Draft FDA Artificial Pancreas Guidance

by Leighann on December 1, 2011

Today there was some news about the artificial pancreas. I haven’t digested it all yet, but thought you might like to read up.

CNN: Artificial pancreas could be ‘holy grail’ for Type 1 diabetics (Nov 26, 2011)

Reuters: Insight – Diabetes breakthrough stalled in safety debate (Dec 1, 2011)

FDA: Draft Guidance for Industry and Food and Drug Administration Staff – The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas Device Systems (Dec 1, 2011)

And also read the FDA and JDRF press releases below.

 

Artificial Pancreas Project

Image courtesy of CNN. Click for original source.

FDA NEWS RELEASE

For Immediate Release: Dec. 1, 2011
Consumer Inquiries: 888-INFO-FDA
FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals

Agency provides options for device designs and studies

The U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

To facilitate development of this novel product in an evolving area, the draft guidance provides flexible recommendations for design and testing that meet statutory requirements for safety and effectiveness. For example, the draft guidance provides for flexibility in choice of study endpoints, number of patients to be studied and the length of the clinical trial.

“The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works.”

Type 1 diabetes is a serious, chronic condition in which the pancreas produces little or no insulin, a hormone needed to properly control blood glucose (sugar) levels. People with type 1 diabetes must monitor their blood sugar using a glucose meter throughout the day, calculating how much insulin is needed to lower their blood glucose levels, and administering the necessary dose using a syringe or insulin pump to deliver insulin into subcutaneous tissue.

An artificial pancreas system does not involve synthetic or artificial tissue or organs. Instead, it combines two medical devices, an insulin pump and a continuous glucose monitor or CGM that receives information on glucose levels from a sensor placed under the patient’s skin. The pump and CGM work together, monitoring the body’s glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm.

While not a cure, an artificial pancreas could reduce dangerous high and low blood sugars, providing a better quality of life for those with diabetes and lowering the risk for future diabetes-related complications.

The guidance recommends a three-phase clinical study progression so that studies may move to an outpatient setting as quickly as possible. To further streamline clinical studies, the guidance suggests ways sponsors may leverage existing safety and effectiveness data for components that may make up an artificial pancreas system, as well as data gathered from clinical studies conducted outside of the U.S.

Sponsors also have the choice of showing that the system provides glycemic control as well as standard therapies, or showing that it provides better glycemic control when compared to other therapies.

When final, the guidance will help manufacturers and investigators assemble submissions for clinical trials as well as product approval submissions.

In June, the FDA issued a draft guidance outlining the agency’s expectations about the nonclinical testing and clinical trials for a first-generation artificial pancreas system called a Low Glucose Suspend System. Such a system helps eliminate, or reduce the severity of, a dangerous drop in blood glucose levels by temporarily suspending insulin delivery when glucose levels approach a low threshold.

Today’s guidance was informed by the comments on the Low Glucose Suspend System guidance document. It addresses future generation artificial pancreas devices such as a treat-to-range system that would adjust insulin dosing if a person’s glucose level approaches a low or high threshold and a treat-to-target system that would set target glucose levels and try to achieve these levels at all times. This system would be fully automated and require no interaction from the user, except for calibration of the CGM system.

FDA will be publishing a Federal Register notice in a few days to solicit public comment on the draft guidance.

For more information:
Artificial Pancreas System
The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems Draft Guidance
FDA: Medical Devices

JDRF NEWS RELEASE
December 1, 2011
JDRF Encouraged By Draft FDA Artificial Pancreas Guidance

FDA’s Draft Guidance Is A First Step to Providing Access to Life-Saving Technology for Millions with Type 1 Diabetes

Washington, D.C. – The JDRF today said it is encouraged that the Food and Drug Administration (FDA) has issued a draft guidance which appears to lay a foundation for accelerating the development and availability of artificial pancreas technology (AP) that will improve the lives of millions of Americans living with type 1 diabetes (T1D).

“Our initial review of the draft AP guidance indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field,” said Jeffrey Brewer, President and CEO of JDRF.  “It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP’s safety and efficacy, and if that turns out to be the case it is good news.”

Artificial pancreas technologies have the potential to be the most revolutionary advance in treating T1D since the discovery of insulin.  They will allow the millions of Americans with T1D to maintain tighter control of blood glucose levels, thus significantly reducing the risk of both high blood sugar (hyperglycemia), which can cause long-term complications including heart disease, blindness and stroke, and low blood sugar (hypoglycemia), which can be life-threatening.  It would also free them from much of the daily burden of managing the disease.

In 2006, the FDA added artificial pancreas technology to its Critical Path list, making a commitment to advance these systems. The draft guidance is the first step to getting the technology to those in dire need.

“To be sure, we have a ways to go before AP technologies are available to patients but this draft guidance suggests that Commissioner Hamburg and the FDA are committed to fostering innovation and being a global leader in bringing life-saving technologies for T1D patients to the U.S market,” said Brewer.  “In the next few weeks, we will review the draft guidance in detail and provide detailed comments to the FDA so that the final guidance unmistakably lays out the pathway to put AP technologies in patient’s hands as soon as possible.  In the end, that is what this is all about.”

About the Artificial Pancreas

The artificial pancreas (AP) is an external device which people with T1D could use to do what their bodies cannot—control both high and low blood sugar around the clock. It works by combining a continuous glucose monitor (CGM) and an insulin pump with sophisticated computer software to provide automatically the right amount of insulin at the right time.

One of JDRF’s top priorities is the development of the AP.   JDRF-funded studies have shown greatly improved clinical outcomes from early trials of prototype AP systems.  FDA’s guidance on artificial pancreas systems will allow for these systems to be further developed, tested in outpatient pivotal trials, and eventually approved for people with T1D.

An overwhelming amount of support from researchers, clinicians, policymakers, and patients called on the FDA to advance the development of an AP.  Over 100,000 people in the diabetes community signed JDRF’s petition which urged the FDA to adopt clear guidance, and leading clinical organizations specializing in diabetes care urged the FDA to ensure that the development of an artificial pancreas is not delayed by unnecessary regulatory roadblocks. Furthermore, Congress demonstrated vast support for a reasonable and timely guidance from FDA, with 252 Representatives and 62 Senators having urged the FDA to act in the best interest of type 1 diabetes patients.

For more information, please visit www.jdrf.org.

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