The Diabetes Community can’t wait until the first tubeless insulin pump becomes a “closed loop” automated system, with the introduction of the Omnipod 5 expected by the end of 2021.

This new system will combine the Omnipod patch pump with the Dexcom G6 continuous glucose monitor (CGM) and a controller algorithm to help automate insulin delivery.

Notably, Omnipod 5 is set to bring mobile app control and insulin dosing directly from your smartphone, eliminating the need to carry a separate Personal Diabetes Manager (PDM) around to control the system.

Omnipod maker Insulet in Massachusetts had experienced some delays with this product due to the COVID-19 pandemic, but now pivotal trials are complete and they and submitted it to the Food and Drug Administration (FDA) right around the start of the year. Many expect the federal agency will give it their green light by mid-2021. As in, it could be ready for purchase by patients by the end of the year!

Omnipod 5 is the latest Automated Insulin Delivery (AID) system that combines an insulin pump and a CGM with a controller 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 will be the third commercially available AID system, after Medtronic’s original 670G and the newer Tandem Control-IQ system. But Omnipod brings the first AID system with a no-tubing pump.

It is a major upgrade from Insulet’s latest Omnipod DASH platform launched in 2019 and uses the same pods and mobile app. It will first connect with the Dexcom CGM and later with Abbott’s FreeStyle Libre, Insulet says.

Here are some of the key features to know about:

  • It’s the same size and shape as existing Pods, worn for up to 3 days and holding anywhere between 85 and 200 units of insulin.
  • Unlike previous Omnipod versions, this new system will eliminate the need to carry a separate PDM controller device, as users can control it directly from a smartphone app.
  • At first, the mobile app will be compatible only with certain Android smartphones, but eventually it will work with iPhones.
  • Insulet has said during investor earnings calls that it will provide a basic phone to those who don’t have a compatible smartphone, for use exclusively with the Omnipod 5 app.
  • The algorithm will make 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 users recorded insulin sensitivity factors.
  • It allows for varying glucose targets for different times of day.
  • Glucose targets are customizable in 10 mg/dL increments between 110 to 150 mg/dL — different than other first-generation AID systems that have fixed targets you can’t change.
  • It includes a “HypoProtect” feature to ward off low blood sugar that temporarily sets the target to 150 mg/dL and minimizes basal insulin delivery for exercise.
  • The system learns a user’s needs after the first two or three 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.
  • You still need to bolus 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.

What’s unique compared to competing commercial systems is that Omnipod 5 will be the only tubeless patch pump system offering automation, plus the first to offer full smartphone control including dosing capabilities from the phone.

The Omnipod 5 pivotal trial data shows promising results, which is great news for anyone considering switching to this system.

Initial results were released in spring 2021, but the full pivotal trial data was summarized and published in June 2021 leading up to the American Diabetes Association’s annual Scientific Sessions conference.

This multicenter clinical study at six sites across the United States included a total of 241 participants with type 1 diabetes (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 that data, of course, is the impact on quality of life a 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 of that convinces you to make the switch will be a personal choice. But there’s no doubt that excitement has reached a fever pitch over the positive trial results in the months leading up to the Omnipod 5’s eventual release, and the choice that it will offer.

In Pennsylvania, longtime T1D Pat Pitarra sees the Omnipod 5 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 (CRNP) 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 one.

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. Having no tubes like traditional insulin pumps 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 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.

“I can’t tell you how excited I am,” he told DiabetesMine. “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 PDM (Personal Diabetes Manager) 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 in itself — 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.”