Thursday, March 13, 2008

Type 1 cure trials start

This is the most exciting news I've had since my diagnosis with diabetes 25 years ago.

Today ClinicalTrial.gov posted a trial announcement looking for people to participate in the first trial for a possible cure for type 1 diabetes. This is based on the research led by Dr. Denise Faustman over the last decade.

To quote the site "This is the first step in trying to cure established type 1 diabetes". Tell me that's not a big thrill.

When I spoke with Dr. Faustman in January, she was hoping that they could trial this approach with relatively small numbers of people. It seems she was successful, they are looking for 25 subjects to participate in this trial. Dr. Faustman mentioned that the early trial would be used to try and establish basic dosing information and determine whether the approach actually works in people.

As usual for this type of trial there will be two groups of participants, some taking BCG and others taking saline as a placebo. You would receive an inoculation at the start and at 4 weeks into the trial. It's a double blind trial. Neither your nor the investigators will know who's receiving which substance.

BCG has been used for many years as a vaccination for tuberculosis. It's also used in immunotherapy for cancer and other diseases. It's low cost, approximately $3 for a tuberculosis vaccination. It's also not 'owned' by a specific pharma company, so it should be readily available.

I would sign up for this trial today...but I don't qualify. My age and previous inoculation with BCG exclude me. I do hope that's not always the case.

If you're thinking about it, please take a close look at both the inclusion and exclusion criteria. There are a lot of these.

We're definitely living in exciting times.

Labels: , , ,

Abbott FreeStyle Navigator is approved

Today Abbott reported that the FDA has (finally) approved the FreeStyle Navigator continuous glucose monitor(CGM) for sale in the US.

This is one of the most anticipated CGM devices. Many people I've spoken with have expected that this CGM will solve all the shortcomings of the Dexcom and Minimed devices. I've also talked with several people who have been using the Navigator. My take is that this is no more perfect that the existing CGM alternatives.


Abbott, who even has a special site for the Navigator, says that it will be available in the second quarter of 2008. Like all CGMs you will need a prescription to get hold of one.

A few interesting aspects of the Navigator:
  • Five-day sensor.
  • Five direction arrows to indicate rising or falling blood sugar
  • The receiver has a built-in FreeStyle meter.
  • Designed to 'accomodate' swimming. Does that mean the receiver is waterproof?
  • The receiver can be up to 10 feet from the transmitter
You can see a short movie illustrating how the system works. It's available on the Abbott site.

One part of this animation shows the sensor being worn on the back of the arm. That's a very different location that is currently recommended for CGM sensors.

I'll post more news about the FreeStyle Navigator as I learn about it.

Update: My understanding is that the built-in FreeStyle meter is used to calibrate the Navigator. I do not think they support manual input of the values. I'll try to confirm this and update the page when I learn more.

Labels: , ,

   Blog Directory - Blogged