PrintFridley-based Medtronic took another step Monday toward capitalizing on the potentially huge market in devices for diabetics by announcing Food and Drug Administration approval for its continuous glucose monitoring devices for children and teenagers.
The devices, which were approved last year only for adults, are key to what stock analysts and health experts have described as a sort of "holy grail" product in diabetes: an artificial pancreas. Such a device would link a real-time glucose monitor and an insulin pump, thereby enabling diabetics to maintain normal blood sugar levels without self-administered insulin shots and frequent finger sticks to test glucose levels.
More than 1 million people in the U.S. have Type 1 diabetes, a condition in which the pancreas no long produces insulin, the hormone that breaks down glucose, or sugars, in the blood. An even larger group of patients with Type 2 diabetes also might benefit from a product that functions like an artificial pancreas.
That grandiose product, however, remains in the distance, and the immediate impact of Monday's announcement was more pragmatic. Diabetic patients ages 7 to 17 now might have a better shot at having a doctor prescribe one of the Medtronic devices, and their parents might have better luck lobbying health plans to pay for it.
"We've seen kids get reimbursement for the device when it's been prescribed (prior to Monday's announcement), but this certainly helps," said Aaron Kowalski of the Juvenile Diabetes Research Foundation.
Glucose monitors help patients control their diabetes by showing when blood sugar levels are getting high or low.
When confirmed by a finger stick glucose test, a high reading prompts diabetic patients to take insulin — either by taking an insulin shot or operating a wearable insulin pump. Patients know to eat when readings are low.
The FDA approval applies to two Medtronic products: the Guardian Real-Time System, which is a stand-alone glucose monitor, and the Paradigm Real-Time System, which is an insulin pump that includes monitoring technology. In both cases, small sensors placed under the skin transmit data to the monitor.
Studies have shown that Medtronic's real-time monitoring systems can help patients lower their HbA1c levels — a key indicator of how well a diabetic is controlling the disease — by as much as 2 percentage points, said Steve Sabicer, a spokesman for Medtronic's California-based diabetes division. For every 1 percentage point drop in HbA1c, there is a 35 percent reduction in diabetes-related complications such as blindness, amputation and organ failure, Sabicer said.
Both Medtronic and a San Diego-based company called DexCom sell continuous glucose monitors, although only Medtronic has approval for a combination insulin pump and glucose monitor, said Kowalski of the diabetes foundation. The company also has the only continuous glucose monitor approved for children and teenagers age 7 to 17 that is actively being marketed today.
Illinois-based Abbott Laboratories and London-based Smiths Medical, which operates its diabetes division in Arden Hills, are also competing in this area.
"We encourage the competition, because we think the more companies that are doing this, the better the devices will get," said Kowalski, who noted that his foundation announced in September $6 million in grants to speed artificial pancreas research.
Health plan coverage for the new technology is key to its broad adoption.
The Medtronic monitor costs about $1,000, and requires that patients replace sensors on the device every three days. At a cost of $35 each, the annual tab for sensors would come to about $4,200.
Karyn Jones of Blaine said any costs have been worth it in the case of her 10-year-old daughter, Alyssa, who received the Paradigm system in June. Jones credits the technology with helping to prevent seizures that can come when blood sugars get too low.
"There is still a cost involved for us," Jones said, acknowledging that some costs likely are lower in the family's health plan since she works at Medtronic. "But is it worth the peace of mind? To me, it absolutely is."
Christopher Snowbeck can be reached at 651-228-5479 csnowbeck@pioneerpress.com .
