A new insulin-pump delivery system just released in Australia represents an advance in technology but is not a full "artificial pancreas," as many headlines around the world have mistakenly reported.
The MiniMed 640G with Smartguard (Medtronic) automatically suspends insulin delivery when the system predicts that the wearer's glucose is dropping rapidly and will hit a low "limit" and then resumes delivery when glucose levels recover.
The predictive aspect, dubbed "predictive low-glucose management" technology, represents an advance over the current "threshold-suspend" technology in the MiniMed 530G with Enlite, approved in the United States in September 2013. That device suspends insulin delivery when glucose levels reach a preprogrammed low threshold and resumes delivery after 2 hours if there is no input from the user.
The new system is the first to act on the glucose rate of change related to predicting a low limit. The algorithm incorporated into the system also determines when to resume the basal insulin delivery based on the sensor glucose value, a Medtronic spokesperson told Medscape Medical News.
Also new in the 640G are a simpler user interface, full-color screen, and waterproof design.
Medtronic Diabetes is releasing the 640G first in Australia and anticipates launches in other countries in the next few months pending approvals. In the United States, a clinical trial assessing the device's safety and performance is under way and scheduled to wrap up in April 2015.
Once completed, those data will be submitted to the US Food and Drug Administration, according to the Medtronic spokesperson.
Misleading Headlines Around the World
There has been confusion about the concept of the still-investigational "artificial pancreas," generally used to mean a fully closed insulin-delivery system that relies on communication between the continuous sensing device and the insulin- (and possibly glucagon-) delivery systems to keep blood glucose levels within both high and low targets with little or no user input.
A Medtronic Diabetes press release described the 640G as a "next-generation insulin-pump system and another critical step toward an artificial pancreas."
Nonetheless, articles in the Australian media about a 4-year-old boy in Perth, Western Australia, who received the 640G, used the words "World's First Artificial Pancreas" in their headlines. The story was subsequently reported worldwide by numerous newspapers, including the Guardian in the United Kingdom, and websites such as Bloomberg. Even diabetes.co.uk, a patient-support website, made the same claim.
In response, the Australian affiliate of the Juvenile Diabetes Research Foundation issued a statement of clarification, stating: "We've still got work to fully achieve our goal [of an artificial pancreas] and we need your help to get there."
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Cite this: New Insulin Pump Prompts 'First Artificial Pancreas' Headlines - Medscape - Jan 23, 2015.