'Diabetes Insulin Guidance System' Automatically Updates Weekly Insulin Dosage For Better Glycemic Control, Fewer Hypoglycemic Events

Date: May-10-2012Newly 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   Average patient blood glucose levels improved progressively from a baseline of 174.2 mg/dL(±36.7) to 163.3mg/dL(±35.1); (p   Glucose levels falling below the hypoglycemic threshold (glucose
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
Study Design

The 16 week feasibility trial (consisting of a 4 week run-in period, followed by 12 weeks of active intervention) was conducted as a prospective, open-label, uncontrolled, single-arm, single-center study that aimed to assess the ability of DIGS to provide safe and effective, unsupervised weekly insulin dosage adjustments. Study participants were insulin-using adults with either type 2 or type 1 diabetes and an HbA1c above 7.4% (indicating their diabetes control was not at target even though they had been on insulin therapy for years prior to this study). Participants were enrolled in one of three treatment groups: 1) type 1 diabetes treated with basal-bolus insulin therapy using carb counting; 2) type 2 diabetes treated with basal-bolus insulin therapy without counting carbs; and 3) type 2 diabetes treated with twice-daily biphasic insulin. Patients were asked to test and record their blood glucose before each insulin injection. The primary study outcome was the fraction of dosage adjustments made by DIGS and conveyed to the patients without intervention after study team review. Reductions in HbA1c and mean glucose were used to assess efficacy. The safety of the weekly adjustments was evaluated using the frequency of hypoglycemia (blood glucose <65 mg/dL).
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