Dash, Tidepool Loop, Horizon: the Future of Omnipod

12/4/19
WRITTEN BY: Todd Boudreaux
FacebookTwitter
 

As the only tubeless insulin pump currently available, Omnipod has differentiated itself in the marketplace.

The Omnipod Dash saw a wide release in the U.S in April 2019, and the new technology was on full display at the American Diabetes Associations Scientific Sessions (ADA 2019) in June.

With Medtronic’s MiniMed 670G currently available, and Control-IQ from Tandem expected in late 2019, one thing is clear: the immediate future of diabetes management is hybrid closed loops: pumps that can adjust your basal rates based on blood sugar readings from a CGM, but still require bolusing for meals.

Insulet’s hybrid closed loop  — Omnipod Horizon — is gearing up to enter Phase 3 clinical trials later this year and aiming for a public release in the second half of 2020.

Tidepool Loop also announced last November that Omnipod would be the first official pump partner for the company as they seek FDA approval for their app. “Our investment in mobile technology and interoperability ensures rapid innovation cycles, and enables best-in-class development of automated insulin therapy options for our patients,” Dr. Trang Ly, Senior Vice President and Medical Director for Insulet Corporation said.

Get all the information on the current and future iterations of Omnipod below

 

Omnipod DASH™ Insulin Management System Insulet collaboration with Tidepool Loop Program Omnipod HORIZON™ Automated Glucose Control System
  • Available now in the U.S.
  • Controlled via PDM (personal diabetes manager) on locked-down Android device
  • No upfront costs for PDM
  • Communicates via Bluetooth Technology
  • Works with Omnipod DISPLAY app on smartphones
  • CalorieKing food library with over 80,000 food items on PDM Bolus calculator
  • Expected 2nd half of 2020
  • Hybrid closed loop using Tidepool app for iOS and DASH Pods
  • Will use readings from Dexcom G6
  • Control pump from iPhone (no PDM)
  • Algorithm is in the app, must be in range of device to operate
  • Tidepool is currently recruiting for an observational study, and will be seeking FDA approval for the app

 

  • Expected 2nd half of 2020
  • Hybrid closed loop using Omnipod algorithm
  • Will use readings from Dexcom G6
  • At launch, control pump from app on select Samsung phones or from locked-down PDM
  • Algorithm is on pods, which do not need to be in range of PDM to operate
  • Investigational device, expected to enter pivotal trials late 2019

DASH

As reported in April 2019, the The Omnipod DASH™ Insulin Management System is now officially available in the United States following a limited market release. Beyond Type 1 has highlighted some of the key updates for the DASH in the past which include an updated PDM (Personal Diabetes Manager) that features a touchscreen color display. The PDM is a locked-down Android device that communicates with the pods via Bluetooth wireless technology.

By switching to Bluetooth, Insulet is laying the groundwork for current and future integrations with compatible technology. Dr. Ly explained the importance of Bluetooth, saying, “Not only is that the technology that we use to communicate between the PDM and the pod, but it also allows the pod to communicate with other Bluetooth devices in future generation products. With our Horizon product, the pod will communicate via Bluetooth to Dexcom CGM.” She went on to add that the Bluetooth technology “allows the [PDM] to communicate with the user’s own personal phone… which will allow the user to see the insulin information through [the Omnipod DISPLAY app].”

Perhaps most importantly for consumers, the DASH™ PDM will be offered at no cost with the purchase of pods. Insulet CEO Shacey Petrovic said of the new payment structure, “We made the decision with DASH to eliminate the upfront cost of the system, and that’s an ongoing commitment… Our goal is to be able to bring more innovation to market and enable patients to not have to be locked into a four-year contract. The idea is as we get better and better at innovation, people will be able to move to those innovations without any restrictions and without any cost upfront.”

Not all insurance companies are covering DASH at this time, and you can check on the Omnipod website to see if you’re covered. The company has said that if you are not covered, they will help you with an appeals process.

TIDEPOOL LOOP

The Bluetooth functionality of DASH allows for the possibility to become part of an interoperable hybrid closed loop in the future. Last fall, Tidepool announced plans to deliver an officially supported, FDA-regulated Loop app that will be available via the App Store. In November 2018, they announced that Insulet would be their first official partner, with the idea that when the Tidepool Loop app is approved, it will be able to work in tandem with the Omnipod. The Jaeb Center for Health Research (JCHR) is currently conducting an observational study, working with Loop developers to collect information from adults and children with Type 1 diabetes using Loop.

“We just fundamentally agreed with the premise of interoperability, and we believe our job is to make our Omnipod the best delivery system, but people should be able to use whatever sensor and whatever other information that they want to and can,” Petrovic said.

An important distinction between Tidepool Loop and Horizon is that the algorithm for Loop will be on your iPhone, and you will need to be in range of your iPhone for looping functionality. The algorithm for Horizon is on the pods themselves, and that loop therapy will function even when out of range of your PDM or smartphone device.

HORIZON

Perhaps the biggest news from Insulet out of ADA 2019 was the positive trial results regarding the Omnipod Horizon Hybrid Closed-Loop System. The study demonstrated that the system improved glycemic control and was safe for up to four days of use in children as young as two with T1D.

Dr. Greg Forlenza, a pediatric endocrinologist who serves as the Assistant Professor of Pediatrics at the Barbara Davis Center for Diabetes, has conducted several Horizon studies, and discussed the results at ADA: “This is a 48 to 72 hour house and hotel study. Participants were two to six years old with A1C of less than 10%. As I said, the parents stayed in the house with the kids to help deal with separation anxiety… We were comparing standard therapy to hybrid closed-loop therapy and what we saw here was that… the percent time of target range was significantly improved from their home period from 55% to 73%, and their mean glucose was significantly improved; 172 to 148.”

Horizon is expected to launch in the second half of 2020, and will launch with compatibility as an app on some Samsung phones, meaning users will no longer have to carry a PDM. There will be a locked-down PDM option as well for patients who either do not have a compatible phone or would prefer a separate PDM.

The system has been tested at set points between 120-150 mg/dL, and Dr. Forlenza said the hope is they will be able to go as low as 110 mg/dL. The system also has a hypoglycemia protect mode to minimize hypoglycemia during things like exercise, illness, and other circumstances where patients would be very cautious about going too low.

 


TAGS:

Todd Boudreaux

Todd was diagnosed with Type 1 diabetes in 2000, and has been unofficially advocating for T1D ever since. Before joining the team at Beyond Type 1, Todd wrote and produced television shows for Discovery Channel, Travel Channel and Animal Planet. When he’s not in the office, you can usually find him at a baseball game, traveling or drawing on his Etch A Sketch. You can also follow him on Instagram.