Dive Brief:

• Insulet is pausing the clinical trial it hoped would support commercialization of its new automated insulin delivery system Horizon by year's end after discovering a "software anomaly" that could result in incorrect insulin dosing.
• The company is aiming to have updated software available by the end of April, pushing back the U.S. launch timeline for the automated glucose control system to early 2021. The issue is "rare" and no adverse events have been reported in conjunction with the issue, Insulet said Monday.
• Insulet is hoping the Horizon technology, which was given breakthrough device status in 2018, will gain FDA designation as an interoperable automated glycemic controller, or iAGC. To date, the FDA has designated two systems as iAGCs: Tandem Diabetes' Control-IQ system and, as of a Monday announcement from Tandem, its Basal-IQ system.​

Dive Insight:

The speed bump slows some recent momentum for Horizon. At the Advanced Technologies & Treatments for Diabetes meeting last month, Dexcom said it plans to make its future G7 CGM compatible with the Horizon system, building on an earlier commitment to link its existing G6 device. The same day, Abbott said it plans to integrate its FreeStyle Libre 2 device with Horizon.

During last Tuesday's earnings call, Insulet CEO Shacey Petrovic said the company finished its pre-pivotal testing in December, and the pivotal trial now includes about 240 people between the ages of 6 and 70 who will complete a three-month outpatient study. Petrovic said the company was roughly 35% of the way through the trial.​

As for Insulet's newly identified issue, the company said the system could use an incorrect glucose value that could lead to incorrect insulin dosing. Awareness of the issue is new since the company's earnings call.

The company identified the issue by analyzing cloud-based data, according to comments from Insulet management outlined in a note from medtech analysts at Stifel on Monday morning.

"The issue seems to arise when the tethered CGM [continuous glucose monitor​] is off for an extended period, potentially resulting in an incorrect glucose measurement," the analysts wrote.

The Stifel analysts said the disruption should not affect 2020 guidance, as Insulet wasn't expecting much revenue impact from Horizon this year. Insulet forecast total revenues to grow 14% to 18% this year, after hitting year-over-year growth in 2019 of 31% to about $738 million.

Notably, the announcement comes almost exactly a year after competitor Tandem Diabetes said it was temporarily suspending its clinical trial of Control-IQ, the algorithm ultimately greenlighted in December as the first interoperable automated insulin dosing controller. That issue was also related to a glucose value issue that could affect insulin dosing.

Insulet notified customers and healthcare providers of a separate software hang-up last month, issuing an urgent medical device correction regarding the personal diabetes manager device used in its Omnipod Dash insulin delivery system. In certain conditions, the system could advise an inaccurate bolus insulin dose based on a blood glucose reading taken more than 10 minutes prior.

Shares in Insulet were down roughly 5% in early trading Monday.