All About Omnipod® 5 Automated Insulin Delivery (AID) System

Guest Blogger
Category: Science and Technology

It’s official, the Omnipod® 5 Automated Insulin Delivery (AID) System has been cleared by the Food and Drug Administration (FDA) for individuals ages 6 years and older with type 1 diabetes!

Omnipod 5 is the first tubeless AID system managed through a compatible smartphone1 in the U.S. and the only tubeless AID system that integrates with the Dexcom G6® Continuous Glucose Monitor (CGM) System2 to automatically adjust insulin delivery and manage glucose levels both day and night, helping to protect against highs and lows3. Like Omnipod DASH® it continues to be wearable and waterproof†.

The specifics

Omnipod 5 is designed to make it easier than ever to manage glucose with no multiple daily injections, tubing, or fingersticks4 to help simplify life with diabetes.

The Omnipod 5 System consists of:

  • the tubeless Pod enhanced with SmartAdjust™ technology
  • the Dexcom G6® CGM (not included)
  • and the Omnipod 5 app with its integrated SmartBolus Calculator. The app can be downloaded onto a compatible personal smartphone and is also integrated into the Omnipod 5 Controller, which is provided free with the first prescription.

Every five minutes, with our SmartAdjust technology, the Pod receives a CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery using the user’s desired and customized glucose target, helping to protect against highs and lows5.

Access

Unlike traditional insulin pumps, Omnipod 5 will be available through a customer’s pharmacy6 benefit which comes with the convenience of picking up their Pods just as they would their insulin and other diabetes supplies, and the benefits of no contract, no commitment, and no obligation.

We’ll now start a Limited Market Release (LMR), the length of which is determined by achieving metrics on simplicity, access and commercial readiness to ensure a best-in-class product experience for our Podders®. During LMR, the system will be used by an already predetermined number of people living with diabetes. The great news is, Omnipod 5 is expected to be broadly available shortly after the Limited Market Release.

In the meantime

People with diabetes can enjoy the benefits of Pod Therapy today through OmnipodPromise™, which allows new and existing users to start on Omnipod DASH® and upgrade to Omnipod 5 at no additional cost when product is available7.

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Don’t wait to experience Pod therapy, get started on Omnipod DASH® today with a 30-day free trial*.

Safety info: https://www.omnipod.com/safety
1For a list of compatible smartphone devices visit omnipod.com/compatibility
2Dexcom G6 is not included.
3Brown S. et al. Diabetes Care. 2021;44:1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6 - 70 yrs [adults/adolescents (n= 128; aged 14-70 yrs) children (n=112; aged 6-13.9 yrs)]. Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod 5 hybrid closed-loop phase. Mean time >180 mg/dL in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 32.4% vs. 24.7%; 45.3% vs. 30.2%, P<0.0001, respectively. Median time <70 mg/dL in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 2.0% vs. 1.1%, P<0.0001; 1.4% vs. 1.5%, P=0.8153, respectively. Results measured by CGM.
4If a user’s glucose alerts and readings from the G6 do not match symptoms or expectations or a user is taking over the recommended maximum dosage amount of 1000mg of acetaminophen every 6 hours, one should use a blood glucose meter to make diabetes treatment decisions.
5Brown S. et al. Diabetes Care. 2021;44:1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6 - 70 yrs [adults/adolescents (n= 128; aged 14-70 yrs) children (n=112; aged 6-13.9 yrs)]. Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod 5 hybrid closed-loop phase. Mean time >180 mg/dL in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 32.4% vs. 24.7%; 45.3% vs. 30.2%, P<0.0001, respectively. Median time <70 mg/dL in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 2.0% vs. 1.1%, P<0.0001; 1.4% vs. 1.5%, P=0.8153, respectively. Results measured by CGM.
6Distribution network may be limited at initial launch.
7Only available for users with valid prescription and coverage through their pharmacy benefit. Upgrades subject to user’s insurance coverage.
†The Pod has a waterproof IP28 rating for up to 25 feet for 60 minutes. The Omnipod 5 Controller and DASH PDM are not waterproof.
*To be eligible for 30 Days of Freedom Trial Program, you must complete and sign Program Enrollment and Personal Information Forms and may be required to submit additional documentation. Patients must have been prescribed Omnipod DASH for an FDA-approved indication. For new Pod Therapy patients coming from multiple daily injections or tubed pumps only. Free Omnipod DASH trial program is not available to beneficiaries of Medicare, Medicaid or other federal health care programs, or to members of certain commercial health plans. You agree not to sell, trade, return for credit or seek insurance reimbursement for the PDM or free Pods. After the 30-day trial, your out-of-pocket cost for Pods will depend on your insurance coverage. Other restrictions may apply. Cancel at any time. 30 Days of Freedom Trial Program terms and conditions are subject to change.