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OmniPod 5 User Manual

Automated insulin delivery system
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Omnipod
5 Automated Insulin Delivery System
®
User Guide

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Summary of Contents for OmniPod 5

  • Page 1 Omnipod 5 Automated Insulin Delivery System ® User Guide...
  • Page 2 Resonance Imaging (MRI), a Computed The Omnipod 5 System is intended Tomography (CT) scan or diathermy for single-patient use. The Omnipod treatment. In addition, the Controller 5 System is indicated for use with should be placed outside of the NovoLog /NovoRapid , Humalog ®...
  • Page 4 New Omnipod 5 User Receiving training and understanding the Instructions for Use are needed BEFORE using your new Omnipod 5 System. Follow these steps to get started: 1. Complete Onboarding Before using your Omnipod 5 System, you must complete Omnipod 5 onboarding by visiting omnipod.com/setup.
  • Page 5 To access the complete Omnipod 5 System Technical User Guide At any time while using Omnipod 5, you can access or request the Omnipod 5 Technical User Guide. 1. Download or print a digital copy: • Visit omnipod.com/guides. • Scan this QR code with your smartphone.
  • Page 7 Omnipod 5 App Home Screen ........
  • Page 8 • Cannot communicate with a Dexcom receiver while paired with a Pod. You can set up & start your Dexcom Sensor before or after setting up your Omnipod 5 App. Please consult the Dexcom Instructions for Use for more information. Sensor not included Sensor not included.
  • Page 9 The Omnipod 5 App comes installed on the Controller provided. Connectivity to mobile data or Wi-Fi is important when using the Omnipod 5 System. Make sure to connect to your home or work Wi-Fi network. Initial pump therapy settings, provided by your healthcare provider, are needed to set up your Omnipod 5 App.
  • Page 10 Omnipod 5 App Security on Your Controller After you set up your provided Controller, the Lock and PIN screens appear whenever you wake up your Controller. The Lock screen displays: • Your selected background image. • Today's date and time.
  • Page 12 Omnipod 5. The Transmitter serial number (SN) must also be entered in the Omnipod 5 App to pair the Sensor with your Pod. Locate your Dexcom G6 Transmitter serial number (SN). This can be found in your Dexcom G6 mobile App Settings, on the back of the Transmitter and on the Transmitter box.
  • Page 13 If you have been using the Dexcom G7 receiver, turn it off. Your Sensor will not pair with your Pod if it is still connected to the receiver. Note: You will need to connect each new Dexcom G7 Sensor to both the Omnipod 5 App and Dexcom G7 App for your Pod and Sensor to stay connected.
  • Page 14 Line up the QR code in the green Note: frame, holding both Check that the the Controller and camera lens is applicator steady not blocked by for several seconds. your Controller The photo is taken gel skin. You automatically. It will will also need not be stored.
  • Page 15 Switching Between Sensor Types The Omnipod 5 System is compatible with more than one model of Sensor. If you start the System on one type of Sensor and move to a different Sensor in the future, you can switch your Sensor type from the Manage Sensor screen.
  • Page 16 Omnipod 5. Wash your hands with soap and water. Clean the top of the insulin vial with an alcohol prep swab. On the Omnipod 5 App, locate the Pod activation screen. • After first time • From the POD...
  • Page 17 An arrow on the white paper backing points to the fill port. Slowly push the plunger down to completely fill the Pod. • The Pod will beep twice to indicate that the Omnipod 5 Pod is ready to proceed.
  • Page 18 SET UP A NEW POD (continued) Activate the Omnipod 5 Pod • With the Pod still in its tray, place it next to and touching the Controller to ensure proper communication. Tap NEXT on the Controller. The system will perform a series of safety checks and automatically primes the Pod.
  • Page 19 • Ideal sites have a layer of fatty tissue. • Ideal sites offer easy access and viewing. • The site should be at least 2.5 cm (1 inch) away from the previous site to avoid skin irritation. • The site should be at least 5 cm (2 inches) away from your navel.
  • Page 20 How to Change the Pod • Tap CHANGE POD. • Tap POD INFO. • Tap VIEW POD DETAILS. • Tap DEACTIVATE POD. After the Pod is deactivated, gently lift the edges of the adhesive tab from the skin and remove the entire Pod. Tip: Remove Pod slowly to help avoid possible skin irritation.
  • Page 21 Omnipod 5 System Modes System Modes The Omnipod 5 System has two operating modes: Automated Mode and Manual Mode Automated Mode Manual Mode • Adjusts every 5 minutes. • Uses your Basal Programme. • Adapts by updating your Total Daily Insulin with every Pod change.
  • Page 22 Manual Mode Automated Mode How it works Basal Insulin Insulin is delivered Insulin is delivered and adjusted according to the active automatically based on sensor Delivery Basal Programme. glucose values and 60-minute prediction. When sensor glucose values are not available for adjustments, in Automated: Limited, the System constantly compares Automated Adaptive...
  • Page 23 Adaptive Basal Rate is a continuous baseline that the System can adjust up or down every 5 minutes in response to your sensor glucose values. For your first Pod, since the System doesn't have any history yet, your Total Daily Insulin and initial Adaptive Basal Rate are estimated from the Basal Programme you entered during set-up.
  • Page 24 • An active Pod Home screen. and saved Sensor information within the Omnipod 5 App are required. Note: Before switching to Automated Mode, an active Temp Basal, Extended Bolus or insulin pause must first be cancelled. • Confirm that the mode switched.
  • Page 25 Great things take time • You can begin using Automated Mode with your first Pod. • Over time, with every Pod change, Omnipod 5 will adapt to better match your insulin needs. • Optimising your insulin delivery could take from a few days to a few weeks, depending on your previous therapy, starting settings and Total Daily Insulin delivered.
  • Page 26 Total Daily Insulin. Bolusing for meals and to bring down high glucose will help your System learn your insulin needs as it adapts over time. For more information about treating high and low glucose and handling sick days, see Section 10: Staying Safe with Omnipod 5.
  • Page 27 Get to Know the App Omnipod 5 App Home Screen Alarms and Notifications Current System Mode Menu Button Tab Views: • DASHBOARD Insulin on • INSULIN Board (IOB) • POD INFO Sensor Glucose Value and Trend Arrow Last Bolus Sensor Graph...
  • Page 28 Glucose Trends and Indicators SENSOR GLUCOSE VALUE COLOUR KEY: The sensor glucose value and trend arrow will change colour depending on your Glucose Goal Range. Sensor glucose value within Glucose Goal Range (Manual Mode). Trending steady Sensor glucose value within Glucose Goal Range (Automated Mode).
  • Page 29 Hazard Alarms are high-priority alarms that indicate a serious problem has occurred and you may need to remove your Pod. Hazard Alarms related to the App Omnipod 5 App Error The System detected an error with the App. The Controller may restart. Omnipod 5 Memory The System detected an error with the App.
  • Page 30 This alarm can let you know to step in and check your Sensor, your Pod and your glucose. Switch to Manual Mode for 5 minutes or longer to acknowledge this alarm. Notifications Action Item notifications are for technical System tasks that need your attention, such as App settings or updates.
  • Page 31 Key Insulin Delivery Actions Deliver a Bolus Automated Manual Note: USE SENSOR button is active only when Omnipod 5 is receiving sensor glucose values. Note: Extended Bolus is available only in Manual Mode. • Tap the Bolus • Tap on the Carbs field to button on the manually enter carbs.
  • Page 32 Note: Always bolus for meals as directed by your healthcare provider. In Automated Mode, bolus doses still require your programming and delivery. Failure to deliver a bolus for meals could lead to hyperglycaemia.
  • Page 33 KEY INSULIN DELIVERY ACTIONS (continued) Custom Foods Omnipod 5 allows you to save carb information for certain favourite foods, snacks or meals (Custom Foods) that you might eat frequently. To create or edit a Custom Food, tap Custom Foods from the Menu.
  • Page 34 Start the Activity Feature Note: The Activity feature is available only in Automated Mode The Activity feature of the Omnipod 5 System can be enabled for times when there may be a decrease in insulin needs, like exercise. It will set the Automated Mode Target Glucose to 8.3 mmol/L (150 mg/dL) and reduce...
  • Page 35 You can cancel the Activity feature at any time. Upon cancellation or expiry of the defined time period, full automated basal delivery starts on its own and the Omnipod 5 System returns to using the user-defined Target Glucose. • Tap CANCEL on •...
  • Page 36 Insulin delivery does not automatically start at the end of the paused period. You must tap START INSULIN to start insulin delivery. Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalised recommendations.
  • Page 37 • Tap VIEW. • Tap YES. • Tap to edit programme or tap NEXT to edit basal time segments and rates. Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalised recommendations.
  • Page 38 KEY INSULIN DELIVERY ACTIONS (continued) • Tap the time segment • To start the Basal to edit. Programme now, tap START. Otherwise, tap • Tap SAVE after NOT NOW to save for use confirming edits in the at a later time. Basal Programme.
  • Page 39 • Tap CONFIRM. • Tap START. • Review selections are correct and tap START. Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalised recommendations.
  • Page 41 Omnipod 5 Pivotal Study in Children, Adolescents and Adults (6–70 years) The goal of the pivotal study of the Omnipod 5 System was to assess the safety and efficacy of the system. This single-arm, multicentre, prospective study enrolled 112 children (6 to 13.9 years) and 128 adolescents and adults (14 to 70 years).
  • Page 42 (Q1, Q3). The median is the middle number in an ascending list of numbers and the interquartile range represents the middle 50% of values. *Change between standard therapy phase and Omnipod 5 System phase was statistically significant.
  • Page 43 ≥ 13.9 mmol/L, ≥ 250 mg/dL (15.0%) (5.1%) (12.7%) (7.0%) (std dev) Avg % 6.7% -4.8%* 4.2% 1.5% -2.7%* ≥ 16.7 mmol/L, ≥ 300 mg/dL (9.1%) (2.5%) (8.0%) (3.1%) (std dev) *Change between standard therapy phase and Omnipod 5 System phase was statistically significant.
  • Page 44 3-month Omnipod 5 System treatment phase. Adolescents, adults and children experienced a reduction in A1C after 3 months of Omnipod 5 System use regardless of baseline A1C < 8% or ≥ 8% category. Subgroup Analysis of Change in Average A1C(%) by Baseline A1C(%) Baseline A1C <...
  • Page 45 A study was conducted on 25 participants with type 1 diabetes aged 6–70 years to assess the Omnipod 5 CGM-informed SmartBolus Calculator. During Phase 1, participants used the Omnipod 5 system in Manual Mode for the first 7 days without a connected CGM (standard SmartBolus Calculator).
  • Page 46 Omnipod 5 Clinical Study in Very Young Children The goal of this study was to assess the safety and effectiveness of the Omnipod 5 System in children with type 1 diabetes aged 2 to 5.9 years. This single-arm, multicentre, prospective study enrolled 80 children.
  • Page 47 (Q1, Q3). The median is the middle number in an ascending list of numbers and the interquartile range represents the middle 50% of values. *Change between standard therapy phase and Omnipod 5 System phase was statistically significant.
  • Page 48 3.9% -9.1%* ≥ 13.9 mmol/L, ≥ 250 mg/dL (13.2%) (3.9%) (std dev) Avg % 4.3% 1.2% -3.1%* ≥ 16.7 mmol/L, ≥ 300 mg/dL (6.7%) (1.6%) (std dev) *Change between standard therapy phase and Omnipod 5 System phase was statistically significant.
  • Page 49 3-month Omnipod 5 System treatment phase analysed by baseline A1C%. Participants experienced a reduction in A1C after 3 months of Omnipod 5 System use regardless of baseline A1C < 8% or ≥ 8% category. Subgroup Analysis of Change in Average A1C(%) by Baseline A1C(%) Baseline A1C <...
  • Page 50 During Phase 1, participants used the Omnipod 5 system in Manual Mode for the first 7 days without a connected CGM (standard SmartBolus Calculator). In Phase 2, participants used the Omnipod 5 system in Manual Mode with a connected CGM (CGM-informed SmartBolus Calculator) for 7 days.
  • Page 51 • At startup: Adjacent and touching, with the Pod either in or out of tray, to ensure proper communication during priming. • During normal operation: Within 1.5 metres (5 feet) of each other. Depending on the location, the communication distance may handle separations up to 15 metres (50 feet) away.
  • Page 52 CGM System Instructions for Use. Pod Specifications Size: 3.9 cm wide x 5.2 cm long x 1.45 cm high (1.53" x 2.05" x 0.57") Weight (without insulin): 26 grams (0.92 oz) Operating temperature range: Pod operating environment of 5°C to 40°C (41°F to 104°F).
  • Page 53 Accuracy test results: The following graph shows the flow accuracy of the Pod against given time periods. The measurements were made using a Pod with a basal rate of 0.5 μl/h (which delivers 0.05 U/h of U-100 insulin) at a high operating temperature. The overall mean percentage flow error was  1.40%.
  • Page 54 Quality of Service The Omnipod 5 System includes two wireless transmission pathways. Insulet defines the quality of service of the Omnipod 5 System for each of the two pathways: Omnipod 5 App to Pod wireless communication definition Successful transfer of commands, data and alarms between the Controller and Pod when in communication range (within 1.5 metres...
  • Page 55 Decrease in BG Reading (0.1 mmol/L, 1 mg/dL decreases amount of suggested increments) bolus dose. Maximum Bolus Enter in Omnipod 5 App Limits amount of single 0.05–30 U Settings or during First bolus dose. (0.05 U increments) Time Setup...
  • Page 56 • The SmartBolus Calculator refreshes values every 5 minutes. If you do not start your bolus within 5 minutes of entering the SmartBolus Calculator, the Omnipod 5 System will need to clear the screen so that it has the latest IOB and Sensor information. When changing time zones, always check your IC Ratio and Correction Factor settings for the new time to ensure it still meets your body's true insulin needs.
  • Page 57 The SmartBolus Calculator considers the values you Calculator input for a given bolus calculation to be valid for up to 5 minutes from initial entry of the value into the Time Out SmartBolus Calculator. If 5 minutes or more have elapsed, you will be notified that you must refresh the SmartBolus Calculator and input the values again.
  • Page 58 Bolus size: 0.05–30 U in 0.05 U increments Delivery performance characterisation To assess bolus delivery accuracy, 12 Pods were tested by delivering a minimum, intermediate and maximum bolus amount (0.05, 5.00 and 30.0 Units). The following table summarises the typical bolus performance observed for the requested minimum-, intermediate- and maximum-size bolus for all pumps tested.
  • Page 59 1,192/5,987 582/5,987 121/5,987 0/5,987 percent of boluses (8.4%) (19.9%) (9.7%) (2%) (0%) within range Amount of Insulin Delivery for an Intermediate (5.00 U) Bolus Request Amount (Units) < 1.25 1.25–3.75 3.75–4.50 4.50–4.75 4.75–5.25 (% of settings) (< 25%) (25–75%) (75–90%) (90–95%)
  • Page 60 Amount of Insulin Delivery for a Maximum (30.0 U) Bolus Request Amount (Units) < 7.5 7.5–22.5 22.5–27.0 27.0–28.5 28.5–31.5 (% of settings) (< 25%) (25–75%) (75–90%) (90–95%) (95–105%) Number and 0/72 0/72 0/72 0/72 72/72 percent of boluses (0%) (0%)
  • Page 61 [min, max] [28.85, 31.39] [177.49, 181.15] Note: A measurement at the 12-hour period with a 30.00 U/hr basal rate is not applicable to the Omnipod 5 System as the reservoir will empty at approximately 6 ²/ ³ hours at this rate.
  • Page 62 Omnipod 5 System detects a blockage, it sounds a Hazard Alarm and prompts you to deactivate and change your Pod. A blockage Hazard Alarm sounds when an average of 3 units to 5 units of missed insulin occurs. The following table depicts blockage detection for three different situations when using U-100 insulin.
  • Page 63 Omnipod 5 System Label Symbols The following symbols appear on the Omnipod 5 System or its packaging: Symbol Meaning Symbol Meaning Do not re-use MR unsafe Do not use if package is Refer to instruction damaged and consult manual / booklet...
  • Page 64 (France) The puncture waste must be placed (France) Packaging in a DASTRI needle box. intended for recycling These needle boxes are distributed by pharmacies. Charging cable Charging adapter Fill Syringe and Needle Assembly Controller skin Omnipod 5 Controller...
  • Page 66 Staying Safe while Using the Omnipod 5 System General Warnings Warning: DO NOT use the Omnipod 5 System if you are unable or unwilling to Warning: Read all the instructions use it as instructed by the Instructions for provided in the Instructions for Use Use and your healthcare provider.
  • Page 67 Sanofi and Kirsty are compatible combustion of the Pod or Omnipod 5 with the Omnipod 5 System for use up to Controller, which can cause severe 72 hours (3 days). Follow your healthcare burns to the body.
  • Page 68 Glucose Warnings Warning: ALWAYS be aware of your current sensor glucose value, trust how Warning: ALWAYS follow your healthcare your body feels and do not ignore provider's guidance on appropriate symptoms of high and low glucose. Even glucose monitoring to avoid though insulin delivery adjusts hyperglycaemia and hypoglycaemia.
  • Page 69 App fails to beep during a diagnostic test, hyperglycaemia. call Customer Care immediately. Continuing to use the Omnipod 5 System Warning: NEVER use a Pod if, while you in these situations may put your health are filling the Pod, you feel significant...
  • Page 70 Omnipod 5 App if: • You have not installed a required update to the Omnipod 5 App. • An update for the Omnipod 5 App is not yet available to fix a known issue. Use a different insulin delivery method. Failure to deactivate your Pod and use...
  • Page 71 ALWAYS confirm the Dexcom G6 Transmitter serial number (SN) or Dexcom G7 pairing code and serial number you save in the Omnipod 5 App matches the one you are wearing. In cases where more than one person in the household uses a Dexcom Sensor,...
  • Page 72 NOT be used in delivered based on your old time zone, people who require less than 5 units of which may cause disruptions in your insulin per day, as the safety of the...
  • Page 73 If you do not start closer than 30 cm (12 inches) to any part insulin delivery, you could develop of the Omnipod 5 System, as it may hyperglycaemia. impact the communication between your Controller and your Pod.
  • Page 74 Controller, you can miss important notifications and alarms from the Caution: DO NOT expose your Controller Omnipod 5 App. If you do not hear battery to high heat [> 30°C (> 86°F) alarms and notifications from your during storage and > 40°C (> 104°F) Controller, you might not make the during use].
  • Page 75 Pod. The fill syringe is • Contact your healthcare provider. intended for single use only and should Treat the infection according only be used with the Omnipod 5 to instructions from your System. Failure to follow the instructions healthcare provider.
  • Page 76 Omnipod 5 App. Delivery of insulin Your Pod will still sound and you will be in Manual Mode or Automated Mode...
  • Page 77 Taking Care of Your Controller and Pod Pod and Insulin Storage Extreme heat or cold can damage Pods and cause them to malfunction. It is especially important to store your insulin in a well-controlled environment. Inspect insulin before using it; never use insulin that looks cloudy or discoloured.
  • Page 78 Safe Use of the Controller Battery To safely use the rechargeable battery: • Store and charge the Controller in a cool, dry place out of direct sunlight to prolong battery life. Avoid leaving the Controller in a car where temperature extremes can permanently damage the battery.
  • Page 79 Device Complaints If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and/or its authorised representative and to your national authority. Contact details for the manufacturer can be found on the back cover of this document.
  • Page 81 Important Notes: • Make sure your blood glucose is at least 5.6 mmol/L (100 mg/dL) before driving or working with dangerous machinery or equipment. • Even if you cannot check your blood glucose, do not wait to treat symptoms of hypoglycaemia.
  • Page 82 Action Plan Never ignore the signs of low blood glucose, no matter how mild. If left untreated, severe hypoglycaemia 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: •...
  • Page 83 Troubleshooting Hyperglycaemia (High Glucose) Blood Glucose (BG) Reading ≥ 13.9 mmol/L (250 mg/dL) Hyperglycaemia Symptoms • Frequent urination • Unusual thirst or hunger • Fatigue (i.e. at night) • Blurred vision • Unexplained weight loss • Slow healing of cuts or sores If you're experiencing symptoms of high glucose: 1.
  • Page 84 Troubleshooting Frequent Hyperglycaemia Check Settings Check History Detail • Are you in Automated Mode? • Alarm history: Did you ignore or not hear alarms that should have • Do you have the Activity feature been addressed? enabled? • Last bolus: was the bolus too •...
  • Page 85 Check Pod Check Your Adhesive Dressing Check your cannula through the viewing window • Is the adhesive dressing coming loose from your skin? • Did the cannula slip out from • Is the Pod becoming detached under your skin? from the adhesive dressing? •...
  • Page 86 • Use Temp Basal as directed by your healthcare provider. • A fever above 38°C (100.5°F). • Stay hydrated. • Moderate to large urine ketones or ≥ 1.0 mmol/L blood ketones. • Monitor urine output.
  • Page 87 • Glucagon kit and written instructions for administering a glucagon dosage if you are unconscious. Always follow Omnipod 5 System instructions. Failure to do so could result in under-delivery or over-delivery of insulin, which can lead to hypoglycaemia and hyperglycaemia.
  • Page 88 All such decisions and treatment should be discussed with a healthcare provider who is familiar with your individual needs. © 2025 Insulet Corporation. Insulet, Omnipod, the Omnipod logo and SmartAdjust are trademarks or registered trademarks of Insulet Corporation. All rights reserved. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.