Statement from Medtronic Diabetes, via Twitter
PLAINSBORO, N.J. – Early Friday, Medtronic Diabetes sent ripples through the type 1 diabetes community with its announcement that MiniMed® 530G with Enlite® had received approval from the US Food and Drug Administration. Significantly, FDA allowed Medtronic to call the new technology an “artificial pancreas” system, the first use of that term in the United States.
As Medtronic would explain, this was the first FDA approval in a new category: Artificial Pancreas Device System: Threshold Suspend. The term “artificial pancreas” set off debate among the highly connected T1DM community that is not without consequence for patients – or for payers.
With speculation about an artificial pancreas rising, the September edition of Evidenced-Based Diabetes Management looked at the three systems that were being considered by the FDA – including the threshold suspend technology Medtronic announced Friday – and asked the next questions: Assuming the technology is approved, will insurers pay for it? How will this potentially life-altering advance make its way into the hands of the persons with diabetes who need it most? (See story, click here.)
As Evidence-Based Diabetes Management wrote, depending on whether the system in question is threshold suspend, control-to-range or control-to-target, some payers will consider systems in light of their experiences with the component parts – insulin pumps and continuous glucose monitors (CGM), while others will look them as a new technology. In online responses to patients, Medtronic said out-of-pocket costs would vary by plan, and that it had 600 such relationships nationwide.
Friday’s announcement by Medtronic was met initially with online euphoria, tempered over the next 48 hours with skepticism from some diabetes advocates that the company had overstated its advancement with the use of the term “artificial pancreas.” Medtronic responded, “Our vision is to develop a fully automated artificial pancreas requiring minimal to no interaction.” The threshold suspend technology, the company said, “is an important first step toward that goal.”
Indeed, the influential DiabetesMine blog, which cautioned readers about the “artificial pancreas” label, still called the Medtronic device an important step, due to its automated function that can suspend insulin when sensor glucose values reach a preset level – and the patient doesn’t respond to an alarm. Medtronic touts the Enlite sensor as smaller, more comfortable, 31 percent more accurate, and says it detects up to 93 percent of hypoglycemia episodes when alerts are on.
CONTACT: Mary Caffrey (609) 716-7777 x. 144
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Company Name: American Journal of Managed Care
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