Innovative Insulin Pump Approved; Avandia Restricted to Mail-Order

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Innovative Insulin Pump Approved
On November 16, the US Food and Drug Administration (FDA) approved the t:slim insulin pump. The device is one of the first pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative, which establishes additional requirements for pump manufacturers to ensure safety and effectiveness.

The pump, which is approved for people with diabetes ages 12 and over who require insulin, will be the smallest insulin pump system available and up to 25% slimmer than other pumps, according to manufacturer Tandem Diabetes Care. The pump features a 300-unit cartridge and uses “micro-delivery technology” to facilitate accurate insulin dosing. Pump functions are controlled via a color touch screen; the associated t:connect data management software is compatible with both Macs and PCs. The batteries are rechargeable and, according to this article, will last roughly seven days without recharging.

Extensive user feedback was sought in designing the pump. According to Kim Blickenstaff, president and CEO of Tandem Diabetes Care, “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.”

The t:slim is expected to hit the US market sometime in early 2012.

For more information about the t:slim insulin pump, see the Tandem Diabetes Care Web site or check out the related blog entry on Diabetes Mine.

Avandia Restricted to Mail-Order
In other news, the diabetes drug Avandia (rosiglitazone) and combination medicines containing this drug are now available solely through certified mail-order pharmacies and can no longer be obtained in retail pharmacies.

In 2010, the FDA required the manufacturer to create a restricted-access program for the drug after a large meta-analysis (in which statistics from several studies are combined and examined) indicated that Avandia was associated with a substantially increased risk of heart attack. As of November 18, only those enrolled in the Avandia-Rosiglitazone Medicines Access Program can receive Avandia, Avadamet, or Avandaryl. The program restricts use of these medicines to people who have not been able to control their diabetes with other medicines and who have decided, in consultation with their health-care provider, not to take Actos (pioglitazone), the other drug in the thiazolidinedione class.

For more information on the access program, click here.

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