Omnipod® Case Studies

In a subgroup analysis of the Omnipod 5 pivotal study, people with diabetes who transition to Omnipod® 5 directly from multiple daily injections (MDI) demonstrated significant improvement in HbA1c and time in range (TIR) a,b,1. Omnipod® 5 users also demonstrated improvements in diabetes-specific psychosocial measuresc.

The highly favourable glycaemic outcomes reported in pivotal trials of Omnipod® 5 were replicated among children, adolescents, and adults in a real-world setting2,3.

 

This page contains Case Studies in a real world setting to support peer-to-peer learning of the clinical benefits of the Omnipod® 5 system.

 

54-year-old with 51 years of diabetes, previously using Omnipod DASH. Issues with angina and hypoglycaemia before switching to Omnipod 5.

 

Preschool child on tubed insulin pump and continuous glucose monitor (CGM). Difficulty achieving glycaemic target, plus heavy parental burden. Transitioned to Omnipod 5 with continuous glucose monitor (CGM).

 

Preschool child on Omnipod and continuous glucose monitor (CGM). Transitioned to Omnipod 5 to improve HbA1c and time in range (TIR).

 

Young adult with very high HbA1c (13.6%), low time in range (TIR) (10%) and feeling very burned out by diabetes care. Previous regimen of multiple daily injections (MDI) and continuous glucose monitor (CGM) before switching to Omnipod 5.

 

9-year-old with 6-year history of T1D. Commonly missed boluses and hesitant to administer mealtime injection in the school. Transition to Omnipod 5 shows improvement in blood glucose management.

 

Adolescent with T1D and burn out, low time in range (TIR) and 13.6% HbA1c. Improvements after just one week of Omnipod 5 compared to previous multiple daily injections (MDI) therapy. 

 

28-year-old on AID System with hypothyroidism, celiac disease, and ADHD. Switched to Omnipod 5 with continuous glucose monitor (CGM).

 

Newly diagnosed, active 12-year-old Football player. Previously on multiple daily injections (MDI) and continuous glucose monitor (CGM) before switching to Omnipod 5. Issues with high HbA1c and loss of independence.

 

54-year-old with stressful job dealing with T1D for 20 years. Struggles with post-prandial hyperglycaemia and hypoglycaemia. Transitioned from multiple daily injections (MDI) to Omnipod 5 and a continuous glucose monitor (CGM).

 

9-year-old on multiple daily injections (MDI) and continuous glucose monitor (CGM) with history of missing boluses and discontinuing pump therapy. Transitioned to Omnipod 5 to improve independence and reduce disruption at school.

Disclaimer: a. in a subgroup analysis; b. the results for subgroups of prior MDI or tubed pump therapy users should be interpreted with caution due to the small sample size; c. Participants completed questionnaires assessing psychosocial outcomes- problem areas in diabetes (PAID); hypoglycaemia confidence scale (HCS); World Health Organisation-5 Well-Being Index (WHO-5); Pittsburgh sleep quality index (PSQI); insulin device satisfaction survey (IDSS); and system usability scale (SUS)

Reference: 1. Brown S. et al. Diabetes Care. 2021;44:1630-1640. 2. Lal R et al. Real-World Glycaemic Outcomes of 36,634 Adults with Type 1 Diabetes Using the Omnipod® 5 Automated Insulin Delivery System with Cloud-Based Data Management. Presented at the American Diabetes Association Meeting, June 23–26, 2023. 3. Sherr et al. Real-World Glycaemic Outcomes of 18,516 Children and Adolescents with Type 1 Diabetes Using the Omnipod® 5 Automated Insulin Delivery System with Cloud-Based Data Management. Presented at the American Diabetes Association Meeting, June 23–26, 2023.


Risk Statement
Important Safety Information: Omnipod® 5 System safety and intended use information.
The Omnipod 5 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 and/or ongoing supervision of a qualified healthcare professional. The Omnipod 5 System is compatible with the following U-100 insulins: NovoLog(R)/NovoRapid(R).Humalog®, and Admelog(R)/Insulin lispro Sanofi(R). The Omnipod 5 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 Pod is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and compatible to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. The Omnipod 5 SmartBolus Calculator is intended to calculate a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), 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. 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.
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 hypoglycaemia, and 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, phone control not available in international markets, should be placed outside of the procedure room. Exposure to MRI, CT, or diathermy treatment can damage the components.
Visit www.omnipod.com/safety for additional important safety information.
©2023 Insulet Corporation. Omnipod, SmartAdjust and the Omnipod® 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 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. All rights reserved. Insulet Netherlands B.V. Stadsplateau 7, 3521 AZ Utrecht, Netherlands.