Disposable Insulin Delivery Device Got FDA Clearance

The V-Go Disposable Insulin Delivery Device has received 510(k) clearance from the U.S. Food and Drug Administration.

The V-Go is for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. V-Go devices will be available in a preset basal rate to deliver 20, 30, or 40 Units of insulin in one 24-hour period (0.83 U/hr, 1.25 U/hr or 1.67 U/hr, respectively) and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period). The V-Go offers a simple way to deliver basal-bolus therapy.

The V-Go is the first simple, fully disposable device for the delivery of basal-bolus insulin therapy for adults with 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 engineered to simplify basal-bolus insulin therapy for the millions of people suffering from Type 2 diabetes. 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.

About Diabetes

Diabetes is a chronic and progressive disease in which the body fails to produce or properly utilize insulin, a hormone that regulates blood sugar (glucose) levels.1 High blood glucose levels can lead to serious complications, including heart disease, stroke, high blood pressure, blindness, kidney disease, amputation, and even premature death.2

Approximately 23.6 million US children and adults have diabetes, including nearly 6 million who are undiagnosed.2 Diabetes is classified as Type 1 or Type 2. The Type 2 form of the disease is most common, affecting approximately 95% of adults with diabetes.1 In Type 2 diabetes, either the body does not produce enough insulin or the body’s cells do not use insulin properly.1 In Type 1 diabetes, the body stops producing insulin altogether.1,3

To control blood glucose levels, approximately 4.5 million people in the US with Type 2 diabetes take insulin4, which is usually administered by injection. About 3 million of these insulin users have not achieved target glucose levels currently recommended by the American Diabetes Association.4,5 In addition, many people with Type 2 diabetes could benefit from insulin therapy, but refuse to start on therapy or skip taking insulin for a variety of reasons, including interference with daily activities, injection pain, and embarrassment about injecting medication around family and friends or in public.6,7 In one study, approximately 80% of Type 2 diabetes patients only required a single daily basal rate of insulin.8 Using continuous subcutaneous insulin infusion therapy for Type 2 diabetes mellitus patients may lead to improved glycemic control.

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