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Insulin Pumps

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Since the first human trials of insulin pumps in the late 1970s,
insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), has been used for more than 30 years. As technology has developed, insulin pumps have become more user-friendly and smaller. Modern pumps weigh less than 4 ounces and are the size of a pager or cell phone.

The number of patients using CSII has been increasing. The US Food and Drug Administration (FDA) reported that approximately 375,000 adults with type 1 diabetes used external insulin infusion pumps in 2007, compared to 130,000 in 2002.

The FDA classifies insulin infusion pumps as class II devices, which need more than “general controls” (ie, provisions that relate to controlling the quality of the device, preventing issues such as adulteration or misbranding, and tracking components and devices) to ensure reasonable safety and effectiveness.
As with any class II device, the “special controls” required may include additional labeling requirements, mandatory performance standards, and postmarket surveillance.

The chief benefit of insulin pump therapy is customized flexible basal and bolus dosing to meet patients’ individual requirements. Insulin pumps allow users to program different basal rates to allow for variations in lifestyle and bolus doses to allow for variations in diet. Insulin delivery via a pump is more consistent and precise than via syringe or injection pen.

There are newer electronics with complex algorithms capable of calculating insulin bolus doses necessary to maintain glucose level within a set range as measured by a continuous glucose monitor (CGM). Ultimately, this technology will likely lead to an “artificial pancreas” that automatically senses glucose level and its rate of change and adjusts insulin dosing accordingly. However, this technology is still under development and is not ready for clinical use.

Category

Insulin pump

Device details

Accu-check Spirit (Roche Insulin Delivery system)

Dana Diabecare IIS (Sooil Development)

Minimed Paradigm Real-Time Revel (Medtronic Diabetes)

Omnipod (Insulet Corp)

OneTouch Ping (Animas Corp)

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