Omnipod 5 User manual

The Omnipod® 5

Automated Insulin

Delivery System:

A Healthcare Provider’s Guide to

Understanding System Behavior

and Optimizing Initiation

and Management

TABLE OF CONTENTS:

Omnipod®5 System Behavior................................ 4

How CGM Trend Aects Automated Insulin Delivery................4

Omnipod 5 System Communication .............................5

Omnipod®5 System Readiness .............................. 6

Expectation Setting ...........................................6

Preparing for Initiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Omnipod®5 System Start .................................... 7

First Time Setup..............................................7

Pod Placement ...............................................8

Beginning Automated Mode....................................8

Omnipod®5 System Management and Optimization ....... 9

Adjustable Settings ...........................................9

The Activity Feature...........................................9

SmartBolus Calculator .......................................10

Troubleshooting System Communication........................10

Automated Mode Exits .......................................11

Condent Diabetes Management ..............................11

INDICATIONS FOR USE:

The Omnipod 5 ACE Pump (Pod) is intended for the

subcutaneous delivery of insulin, at set and variable

rates, for the management of diabetes mellitus in

persons requiring insulin. The Omnipod 5 ACE Pump

is able to reliably and securely communicate with

compatible, digitally connected devices, including

automated insulin dosing software, to receive,

execute, and conrm commands from these devices.

The Omnipod 5 ACE Pump is intended for single

patient, home use and requires a prescription.

SmartAdjust™ technology is intended for use with

compatible integrated continuous glucose monitors

(iCGM) and alternate controller enabled (ACE) pumps

to automatically increase, decrease, and pause

delivery of insulin based on current and predicted

glucose values. SmartAdjust technology is intended

for the management of type 1 diabetes mellitus

in persons 2 years of age and older. SmartAdjust

technology is intended for single patient use and

requires a prescription.

The Omnipod 5 SmartBolus Calculator is software

intended for the management of diabetes in persons

aged 2 and older requiring rapid-acting U-100 insulin.

The Omnipod 5 SmartBolus Calculator calculates

a suggested bolus dose based on user-entered

carbohydrates, most recent sensor glucose value (or

blood glucose reading if using ngerstick), rate of

change of the sensor glucose (if applicable), insulin

on board (IOB), and programmable correction factor,

insulin to carbohydrate ratio, and target glucose

value. The Omnipod 5 SmartBolus Calculator is

intended for single patient, home use and requires

a prescription.

CONTRAINDICATIONS:

The Omnipod 5 System is NOT recommended for

people who:

• are unable to monitor glucose as recommended by

their healthcare provider

• are unable to maintain contact with their healthcare

provider

• are unable to use the Omnipod 5 System according

to instructions

• are taking hydroxyurea as it could lead to falsely

elevated CGM values and result in over-delivery of

insulin that can lead to severe hypoglycemia

• do NOT have adequate hearing and/or vision to

allow recognition of all functions of the Omnipod 5

System, including alerts, alarms, and reminders

Device components including the Pod, CGM

transmitter, and CGM sensor must be removed

before Magnetic Resonance Imaging (MRI), Computed

Tomography (CT) scan, or diathermy treatment. In

addition, the Controller and smartphone should be

placed outside of the procedure room. Exposure to

MRI, CT, or diathermy treatment can damage the

components.

COMPATIBLE INSULINS:

The Omnipod 5 ACE Pump® is compatible with

the following U-100 insulins: NovoLog®, Humalog®,

and Admelog®.

SmartAdjust technology is compatible with the

following U-100 insulins: NovoLog®, Humalog®,

and Admelog®.

The Omnipod 5 SmartBolus Calculator is compatible

with the following U-100 insulins: NovoLog®,

Humalog®, and Admelog®.

Warning: SmartAdjust technology should NOT be used by anyone under the age of 2 years old. SmartAdjust technology should also NOT be used

in people who require less than 5 units of insulin per day as the safety of the technology has not been evaluated in this population. Warning: DO

NOT use SmartAdjust technology in pregnant women, critically ill patients, and those on dialysis. The safety of SmartAdjust technology has not been

evaluated in these populations. For a full list of warnings and precautions, refer to the Omnipod® 5 Automated Insulin Delivery System User Guide at

www.omnipod.com for complete safety information including indications, contraindications, warnings, cautions, and instructions. 32

Omnipod® 5 System Communication

The Omnipod 5 Automated Insulin Delivery System is the rst and only FDA cleared tubeless automated

insulin delivery system. The Pod contains SmartAdjust™ technology to automatically increase, decrease, and

pause insulin delivery based on current and predicted glucose values. The Omnipod 5 System is intended for

the management of type 1 diabetes in persons 2 years of age and older*.

How CGM Trend Affects Automated Insulin Delivery

EXAMPLE OF DAILY READINGS

TIME 12 AM 12 PM

AUTOMATED INSULIN DELIVERY

USER-INITIATED BOLUS

TARGET GLUCOSE 120 mg/dL

TARGET GLUCOSE 110 mg/dL

GLUCOSE VALUES

CUSTOMIZABLE TARGET GLUCOSE LEVEL

STANDARD GLUCOSE RANGE (70 - 180 MG/DL)

When CGM values

are predicted to be1:System Action

Above Target Glucose

Automated insulin delivery generally increases.

If CGM values are trending downwards, automated insulin delivery may

still decrease or pause even if CGM values are above Target Glucose.

Within Target Glucose Automated insulin delivery is generally maintained to keep CGM values

near Target Glucose.

Below Target Glucose

Automated insulin delivery generally decreases or pauses.

If CGM values are trending upwards, automated insulin delivery may still

increase even if CGM values are below Target Glucose.

Less than 60 mg/dL Automated insulin delivery will always pause.

Omnipod®5 System Behavior

Delivery of insulin in Automated Mode or Manual Mode continues as programmed if away from the

Controller or smartphone. Users should avoid leaving the Controller or smartphone in a place that would

prevent them from hearing alarms or notications from the Omnipod 5 App.

*See list of compatible devices at www.omnipod.com/compatibility.

**The Omnipod 5 System must be used with the Dexcom G6 mobile app

and is not compatible with the Dexcom receiver.

*The Omnipod 5 System can be used with or without a CGM, but to benet from automated insulin delivery, it must be paired with the

Dexcom G6 CGM. The Omnipod 5 System is cleared for use in ages 2 years+. The Dexcom G6 CGM is sold separately.

Controller or compatible*

smartphone with

Omnipod 5 App

Omnipod 5 Pod

with SmartAdjust™ technology

Smartphone** with

Dexcom G6 app

Dexcom G6 CGM

Pod receives CGM values

Preparing for Initiation

■While AID technology has been shown to improve overall glycemic control3, hypoglycemia

and hyperglycemia can still occur. Ensure the user is knowledgeable regarding hypoglycemia

prevention and treatment and troubleshooting hyperglycemia.

■ Set up realistic goals and a follow-up plan with the user to help ensure success.

■ Encourage the user to download the Omnipod 5 Simulator prior to

Omnipod 5 System start to experience a system overview

and interact with key features and functionality.

*See list of compatible devices at www.omnipod.com/compatibility.

First Time Setup

The Omnipod 5 App can be downloaded to a

compatible* smartphone and is also integrated into the

Omnipod 5 Controller. If using the Omnipod 5 App on a

compatible smartphone, users will need to sign into the

Insulet-provided Controller rst.

Setting up the system for the rst time will include

signing in with an Omnipod ID and entering initial

insulin settings. To create an Omnipod ID, users will

visit Omnipod.com/setup to create their account,

Expectation Setting

Realistic expectation setting with users before initiating the

Omnipod 5 System is essential. Establishing expectations for

automated insulin delivery (AID) technology at initiation promotes

retention and optimal outcomes2.

Over time, the Omnipod 5 System will continue to adapt to the user’s

needs as it builds history on the user’s insulin requirements1.

The Omnipod 5 System is also known as a hybrid closed-loop

system since user intervention is required.

Prior to initiation, convey necessary user actions:

■Need to deliver bolus for carbohydrate intake at meals and

snacks to minimize postprandial hyperglycemia.

■Need to perform Pod & sensor changes.

■Need to respond to alerts & alarms.

Pod shown without the

necessary adhesive.

Pod

CGM

ADULT PLACEMENT EXAMPLES

PEDIATRIC PLACEMENT EXAMPLES

FRONT BACK

Pod

CGM

Pod Placement

Careful Pod and CGM placement are important

to optimize connectivity. Place the Pod so it is:

■In direct line of sight of the CGM

■ At least three inches from the CGM

sensor site

■ Horizontal or diagonal on the abdomen,

hip, lower back, or buttocks

■ Vertical or at a slight angle on the upper

arm or thigh

■Avoiding sites where belts, waistbands, or

tight clothing may rub against or dislodge

the Pod or CGM

■ Avoid placing the Pod over a mole, tattoo,

or scar, where insulin absorption could

be reduced

Connecting the CGM is done by entering the

Dexcom transmitter serial number into the

Omnipod 5 App. The connection process can take

up to 20 minutes.

Note: The Dexcom G6 receiver cannot be used

with the Omnipod 5 System because the Omnipod

5 System is compatible only with the G6 app on a

smartphone. All sensor and transmitter-specific

actions are controlled through the Dexcom G6 app.**

**Dexcom CGM sold separately. The Omnipod 5 System must be used with the Dexcom G6 mobile app and is not compatible with

the Dexcom receiver. All Dexcom G6 alerts are configured and driven by the Dexcom G6 app.

Omnipod®5 System Readiness Omnipod®5 System Start

link data management accounts, and learn about

training options.

After Omnipod 5 App setup is complete, the user will

then activate a Pod and connect their CGM to the

Omnipod 5 System.

The Pod should be changed at least once every

3 days or after delivering 200 units of insulin,

whichever comes rst.

6 7

Adjustable Settings

Automated Insulin Delivery

Target Glucose is the only adjustable setting that directly impacts

automated insulin delivery.

• Customizable to user needs

• 110, 120, 130, 140, 150 mg/dL

• Up to 8 time segments

Target Glucose is used for both the target for automated insulin delivery

in Automated Mode as well as the target for correction bolus dosing in

Automated and Manual Modes.

Manual Basal Delivery SmartBolus Calculator

Adjusting Basal Program segments only

impacts Manual Mode basal insulin delivery.

• Basal Program (Manual Mode)

SmartBolus Calculator settings impact suggested

bolus doses in Automated and Manual Modes and

include:

• Target Glucose and Correct Above Values

• Insulin to Carb Ratio

• Correction Factor

• Duration of Insulin Action

• Reverse Correction

• Minimum Glucose for Calculations

The Activity Feature

The Activity feature is an optional feature in Automated Mode. When enabled,

the Activity feature reduces automated insulin delivery and temporarily sets

the Target Glucose to 150 mg/dL. The Activity feature is ideal during times of

anticipated decreases in insulin needs such as aerobic exercise, or other periods

of caution towards hypoglycemia.

Activity can be set for 1-24 hours in one-hour increments. Upon cancellation or

expiration of the dened time period, full automated insulin delivery starts on its own

and SmartAdjust™ technology returns to using the Target Glucose dened in settings.

Beginning Automated Mode

An active Pod and CGM transmitter serial number are required to switch to Automated Mode. Users can

switch to Automated Mode immediately with the rst Pod.

■With the first Pod wear, since no recent insulin delivery history is available, SmartAdjust™

technology uses the user-entered Basal Program as a baseline to initiate automated insulin

delivery. As a safety measure, automated insulin delivery will be more restrained for the rst Pod.

■ With subsequent Pod changes, SmartAdjust™ technology uses the “adaptive basal rate” as a

baseline for automated insulin delivery.

- The adaptive basal rate is based on insulin delivery history.

- Adaptivity adjusts with each Pod change to meet individual insulin needs.

Omnipod® 5 System Start

Omnipod® 5 System Management and Optimization

Screen images shown in this guide are examples only and

are not suggestions for user settings.

8 9

Automated Mode Exits

A user will be prompted to switch to Manual Mode to

complete certain actions. These actions include:

■ Manually pausing and starting insulin delivery.

■Editing a Basal Program.

■ Changing the time or time zones.

In rare instances, a user will be required to switch to Manual

Mode if they receive an Automated Delivery Restriction. This

advisory alarm occurs in Automated Mode when insulin was

either paused or at maximum delivery for too long. The user

will be instructed to use a meter to check their blood glucose

(BG) and determine next steps. The user will need to switch

to Manual Mode for at least ve minutes and should not

return to Automated Mode until conrming CGM accuracy.

Condent Diabetes Management

Viewing History:

The Omnipod 5 App includes a CGM Graph to display

CGM readings and historical insulin delivery.

The History summary, including CGM time in range details

and insulin delivery, and a list of automated events can

also be accessed from the History Detail screen.

Cloud-Based Management:

The Omnipod 5 App will provide automatic ow of data to the

cloud-based data management system on an hourly basis.

This allows healthcare providers to review insulin delivery

and sensor glucose patterns without manual uploads.

Connectivity to cellular data or Wi-Fi is important when

using the Omnipod 5 System. Staying connected to cellular

data or Wi-Fi will allow notication of important over-the-

air updates as well as seamless auto-uploading of data

to Insulet’s secure cloud. The Omnipod 5 Controller is

equipped with a SIM card that allows connection to cellular

data at no cost.

SmartBolus Calculator

Omnipod 5 is the only system to incorporate CGM value and trend into the

Bolus Calculator.

CGM-Informed

■Automatically increases or decreases suggested bolus based on CGM

value and trend.

■ Available in both Automated and Manual Modes.

Insulin on Board (IOB)

■May reduce the suggested bolus based on existing IOB.

■ IOB may come from previous meal boluses, previous correction boluses,

or automated insulin deliveries.

Troubleshooting System Communication

Pod & CGM

At times, the Pod and CGM may lose connection while in Automated Mode.

Common reasons for loss of communication may include:

■Pod and CGM not being within line of sight on the body.

■Temporary loss of communication due to environmental interference.

■ Sensor warm-up or required calibration.

When this occurs, SmartAdjust™ technology can no longer fully adjust automated insulin delivery

and Automated Mode becomes “Limited”.

In Automated Mode: Limited, the Omnipod 5 System will deliver basal insulin based on a calculation

of user-entered settings and past insulin delivery history. When the System enters Limited state,

SmartAdjust technology never gives more than the Basal Program that would be active during

Manual Mode.

Check the Dexcom G6 app to see if there are any necessary CGM actions required to re-establish

communication. Full Automated Mode will automatically resume once CGM values become available.

Pod & Omnipod 5 App

At times, the Omnipod 5 App may lose communication with the active Pod. If this occurs, the POD INFO

tab on the Omnipod 5 App will display “No Pod Communication” and the user will have the option to tap

MORE INFORMATION for details.

When there is no Pod communication, the Pod continues delivering insulin according to settings active

on the Pod before losing communication. For example, automated insulin delivery from the Pod will

continue in Automated Mode.

Bring the Controller or smartphone within 5 feet of the Pod to restore communication.

Omnipod®5 System Management and Optimization Omnipod® 5 System Management and Optimization

10 11

References

1. Forlenza G et al. First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults

with Type 1 Diabetes. Diabetes Technology & Therapeutics. 2021;23(6). 2. Boughton CK, Hartnell S, Allen JM, Fuchs J, Hovorka R. Training and Support

for Hybrid Closed-Loop Therapy. Journal of Diabetes Science and Technology. September 2020. doi:10.1177/1932296820955168 3. American Diabetes

Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes - 2021. Diabetes Care 2021; 44(Suppl.1); S85-S99.

Medical Disclaimer: This handout is for information only and is not a substitute for medical advice and/or services from a healthcare provider. This handout may not be relied upon in any way in

connection with personal healthcare related decisions and treatment.