What follows is Medtronic's response to Zachariah Kramer's letter to Diabetes Health cautioning against unrealistic expectations about CGM systems.

Medtronics Diabetes’ Response,

June, 2008

Diabetes therapy has undergone a number of significant advances over the years.  Patients are now more than ever empowered to manage their diabetes with the advent of continuous glucose monitoring (CGM).  As with any new technology or therapy, there are criticism and challenges.  All of these concerns are legitimate, but I believe the clinical benefit and improved protection associated with CGM vastly outweigh those concerns.

Diabetes Mellitus is a chronic disease that is best managed by the patient who has both access to continuous information needed for continuous decision making and evaluation as well as guidance from a team of care givers. It can not be managed successfully blind to vital information such as undetected high and low blood sugars, time spent above or below normal glucose targets or the response to a multitude of life events. If managed by individual, episodic data we as healthcare professionals are unable to successfully tailor diabetes treatment to the individual needs and responses of each person with diabetes. Without the added information from CGM, diabetes as a chronic disease will continue to be managed unsuccessfully using acute care models.

The clinical understand of diabetes has also changed because of CGM.  Clinical evidence has shown that CGM use can lower A1c by as much as one percentage point.   That’s significant when you consider that for every point reduction in A1c long-term side effects are reduced by 25 percent.  But even more exciting, continuing clinical evidence points to the importance of glucose rate of change, area under the curve and glucose variability as components of optimal diabetes control.  Without CGM to enlighten us, we would never have learned about these silent variables of diabetes health.  

In the short-term, CGM will not replace the fingerstick meter.  It is true that companies like Medtronic are seeking ways to reduce or do without those inconvenient finger pricks, but those studies will require multiple years of significant clinical scrutiny.  Instead, I’d shift the dialog to more about the value of this new technology, rather than what it replaces.  

Let me illustrate the point.  Say you’re going to bed and take a fingerstick reading.  Your meter reads 125 mg/dl reading.  What do you do?  You ask yourself, “Am I going up?  Am I going down?”  Worse yet, “Should I give myself a shot, or do I run the risk of running high all night?”

With CGM, you have the added information of trending and directional arrows.  You know EXACTLY where you’re headed.  Also, with the built-in alarms, even if your glucose takes a turn for the worse, the device will wake you up before your situation becomes a real emergency.  Since when could a fingerstick meter do the same?

Cost is the most compelling argument.  I agree that new technologies always cost more than the standard of care.  CGM is still in its infancy, and as demand increases costs will come down.  We at Medtronic are working aggressively to reduce production costs and secure broader health insurance coverage to address this very real concern.  

The tide has shifted as CGM technology has continued to prove its benefit.  The emerging consensus among physicians is no longer “if” but rather “when” this technology will become widely adopted and accepted as the standard of care.  We all need patience and perseverance to ensure CGM therapy reaches those who desperately need the power of real-time diabetes control.

Sincerely,

Alan Marcus, MD
Chief Medical Officer
Medtronic Diabetes