Newly published results from a clinical study of the
Diabetes Insulin Guidance System (DIGS™), under development by Hygieia, Inc.,
demonstrate DIGS’ potential to improve blood glucose control for insulin-using
patients with type 2 or type 1 diabetes. DIGS automatically adjusted insulin
dosage based on each individual’s reported blood glucose results. Over the
12-week intervention period of the study, investigators observed:
- Out of a total of 1,734 individual dosage adjustments, the
study team over-rode the DIGS-instructed dosage only twice. - Mean HbA1c levels decreased from a baseline of 8.4%(±0.8) to
7.9%(±0.9); (p<0.05); - Average patient blood glucose levels improved progressively
from a baseline of 174.2 mg/dL(±36.7) to 163.3mg/dL(±35.1); (p<0.03); and - Glucose levels falling below the hypoglycemic threshold
(glucose < 65 mg/dL) during the 12-week active phase were significantly
milder than the ones reported during the 4-week run-in period (P = 0.02).
The Phase 1 study, published online this week in Diabetes
Technology and Therapeutics, took place at the International
Diabetes Center
at Park Nicollet, Minneapolis,
MN under the direction of
principal investigator, Richard M. Bergenstal, MD. The study was funded by the
National Institutes of Health, NIDDK Program (award number R41DK085974).
Ultimately, most patients with type 2 diabetes and all
patients with type 1 diabetes require insulin therapy. However, despite the
availability of a variety of insulin formulations and treatment regimens, most
insulin users do not achieve an optimal glycemic target (e.g. HbA1c<7%) and
are thus at increased risk of developing complications of diabetes. Over the
years, multiple clinical studies have shown that frequent insulin dosage
titration is a key element for achieving and maintaining good glycemic control,
with physicians or other diabetes experts contacting patients every few days or
weeks to make dosage adjustments. Unfortunately, implementation of such
frequent insulin titration in day-to-day clinical practice has been hindered by
a lack of sufficient medical expertise as well as limited time for frequent
health care provider contact.
“The proprietary DIGS technology developed by Hygieia,
Inc. measures blood glucose, analyzes patterns in those measurements, and
automates insulin dosage titration,” said Dr. Bergenstal. “In this
study, our team found that DIGS worked amazingly well. After a four-week run-in
to establish baseline glucose levels for each patient, 1734 individual insulin
dosage adjustments were made by the DIGS software over the 12 week intervention
period. Our team gave those newly determined insulin dosage instructions to the
study participants each week without changing the suggested intervention in all
but two instances. This demonstrates the possibility that DIGS could automate
weekly dosage adjustment safely and effectively – something that none of our
current tools is capable of achieving.”
Mary Johnson, Director of Research at the International Diabetes
Center, stated regarding
results achieved by one of the study participants, “We accomplished in 12
weeks using DIGS what our usual standard of care might have taken three years
to do.”
Asked what DIGS in a handheld device might afford those on
insulin therapy, Martha Funnell, MS, RN, CDE, Research Scientist, Michigan
Diabetes Research and Training Center, University of Michigan remarked,
“This technology might just enable us to provide many more patients with
the ability to achieve our best standards of care. The benefits could go beyond
better glycemic control and help people with diabetes feel more confident about
managing their insulin between health care appointments.”