Hygieia is touting some impressive results for insulin users with either Type 1 or Type 2 diabetes who used the new company's initial product, a handheld device for automatically adjusting insulin based on variations in patient's glucose. Results of the Phase 1 study were published online this week in Diabetes Technology and Therapeutics.
According to the study, the important mean HbA1c levels declined from a baseline of 8.4%(±0.8) to 7.9%(±0.9), over the 12-week period, while average glucose levels improved from 174.2 mg/dL(±36.7) to 163.3mg/dL(±35.1). The study says the study team had to override the automatic applied dosage only twice out of 1,734 doses given.
Episodes of glucose levels falling below the hypoglycemic threshold of < 65 mg/dL were milder during the 12-week active phase than those episodes reporting during the four-week, run-in period, it reports.
Hygieia points out that the difficulty for any insulin user is to manage their use to try to hit the optimal glycemic target of HbA1c<7% to try to prevent complications. It says its Diabetes Insulin Guidance System, or DIGS, measures blood glucose, analyzes patterns in those measurements and automates insulin dosage titration.
Mary Johnson, director of research at the International Diabetes Center where the study was conducted said, "We accomplished in 12 weeks using DIGS what our usual standard of care might have taken three years to do."
Of course in the U.S. and worldwide, diabetes is an enormous market and many people with the disease are not very disciplined or able to keep their blood glucose at optimal levels. Many companies are looking at a variety ways to make treatments both easier and more effective and there are big rewards for those that can.
- Read the release
- the study in Diabetes Technology & Therapeutics