Artificial Pancreas Could Revolutionize Diabetes Care, If FDA Will Allow It

A November 26 CNN article on the development of an artificial pancreas is noteworthy because it highlights the nexus between medical device enabling technologies, end-use medical products, clinical trials, and the much-criticized FDA approval process.

Based on a sensor placed under the skin for measuring blood sugar, an artificial pancreas mimics the glucose-regulating function of a healthy organ, the article explains. After the sensor measures the blood sugar level, information is sent to a receiver, prompting a pump to deliver insulin in controlled doses. A glucose meter calibrates the sensor, and software checks the body's blood sugar so that the correct amount of insulin can be automatically dispensed at the right time.

The trouble is, the device has not yet received FDA approval. "While the potential benefits are enormous, an artificial pancreas system is considered a significant-risk device, meaning it presents a potential for serious risk to the health, safety or welfare of a patient," remarked Charles Zimliki, chair of FDA's Artificial Pancreas Critical Path Initiative, at a Senate committee in June. "If not properly designed, use of an artificial pancreas device in an outpatient setting can place patients at significant risk, because the device controls the administration of insulin without the oversight of health care professionals."

The delay in bringing such a device to market has many experts shaking their heads. "Here in the U.S. we're now almost three years behind and the first study to test these systems is just going to launch in the next month, which means it's going to be another year or so before patients even have access," comments Aaron Kowalski, assistant vice president of treatment therapies at the Juvenile Diabetes Research Foundation (JDRF; New York, NY), which has been collaborating with FDA on the artificial pancreas. "What JDRF is advocating for is to ensure that people here in the U.S. have access to these tools in a timely manner."

In response to its critics, FDA argues that other countries have different regulatory systems that do not require the same safety and effectiveness data for a product with the risk level of an artificial pancreas. However, some experts do not agree. For example, Michelle Magee, an endocrinologist and director of the MedStar Diabetes Institute at Washington Hospital Center (Washington, DC), says, "The data from other countries showed that the system could be used safely and effectively. It's been somewhat disappointing that it has taken so long to get approval here."

Although it may be viewed as too little too late, FDA is expected to release new guidance for future artificial pancreas systems on December 1. --Bob Michaels