Companies seek FDA approval of wireless, implantable diabetes monitors

One of the knocks against all this great, new home-monitoring technology is that there hasn't been enough scientific evidence of back-end savings to justify the added up-front expense. Slowly, that's changing.

A clinical trial of 50 patients, supported by Atlanta-based ALR Technologies, maker of the ALRT Health-e-Connect Internet-based diabetes monitoring system, found that those who used Health-e-Connect to track compliance with doctors' orders saw their A1C levels drop from 8.8 percent to 7.6 percent. Researchers who tested the system in Western Canada reported their findings in the August issue of Diabetes Care.

"The effectiveness of using ALRT HeC system compares favorably to the recently introduced diabetes medications but at a lower cost with no side effects," lead investigator Dr. Hugh D. Tildesley, an endocrinologist at St. Paul's Hospital in Vancouver, British Columbia, says in an ALRT press release.

Based on this evidence, ALRT recently filed a 510(k) form with the Food and Drug Administration, seeking permission to market Health-e-Connect in the U.S. The company expects approval before the end of the year.

Meantime, a small San Diego-based firm called GlySens is seeking FDA approval for a pilot test of an implanted wireless sensor to monitor blood-glucose levels in diabetics. The sensor would substitute for the the regular finger pricking that makes manual diabetes monitoring so difficult and uncomfortable for many patients.

"My impression would be that most physicians and patients would gravitate toward this system because it would be easier for them," Dr. Michael Gottschalk, a pediatric endocrinologist with Rady Children's Hospital in San Diego, tells the San Diego Union-Tribune.

To learn more:
- see this ALR Technologies press release 
- read the Diabetes Care abstract 
- take a look at this San Diego Union-Tribune story

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