A Medical Device Daily

Over the last six years, Americans being treated for diabetes improved control of their disease by a significant 44.4%. As of December 2006, more than half, or 54.6% had reached treatment goals for glycemic control, according to the “Quest Diagnostics Health Trends Report on Diabetes” from Quest Diagnostics (Lyndhurst, New Jersey).

The report, presented Saturday at the scientific sessions of the American Diabetes Association (ADA; Alexandria, Virginia), suggests that despite those overall gains, hemoglobin A1c values have plateaued since 2004, with 45% of patients in 2006 failing to reach treatment targets of HbA1c levels less than 7%.

A companion analysis of HbA1c tests revealed a significant seasonal variation in blood glucose control with HbA1c levels peaking in the winter and falling in the summer. These seasonal differences depend on the patient age and level of A1c control, but were most apparent in the elderly — greater than or equal to age 80 — and those with the highest levels of HbA1c , or at least 9% and above.

The report is based on findings from 22.7 million de-identified HbA1c tests, a key indicator of diabetes control, performed by Quest between 2001 and 2006 on 4.8 million patients who saw a healthcare professional and were classified as having diabetes.

The company said that the number of tests included in the study is more than 50 times that of other published reports on diabetes health.

“These data demonstrate incredibly significant improvements in diabetes management in the last six years, probably due to improved education, new medications and adherence to treatment guidelines,” said study co-author Francine Kaufman, MD, professor of pediatrics at the Keck School of Medicine, University of Southern California (Los Angeles), and past president of the ADA. “But more than 4 in 10 people with diabetes still fail to reach treatment goals, which indicates physicians and patients must continue to be committed to management of medication, physical activity, food intake and glucose monitoring.”

About 2.4 million diabetic foot ulcers are diagnosed each year in the U.S., many progressing to lower limb amputation. It is estimated that the U.S. healthcare costs for treating diabetic foot ulcers and related amputations exceed $10 billion per year.

In product announcements from the conference:

• IYIA Technologies (San Marcos, California) reported its launch of O₂Misly, its product for the treatment of slow-healing diabetic foot ulcers. The O₂Misly device is designed to offer a combination adjunctive therapy to the standard-of-care for treating non-healing ulcers.

O₂Misly provides oxygen infused under tension in a closed chamber blended with a mist, which also delivers an antimicrobial to the affected area. This therapy can be delivered in a clinician’s office and does not require the patient to be enclosed in a pressurized tube, as with total hyperbaric oxygen therapy. The O₂Misly office-based therapy is expected to be much less expensive compared to the hospital-based hyperbaric chamber treatment, the company said.

IYIA has conducted a clinical trial over the last 18 months with patients enrolled having failed previous standard-of-care therapy before they could be included in the trial. Of the patients treated with O₂Misly, 75.5% were healed within 12 weeks. Of the patients treated 20 weeks with O₂Misly^, 100% were healed, the company said.

• Bodymedia (Pittsburgh), focused on metabolic assessment and behavioral therapy solutions, reported the launch of SenseWear WMS (Weight Management Solution).

WMS is the “first ever” web-based clinical weight management solution to focus on behavior therapy, the company said. Best suited for obesity, diabetes and cardiovascular disease, the system enables continuous accurate tracking of health metrics such as calories burned, calories consumed, physical activity and sleep.

SenseWear WMS is designed to improve patient outcomes by increasing patient adherence to behavioral prescriptions.

Colleen Cook, president of Bariatric Support Centers International (Salt Lake City), said, “Having access to this personalized data allows each patient to better understand their own metabolism. With that understanding and the essential feedback that this program provides, patients will be empowered to make the changes necessary to reach and maintain a healthy weight and truly understand how behavior impacts weight and the daily management of their condition.”

• Biodel (Danbury, Connecticut), reported the presentation of additional clinical data from its VIAject program.

As disclosed in an oral presentation entitled “Management of Insulin Treatment — New Technologies and Beyond,” abstract number 34-OR: interim results of Biodel’s Phase III clinical trials demonstrated statistically significant daily meal-time (prandial) dose reductions in patients with Type 1 and Type 2 diabetes using VIAject.

Type 1 patients receiving VIAject showed a 28% reduction in daily prandial dose while control patients receiving Humulin R showed a non-significant increase of less than 1%. Type 2 patients receiving VIAject showed a 49% reduction in daily prandial dose while control patients receiving Humulin R showed a non-significant increase of 2.3%.

VIAject is a rapid-acting form of injectable human insulin for meal-time use by patients with Type 1 or Type 2 diabetes and is comprised of commercially available recombinant human insulin and our proprietary formulation of ingredients, all of which are Generally Regarded As Safe (GRAS) by the FDA. Biodel is currently evaluating VIAject in ongoing Phase III clinical trials.