Diabetes healthcare company Hygieia’s d-Nav Diabetes Insulin Guidance System (DIGS) won CE Mark approval in the European Union for treatment of patients with poor glycemic control.
DIGS automatically updates insulin dosage as needed, providing users with the updates at-time rather than requiring a clinical visit. A pair of U.K. diabetes centers plan to start using d-Nav this fall, and an Irish hospital will begin a 6-month service evaluation of the technology, according to a press release.
"Studies to date with DIGS have demonstrated the technology’s potential to bridge this gap between knowledge and more effective healthcare delivery to more people," Martin Stevens, evaluation lead at Heartlands hospital in Birmingham, said in prepared remarks.
“d-Nav may provide the crucial ‘missing link’,” said Dr. Roy Harper, evaluation lead at the Ulster Hospital in Northern Ireland, in a prepared statement. “d-Nav updates each patient’s insulin dosage using their own individual insulin therapy regimen and their glucose patterns.”
Studies shows that insulin therapy is more effective when it is frequently adjusted based on blood glucose patterns, according to the press release.
Harper added that "d-Nav may transform the type of support we can give to our patients and help us move from traditional episodic interactions to a much more continuous level of patient support."
The d-Nav device has not received regulatory clearance from the U.S. FDA.
