Dexcom Advances Diabetes Management with 15-Day CGM Sensor and Expanded Type 2 Applications
核心洞察
Dexcom (搜索)'s new 15-day continuous glucose monitor (搜索) demonstrates 8% mean absolute relative difference, positioning it as the most accurate CGM (搜索) on the market while awaiting FDA clearance expected in the second half of 2023.
Tandem Diabetes Care's Control-IQ+ (搜索) algorithm for Type 2 diabetes (搜索) showed significant clinical benefits in a pivotal trial, with patients experiencing a 0.9% reduction in A1C and 16% improvement in time spent in target blood sugar range.
Healthcare provider survey across six countries revealed strong support for CGM (搜索) as standard care for Type 2 diabetes (搜索) patients, with 96% of providers endorsing CGM use for those taking multiple daily insulin injections.
Dexcom (搜索) has unveiled promising clinical data for its new 15-day continuous glucose monitor (搜索) (CGM (搜索)) at the Advanced Technologies & Treatments for Diabetes (搜索) conference in Amsterdam, showcasing what the company claims is the most accurate CGM on the market with a mean absolute relative difference (MARD) of 8%.
The extended-wear sensor would match the duration of competitor Abbott's Freestyle Libre 3 Plus (搜索) and represents a significant advancement in Dexcom (搜索)'s product lineup. The company has submitted the device for FDA review and anticipates clearance in the second half of 2023, according to Chief Operating Officer Jake Leach.
"Our first 15-day product was Stelo (搜索), the over-the-counter CGM (搜索) we launched last year. The millions of people that use G7 (搜索) will have access to a 15-day sensor," Leach explained in an interview. "That product is under review by the FDA right now. We're hoping to launch it later this year."
Analysts view the development positively, with Leerink Partners analyst Mike Kratky noting that Dexcom (搜索) could potentially boost its margins with similar insurance reimbursement for two sensors rather than three per month.
Type 2 Diabetes Management Advances
The conference also highlighted significant progress in Type 2 diabetes (搜索) management technologies. Tandem Diabetes Care presented pivotal trial results supporting its recent FDA clearance for the Control-IQ+ (搜索) algorithm for Type 2 diabetes, making it the second company with an authorized automated insulin delivery system for this population after Insulet (搜索).
Tandem's randomized controlled trial enrolled 319 participants and demonstrated that people using the Control-IQ+ (搜索) algorithm paired with Dexcom (搜索)'s G6 (搜索) sensor achieved a 0.9% reduction in A1C compared to a 0.3% reduction in the control group. Additionally, users experienced a 16% improvement in time spent in target blood sugar range—an increase of 3.4 hours per day compared to controls. These results were published in the New England Journal of Medicine.
J.P. Morgan analyst Robbie Marcus characterized the results as "another positive data point that should continue to support Type 2 pump adoption broadly," though he noted that Insulet (搜索) is expected to maintain majority market share due to its patch-pump form factor.
Insulet (搜索) also presented data from a sub-analysis of its pivotal trial that supported its Type 2 indication. The single-arm trial showed that Type 2 patients taking insulin experienced similar glycemic benefits—such as improvements in HbA1c and time in range—regardless of whether they were also taking GLP-1 (搜索) or SGLT2 (搜索) medications.
Growing Support for CGM in Type 2 Diabetes
Dexcom (搜索) shared results from a survey of 664 healthcare providers across Germany, Italy, the Netherlands, Saudi Arabia, Spain, and the United Kingdom, revealing strong support for expanded CGM (搜索) use in Type 2 diabetes (搜索). Half of the surveyed providers stated that CGMs should be the standard of care for people with Type 2 diabetes, regardless of insulin use, while 96% supported CGM use for people taking multiple daily insulin injections.
"We were very pleased with the results of that survey. The strong feedback was that CGMs should be the standard of care for people with diabetes (搜索)," said Leach. "The vast majority of people with diabetes, two-thirds at least, don't treat their diabetes with insulin. And so in most countries, they don't have access to CGM (搜索)."
Leach noted that coverage for CGM (搜索) technology continues to improve annually but acknowledged there's "still a long way to go." In the United States, he estimated that about one-third of people with diagnosed diabetes (搜索) would now have coverage following previous decisions for intensive insulin users and basal insulin users.
Regulatory Considerations
Earlier this month, Dexcom (搜索) disclosed receiving an FDA warning letter regarding documentation practices at two of its U.S. manufacturing sites. Leach clarified that the warning letter doesn't affect the company's ability to get new products approved or continue manufacturing existing sensors.
"The FDA inspected two of our manufacturing sites in the United States but spent a lot of time looking at how our design documents traced all the way through to our production testing, and how we build our sensors," Leach explained. "The warning letter is their response saying, 'You've answered a lot of our questions, but there's still some that we have open that we need to work together on.'"
Dexcom (搜索) remains committed to addressing the FDA's concerns while continuing to advance its product pipeline, with the 15-day sensor representing a key development in the company's strategy to expand CGM (搜索) accessibility and improve diabetes (搜索) management outcomes.