Omnipod 5: FDA Cleared As First Tubeless Closed Loop System (2024)

Insulet’s Omnipod 5 received FDA clearance on Jan. 28, 2022. It is the first commercially available, automated and tubeless insulin delivery system that can be managed through your smartphone.

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The Diabetes Community now has the first-ever closed loop system that automates insulin delivery with no need for plastic tubing attached to your body. And this new system will be the first that is Food and Drug Administration (FDA)-cleared to be controlled by your smartphone.

First FDA-cleared at the start of the year, the Omnipod 5 system launched fully in the United States in early August 2022 for those 6 years and older. This is made by Boston-based Insulet Corp. and it marks the company’s entry into the automated insulin delivery (AID) universe.

The new system combines the little white Omnipod patch pump with the Dexcom G6 continuous glucose monitor (CGM) and a controller algorithm to automate insulin delivery. Notably, Omnipod 5 makes history as the first such system to get FDA clearance for mobile app control and insulin dosing directly from your smartphone, eliminating the need to always carry a separate controller unit.

“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” Insulet’s President and CEO Shacey Petrovic said. “This has been the better part of a decade in the making… and with many technical hurdles and the pandemic delays, it was not a straight road. To tackle all those challenges and to now be here, pushing the field forward with an incredible novel technology that brings a lot of firsts to market, it’s very much the proudest moment of my career.”

Originally known as “Omnipod Horizon,” the launch of Omnipod 5 brings much excitement, even while some people question the company’s choice to sell this new system only through pharmacies at launch.

The technology got FDA clearance on Jan. 28, 2022, just over a year after Insulet submitted the product to the agency. It marks the fourth commercially available AID system in the United States, but the first without tubing.

Insulet’s Omnipod 5 system is the latest AID system that combines an insulin pump and CGM with a controlling algorithm to automatically adjust insulin in response to predicted glucose levels. Specifically, these are referred to as hybrid closed loop systems because they partially mimic what a healthy pancreas does automatically — but some user intervention is still required around food intake and exercise.

Omnipod 5 becomes the fourth commercially available AID system, after Medtronic’s original 670G launched in 2016, the Tandem Control-IQ system in January 2020, and the MiniMed 770G in September 2020.

But Omnipod 5 — filed with the FDA on Dec. 23, 2020 — stands out as the first AID system to use an insulin pump that doesn’t require any tubing. It’s a patch pump that sticks directly on your skin. This system was recently selected as a 2022 Innovation Award honoree at the big Consumer Electronics Show (CES) in Las Vegas, in the categories of both wearable technologies and health and wellness.

While it also uses Bluetooth-enabled Pods and a mobile app like Insulet’s Omnipod DASH platform launched in 2019, the Omnipod 5 uses different Pods entirely and is a major upgrade in terms of functionality.

It will first connect with the Dexcom G6 CGM, and down the road Insulet says it will also work the future CGMs like the Dexcom G7, which is currently under FDA review and could be approved before long in 2022.

Here are some of Omnipod 5’s key features to know about:

• Pods. The new Omnipod 5 Pods are the same size and shape as existing DASH Pods, worn for up to 3 days and holding between 85 and 200 units of insulin, but they are not the same Pods and aren’t compatible with the earlier versions. Once the insulin’s gone or that 72-hour window runs out, you dispose of the Pod and put a new one on your body. They are waterproof in 25 feet of water for up to an hour.
• Kids. This product is initially OK’d for those with type 1 diabetes (T1D) as young as 6 years old. Insulet plans to soon submit its pivotal trial data for the preschool age group, as young as 2 years old. Of course, if prescribers are willing to write off label prescriptions, then younger kids can still get the new Omnipod 5.
• Type 2 diabetes? While Omnipod 5 isn’t currently labeled for those who have type 2 diabetes, Insulet tells DiabetesMine that it’s presently conducting a clinical trial focused on T2D and will work with the FDA on a larger study needed for that expanded T2D indication.
• Smartphone control or separate controller. Unlike previous Omnipod versions that have a separate controller device, Omnipod 5 users can control this new system directly from a smartphone app. Compatible phones will initially only include certain Android smartphones, but eventually it will work with iPhones as well. Free with each person’s first prescription, Insulet will provide a handheld controller for those who don’t have a compatible smartphone to use exclusively with the Omnipod 5 app. Notably, the FDA did not require this, but the company chose to offer a controller to every customer who may want one.
• SmartAdjust. The algorithm is built directly into each Pod and makes auto-adjustments to basal (background) insulin rates every 5 minutes, based on current and projected glucose values from the connected CGM. It also takes into consideration insulin on board (IOB) that’s already been dosed, and the user’s recorded insulin sensitivity factors. This automation is what Insulet dubs as “SmartAdjust” technology.
• Customizable targets. Glucose targets are customizable in 10 milligram per deciliter (mg/dL) increments between 110 to 150 mg/dL — different than other first-generation AID systems that started with fixed targets you can’t change. It also allows for varying glucose targets for different times of day, as many as 8 different programs throughout the day.
• Activity feature. This can be used during times of elevated risk of low blood sugars, such as exercise. You can raise the target glucose to 150 mg/dL and reduce automated insulin delivery in 1-hour increments anywhere between 1 to 24 hours.
• Food and correction boluses. You still need to take a bolus dose for food and can manually deliver insulin corrections for higher blood sugars, but the smart algorithm will automatically increase or decrease those boluses based on CGM trends if glucose levels are rising or falling.
• No Extended boluses: Many insulin pumpers have gotten familiar with the ability to deliver a portion of insulin over a longer period of time, but the Omnipod 5 doesn’t allow for that. You can switch off the auto-mode to a more manual mode with “traditional” pump settings, but it’s not allowed when using the automated insulin capabilities. Insulet says their clinical research shows the smart algorithm in Omnipod 5 does a better job handling those higher fat meals like pizza, versus having someone just guesstimate how much insulin should be delayed over time.
• Adaptive learning. The system learns a user’s needs after the first 2 or 3 Pods, with the smart algorithm making more aggressive self-adjustments based on results during the past several days. It takes about 9 days for a new foundational basal program to be set.
• Talking to CGM. Dr. Trang Ly, Insulet’s senior VP and medical director, says the Omnipod 5 does need to maintain a “line of sight” with the Dexcom CGM, in that the Bluetooth-enabled Pods need to communicate with the Bluetooth G6 sensors. That means a Pod and G6 sensor should be worn on the same side of the body to avoid connectivity issues.
• Adjustment for sensor failures. After you’ve worn a Pod for at least 48 hours, the Omnipod 5 begins an adaptive basal rate based on what it’s learned. If CGM data is absent at any time, there’s a limited state of automation where the system basically makes a judgement call on whether your programmed basal rate or the adapted rate is more conservative and goes with that.

As noted, Omnipod 5 is unique compared to competitive commercial systems in being the only tubeless patch pump system offering automation and the first-ever to offer full smartphone control, including dosing capabilities from the phone. Tandem Diabetes Care is also working toward that goal with a mobile bolusing feature via smartphone app, but to date that has not yet been FDA approved.

Insulet’s executive leadership also says that even with Omnipod 5’s availability, there’s currently no plan to discontinue its earlier Omnipod versions, such as DASH.

Insulet started a limited market release in the United States on the day of its FDA clearance announcement. That involves a group of preselected individuals — beta testers, if you will — who got first dibs on the new Omnipod 5. Insulet planned to learn what it could from those early adopters, and integrate learnings into training processes and customer service protocols for the broader rollout around the country.

That broader rollout took place in mid-2022 before eventually being fully launched for everyone in early August 2022.

Insulet is offering an upgrade program called OmnipodPromise, which allows new and existing customers to start on the Omnipod DASH and then upgrade to Omnipod 5 at no additional cost once insurance coverage is available.

Only sold at pharmacies

You’ll buy the Omnipod 5 directly through the pharmacy, as it’s not covered as DME the way most other expensive diabetes technology is generally categorized. The good news is that for many people, using their pharmacy benefit coverage rather than relying on DME is a plus, since DME often brings higher deductibles and coinsurance costs.

Yet, this could prove to be problematic, as not all insurers are willing to cover insulin pumps — even the Omnipod patch pump — as a pharmacy benefit. They insist on DME coverage, and that may mean that some will not have access if Insulet isn’t able to secure DME channel coverage.

“My insurance won’t cover Omnipod through pharmacy,” T1D Jill Lockhard in Arkansas told DiabetesMine. “I wasn’t able to upgrade to the DASH because of this. I badly need the Omnipod 5! My A1C hasn’t been the best the last 2 years due to the stress of working on the frontline with COVID.”

Others in the online community echoed these concerns, pointing out their disappointment that Insulet isn’t acknowledging the insurance reality for many people. Insulet responds that it will work with diabetes care teams on insurance appeals, but that isn’t good enough for those who’ve found insurance barriers on pharmacy coverage.

“Hoping this will medically bill as DME because we do not have pharmacy coverage,” Kansas D-Mom Janalin Hood told Insulet in an online comment. “I cannot stand to think of bearing full cost of our favorite pump, or more likely being forced to switch to a tubed pump for our son.”

Another interesting point: Some in the online community note how the Omnipod 5 name could cause some confusion in the pharmacy channel, given that all Pods come in 5-packs.

When asking about the new closed loop system, pharmacists and insurance companies who aren’t familiar with the technology could mistake that for Omnipod DASH 5-packs. That means it may require more attention when placing an Omnipod 5 order to ensure the correct product is being requested.

Omnipod 5 pivotal trial data released in June 2021 showed promising results.

The multicenter clinical study at six sites across the United States included a total of 241 participants with T1D, including 112 children and 129 adults and adolescents. They used the Dexcom G6 with their usual insulin treatment routine for the first 2 weeks of the trial for baseline data, and then they switched to Omnipod 5 for 3 months.

Results show that in general, study participants saw increased Time in Range (TIR), less hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and a drop in A1C levels. Here are the results at a glance:

• Time in Range:
  • TIR in adults and adolescents increased from 65% to 74%, or more than 2 hours per day.
  • TIR in children increased from 52% to 68%, or more than 3 1/2 hours per day.
• Hyperglycemia:
  • Time spent over 180 mg/dL decreased from 32% to 25% in the adult trial.
  • Time spent over 180 mg/dL decreased from 45% to 30% in the pediatric trial, a difference of about 3 1/2 hours per day.
• Hypoglycemia:
  • Time spent below 70 mg/dL decreased from 2.0% to 1.1% in the adult trial.
  • There was no decrease in this range for children from the baseline data, which was already low at only 1 percent.
• A1C averages:
  • For adults and adolescents, A1Cs decreased from 7.2% to 6.8%.
  • Children saw A1Cs drop from 7.7% to 7%.

This data suggests that Omnipod 5 can help people significantly improve their diabetes outcomes within a matter of months.

What isn’t fully captured in the data, of course, is the impact on quality of life that technology like this can provide. One hint at that may be the fact that 92 percent of adults and adolescents, along with a whopping 99 percent of children who took part in the studies, chose to continue using Omnipod 5 in a 1-year extension phase of the trial. That shows a big appeal, especially by people who had the choice to return to using a different closed loop system.

Whether all that convinces you to make the switch will be a personal choice. But there’s no doubt that excitement about the Omnipod 5 and the choice that it offers people reached a fever pitch in 2021.

In Pennsylvania, longtime T1D Pat Pitarra points out that currently there is no good option right now for those who don’t wish to wear a traditional tubed pump. Pitarra has been on an insulin pump since 1996 and has used most of the different brands available through the years, given his career as a Certified Registered Nurse Practitioner and diabetes educator for many years that gave him access to trying them out.

As someone who spends a lot of time in the water in lakes, indoor and outdoor pools, and hot tubs, and teaches water aerobics, he says that means he must basically adjust his activities to accommodate the diabetes device rather than have it fit more comfortably into his life.

“Although I have gotten very used to tubing, going tubeless was wonderful, and if the control is anything like (Tandem) Control-IQ, I would love to try it,” he told DiabetesMine. “It’s about giving people with diabetes a needed choice.”

Jaime Smilowitz in New York says she’s also excited about any diabetes management advances, and with nearly 50 years of T1D experience under her belt, she sees the Omnipod 5 as a big step forward.

She’s used many different pumps through the years and currently uses the Tandem Control-IQ system. But none of those, including the current tech she’s using, offer that same tubeless aspect that Omnipod 5 will offer. Not having the tubing that traditional insulin pumps do is a huge benefit to her, she says, opening up doors that aren’t currently possible from any other FDA-cleared closed loop technology.

“You really can’t measure how much that flexibility means until it’s available, and you can get rid of those wires attached to you,” she said. “Sometimes it feels odd that I’m so excited about this because I’ve seen it all, starting with early insulin pumps that came from testing urine with a pill in the test tube.”

Many parents of kids with T1D echo that excitement.

In New Hampshire, D-Dad Caleb Smith believes the Omnipod 5 will be a game-changer for his 2-year-old son, who was diagnosed with T1D in April 2021. Even with the higher age range for now, the technology still provides hope.

“I can’t tell you how excited I am,” he told DiabetesMine before the FDA clearance news in early 2022. “His little body just doesn’t have room for all of these sensors and Pods. The reduced sizes of the newer Dexcom CGM and Omnipod 5 (compared to their previous models) is going to make altering sites so much easier!”

D-Mom Caren Sterner in the Hudson Valley area of New York also sees the Omnipod 5 as a game-changing device for her family and 11-year-old son, Ryan, who was diagnosed with T1D when he was 8 in April 2018.

Like many kids initially diagnosed, he started out using fingerstick glucose testing along with a syringe and vial for insulin injections. After about 6 months, the family transitioned to the Dexcom CGM to find “a little more normalcy at school.” They moved on to insulin pens soon after, and that allowed Ryan to become more independent, his mom said, but it was the Omnipod that changed everything.

Ryan saw another boy at school with the tubeless patch pump, and his mom says he “liked the tubeless aspect and the fact that it’s not as obvious when you are giving yourself insulin.”

He started on Omnipod in June 2020. But it has limitations, Sterner said, because it doesn’t directly talk with the Dexcom G6 and help to automatically adjust insulin doses based on that CGM data. With Ryan going through puberty and his basal insulin needs changing constantly, she says it’s exhausting to constantly check the CGM anticipating a high or low.

When he heard at a recent endocrinology appointment about the next-generation Omnipod 5, the D-Mom says her son’s eyes lit up.

“He feels that it would give him a little more freedom as well as a more restful night,” Sterner said, noting that it would also eliminate the need to carry that separate handheld controller by allowing for direct-smartphone interaction.

Of course, even with all the promised features and the hope it provides, Sterner says they’d have to get insurance coverage and that could be challenging, as their family’s insurance denied coverage for the Omnipod DASH device, so they are using the older Omnipod model.

“Being a tween is hard enough, but adding T1D to that just stinks,” she said. “Any type of technology that can help make him smile — and improve his management — is fantastic.”