July 21, 2004
Blood Tests and Insulin Injections, Research: Monitoring
Question from Centre Hall, Pennsylvania, USA:
We are constantly looking for a better way to check our son’s blood sugar level. We need to test 8 to 10 times a day as he is just beginning to recognize lows. He is the typical five year old boy. He is very active, loves sports, and will start school in September this year.
We purchased a GlucoWatch last year hoping that this would be the answer, but after a high skip level, some errant readings, the twice a day change, three hour warm up time and a rash on his arm, we quit using it.
Now we see that Pendragon Medical has had a watch of their own, using spectography, approved and selling them in about 10 European countries. What does that mean? How does this work?
We find very little written on this new monitoring system except on their web site and am hoping you can shed some light on if anyone has done some testing in the States on this and if it really works. Obviously, some stick testing will still be necessary, but if we can cut that to five times a day and use the watch as a safety net from times we think he “should be okay” that would be such a relief!
We know insurance will lag years behind in paying for this technology, but are willing to pay, if it works. Also, when this type of product is “approved” for those over 18 years old, does that mean it could be harmful to small children? Or, is it really just a size and liability issue and hard for the manufacturer to do testing on young children?
Answer:
As of July 2004, the only non-finger stick glucose testing system available for sale in the US for consumer use is the GlucoWatch. Later this year, Medtronic MiniMed’s Guardian Continuous Glucose Monitoring System will be available, having received FDA approval earlier in 2004.
Many other companies are working on continuous blood glucose monitoring systems. The Abbott Diabetes Care (formerly TheraSense) Navigator is before the FDA now. Researchers involved in clinical trials anticipate that more products will be available in the coming years.
While most of these devices are initially approved for use by adults, once approved, physicians can and do prescribe them for children. This is called “off label” use. The DirecNet group is also investigating continuous sensing technology and has published numerous studies that have been reported in the Daily Care news section of this web site.
JSH
