Navigation Links
FDA Moves to Speed Development of Artificial Pancreas Systems
Date:12/1/2011

By Steven Reinberg
HealthDay Reporter

THURSDAY, Dec. 1 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday issued new guidelines aimed at helping speed up the development of artificial pancreas systems.

If they become a reality, such technologies could make a huge difference for people with type 1 diabetes, who need insulin injections to control their blood sugar and survive.

Artificial pancreas systems combine current technologies for continuous blood sugar monitoring and pumps to deliver insulin as needed. These systems are designed to keep patients' insulin levels within normal ranges, by reacting to changes in blood sugar.

So far, however, equipment problems, computer glitches and problems with the insulin used have hampered development of these systems, the FDA said in a news release.

"We really are trying to get these devices to the market as quickly as possible," Charles Zimliki, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative, said during a news conference Thursday.

That's why the agency has taken the unusual step of developing a guidance for approval, something which is usually done after a device had been developed and tested, he said.

Zimliki said he has no idea when an approved device might be available. To date, the FDA has approved more than 20 clinical studies for artificial pancreas systems.

The FDA's new guidelines make designing, testing and safety and effectiveness requirements more flexible. For example, they propose more flexibility in the choice of clinical trial outcomes, number of patients needed and the length of the trial.

"We really wanted to make a push; we felt like it was a good idea to give academicians and people that aren't familiar with the regulatory process a pathway to develop these systems," Zimliki said. "We want people to move these things forward; we think this guidance will allow people to get a safe and effective product on the market quickly."

In type 1 diabetes, the pancreas produces little or no insulin, an essential hormone necessary for controlling blood sugar. People with type 1 diabetes have to monitor their blood sugar throughout the day, and calculate how much insulin they need to lower their blood sugar, which is delivered using a syringe or insulin pump.

An artificial pancreas system combines an insulin pump and a continuous glucose monitor with a sensor placed under the patient's skin. The pump and monitor work together, tracking blood sugar and automatically pumping measured doses of insulin as determined by a computer algorithm.

These systems help eliminate, or reduce the severity of dangerous drops in blood sugar by stopping insulin administration when blood sugar levels near a predetermined threshold.

The device is not a cure, but it might reduce dangerous high and low blood sugar levels, giving patients a better quality of life and reducing the risk of diabetes-related complications, the FDA said.

The new guidelines recommend a three-phase clinical study progression "so that studies may move to an outpatient setting as quickly as possible." The agency is also suggesting other ways to streamline the testing process, including ways to use existing safety and effectiveness data for the components that make up the system, and allowing data from clinical studies done outside of the United States to be used in the approval process.

In addition, those conducting the clinical trials have the option of demonstrating that the system controls blood sugar as well as standard therapies, or showing that it gives better blood sugar 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," the FDA said.

In June, the FDA released a draft guidance on safety and effectiveness goals for researchers and industry in developing the Low Glucose Suspend System, a first-generation artificial pancreas system. Those results helped inform this new guidance, Zimliki said

Hurdles in developing these systems include making sure the implanted sensors remain clear, the need to periodically recalibrate blood sugar monitors, problems with the software needed to operate insulin infusion pumps, problems creating algorithms to deliver insulin that take into account how long it takes the body to absorb it, the need for a faster-acting insulin and the overall development of safer and more reliable algorithms.

Another issue is the lack of a glucagon formulation that can be used in infusion pumps. Glucagon is a hormone used to treat severe low blood sugar. "There is a need for a glucagon formulation that is stable over several days and can be delivered by an infusion pump," the FDA said.

More information

For more on type 1 diabetes, visit the Nemours Foundation.

SOURCE: Dec. 1, 2011, teleconference with: Charles L. Zimliki, Ph.D., leader, Artificial Pancreas Working Groups and Critical Path Initiative, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Medicare Cost-Saving Moves Can Backfire
2. Idaho House Moves State Closer to Health Care Disaster
3. California Moves Toward Listing BPA as Reproductive Toxin
4. Sun Spark Purity Moves Aggressively into the Market of Pure Lidocaine Powder and Caffeine Powder
5. Bella Medspa Moves into New Newtown Bucks County Office
6. LazyTown Sportacus and Michelle Obama moves Washington DC
7. Mind Reading Moves Closer to Reality
8. Recent Studies Show MAstertuck℠ Technique Removes Large Amounts of Body Fat without Tummy Tuck Surgery
9. Artificial Pancreas for Type 1 Diabetes Moves Closer to Reality
10. Recent Book Moves Beyond Defensive Medicine, Tackles Entitlement Reform
11. Astra HR Moves its Corporate Headquarters to King Farm, Rockville, MD
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Moves to Speed Development of Artificial Pancreas Systems 
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating ... many ways they remain in the eye of the beholder, according to experts who ... of The American Journal of Managed Care. For the full issue, click here ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/24/2016)... ... , ... A recent article published June 14 on E Online ... on to state that individuals are now more comfortable seeking to undergo not only ... calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg ... Legal Elite. The attorneys chosen by their peers for this recognition are considered among ... Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite Hall ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 Research and Markets ... for Companion Diagnostic Tests" report to their offering. ... Companion Diagnostics The World Market for Companion ... medicine diagnostics. Market analysis in the report includes the following: ... (In Vitro Diagnostic Kits) by Region (N. America, EU, ROW), ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced ... as its e-clinical software solution of choice.  This ... best possible value to their clients by offering ... The preferred relationship establishes nowEDC as the EDC ... for MedSource,s full-service clients.  "nowEDC has long been ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 Roche ... received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) ... severe sepsis or septic shock. With this clearance, Roche ... provide a fully integrated solution for sepsis risk assessment ... associated with bacterial infection and PCT levels in blood ...
Breaking Medicine Technology: