CGM Study results posted in NEJM

The New England Journal of Medicine has just published a paper on a JDRF-funded study showing how continuous glucose monitors impacted blood glucose control.

The study proved that CGM's resulted in better blood sugar control for people over 25. Hopefully this paper will be useful in supporting insurance claims for coverage of CGM devices. Maybe you'd like to send a copy(PDF) to your insurance company when you make a claim for CGM coverage.

I'm excited that this independent study of a relatively large number of people showed such good results. A few more like this, and it will be hard for companies to argue that CGM's are experimental devices.

Dexcom summarized the paper like this:

Highlights of the study results include:
-- Patients 25 years of age or older who used CGM showed significant improvement in glucose control as measured by HbA1c.
-- Most importantly, this improvement in control was observed without an increase in hypoglycemia (low blood sugar), which is a common concern in intensively managed patients trying to achieve improved glucose control.
-- In all ages, patients who used CGM at least six days a week had substantially improved HbA1c levels.

While Medtronic's press release had the following to say:

In addition to successfully meeting statistical significance for the primary endpoint of absolute A1c reduction, the adult cohort in the study – patients 25 to 72 years old – also successfully met all secondary endpoints with statistical significance (including A1c of less than 7.0 percent, A1c of less than 7.0 percent with no severe hypoglycemia, greater than 10.0 percent relative reduction in A1c and greater than 0.5 percent absolute reduction in A1c).

Younger patient populations did not see a statistically significant reduction in A1c. However, patients in those study arms used the Personal CGM device less often than prescribed (50 percent of the time or less). All patients, regardless of their age, experienced A1c reductions when they used the device at least six days a week. The most compliant study arm – adults 25 to 72 years old – used the device more than 85 percent of the time and subsequently saw the greatest improvement in A1c. These findings expand upon the results of previous studies – like the Star 1 Study – demonstrating that more consistent use of Personal CGM results in more significant reductions in A1c.

Labels: CGM, Dexcom, JDRF, Medtronic, study

posted by Bernard @ 11:00 AM 1 Comments Links to this post