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Automated insulin dosage titration system demonstrates positive clinical study results
Date:5/11/2012

ANN ARBOR, MI (May 9, 2012): 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 da
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Contact: Joan Kureczka
Joan@kureczka-martin.com
415-821-2413
Kureczka/Martin Associates
Source:Eurekalert

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