has run out of insulin.

There also may be rare instances when a Pod change is necessary for the

system to keep working.

Removing old Pod

1. Gently lift the edges of the adhesive tape from the user’s skin and remove

the entire Pod. Remove the Pod slowly to help avoid possible skin irritation.

2. Use soap and water to remove any adhesive that remains on the skin, or,

if necessary, use an adhesive remover.

3. Check the infusion site for signs of infection.

4. Dispose of the used Pod according to local waste disposal regulations.

Caution: Do not apply a new Pod until you have deactivated and removed

the old Pod. A Pod that has not been deactivated properly can continue to

deliver insulin as programmed, putting the user at risk of over infusion and

possible hypoglycemia.

MIN

ll

line

Filling a new Pod

1. Take the ll needle and twist clockwise onto

syringe. Remove protective cap on needle.

2. Pull back on plunger to draw air into syringe

equal to the amount of insulin.

3. Empty air into vial of insulin.

4. Turn vial and syringe upside down and

withdraw insulin.

5. Tap or ick syringe to remove any bubbles.

Leaving the Pod in its tray, insert the syringe

straight down into the ll port and empty out

all of the insulin. Be sure the Pod beeps twice.

Put the Controller/app right next to the Pod

and press NEXT.

Clear

Needle Cap

Fill Port

Adhesive

Backing

BOTTOM

TIP!

You must ll the Pod

with at least 85 units

of insulin, but no

more than 200 units.

Fill the Pod

with _____ units

12 13

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

SECTION 2 | RESPONSE SECTION 2 | RESPONSE

Pod placement

Carefully follow the

on-screen instructions.

See right for proper

Pod locations

Check the Pod after

insertion to ensure

that the cannula was

properly inserted by

looking to see if the

pink window is visible

TIP!

For optimal connectivity, the Pod

should be placed in direct line of sight

of the CGM. Always put the Pod in a

new location.

Best placement for CGM and Pod

YOUTH/ADULT

CHILD

Pod

CGM

Pod

CGM

Pod

CGM

Arm & Leg:

Position the Pod vertically or at a slight angle.

Back, Abdomen & Buttocks:

Position the Pod horizontally or at a slight angle.

Pod positioning

Pod shown without the necessary adhesive.

14 15

SECTION 2 | RESPONSE SECTION 2 | RESPONSE

Managing activity and exercise

What is the Activity feature?

While in Automated Mode, there may be times

when you would like less insulin automatically

delivered. When the Activity feature is started,

the SmartAdjust™ technology reduces insulin

delivery and automatically sets the target

glucose to 150 mg/dL for the time you choose.

When can the Activity feature be used?

During activities like sports, swimming, yard

work, a walk in the park, or any other time

when the glucose level tends to go low.

How do I start the Activity feature?

1. Tap the menu button

2. Tap ACTIVITY

3. Enter the desired duration, then tap CONFIRM

4. Tap START

TIP!

This is when we like to use

the Activity feature:

_________________________________________

________________________________________

The Pod has an IP28 rating for up to 25 feet for 60 minutes. The controller is not waterproof. The Dexcom G6 sensor and transmitter

are water-resistant and may be submerged under eight feet of water for up to 24 hours without failure when properly installed.

16 17

Hazard Alarms

High priority alarms that indicate a serious problem has

occurred and a Pod change may be needed

Advisory Alarms

Lower priority alarms that indicate a situation exists that

needs attention

Notications

Reminder of an action that should be performed

WARNING:

Respond to Hazard Alarms as soon as possible. Pod Hazard

Alarms indicate that insulin delivery has stopped. Failure to

respond to a Hazard Alarm can result in hyperglycemia.

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

SECTION 3 | TROUBLESHOOTING SECTION 3 | TROUBLESHOOTING

Viewing history

To view the history summary and detail information go to the History Detail

screen by tapping the Menu button ( ) and then tapping History Detail.

Notications, alerts and alarms

Follow the instructions on the screens to acknowledge the alarms

and take action.

Details Section

• Swipe to see

expanded details

• You can see record

of previous activity

from the Pod,

including bolus

history, switches

between modes,

and activation of

dierent features,

such as the

Activity feature

Date

• Tap AUTO

EVENTS to see

automated details

• Tap SUMMARY to

view the average

CGM value and

CGM in Range

18 19

SECTION 3 | TROUBLESHOOTING SECTION 3 | TROUBLESHOOTING

System states

There are times when the Pod, CGM, and/or Omnipod®5 Controller/App

have issues communicating, but there are simple steps that can x these issues.

Automated Mode: Limited

Automated Mode: Limited occurs when the Pod

and CGM lose connection while in Automated

Mode. When this occurs, the system can no longer

fully adjust automated insulin delivery but will

continue to deliver a steady basal insulin until

CGM values return.

What should you do?

• First, make sure the Pod and Dexcom CGM

are in a direct line of sight and ensure that

the Dexcom app is still receiving values.

• If the Dexcom app is still receiving values,

then it could be an issue with the Pod

communicating with the Dexcom CGM. If not,

then the issue may be with the Dexcom CGM.

No Pod communication

There may be times when the Pod and Omnipod®5

Controller/App are unable to communicate. If you

see a “No Pod Communication” message, don’t

worry. The Pod is still delivering insulin according

to its last instructions, and will update the Pod

status when communication is restored.

What should you do?

• First bring the Omnipod 5 Controller/App and

active Pod closer – within 5 feet of each other

to try to restore communication.

• If the communication issue remains, the

Omnipod 5 App will oer you options to resolve

the communication issue. Leave any options to DISCARD

or DEACTIVATE POD as last choice after trying the other options.

Supplies to have on hand:

Always keep an emergency kit with you to quickly respond to any diabetes

emergency or in the case that your Omnipod®5 System stops working.

Always carry supplies to perform a Pod change should you need to replace

your Pod at any time.

Several new Pods

A vial of insulin and syringes

Glucose tabs or other

fast-acting carbohydrates

Dexcom supplies

Blood glucose meter and strips

Ketone meter and strips

or ketone urine strips

Lancets

Alcohol swabs

Glucagon kit

Omnipod 5 Caregiver Guide

Contact Information

Primary Caregiver: ____________________________________________________________

Customer Care: 1-800-591-3455

Notes:

Add additional information here, such as daily schedule, or how to change

a CGM.

________________________________________________________________________________________

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

20 21

SECTION 1 | CATEGORY

Important User Information

The Omnipod 5 Automated Insulin Delivery System is indicated for use

by individuals with Type 1 diabetes mellitus in persons 2 years of age and

older. The Omnipod 5 System is intended for single patient, home use

and requires a prescription. The Omnipod 5 System is compatible with

the following U-100 insulins: NovoLog®, Humalog®, and Admelog®.

Refer to the Omnipod 5 Automated Insulin Delivery System User

Guide and www.omnipod.com/safety for complete safety information

including indications, contraindications, warnings, cautions, and instructions.

WARNING: DO NOT start to use the Omnipod 5 System or change settings

without adequate training and guidance from a healthcare provider. Initiating

and adjusting settings incorrectly can result in over-delivery or under-delivery

of insulin, which could lead to hypoglycemia or hyperglycemia.

Screen images shown in this guide are examples only and are not suggestions

for user settings. This guide is for informational purposes only. Be sure to

consult with your healthcare provider before making any treatment decisions.

The Omnipod 5 System is designed to work with the Dexcom G6 CGM.

The Dexcom G6 CGM System is sold separately. Use of the Dexcom app

on your personal smartphone is required. Be sure to review both the

Omnipod 5 System User Guide and Dexcom G6 User Guide before using

the system.

Potential Risks

• Inaccurate CGM values could cause the System could deliver an

inaccurate dose of insulin

• Wearing a Pod might cause infection

• Kinks or air bubbles in the cannula, or dislodging of the cannula can

aect insulin delivery

• Hardware defects, software glitches, and Pod failures can cause an

interruption in insulin delivery

These potential risks could lead to the over-delivery or under-delivery

of insulin which can result in hypoglycemia or hyperglycemia. For full

details on potential risks refer to the Omnipod 5 System User Guide.

22 23

Customer Care: 1-800-591-3455

Insulet Corporation, 100 Nagog Park, Acton, MA 01720

omnipod.com

For more information on indications, warnings and complete instructions on how to use the Omnipod®5 System, please consult the Omnipod 5 User Guide.

The Bluetooth®word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under license.

Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. and used with permission. All other trademarks are the property of their respective owners.