SAN FRANCISCO – The U.S. FDA has been following the lead of the many proactive diabetes patients who have cobbled together devices and software to get the equipment they need. In 2018, the agency started to approve interoperable diabetes devices with San Diego-based Dexcom Inc.’s G6 integrated continuous glucose monitoring (iCGM) system. An interoperable insulin pump from Tandem Diabetes Care got the next nod from the FDA in 2019.
Now, Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod Horizon. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. In combination, the devices will operate as a closed loop system to automatically adjust insulin dosage over time in response to blood glucose levels.
Looking at the Horizon
The Acton, Mass.-based company just started a 240-patient pivotal trial for Omnipod Horizon in late December. The patch-like insulin pod and accompanying Android smartphone app have a breakthrough device designation from the FDA. It will be the first such product that is controlled via a secure app on a personal smartphone, rather than with a locked, dedicated Android phone as was previously the case with the prior iteration Omnipod Dash.
Insulet just launched the Omnipod Dash about nine months ago in the U.S. and two months ago in Europe, but the company spent much of its J.P. Morgan Healthcare presentation focused not on the recent launch, but on the next-gen product that’s expected to come out during the second half of 2020.
“The goal here is to deliver, again, unparalleled outcomes with unparalleled ease of use. So, we made some very specific design choices with the system to be able to deliver on those two goals. The first thing we did is: design for greater time in closed loop,” said Insulet president and CEO Shacey Petrovic on the Omnipod Horizon. “We put the algorithm directly on the pod, which never needs to be removed for exercising or showering with the goal of keeping the user in closed-loop regardless of how close they are to their phone, for example. This, we believe, will deliver more time in loop, which then has the potential to drive more time in range.”
“The second thing that Horizon offers is personalized therapy. The algorithm is adaptive, and will learn and grow with the user. So as a user, for example, goes through a growth spurt and might require more insulin or somebody who adopts an exercise routine more regularly, the algorithm will adapt and will adjust the insulin dosage as necessary to deliver optimal glucose control,” she continued. “Then finally, and probably most exciting for our users, we will be the first to market with a personal smartphone control of Omnipod. This is the single most asked for a feature in our system.”
Interoperability goes mainstream?
The promise of interoperability for diabetes devices have helped to boost company share prices. Since the start of 2018, Insulet has already more than doubled its valuation to $11.5 billion – and it’s working to convince Wall Street that its newest product iteration will enable a relatively niche product to go more mainstream. Dexcom and Tandem have also seen their valuations skyrocket in the last few years.
Insulet is expecting that pairing the Omnipod Horizon with G6 will enable it to tap into the CGM’s user base. Neither insulin pumps nor CGMs have vastly penetrated into the multi-daily insulin injector population, but Wall Street is betting that a tipping point may be ahead as the products become easier and cheaper to use thereby making the improved patient outcomes more widely accessible.
If that is indeed the case, Insulet may be able to tap into an enormous market. Globally, 95% of the people who require insulin routinely rely on multiple daily injections, while the remaining 5% use conventional tube insulin pump therapy. That’s despite the fact that insulin pump use can smooth out the highs and lows of daily blood glucose levels, increasing a patient’s time in the desired blood glucose range and decreasing the risk of complications.
Closed loop management of diabetes has long been an industry goal. Various combinations of devices are in testing, but Dublin-based Medtronic plc has the only FDA-approved hybrid closed loop device. Medtronic will present pivotal clinical trial data on the next-gen version at the American Diabetes Association meeting in June. But its efforts thus far have been limited largely to highly motivated early adopters, as the technology remains relatively complex.
Milpitas, Calif.-based Bigfoot Medical Inc. is also developing a closed-loop diabetes device, but first it’s looking at an FDA submission and launch this year for an injection-based digitized insulin dosing platform that integrates with partner Abbott’s Freestyle Libre CGM. The startup just received a $35 million series C round to propel it toward those goals.
Insulet is already the market leader in pediatrics. The Omnipod Horizon aims to further extend that with a caregiver app to track users blood glucose. In addition, Insulet aims to further capitalize on its distribution via the pharmacy channel that requires no major upfront investment. A standard insulin pump can cost anywhere from about $2,000 to $6,000 out-of-pocket and upfront.
What all these players are chasing is the best way to get the latest diabetes technology to the growing masses of multi-daily insulin (MDI) injecting diabetes patients that can optimally manage the disease in order to improve patient outcomes and trim related health care costs.
“In pre-pivotal trials, we did receive quite a bit of feedback from trial participants, particularly pediatrics, on how great the control has been – and how this lack of excursions, not chasing highs and lows means that people are much more confident in the system, particularly around meal times and around changing of routines,” said Petrovic in the breakout session detailing the Omnipod Horizon testing thus far.
“If we can keep people in range, it's another opportunity to drive insulin reduction of total daily dose reduction,” she continued. “We know today that Omnipod reduces the total daily dose of insulin anywhere from 16% to 27% depending on whether you're type 2, type 1 or MDI or pump user. By keeping people in range more consistently, we should be able to further reduce the total daily dose of insulin required by users.”