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FDA Approves New Type of Insulin Delivery Device
December 10, 2010
On December 8, the US Food and Drug Administration (FDA) approved a novel tool for diabetes management known as the V-Go Disposable Insulin Delivery Device.
The V-Go, which is intended to replace multiple daily insulin injections, adheres to the skin and is designed to be worn under the clothing for 24 hours before being replaced. It delivers basal and bolus insulin subcutaneously (under the skin) through a microneedle; the device can deliver preset basal rates of 20, 30, or 40 units of insulin in a 24-hour period (0.83 units/hour, 1.25 units/hour, or 1.67 units/hour, respectively) and on-demand bolus doses in 2-unit increments up to a total of 36 units in a 24-hour period. The V-Go, which is approved for use in adults with Type 2 diabetes, uses no electronic parts and weighs roughly 1 ounce when full.
Kristine Paterson, CEO of manufacturer Valeritas, Inc., says, “The V-Go Disposable Insulin Delivery Device is the first fully disposable, nonelectronic basal-bolus device that is specifically designed with the Type 2 population in mind. We believe that the simple user features of the V-Go will allow more patients with diabetes to adhere to their insulin regimen, which ultimately may lead to better control.”
V-Go is scheduled to become commercially available in the United States in 2011. Pricing details have not yet been disclosed.
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