omnipod Omnipod 5 Automated Insulin Delivery System User Manual
- October 30, 2023
- omnipod
Table of Contents
Omnipod 5 Automated Insulin Delivery System
INDICATION:
FOR PEOPLE WITH INSULIN REQUIRING TYPE 1 DIABETES AGED 2 YEARS AND OLDER.
Automated Insulin Control
automated insulin control for people with type 1 diabetes1
Omnipod 5* with SmartAdjust™ technology proactively manages insulin delivery
every 5 minutes using a customized glucose target to help minimize the time in
hyperglycaemia and hypoglycaemia.b,c,d1
- Choice of glucose targets by the time of day, throughout the day; adjustable from 110–150 mg/dL (6.1–8.3 mmol/L)e
- The only AID System with SmartBolus calculator, informed with Dexcom G6 CGM value and trend
OMNIPOD 5 IMPROVED GLYCAEMIC CONTROL FOR ADULTS, ADOLESCENTS, AND CHILDREN WITH T1D IN PIVOTAL STUDIES C, D, F1, 2
- 76% time in range at a target of 110mg/dl (6.1mmol/L) in adults and adolescents (14-70 years) and 68% overall TIR in children (2-13.9 years)
- HbA1c was significantly reduced in very young children (2.0-5.9 years), children (6-13.9 years), and adults and adolescents (14-70 years) by 0.5%, 0.7% and 0.4% respectively1,2
- 33% reduced time in hyperglycaemia in children, 24% in adults and adolescents 1
- 60% reduction in hypoglycaemia overnight and 46% overall in adults and adolescents 1
Adjustments on the go c,b1
No more multiple daily injections, tubing, or fingersticksh1
- Tubeless, waterproof,i Pod with built-in SmartAdjust™ technology
- Integrated with the accurate Dexcom G6 CGM System j
IN THE OMNIPOD 5 PIVOTAL STUDY
- Adults reported lower stress when eating compared to prior therapy c,g
- Parents of children reported better sleep quality compared to prior therapy c,g
- Adult users and parents of children felt confident in staying safe from the risk of hypoglycaemia compared to prior therapy c,g
Generation AID, CE-marked and coming soon
*Omnipod 5–next generation AID, CE-marked and coming soon**
- Improved glycaemic control across all age groups from age 2 in two pivotal studies, while time in hypoglycaemia remained low b,c,d,f 1,2
- No more multiple daily injections, tubing, or fingersticks h1
- Tubeless, waterproof, i Pod with built-in SmartAdjust™ technology
SPEAK REP WITH YOUR
EXPLORE THE BENEFITS OF OMNIPOD 5
Whether better suited to CSII, or in need of a simple tubeless insulin delivery system in the run-up to Omnipod 5… Omnipod DASH® could be a good solution today
Important Safety 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 the supervision of the user’s healthcare provider. 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.
When used in automatic mode with Dexcom G6 CGM, the Omnipod 5 System makes adjustments to insulin delivery every 5 minutes based on the user’s current CGM value, glucose values predicted 60 minutes in the future, glucose trend, and past insulin delivery to bring glucose to a user-defined target. b Requires a Dexcom G6 CGM. c Prospective pivotal trial in 240 participants with T1D aged 6–70 yrs (128 adolescents/adults aged 14–70 years and 112 children aged 6¬–13.9 years). The study included a 14-day ST phase followed by a 3-month Omnipod 5 HCL phase. The incidence rates of severe hypoglycemia and diabetic ketoacidosis during the AID phase were 4.8 and 1.2 events per 100 person-years, respectively.1 d Meantime in range (70–180 mg/dL [3.9–10.0 mmol/L]) as measured by CGM in adults/adolescents and children ST vs 3-month Omnipod 5: 64.7% vs 73.9%, P<0.0001; 52.5% vs 68.0%, P<0.0001, respectively. Mean HbA1c: baseline vs Omnipod 5 use in adults/adolescents and children, respectively (7.16% vs 6.78%, P<0.0001; 7.67% vs 6.99%, P<0.0001).
Meantime above range (>180 mg/dL [10.0 mmol/L]) as measured by CGM in adults/adolescents and children ST vs 3-month Omnipod 5: 32.4% vs 24.7%; 45.3% vs. 30.2%, P<0.0001, respectively. Median time below range (<70 mg/dL [3.9 mmol/L]) as measured by CGM in adults/adolescents and children ST vs 3-month Omnipod 5: 2.0% vs 1.1%, P<0.0001; 1.4% vs 1.5%, P=0.8153, respectively. Median time below range (<70 mg/dL [3.9 mmol/L]; 12 AM – < 6 AM) as measured by CGM in adults/adolescents and children ST vs 3-month Omnipod 5: 2.07% vs 0.82%, p<0.0001; 0.78% vs 0.78%, P=0.0456, respectively. Comparisons are relative changes.1 e Glucose targets can be adjusted in up to 8 segments per day. f Prospective trial in 80 participants with T1D aged 2–5.9 yrs. The study included a 14-day ST phase followed by a 3-month Omnipod 5 HCL phase.
Meantime in range (70–180 mg/dL [3.9–10.0 mmol/L]) in very young children as measured by CGM: ST = 57.2%, 3-month Omnipod 5 = 68.1%, P<0.05. Mean HbA1c: ST vs Omnipod 5 use in very young children 7.4% vs 6.9%, P<0.05. Median time below range (<70 mg/dL [3.9 mmol/L]) as measured by CGM: ST vs Omnipod 5 use in very young children (2.2% vs 1.9%, P<0.05).2 g Prior therapy in adults and children, respectively: 15.6% MDI, 84.4% CSII; 9.6%MDI, 90.4% CSII. During the Omnipod 5 pivotal trial, adults aged 18–70 years (N=111) experienced an improvement in eating distress survey score after 3 months of Omnipod 5 use compared to ST: mean T1-DDS Eating Distress Subscale: 1.74 vs. 1.97, respectively.
Parents of children aged 6–11.9 years (N=82) and adults aged 18–70 years (N=111) experienced an improvement in hypoglycaemia confidence survey score after 3 months of Omnipod 5 use compared to ST: mean HCS score = 3.59 vs 3.34; and 3.65 vs 3.52, respectively. 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 ST: mean PSQI Overall Sleep Quality Subscore = 0.70 vs 1.13, respectively.1 h If glucose alerts and readings from Dexcom G6 do not match symptoms or expectations, a blood glucose meter should be used to make diabetes treatment decisions. i 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. j Dexcom G6 CGM System sold separately. The Omnipod 5 System must be used with the Dexcom G6 app and is not compatible with the Dexcom G6 receiver.
AID, automated insulin delivery; CGM, continuous glucose monitor; CSII, continuous subcutaneous insulin infusion; DKA, diabetic ketoacidosis; HbA1c, glycated hemoglobin; HCL, hybrid closed loop; MDI, multiple daily injections, ST, standard therapy; T1D, type 1 diabetes.
References
- Brown S et al. Multicenter trial of a tubeless, on-body automated insulin delivery system with customizable glycemic targets in pediatric and adult participants with type 1 diabetes. Diabetes Care. 2021;44(7):1630-1640.
- Sherr JL et al. Safety and glycemic outcomes with a tubeless automated insulin delivery system in very young children with type 1 diabetes: a single-arm, multicenter clinical trial. Diabetes Care. 2022; doi: 10.2337/dc21-2359 [Online ahead of print].
© 2022 Insulet Corporation. Omnipod, SmartAdjust, and the Omnipod 5 logo are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved. Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. and are used with permission. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation. 1 King St, Hammersmith London W6 9HR INS- OHS-07-2022-00001 v.1
References
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