How much is too much?

How much is too much?

According to a study published in the British Medical Journal (BMJ) Americans with type 2 diabetes may be getting unnecessary tests – and, in some cases, needless changes in medication. Published online on December 8th the study’s findings are based on insurance claims made between 2001 and 2013 for 31,545 type 2 diabetes patients age 18 and older. All of the adults in the study had HbA1c levels that were consistently below 7% within the previous two years.

Nearly 55% underwent HbA1c tests three or four times per year. Another 6% had at least five tests per year. Frequent HbA1c tests were also associated with increased odds that patients would be started on additional medications to control their glucose levels.

The authors of the study concluded;

“Clinically unnecessary testing can have detrimental effects for both the patient and the healthcare system. Excessive tests can cause unnecessary patient discomfort and anxiety, and because of the potential for false positive results caused by expected short term biological and analytical variability of the HbA1c test, they can increase the risk of further needless testing, specialist referral, and treatment change. Availability of a laboratory result could compel a doctor and patient to act, even if not clinically indicated or beneficial. We saw this in our study population, in which excessive testing was associated with an increased likelihood of treatment intensification despite normal levels of HbA1c.”

The results of this study seem to fly in the face of current conventional wisdom where tight glycemic control is considered the gold standard. Which begs the question that perhaps it’s time to change the way we look at what constitutes good control or put another way it might be time to look beyond just HbA1c. For better or worse HbA1c has established itself as the “gold standard” for measuring control. There are several reasons for this not the least of which is the result is super easy to understand, a reading of 7 or below is good, above 7 not so good.

However, there is a growing body of evidence which suggests that not every patient should strive for that magical reading of 7 or below. That getting to this level may actually do more harm than good. There is also a growing belief that HbA1c by itself does not tell the whole story, that there can be two patients with the exact same HbA1c but because of glycemic variability one is in better control than the other. Thanks to the growing usage of continuous glucose monitoring systems physicians and researchers are gaining new insights into how glycemic variability impacts patients. That good HbA1c results combined with poor glycemic variability really is not good control.

The simple solution would seem to be obvious, get more patients onto a CGM. While this may seem obvious it is also impractical and not just for cost considerations. While there is no question that the data gathered by a CGM can be invaluable it can also be overkill. Even with advanced cloud enabled analytics that now come with these systems the vast majority of patients don’t want to be attached to a CGM. Nor do physicians want to the adding burden of training patients on how to properly use a CGM.

The way Diabetic Investor sees it would be far simpler and more cost effective if physicians could measure glycemic variability using a simple blood test. A test which would tell them whether the patient is in a tight glycemic range or not. Should this test reveal the patient is not in a tight range they can then take the next logical step and put the patient on a CGM.

Believe it or not such a test does exist known as 1,5-AG. Now before we go any further here let’s be clear that the test does have limitations and is by no means perfect. But as we are seeing the current gold standard HbA1c is also imperfect. However, when looked at together these two imperfect tools for measuring control provide a much better picture of control.

As we move ever closer to outcomes based reimbursement we see drug companies taking a closer look at using 1,5 AG as an additional tool used in conjunction with HbA1c to measure control. That with so many drugs in each category that they will begin adding 1,5 AG to their studies. As we have said many times when there are multiple options in each category and each of these options appear to do the same thing the same way why not attempt to differentiate with adding 1,5 AG. Would a payor not favor an option that not only lowers HbA1c but also keeps the patient in a tighter glycemic range? Would this not be an easy, simple and cost effective method for gaining an edge in this very competitive market?

Now we’re pretty sure that the eggheads will debate this issue, looking at every angle and debating the merits of using an additional biomarker. They will likely note that 1,5 AG is imperfect, which seems odd as these same eggheads acknowledge the current gold standard HbA1c is also imperfect. They will insist that if we really want a better picture of control just slap a CGM on every patient. Yet as we have noted already this just isn’t practical.

Perhaps it’s time with all this emphasis on getting patients under control that we actually develop better methods for defining control. That perhaps it’s better to use two imperfect markers together then it is to use one, that these two results would tell a more complete story. Perfection would be nice but even a six-year-old knows there is no such thing as perfect.