New Monitoring System Approved by FDA- Potential for Future Robotic Diagnostics

The FDA has just approved the FreeStyle Navigator Glucose Monitoring System - a glucose sensor that reports glucose values continuously for up to 120 hours.  Here is a copy of the FDA PMA letter.  This device is interesting to me since it works with a sensor inserted in either the abdomen or the back of the upper arm.   The device then continuous provides glucose readings and updated glucose trend information for viewing and contains a built-in alarm that can be programmed to alert the user when results fall below pre-set values.  Other similar devices have been approved that monitor for 7 days. 

Potential for Future Robotic Diagnostics  I have written before that I predict a whole new field of chip based biologic disease screening and monitoring in the future.  This is another step to that result.  Here a sensor is placed under the skin that measure blood sugar.  In the future minitaturized chips could be placed in any body cavity or organ to sense any imaginable molecule.

Options for Future Diagnostics: 

1. DNA based sensors screen for cancer metastasis or recurrances such as an intrabdomnal ovarian cancer detector.
2. Sensore that measure drug levels in target tissues - chemotherapy of course comes to mind
3. protein sensors that look for the earliest stages of disease development.

As personalized genetics becomes more widespread, we will identify individuals at particular risk for particular diseases before they occur.  Since the genetic basis of these diseases will be known markers will likely exist.  Implanted chip sensors could then be placed to sniff for these markers and wireless transmit the alarm- or even deliver a predetermined treatment agent- all before there is any external sign of the disease.  First generation implantable devices such as this for blood sugar monitoring are lisated here (none yet available):

• The SMSI Glucose Sensor
• The Animas Glucose Sensor
• Implanted Glucose Bio-sensor
• The Dexcom LTS (long term system)

Here are links to some of the technology that will be involved for these future diagnostics including tiny sensors that transmit with RFID, smartdust sensors the size of a speck of dust or less, smart pills that travel through the body transmitting data and the concept of personalized genetic information based diagnostics and personalized genetics in general.

All approved continuouis blood sugar monitoring devices are here and a comparison from a patient site here:  

• FreeStyle Navigator
• Medtronic Minimed Paradigm Real Time Continuous Glucose Monitor
• The Guardian by Medtronic Minimed
• Dexcom STS
• GlucoDay S
• The Animas GlucoWatch

As an aside - in terms of glucose monitoring the use of thse devices may come into question.  An ongoing diabetes study called ACCORD was cut short in one treatment arm when it was shown that ultra tight strict blood sugar control in diabetics with heart disease actually WORSENED outcomes!