A Bad Idea Gets Worse
Yesterday we wrote about a study that basically found patients would rather give up years of their lives rather than deal with their diabetes. The fact is diabetes is a complex disease and no two patients can are treated exactly the same. This is one reason why HbA1c tests are so useful, it provides a standard for the patient and physician. It is also the easiest number for a patient to understand, 7 or below good – 7 or higher need to do some work. Yet for reasons lost on everyone the EASD, ADA, IFCC and IDF want to replace A1c with average blood glucose.
These organizations somehow got together with the foolish belief that patients do not understand what A1c results mean. To compound this foolishness these organizations are also want to change how A1c is calibrated. During the DCCT trials an A1c of 6% was calibrated to be an average blood glucose of 135 mg/dl, 7% was equal to 170 mg/dl. Just what this new calibration method will be is anyone guess.
The fact the one of the reasons these organizations want to change the calibration method has to do with the introduction of continuous glucose monitors is cause for concern. While these systems can provide valuable data they aren’t accurate enough. There is a reason that none of the current systems are not approved as a replacement for conventional monitors.
Also weighing in on this issue is the American College of Physicians (ACP) who issued a guidance statement on what A1c level is optimal for type 2 patients. The ACP issued 3 statements:
Statement 1: The goal for glycemic control should be set as low as is feasible to prevent microvascular complications of diabetes, while avoiding undue risk for adverse events or placing an unacceptable burden on patients. Discussing with the patient the risks and benefits of specific levels of glycemic control should precede setting treatment goals.
Based on individualized assessment, a hemoglobin A1c level less than 7% is a reasonable target for many patients, but not for all. Hemoglobin A1c goals higher than 7% may be indicated for patients who are elderly or frail, who are at higher risk for adverse events from tight control, or who have substantially lowered life expectancy from comorbid conditions. More stringent targets may be indicated in patients who are at increased risk for microvascular complications.
Statement 2: Individualized evaluation of risk for complications from diabetes, comorbidity, life expectancy, and patient preferences should determine the specific goal for hemoglobin A1c level.
Statement 3: The ACP committee recommends additional research to evaluate the optimal level of glycemic control, particularly in patients who have significant comorbid conditions.
“Understanding the benefits and harms of various levels of glycemic control remains challenging, particularly in patients with other comorbid conditions,” the authors conclude. “In addition to the importance of glycemic control, management of blood pressure and lipid levels is also essential to prevent complications of diabetes. Further research that elucidates optimal level of glycemic control in patients of different ages, in patients with comorbid conditions, and in patient populations representative of those seen in practice would provide important additional guidance for management of diabetes.”
Diabetic Investor fails to see how any of these proposed changes or statements will actually help patients or the physicians who treat them. In many ways these changes could actually make matters worse. Think of the impact this would have on drug companies who have drugs in clinical trials. Currently A1c is considered the gold standard and the ability to lower A1c is the typically the primary endpoint for clinical trials. The FDA already has enough problems on their hands and changing A1c or using a new number will only add to their problems.
Glucose levels are not like a person’s body temperature and can vary widely throughout the day. Food intake, exercise and stress are just a few of the factors that can affect glucose levels. This is one reason the majority of patients do not monitor their levels.
Secondarily, all of this talk of changing how the numbers are calibrated or what number to use makes the assumption that diabetes is the only issue the patient has to deal with. This academic approach fails to take in account what goes in the real world. Namely besides worrying about their diabetes, patients are also told to watch their weight, cholesterol levels, etc. With all these different levels to monitor it’s no wonder patients simply give up and do what they feel is best.
As we mentioned yesterday simplicity is not the only key to better drugs and devices, it also is key with the dismal state of patient education. Let’s get real here folks, as easy as the current version of A1c is to understand many patients don’t even know what their A1c is. Can you imagine a primary care physician actually explaining average blood glucose to a patient?
Perhaps the current version of A1c has its limitations and is not perfect. However, it still is the easiest and perhaps only number that both patients and physicians understand. Instead of fixing something that isn’t broken these organizations should put their efforts towards something that really needs fixing; patient education.
As Dean William Ralph Inge once said “There are two kinds of fools: one says “This is old, therefore it is good”; the other says, “This is new, therefore it is better.”