Next Steps for Artificial Pancreas Clinical Testing

Diabetes experts at a meeting convened by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) took the next step in advancing efforts toward the development of an artificial pancreas: putting forth clinical recommendations to ensure the safe and effective testing of artificial pancreas technology in real-life situations….

At the meeting there was a strong consensus among leading clinicians, researchers and industry leaders regarding the path toward outpatient studies for both low-glucose suspend and artificial pancreas systems.  

Even with treatments available today, tight blood sugar control remains a challenge and daily struggle for those living with Type 1 diabetes. In fact, the majority of people living with the disease are not achieving recommended target levels. “An artificial pancreas, essentially a device that would both measure blood sugar and dispense appropriate amounts of insulin to keep levels in optimal range, would take much of the guesswork out of daily management of the disease,” said Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies at JDRF. “In the long-run, controlled blood sugar levels will help to lessen or avert the devastating complications from Type 1 diabetes.” 

To date, artificial pancreas devices have been successfully tested in controlled inpatient or hospital settings, demonstrating the potential for this technology to improve blood sugar control. Now it must be tested safely in real-world conditions. And clear and reasonable regulatory guidelines must be established to ensure that the upcoming studies advance the technology to reach patients as soon as possible. 

Jeffrey Brewer, President and CEO of JDRF, stated that, “We believe a safe and effective first generation artificial pancreas system is possible with today’s technology, even as we continue to encourage development of improved devices. Experts at today’s FDA workshop outlined a clear path forward to safely speed the development and delivery of artificial pancreas systems to patients.”  

To help advance these efforts, JDRF formed a Clinical Panel of internationally renowned leaders in the diabetes field to make recommendations to FDA on key clinical steps and issues critical to the advancement of studies of these systems outside of the hospital. Panel members included David Nathan, Director, Clinical Research Center and Diabetes Center at Massachusetts General Hospital and Professor of Medicine, Harvard Medical School; and William Tamborlane, Professor and Chief of Pediatric Endocrinology and Diabetes, Yale University School of Medicine.

The panel developed a series of clinical recommendations that were shared at today’s meeting. They were based on key areas addressed by the FDA, NIH, JDRF, clinicians and industry. First, the recommendations addressed questions on how should studies on artificial pancreas systems move safely from inpatient (hospital) settings to outpatient (real-world) testing. Second, the panel identified which subset of patients should be considered when testing artificial pancreas systems. The third area focused on how to ensure the safety of patients participating in the studies and eventually for everyday use. Lastly, the panel identified what outcomes should be measured in studies to demonstrate the safety and effectiveness of the device.  

According to panel chair Robert Sherwin, M.D., Yale University, “The panel believes, with certain safeguards, artificial pancreas systems can be safely tested in real world settings.”  

“The incidence of Type 1 diabetes is on the rise. Today’s tools to manage the disease are insufficient. We have the technology at our disposal to make an artificial pancreas work. Now it’s time to move forward quickly to define the regulatory pathway so final studies can be completed and better technologies can be made available to adults and children struggling with this difficult disease,” added Mr. Brewer.  

Publisher’s Comment:

What are the realities involved with the development of a true artificial pancreas? 

Although insulin pumps and CGM have improved dramatically, neither technology has reached a level that should place control of a patient’s life in the hands of a very sophisticated piece of technology. Even if such a system was developed it would be costly.  It’s questionable that insurers would provide reimbursement for a system that is likely to cost more than $10,000. 

Even more important, is such a system even needed? The simple fact is tight glycemic control is being achieved today using existing technologies: technologies which are controlled by the patient and that do not leave life altering decisions up to a machine. The reality is that an artificial pancreas is something that would be nice to have but is it really necessary? 

Even if it was approved, it would only be used by a handful of patients. Perhaps a better question is: are there not more pressing issues needing to be addressed that would benefit a greater percentage of patients? 

One fact remains unchanged as nearly two-thirds of all patients are not properly controlling their diabetes, a fact that won’t change with the introduction of an artificial pancreas. The problem is not a lack of technology: the problem is getting patients to use available technology effectively.

Bottom line, it is actually easier to develop great technology than to teach patients how to effectively use any technology.  New technology is truly worthless unless the patient understands how to use it to effectively manage their diabetes. — SF