Omnipod® 5

Omnipod 5 Automated Insulin Delivery System is the first wearable, tubeless, hybrid closed loop system that integrates with the Dexcom G6, Dexcom G7 and FreeStyle Libre 2 Plus Sensors, for people with type 1 diabetes aged 2 years and older requiring insulin.

Three Simple Parts

Controller + Pod + Sensor 

Omnipod 5 Omnipod 5
Screen image is an example for illustrative purposes only. Pod and Sensors shown without necessary adhesive. Sensors sold separately and require a separate prescription.

Omnipod 5 Controller

The Omnipod 5 Controller allows you to monitor and control the Pod using Bluetooth® wireless technology.

Omnipod 5 Controller Omnipod 5 Controller



Pod

Tubeless, wearable, and waterproof,** the Pod, with built-in SmartAdjust™ technology, sits right on your patient’s body and automatically§ adjusts insulin delivery for up to 3 days or 72 hours.

§ Automated Mode requires compatible CGM Sensor

**The Pod has an IP28 rating for up to 7.6 metres (25 feet) for up to 60 minutes. The Omnipod 5 Controller is not waterproof. Please consult Sensor manufacturer user guide for Sensor waterproof rating.

Omnipod POD no adhesive Omnipod POD no adhesive
Pod shown without necessary adhesive


Sensor

Continuously sends glucose values to the Pod, so your patients can get real-time data without the finger pricks.

Fingerpricks required for diabetes treatment decisions if symptoms or expectations do not match readings.

Omnipod 5 Omnipod 5
Sensors shown without the necessary adhesive. They are sold separately and each require a separate prescription.

SmartAdjust™ Technology

 

Icon Predicts

Predicts

Glucose 60 minutes into the future

Icon Adjusts

Adjusts

Insulin delivery using the selected Target Glucose

Icon Delivers

Delivers

Insulin doses every 5 minutes (as needed)

Always adjusting, so you don’t have to.

Omnipod® 5 with SmartAdjust™ technology automatically adjusts to your patients’ personal needs by increasing, decreasing, or pausing insulin delivery every five minutes – which may help protect against highs and lows.1,2 Watch this video to learn more.

 

 

Improved Clinical Outcomes

Omnipod 5 improved glycaemic control in adults, adolescents and children with T1D in pivotal studies. 1,2

76%

time in range (TIR) at a target of 6.1 mmol/L (110 mg/dL) in adults and adolescents (14–70 years) and 68% overall TIR in children (2- 13.9 years)1,2

HbA1c

was significantly reduced in very young children (2.0–5.9 years), children (6–13.9 years), adults and adolescents (14–70 years) by 0.5%, 0.7% and 0.4% (4.2, 6, and 7.8 mmol/mol) respectively1,2

HbA1c = glycated hemoglobin

33%

reduced time in hyperglycaemia in children and 24% in adults and adolescents1

60%

reduction in time in hypoglycaemia overnight and 46% overall in adults and adolescents1

Omnipod® 5 improved users’quality of life in clinical studies3,4

  • Parents of children using Omnipod 5 reported improvements in quality of life, sleep quality, confidence avoiding hypoglycemia, and mental well-being3,4
  • Adults using Omnipod reported improvements in diabetes distress, stress eating, confidence avoiding hypoglycemia, and mental wellbeing3,4
In a 3-month clinical study, 3 cases of severe hypoglycaemia and 1 case of diabetic ketoacidosis (DKA) were reported in participants aged 6-70 years during Omnipod® 5 System use. These cases were not related to automated insulin delivery malfunction.
References:
1. Brown S. et al. Diabetes Care. 2021;44:1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6 - 70 yrs [Adults N=128, aged 14-70 years, Children N=112, aged 6-13.9 years). Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod 5 hybrid closed-loop (HCL) phase. Mean time in hyperglycaemic range (>10.0 mmol/L or >180mg/dL) as measured by CGM in adults/adolescents and children ST vs. 3-mo Omnipod 5: 28.9% vs. 22.8%; 44.8% vs 29.7%, P<0.0001, respectively. Mean time in hypoglycaemic range (<3.9 mmol/L or <70 mg/dL) as measured by CGM in adults/adolescents and children ST vs. 3-mo Omnipod 5: 2.89% vs. 1.32%, P<0.0001; 2.21% vs. 1.78, P=0.8153, respectively. Mean time in range (3.9-10.0 mmol/L or 70-180mg/dL) in children as measured by CGM: ST = 52.5%, 3-mo Omnipod 5 = 68.0%, P<0.0001. Mean HbA1c: ST vs. Omnipod 5 use in adults/adolescents and children, respectively (7.16% vs 6.78% or 55 mmol/mol vs. 51 mmol/mol, P<0.0001; 7.67% vs 6.99% or 60mmol/mol vs 53 mmol/mol), P<0.0001). Average time above range (>10 mmol/L or >180 mg/dL) in children: ST vs. 3-month Omnipod 5 = 45.3% vs. 30.2%. Change is relative comparison. Average time above range (>10 mmol/L or >180 mg/dL) in adults: ST vs Omnipod 5: 32.4% vs. 24.7%. Change is relative. Mean time in hypoglycaemic range (<3.9 mmol/L or <70mg/dL as measured by CGM; 12AM - < 6AM) in adults as measured by CGM: ST: 2.07% vs. Omnipod 5: 0.82%, P<0.0001 Comparison is a relative change.

2. Sherr J. et al. Diabetes Care. 2022; 45:1907-1910. Single-arm multicenter clinical trial in 80 pre-school children (aged 2-5.9 yrs) with T1D. Study included a 14-day standard therapy (ST) phase followed by a 3-month AID phase with Omnipod 5 system. Mean time in hyperglycaemic range (>10.0 mmol/L or >180mg/dL) as measured by CGM in children ST vs. 3-mo Omnipod 5: 39.4% vs. 29.5%, P<0.0001, respectively. Mean time in hypoglycaemic range (<3.9 mmol/L or <70 mg/dL) as measured by CGM in children ST vs. 3-mo Omnipod 5: 3.43% vs. 2.46%, P=0.0204. Mean time in range (3.9-10.0 mmol/L or 70-180mg/dL) in very young children (2 - 5.9 yrs) as measured by CGM: ST = 57.2%, 3-mo Omnipod 5 = 68.1%, P<0.0001. Mean HbA1c: ST vs. Omnipod 5 use: 7.4% vs 6.9% or 57 mmol/mol vs 53 mmol/mol, P<0.05.

3. Hood KK et al. Diabetes Obes Metab. 2024. Study of 81 children aged 6-11.9 with type 1 diabetes using standard therapy (ST) for 2 weeks followed by 3-months of the Omnipod 5 System. Mean caregiver self-reported Hypoglycemia Confidence Scale score ST vs Omnipod 5: 3.34 vs 3.59, p-value <0.0001, respectively. During the Omnipod 5 pivotal trial, parents of children aged 6-11.9 years (N=82) experienced an improvement in emotional distress levels and mental well-being survey scores after 3 months of Omnipod 5 use compared to standard therapy: mean P-PAID-C score = 40.7 vs. 47.4; mean WHO-5 score = 72.9 vs. 67.5, respectively. During the Omnipod 5 pivotal trial, adults aged 18-70 (N=115) experienced an improved diabetes distress survey score after 3 months of AID use: mean: 1.48 vs. 1.64 (P < 0.001). During the Omnipod 5 pivotal trial, parents of children aged 6-11.9 years (N=82) experienced an improvement in emotional distress levels and mental well-being survey scores after 3 months of Omnipod 5 use compared to standard therapy: mean P-PAID-C score = 40.7 vs. 47.4; mean WHO-5 score = 72.9 vs. 67.5, respectively. During the Omnipod 5 pivotal trial, parents of children 6-11.9 years (N=82) experienced an improvement in sleep quality survey score after 3 months of Omnipod 5 use compared to standard therapy: mean PSQI Overall Sleep Quality Subscore = 0.70 vs 1.12, respectively.

4. Polonsky WH et al. Diabetes Res Clin Pract 2022;190:109998. Study of 115 adults aged 18-70 years with type 1 diabetes using standard therapy (ST) for 2 weeks followed by 3-months of the Omnipod 5 System. Mean self-reported Hypoglycemia Confidence Scale score ST vs Omnipod 5: 3.52 vs 3.65, p-value = 0.0002, respectively. Adults aged 18-70 (N=115) experienced reduction in eating distress score in T1-DDS survey after 3 months of Omnipod 5 use vs baseline: 1.73 vs. 1.97, (P=0.0003), respectively.

Initiating a Patient on Omnipod 5

Help your patients get a successful start on Omnipod® 5.

Omnipod 5 Simplifies Data Management

With Glooko®, your patient can access all of their diabetes information in one easy-to-use platform and easily share it with you.

Omnipod 5 Resources for your Patients

All of the resources, all in one place. Visit our resources page for User Guides, How-to-Videos, FAQs and more.

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Important Safety Information: The Omnipod 5 Automated Insulin Delivery System is a single hormone insulin delivery system intended to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in persons aged 2 and older requiring insulin. The Omnipod 5 System is intended for single patient use. The Omnipod 5 System is indicated for use with NovoLog®/NovoRapid®, Humalog® /Liprolog ® ,Trurapi®/Truvelog®/Insulin aspart Sanofi®, Kirsty®, and Admelog/Insulin lispro Sanofi U-100 insulin.

Warning: SmartAdjust technology should not be used by anyone under the age of 2 years old or by people who require less than 5 units of insulin per day as the safety of the technology has not been evaluated in this population.

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.