December 2nd, 2011
08:42 AM ET

FDA issues guidance for artificial pancreas

The FDA issued draft guidance on Thursday, intended for researchers and device manufactures working to develop and gain FDA approval for an artificial pancreas device system for treating type one diabetes.

In June 2011, the FDA provided draft guidance for development of an earlier type of artificial system that would allow an insulin pump to suspend insulin delivery when blood glucose levels reached certain levels. The system is called the Low Glucose Suspend System.

The new guidance is for a more advanced type of insulin pump system that includes programming to allow the pump to run itself and to determine when it should and shouldn’t provide insulin to the diabetic.

While some clinical trials have been performed in hospital-only settings, and show great promise, the new FDA guidance provides a blueprint for testing and developing a so-called artificial pancreas system in clinical trials both in hospital and at-home settings.  The guidance includes parameters for clinical trial including endpoints, results, the number of patients and length. 

Juvenile Diabetes Research Foundation President and CEO Jeffrey Brewer called the FDA guidance “a huge opportunity for patients.” He went on to say that it is a “milestone event that the FDA went on record about how companies working to produce the artificial pancreas can do so in a reasonable period of time,” although he noted that the guidance is “a long and technical document and it’s implications need to be digested.”

The FDA will publish the information in the Federal Register, with a notice soliciting public comment. The JDRF launched its campaign for the development of an artificial pancreas in 2006. Contrary to it’s name, an artificial pancreas does not involve synthetic tissue or organs, but combines existing insulin pump technology with programming that would allow the devices to work without human interaction.  

The artificial pancreas system has been called the “holy grail” for treating type one diabetics who require insulin to maintain healthy blood sugar levels.

The artificial pancreas will use the currently available technologies of an insulin pump (a device worn outside of the body that delivers insulin into the body through tubing attached to a tiny plastic shunt that is inserted into the skin and moved every few days) communicating with a continuous glucose monitoring system (which consists of a sensor that inserts into the skin and communicates blood glucose levels to the insulin pump or to an electronic monitoring device). It adds a third technology– programming for the pump– that uses mathematical algorithms set up to calculate the diabetic’s usage of insulin and allows the pump to self-administer insulin into the diabetic’s body, based upon readings from the glucose sensor.

Together, the technology would provide patients with automatic insulin delivery, instead of  patients having to manually program the pump to deliver insulin. The artificial pancreas will allow type one diabetics to maintain healthy blood sugar levels, and the goal is to prevent unhealthy high and low blood sugar swings that are common in diabetes.

While neither the FDA or JDRF would offer an estimate on when diabetics will see an actual artificial system on the market, the new guidance opens the door for clinical trials to begin more rapidly, and it will potentially speed up the approval process for the devices.

soundoff (4 Responses)
  1. carol

    Maybe they should study people like me. I have lived with people all my life who get cold sores, including my husband.my sister is one of those people who seems to get them frequently. I, however, have never had one.

    December 3, 2011 at 12:24 | Report abuse | Reply
  2. Minnie Paino

    insulin pumps are quite convenient specially for persons suffering from type 1 diabetes. "

    Look at the most popular posting on our very own blog site

    February 3, 2013 at 12:25 | Report abuse | Reply
  3. LaShondra Woodall

    Wow, that is very beneficial information to know that I have to share with my loved one's and family members.

    June 6, 2013 at 20:35 | Report abuse | Reply
  4. Brian

    The AP will be available to the public soon, I would assume no sooner than five years. The real question is will the public be able to afford them. Obama Care will make these devices very expensive to purchase and to use. The consumables for these will be taxed.

    June 7, 2013 at 15:54 | Report abuse | Reply

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