Omnipod® 5 Clinical Outcomes

Strong Clinical Results. Freedom From Tubes.

We are committed to improving your patients’ clinical outcomes across Type 1 and Type 2 Diabetes, while providing them with the tubeless automated insulin delivery they love.

Demonstrated in the Real World1

Icon of 80% and text "TIR" enclosed in an orange circle Icon of 80% and text "TIR" enclosed in an orange circle
Icon of 80% and text "TIR" enclosed in an orange circle Icon of 80% and text "TIR" enclosed in an orange circle

80% Time in Range2

 

Omnipod Podder Garrett V in a studio and has a Pod on his right arm Omnipod Podder Garrett V in a studio and has a Pod on his right arm

“Omnipod has helped my A1C tremendously. I get back time with my friends and family, and it’s made my job easier.”

Garrett V.
On air personality
Living with type 1 diabetes
Sponsored Omnipod 5 user
Podder® since 2023

 

Omnipod 5 RADIANT Randomized Controlled Trial3

The Omnipod 5 RADIANT trials is the first RCT to evaluate the direct transition from multiple daily injections to AID. Adults and children not meeting clinical targets showed

Adults with T1D Achieved:

Icon with an upwards arrow and the words "22% MORE TIR" inside in black text

Increased Time in Range by an average of 22%

Lower A1C with a downwards arrow and everything in orange

Lowered A1C by 0.8%

Heart icon with a heartbeat line in the middle of it in orange color

No increase in hypoglycemia

Children and Adolescents with T1D achieved:

Icon with the text "20% MORE TIR" enclosed within an orange upward-pointing arrow

Increased Time in Range by an average of 20%

Lower A1C with a downwards arrow and everything in orange

Lowered A1C by 0.8%

Heart icon with a heartbeat line in the middle of it in orange color

No increase in hypoglycemia

 

Omnipod Podder Romey in a pink outfit showing off her Pod on her left arm Omnipod Podder Romey in a pink outfit showing off her Pod on her left arm

"It helps me feel like a normal little kid, just with a little bit of help.”

Romey T.

Living with type 1 diabetes
Sponsored Omnipod 5 user
Podder® since 2019

 

Omnipod 5 SECURE-T2D Trial4

The SECURE-T2D trial, the first and most racially diverse type 2 diabetes pivotal study5, demonstrated improved clinical outcomes and quality of life in this population.

Icon of an apple in orange color outline and transparent inside

84% of participants were not carb-counting before enrollment

Icon of a bottle of pills outlined in orange

55% of participants were using a GLP-1

Adults with T2D achieved:

Lower A1C with a downwards arrow and everything in orange

Lowered A1C by 2.1%

Heart icon with a heartbeat line in the middle of it in orange color

No increase in hypoglycemia

 

"I am a nurse and I know the importance of controlling my diabetes but unfortunately, I would miss my insulin injections…I was on a dangerous path. The ups and downs of high and low sugars are gone, and along with it, the terrible symptoms associated with that. Omnipod has been life changing for me.”

Milli
Nurse
Living with type 2 diabetes
Sponsored Omnipod 5 user
Podder® since 2023

 

*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 and type 2 diabetes mellitus in persons 18 years of age and older. The Omnipod 5 System is intended for single patient, home use and requires a prescription. The Omnipod 5 System 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.

1. Forlenza G, et al. Real-world evidence of Omnipod 5 Automated Insulin Delivery System use in 69,902 people with type 1 diabetes. Diabetes Technol Ther. 2024.


2. Forlenza G, et al. Diabetes Technol Ther (2024). Restrospective analysis of real-world evidence with 5,846 (20.4%) of the 28,612 adults with type 1 diabetes using Omnipod 5 who utilized the 110 mg/dL glucose target had 80% Time in Range or greater. Omnipod 5 results based on users with ≥90 days CGM data, ≥75% of days with ≥220 readings available.


3. Wilmot E, et al. Presented at: ATTD; March 19-22, 2025; Amsterdam, NL. A 13-week randomized, parallel-group clinical trial conducted among 188 participants (age 4-70) with type 1 diabetes in France, Belgium, and the U.K., comparing the safety and effectiveness of the Omnipod 5 System versus multiple daily injections with CGM.

4. Pasquel FJ, et al. JAMA Network Open (2025). Prospective pivotal trial in 305 participants with T2D aged 18-75 yrs. Study included a 14-day standard therapy (ST) phase followed by a 13-week Omnipod 5 hybrid closed-loop phase. Mean time in range (70-180 mg/dL): ST vs. 13-week Omnipod 5: 45% vs. 66%, P<0.001. Mean HbA1c: ST vs. 13-week Omnipod 5: 8.2% vs. 7.4%, P<0.001. In a subgroup analysis of 68 participants with baseline A1c ≥ 9% Mean HbA1c: ST vs. 13-week Omnipod 5: 10.1% vs. 8.1%, P<0.001. Mean T2-DDAS total intensity score: ST = 2.5, 3-month Omnipod 5 = 2.2, P<0.001. Mean Proportion with T2-DDAS ≥ 2.0, no. (%): ST = 66%; 3-month Omnipod 5 = 55%, P<0.001 9


5. Based on published clinical trials in the current AID T2D landscape
INS-OHS-04-2025-00248 v1.0