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[IP] Interesting tidbit from Diatribe today on Dexcom G4 (and possibly Animas Vibe if inappropriate conclusions can be drawn)



Based on this, it looks like the G4 from Dexcom is going to be approved by
year-end, so this gives hope that the Animas Vibe might be released shortly
thereafter.B B  I'm looking forward to both, although just the G4 would be
nice, but having the Ping be integrated with the CGM would make me very, very
happy.

-Brent

http://www.diatribe.us/issues/46/trial-watch

Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System
in Pediatric Subjects With Diabetes Mellitus
ClinicalTrials.gov Identifier: NCT01667185
Dexcom is beginning an observational study on the effectiveness of
its next-generation continuous glucose monitor (CGM), the Dexcom G4B (see new
now next inB diaTribe #43B for more on this device), in children with type 1
diabetes. As we noted in conference pearls in diaTribe #44, compared to the
current Seven Plus, the Dexcom G4 was found to be
approximately 20% more accurate, especially in hypoglycemia, a
significant worry for children. This study will collect one weekbs worth of
CGM data from children wearing the G4. Study participants must have
type 1 diabetes and be between the ages of 2 and 17. Dexcom is looking
to enroll 145 participants at five locations: Stanford University in
Stanford, CA; the Barbara Davis Center in Aurora, CO; the Rocky Mountain
Diabetes and Osteoporosis Center in Idaho Falls, ID; the University of
Iowa Childrenbs Hospital in Iowa City, IA; and the Joslin Diabetes
Center in Boston, MA. For contact information for each specific site, as well
as a complete list of inclusion and exclusion criteria, please see the
studybs page here.
The study is slated to complete by the end of 2012, at roughly the
same time Dexcom is expected to receive FDA approval of the G4 for adult use.
Dexcombs current Seven Plus is not FDA approved for use in
pediatrics (though off-label use certainly occurs and many patientsb
insurance does pay for pediatric use even though it is not officially
approved).Medtronic offers the only FDA-approved CGM for this age group. We
hope that the G4 will be approved for use in these younger
populations soon, which would help expand the use of CGM and we believe
would be positive for patients overall. Ultimately, we believe 24/7 CGM
use will represent the standard of care for testing glucose for anyone
taking insulin and that intermittent CGM use will come into play for
type 2 patients not on insulin. bAW/AB
.
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