FDA’s Approval of Continuous Glucose Sensor Accelerates Development of Artificia

FDA’s Approval of Continuous Glucose Sensor Accelerates Development of Artificial Pancreas

The approval of the 2nd CGMS into the market place will push forward research on the closed loop artificial pancreas.

"Continuous glucose sensors represent a giant leap forward in care for people with diabetes, allowing them to monitor their glucose levels and precisely dose their insulin based on that real-time information," said Aaron Kowalski, PhD, Director of Strategic Research Projects at JDRF. "This technology should greatly improve glycemic control — which research has shown to be the key to reducing or even eliminating both short and long-term complications of diabetes."

The new device, called the STS Continuous Glucose Monitoring System, from San Diego-based DexCom, Inc., was approved by the Food and Drug Administration for use in people with diabetes. It’s the latest product in what is expected to become a competitive market for continuous glucose monitoring products.

Dr. Kowalski noted that research continues to confirm that current diabetes technology is inadequate. Some studies, he said, have found that even those patients who were intensively managing their disease — measuring their glucose an average of nine times a day — spent less than 30 percent of the day in normal glucose range. The rest of the time their glucose was either too high (which can cause eye, heart, kidney, and nerve disease), or too low (which can cause seizures, comas, and death). But studies have also found that patients using continuous glucose sensors spent 26 percent more time in normal glucose range, and have statistically significant improvements in HbA1c levels, an important measure of longer-term glucose control.

Monitors such as these are the keys to the eventual development of a closed-loop glucose testing and insulin delivery system, or an "artificial pancreas." Continuous glucose sensors read glucose levels on a minute-by- minute basis using a small sensor that is inserted under the skin, which transmits data to a hand-held device. These devices not only provide actual glucose readings, but can tell a patient whether their glucose level is trending upwards or downwards, allowing them to continually adjust their medication, diet and exercise to prevent high and low glucose levels.

Closed loop technology will provide patients and their doctors with far more information about their daily glucose fluctuations and trends, and allow for far tighter control. Patients who aggressively manage their diabetes typically test their glucose up to eight times a day, and provide insulin injections based on that information. The artificial pancreas will test glucose approximately 1,400 times a day, and make insulin dosing information based on that real-time information.

"The development of an artificial pancreas has been one of JDRF’s top research goals, and we are cautiously optimistic that these new products will be as successful and beneficial to people with diabetes as we hope," added Dr. Kowalski. "The next critical steps are for Medicare and private sector insurers to provide reimbursement for these technologies."

The Juvenile Diabetes Research Foundation

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