Medical Device Daily

The FDA has approved two of Medtronic's (Minneapolis) most advanced glucose monitoring systems for use in children and adolescents, providing a group of patients a heightened level of protection against dangerous elevated glucose levels associated with type 1 diabetes, according to the company.

The FDA approved new REAL-Time Continuous Glucose Monitoring (CGM) devices for children and teenagers ages 7-17. Previously approved for only adult patients, Medtronic's REAL-Time CGM will soon be available in specifically designed pediatric models of the MiniMed Paradigm REAL-Time system and Guardian REAL-Time system.

The company received adult FDA approval for the Guardian in July — though it has yet to be launched in the U.S. — and the MiniMed Paradigm in April (Medical Device Daily, April 14, 2006).

According to Steve Sabicer, senior manager of public relations for Medtronic's diabetes business in Northridge, California, approval of this new glucose monitoring system will allow younger patients to have an alternative to the traditional fingerstick meter tests that require them to draw blood samples anywhere from three to 20 times a day. Even more importantly, he told Medical Device Daily, is the ability of these systems to monitor these younger patients overnight.

"Parents will have the piece of mind, especially at night, with hypoglycemic events," said Sabicer. He added that when blood sugar gets low, the patient can go into a seizure or coma that can often prove to be fatal. He noted that adults can more easily discern the onset of a hypoglycemic, "but children might not be able to notice or articulate that they are having a problem so the device has built-in alarms that warn a caretaker or patient that they are experiencing a low blood sugar event before it gets to the point where it could induce a seizure or coma."

The devices are not entirely non-invasive but much less invasive than fingersticks. The devices use a tiny electrode placed underneath the skin to measure glucose levels. The electrode is attached to a transmitter about the size of a key FOB which is taped to the patient's abdomen. The transmitter then beams the information obtained from the sensor to a pager-sized receiver typically worn on a patient's belt.

More than one million patients in the U.S. have type 1 diabetes, often referred to as juvenile diabetes. Of the 30,000 new patients diagnosed with type 1 diabetes every year, almost half, or 13,000 patients, are children. There are more than 175,000 type 1 diabetes patients under 20 years of age, and more than one in every 600 children globally has the condition with some recent studies suggesting that the global incidence in children and adolescents is increasing by roughly 3% annually.

Medtronic said its REAL-Time CGM therapy is clinically proven to help patients monitor and better control their diabetes, clinical studies showing that therapy can reduce the duration of hypoglycemic events, and lower HbA1c levels by as much as two percentage points.

This is significant because as much as 60% of hypoglycemic events go undetected by current glucose monitoring standards, and for every one percentage point drop in HbA1c, there is a 35% reduction in diabetes-related complications like blindness, amputation and organ failure.

"Diabetes management is especially difficult for pediatric patients, and Medtronic REAL-Time CGM therapy could benefit thousands of children and their families who struggle to maintain control of their disease," said Bruce Buckingham, MD, director of Pediatric Endocrinology at Lucille Packard Children's Hospital at Stanford University (Palo Alto, California). "By providing real-time glucose values and alarms, patients can now recognize previously undetected glucose fluctuations."

The systems display real-time glucose values, trend graphs and directional arrows, allowing patients to discover how diet, exercise, medication and lifestyle affect their glucose levels. Armed with this information, Sabicer said patients can gain valuable insights and intervene earlier to reduce the frequency and severity of high and low glucose levels.

The technology alerts patients if their glucose levels fall below — or rise above — preset values, Sabicer said. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required.

The company noted, however, that all therapy adjustments should be based on measurements obtained using a home glucose meter and not on Medtronic REAL-Time CGM system values.

Sabicer said the directional arrows are a really useful feature that a traditional fingerstick testing system cannot provide. He said these systems provide a "static" reading, whereas the GCM system directional arrow provides patients with information on which way their glucose levels are trending.

"You have that information in real-time every five minutes and it reinforces your treatment strategy."

While the Guardian — a stand-alone GCM that Sabicer said the company hopes to launch in the U.S. by the end of April — monitors glucose every five minutes to warn the user of high or low levels, the MiniMed Paradigm uses an added pump to deliver insulin and correct levels.

Ultimately, Sabicer said that these two systems are precursors to the hoped-for artificial pancreas that would be a closed loop system incorporating both the insulin pump and monitoring system.

He said such a system is still probably "five to seven years away from being on the market."