NEW ORLEANS, May 22, 2013 /Business Wire/ – Hemoglobin A1C levels increased over a four-year period for commercially-insured patients with Type 2 diabetes, while modest improvements in A1C control has been shown to improve health outcomes and can lead to substantial healthcare cost savings, according to two studies presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 18th Annual International Meeting.
The two studies, sponsored by Valeritas, makers of the V-Go® insulin delivery device, and conducted in collaboration with HealthCore, a clinical outcomes research company, reviewed data about commercially insured patients being treated for Type 2 diabetes. The first study found that diabetes control, as measured by levels of hemoglobin A1C, worsened among the studied patient population between 2008 and 2011, and the second study suggested that modest improvements in A1C control may lead to substantial cost savings.
Both studies used administrative claims data from the HealthCore Integrated Research DatabaseSM (HIRDSM), associated with a large national health insurer. The studies were jointly designed by Valeritas and HealthCore.
"These studies demonstrate that we, as health professionals, need to help patients better manage their Type 2 diabetes as poor A1C control may have serious human and economic consequences," Matthew Nguyen, PharmD, Vice President, Medical Affairs, Integrated Healthcare Management. "Even modest improvements in hemoglobin A1C levels can have a profound impact on health care spending."
Valeritas sponsored the studies, which underscore the need for innovative approaches to glycemic control. The first study presented at the ISPOR meeting examined medical and pharmacy claims of nearly a quarter of a million individuals for the years 2008 through 2011 who had continuous health plan enrollment for at least one year, and were taking medications for the treatment of diabetes. For those who had A1C readings available, 48.2 percent had an A1C level of less than 7 percent – a marker of good diabetes control -- in 2008. By 2011, that figure fell to 44.5 percent. Those with A1C levels in excess of 9 percent jumped from 15.3 to 17.7 percent over the same period.
The second study assessed the economic impact of A1C changes, using a combination of administrative claims from the HIRD and cost data from previously published literature. Multiple scenarios were estimated, which suggested broad cost savings at the health plan level. For example, if half of the patients with an A1C greater than 9 percent had modest improvements in diabetes control (reduction in A1C of ≥1 percent), the estimated cost savings at the health plan level over a one-year timeframe could be in excess of $50 million across all patients in the health plans investigated in the study.
"At the health plan level, these data suggest that most patients do not have adequate diabetes control and the cost savings from even modestly better glycemic control can be very substantial, making concerted efforts to improve patient outcomes a win-win proposition for all," said Dr. Nguyen.
In order to fuel the human body's cells with glucose, or sugar, insulin is required. While the body continuously produces insulin, people with Type 2 diabetes, the most common form of diabetes, either do not produce enough insulin, or their bodies cannot use the insulin adequately. When there is not enough, or insulin is not used properly, glucose builds up in the blood instead of going into the body's cells. If not controlled properly, diabetes can increase the risk of heart disease, blindness, amputations, stroke, and high blood pressure.
The number of patients diagnosed with diabetes in the United States is alarming and continues to grow. According to the American Diabetes Association, nearly 26 million people in the United States have diabetes,2 with approximately 4.8 million depending on daily insulin injections to help them control and manage their diabetes.3 However, more than half of insulin users do not achieve their recommended target glucose levels for various reasons, including injection pain, or the embarrassment of injecting medication in public.
About the V-Go® Disposable Insulin Delivery Device
The V-Go® is a simple, fully disposable device for the delivery of basal-bolus insulin therapy in adults with Type 2 diabetes. The V-Go provides a continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes, thereby providing an alternative to taking multiple daily insulin injections.
The V-Go is small, lightweight and worn under the patients clothing. It measures just 2.4 x 1.3 x 0.5 inches and weighs approximately 1 ounce when filled with insulin. Patients apply a new V-Go to the skin daily for one 24-hour period. The V-Go is not electronic, making it easy to operate and use.
Important Risk Information: If regular adjustments or modifications to the basal rate of insulin are required in a 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-Unit increments, use of the V-Go Disposable Insulin Delivery Device may result in hypoglycemia. The following conditions may occur during insulin therapy with the V-Go: hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). Other adverse reactions associated with V-Go use include skin irritation from the adhesive pad or infections at the infusion site. The V-Go should be removed before any magnetic resonance imaging (MRI) testing.