Updated to include a statement from Abbott.
Dexcom (NSDQ:DXCM) touted data today from a head-to-head trial comparing its G5 mobile continuous glucose monitoring system with Abbott‘s (NYSE:ABT) recently-approved FreeStyle Libre Flash glucose monitoring system.
The I-Hart study, which enrolled 40 people with Type I diabetes, found that Dexcom’s device reduced patients’ time spent in hypoglycemia by 43 minutes, while Abbott’s system increased patients’ time spent in hypoglycemia by 19 minutes.
The trial also showed that the G5 system cut time spent in hypoglycemia at night by 24 minutes, while use of the Libre system increased time spent in hypoglycemia at night by 9 minutes.
Results from the 8-week trial were first revealed late last year and today were published in a UK journal, Diabetic Medicine.
“This impactful study highlights the importance of innovative technologies in managing a challenging long-term condition which has serious health and psychological outcomes for young people,” principal investigator Nick Oliver said in prepared remarks “It supports the role of real-time CGM devices with alerts and alarms in the clinical pathway for people with type 1 diabetes, especially those with a high risk of hypoglycaemia and impaired hypoglycaemia awareness”.
“We are delighted that the Dexcom G5 Mobile CGM System was able to demonstrate such a significant reduction in hypoglycaemia both during the day and at night, while also reducing the fear associated with hypoglycaemia,” John Lister, GM of Dexcom EMEA, added. “This study also helps to demonstrate the value of real-time CGM with alerts and alarms in helping people manage their diabetes around the clock.”
The trial, which was funded by Dexcom, was limited by its small sample size and limited follow-up, the investigators acknowledged.
Leerink analysts Danielle Antalffy and Rebecca Wang wrote in a note to investors that over the next two or three years, Dexcom plans to come to market with a cheaper device that can still offer real-time monitoring to rival Libre’s price-point. Abbott also expects to launch a real-time version of its Libre monitor, according to the analysts, but the company did not provide a sense of its timing.
“Ultimately, we believe this market will be a tiered market, with a lower cost, more basic option and a higher cost option with the bells and whistles,” the analysts wrote. “While this trial alone isn’t necessarily needle-moving, we think this is a harbinger of things to come, with a number of such studies likely
to follow, particularly now that Libre is available in the U.S.”
“The iHart study demonstrates what we know – that for a small fraction of the population of people with Type I diabetes and hypoglycemia unawareness, a traditional, more expensive CGM device with alarms could potentially help reduce hypoglycemia,” an Abbott spokesperson told Drug Delivery Business News via email.
“For everyone else, there’s FreeStyle Libre – which, at a fraction of the cost has shown significant decrease in hypoglycemia, through both the Impact and Replace clinical studies. And, we have data from more than 250,000 people wearing FreeStyle Libre in the real-world that shows a correlation between more scanning and a decrease in both hypoglycaemia as well as better overall glycemic control.”
