Companies are racing to develop technology that makes it easier and simpler for the estimated 30.3 million Americans with diabetes to manage their blood sugar.
About 9 percent of the population has the disease, according to the Centers for Disease Control and Prevention.
Two spaces that are rife with innovation and change are continuous glucose monitors and insulin pumps. This year was packed with major developments that will continue to play out next year. Here are a few storylines to follow.
How Medtronic’s MiniMed 670G grows
Production delays hobbled the June launch of Medtronic’s hybrid closed-loop system.
The technology has been hailed as a milestone because it’s the first insulin pump that delivers insulin somewhat automatically. The system combines a continuous glucose monitor, an algorithm and a pump. They work together to measure and analyze glucose levels to adjust the amount of insulin delivered accordingly.
Medtronic’s system is considered a hybrid closed-loop because although the Guardian Sensor 3 and MiniMed 670G pump work together, they still require some patient input. For example, patients need to enter information about what they’re eating and calibrate their pumps using fingerstick testing.
The Food and Drug Administration approved the system in September 2016, months earlier than expected. Medtronic had recently introduced the MiniMed 630G system, meaning a number of patients had just purchased a new device. The number of people wanting the new system caused a spike in demand that slowed production, creating a backlog of people waiting to buy it.
The slowdown weighed on Medtronic’s total diabetes segment, which accounts for about 7 percent of its total revenue. The category declined 2 percent in constant currency last quarter. It rose 4 percent last fiscal year, which ended in April.
The company does not break out the total diabetes segment revenue by category, but intensive insulin management represents the bulk of its sales. That group declined low single digits last quarter. Last fiscal year, it grew high single digits.
Medtronic expects to ramp up production in its fourth quarter, which ends in April. Analysts expect fixing the slowdown will help the diabetes segment grow again.
Impact of Abbott’s FreeStyle Libre
Abbott launched its FreeStyle Libre, the first continuous glucose monitoring system that doesn’t require any fingerstick tests to calibrate, earlier this month.
Most continuous glucose monitors need to be calibrated twice per day to stay accurate. That requires patients to prick their finger and draw blood. FreeStyle Libre eliminates the need for that.
Patients insert the quarter-size sensor into the skin on the back of their upper arms, where it can stay for up to 10 days. To see their blood sugar level, they wave a handheld device over the sensor.
Abbott is aggressively pricing and marketing FreeStyle Libre, including offering a free reader and one free sensor to some users of rival Dexcom’s devices. Abbott is capitalizing on its time as the only continuous glucose monitoring system on the market that doesn’t require finger pricks, probably because it may not last long.
Dexcom submitted its latest G6 sensor for FDA approval in November. The original application included calibration, but Dexcom is in talks with the agency to approve a version that wouldn’t require any.
The sensor would send updates to a handheld reader, as well as an iOS and Android app that’s already used with current sensors. Dexcom expects to introduce a G6 sensor that wouldn’t require fingerpricks by the end of 2018.
In the meantime, FreeStyle Libre may actually draw more patients to the market rather than simply cannibalizing Dexcom’s share, said BMO Capital Markets analyst Joanne Wuensch.
Most patients who use continuous glucose monitors are Type 1 diabetics, who typically need to monitor their blood sugar more closely. Simplifying the method of testing and offering sensors at a lower price could convince Type 2 diabetics to try them as well.
Who fills the void Animas left
Johnson & Johnson’s October announcement that it would shutter its Animas insulin pump business created an opening for competitors.
J&J chose Medtronic as its partner to transition its about 90,000 patients, giving Medtronic the largest advantage. Starting in the spring, Animas patients whose warranties are more than two years old will be eligible to receive a free Medtronic MiniMed 630G delivery system. Insulin pumps are under warranty for four years.
The arrangement is expected to lock up the bulk of Animas’ business for Medtronic, said Barclays analyst Matt Taylor. Medtronic already leads the insulin pump market with about 66 percent of share. J&J held 13 percent.
“J&J’s exit opens the door for Medtronic … to gain more market share because they were chosen as the preferred supplier, or the safety net manufacturer for those patients,” Taylor said.
Yet not every Animas patient is expected to switch to Medtronic. Those whose warranties have already expired may shop around and choose another system. Insuletand Tandem Diabetes Care are vying for them.
For a limited time, Tandem is offering eligible Animas patients whose warranties are more than two years old the chance to use a pump for the remaining two years of their warranty for a refundable deposit of $999. Insulet is offering a free trial of its Omnipod system and a free box of 10 pods. Both companies have partnered with Dexcom to give patients a $200 gift card to buy Dexcom’s G5 continuous glucose monitor.
Whether Omnipod receives CMS reimbursement
Insulet has more than 100,000 patients globally. The company’s CEO, Pat Sullivan, said the number would grow larger if its Omnipod insulin delivery system received reimbursement from the Centers for Medicare & Medicaid Services, or CMS. CMS oversees federal health programs such as Medicare and Medicaid.
The Omnipod is a waterproof device that patients attach to themselves for up to three days and control with a handheld device. It differs from traditional pumps because it doesn’t use a tube to deliver insulin.
The Omnipod doesn’t fall under CMS’ technical requirements for coverage, and Sullivan argued that prevents patients both old and young from using it. Insulet was trying to receive approval, Sullivan said, though those talks stalled with administration changes.
“(CMS is) a detriment to patients who have a chronic condition,” Sullivan said. “It really is a tragedy. The government should be promoting innovation and new technology coming into the market, but CMS has been a huge impediment to medical innovation.”
The lack of CMS coverage hasn’t completely hindered Insulet’s growth. Its stock rocketed 86 percent this year, though getting covered could give Insulet an opportunity to reach even more patients.
Originally published by Angelica LaVito at CNBC
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