|The Senseonics sensor--Courtesy of Senseonics|
Upstart Senseonics ($SENH) expects to be the first to introduce a long-term implant to continuously monitor glucose levels in diabetics. It's already under review for a CE mark after disclosing pivotal European data in October. Now, it's detailed the plans for the pivotal U.S. study of its Eversense Continuous Glucose Monitoring System.
The company previously has said it plans to submit for PMA approval from the FDA in the second half of this year, with a potential approval anticipated within 6 to 18 months. The company recently reverse merged to become public and then filed to raise up to $52 million.
The U.S. pivotal trial has started for the 90-day Eversense implant with final data slated for June, according to a description of the trial. Dubbed PRECISE II, the study will include 90 adult diabetes patients who have had a diagnosis for more than one year. It's a non-randomized, single-arm study at up to 10 U.S. sites.
"This U.S. based PRECISE II study will continue to demonstrate the system's safety and effectiveness enabling us to submit necessary data to the U.S. Food and Drug Administration for our PMA approval," said Dr. Tim Goodnow, CEO and President of Senseonics.
The PRECISE II study will compare the Eversense CGM results with those from standard, reference measurements. The investigation will include both clinic visits and home system use with the all of the CGM glucose results, alarms and alerts blinded to the subject for the length of the trial.
The European PRECISE trial met all its primary endpoints. In 44 subjects over a 90-day period, Senseonics found that Eversense had a mean absolute relative difference of 11.4% in the 75-400 mg/dL range when compared to YSI blood reference values. Sensor values were within 20% of the reference values 84% of the time, with no significant adverse events. The study continued and the company expects to report 180-day values early this year.
"Overall our patients were very satisfied with the device and regretted that they couldn't continue using it after the trial," said Dr. Hans DeVries of the Academic Medical Centre at the University of Amsterdam, who is the study lead investigator, said in a statement at the time.
If it receives a CE mark, the Eversense CGM would be the first approved glucose monitor implant. It is expected to be usable for a 90-day period. In addition to the implant, the Senseonics system also includes a data transmitter and a mobile app. The implanted sensor measures only about 3 mm by 16 mm and is inserted into the upper arm or abdomen.
"CGM systems allow people with diabetes to continuously monitor their glucose 24/7, to see glucose trends and patterns, and be alerted to clinically significant high and low glucose levels," said Dr. Ronald Brazg, Clinical Investigator at the Rainier Clinical Research Center in Seattle, WA. "What is different about the Eversense system is that it is implanted in the upper arm for continuous 90 day use, versus the transcutaneous 7-day sensors used by current CGM systems."
- here is the trial start announcement