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Hygieia d-Nav Diabetes Insulin Guidance System (DIGS) Cleared in Europe

October 10th, 2012 Medgadget Editors Informatics, Medicine

Hygieia Inc. (Ann Arbor, MI) has been given the CE Mark in Europe for its d-Nav Diabetes Insulin Guidance System (DIGS). The d-Nav DIGS system was designed to address the need for diabetic patients to regularly adjust their insulin dosage based on historic glucose levels and prior insulin intake. This is typically done with the assistance of a physician during an office visit when glucose levels can be reviewed and adjustments made. The necessity of another trip to the doctor’s, and everything it implies, is a major impediment for diabetic patients to receive regular insulin dosage adjustments.

The d-NAV performs this task regularly and automatically, guiding the patient to take a proper dose, hopefully one very similar to what a person’s physician would advise. A study is scheduled to soon begin that will analyze the effectiveness of the automatic dose guiding algorithm in patients with Type 2 diabetes.

From the press release:

The South Eastern Health and Social Care Trust’s Ulster Hospital in Northern Ireland will conduct a six-month d-Nav service evaluation, under the direction of Dr. Roy Harper.

The Heart of England Foundation Trust and the University of Birmingham are co-sponsoring a year-long observational study at the Heartlands Hospital in Birmingham, under the direction of Prof. Martin Stevens.

“Clinical evidence demonstrates that weekly insulin dosage adjustments can be safely made based solely on blood glucose data the patient generates. Unfortunately this knowledge doesn’t address the reality that our current health care delivery system lacks the time, attention or know-how to deliver that standard of care broadly,” says Prof. Stevens. “Studies to date with DIGS have demonstrated the technology’s potential to bridge this gap between knowledge and more effective health care delivery to more people.”

Press release: Hygieia’s d-Nav™ Receives CE Mark; First DIGS™ Use on U.K. Horizon

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