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FDA Listens to Expert Panel On Artificial Pancreas For Possible Field Test

Last Wednesday, the FDA listened experts outline possible next step for the development of the Artificial Pancreas. So far the Artificial Pancreas has demonstrated that the technology does improve blood glucose control in a hospital or clinical setting.  But clinical settings are not real life and the obvious next step for the artificial pancreas to be tested in our daily lives away from hospitals and clinics!

 

To date, there are a couple of artificial pancreas devices in trial.  Medtronic has their version in clinical trial and they also have a low glucose suspend pump called the VEO and JDRF has partnered with Animas and Dexcom to create an artificial pancreas device.  The VEO is on the market in Europe and Canada, but not here. 

 

Diabetes experts in the field of the Artificial Pancreas met with the FDA and NIH to provide the clinical information and recommendations for the next steps in the development of the artificial pancreas.  Clinicians, researchers and industry leaders agreed that outpatient studies for both low-glucose suspend and artificial pancreas systems are the next step!

 

In addition to clinical experts, JDRF assembled a panel of patients to give advice on how to transition from inpatient to outpatient settings.  The patient panel offered transitional steps before moving to outpatient setting:

Patients need to demonstrate the ability to operate the system

Be responsible for calibration without intervention from medical personnel.

 

Here’s the link to JDRF clinical recommendations

 

For many pump systems are great advancement in

diabetes management, but there is concern over human error.  The artificial pancreas, or closed loop system, would help alleviate the all too common over bolus and under bolus mistake! The FDA reviewed the pump technology and determined that pump error was less the pump and more a problem of patient error. You would think this would give great argument for the Artificial Pancreas, right?

 

Dr. Aaron Kowalski, assistant VP of Treatment Therapies for JDRF commented, “An Artificial Pancreas, essentially a device that would both measure blood sugar and dispense appropriate amounts of insulin to levels in optimal range, would take much of the guesswork out of the daily management of the disease.”

 

One of my beefs with the FDA has been their hesitation to approve Medtronic’s insulin suspend pump called the VEO.  Dr. Fran Kaufman, Medtronic’s chief medical officer of Medtronic Diabetes gave testimony and shared data that in 27 patients who used the VEO combined with continuous glucose monitor (CGM), patients dropped their A1c after 6 months and “ There’s been no evidence of increase in hypoglycemia”.

 

But the FDA Artificial Pancreas team’s concern lies in this statement by Dr. Patricia Beaston, “The CGM and meter are part of the system and they have inherent errors. The fact they agree with themselves makes it hard to make any determination.  If you look within individual patients, the accuracy of the sensor for 3-6 days varies across those patients.  A lot of it is dependent on how well that patient does the calibrations, how often, and the quality of the glucose meter they use to make those calibrations.”

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