How much is enough?

How much is enough?

It’s an understatement to say that the blood glucose monitoring market has been through its fair share of issues. Growth in the market has slowed from double digits to barely any growth at all, even before competitive bidding prices were contracting and usage in spite of numerous advancements in technology hasn’t budged one bit. As Diabetic Investor has been reporting for what seems like years the market has fully transformed itself from a medical device, high margin business to a commodity market where price and cost control are the only things that matters.

Yet not content to see this market totally implode there are some who believe the time has come to add to the expense of the meter companies while providing little if any benefit to the patient. The quest at hand is improving the accuracy of glucose meters, a quest that believe it or not is actually being encouraged by some of the major meter companies.  Now Diabetic Investor isn’t sure why any company currently in the market would encourage this effort but then again this is the wacky world of diabetes where anything can and usually does happen.

Now before we go any further let’s be clear about one thing, Diabetic Investor is not necessarily against the effort to make meters more accurate. However, no one seems to be asking whether this quest will yield much should it be accomplished. Will the patient actually see an improvement in outcomes with more accurate meters? Looked at realistically the answer isn’t all that clear cut.

While there are some 28 million patients with diabetes in the United States, there are just 5 million or so insulin using patients. The harsh reality is that while it would be great if non-insulin using patients tested their glucose on a regular basis, more accurate meters would mean little to these patients. The simple reason is with non-insulin using patients there is no action step taken after the test is completed. These patients do not need this information to properly dose their medications, while the exact opposite is true for insulin using patients.

Yet even for insulin using patients this information while important isn’t used as intended. The reason is not all insulin users are alike. Insulin users fall into three basic categories, insulin plus oral medications, multiple daily injection (MDI) patients and finally insulin pump patients. While it would be great if patients following an insulin plus oral medication therapy regimen tested on a regular basis most physicians dumb down the insulin portion of this regimen by telling their patients to inject a set amount of insulin each day. The patient is not actively encouraged or trained to vary the amount of insulin based on their glucose levels.

This basically means that the more accurate meters would benefit MDI and insulin pump patients. Yet even here the question remains would these patients who need this information to properly dose their insulin truly benefit from more accurate meters. Here again the answer is not as clear cut as it might seem. The reason is glucose readings are just one element used in determining how much insulin should be dosed. Diabetic Investor would argue that other factors such as carbohydrate intact, exercise, stress and a patient’s metabolism are just as, if not more important factors than a single data point. Anyone who disagrees with this should perform a simple test. Take a single data point and vary that data point by 20% and note the differences in recommended insulin intact. Having performed this test already Diabetic Investor can state that varying the carbohydrate data point by 20% + or – has a greater impact on insulin dosing than vary the glucose data point by 20% + or -.

Yes there are rare instances where glucose test results vary by more than 20% but these instances are extremely rare. So again the question becomes is this effort to improve the accuracy of meters truly necessary and more importantly will this effort even if successful improve patient outcomes. Or is this effort just one more attempt to avoid the real issues facing patients and once again falsely believe that improvements in technology will yield better patient outcomes. Just in case anyone doubts the dubious benefits of improvements in glucose monitoring technology consider these facts; smaller sample sizes, alternate site testing, faster test results and of course pretty meter colors have done nothing, zilch, nada when it comes to improving either average testing frequency or patient outcomes.

This latest quest to improve the accuracy of meters is just one more example of how the industry, the FDA and many so-called patient advocates are missing the point. These supporters of improved accuracy have fallen into the trap that better technology equals better patient outcomes when the facts clearly indicate otherwise. These supporters of improved accuracy also have lost touch with reality as they seem to have forgotten that glucose monitoring is a business. A business which is already over-regulated, facing intensifying price pressure and needs this additional cost as much as a raging forest fire needs gasoline.

Still these facts won’t stop this effort no matter how dubious the benefits of success may be. No to the supporters of improved accuracy who seem to believe that better technology is the answer to everything, the quest will continue. If there is one thing that can be counted on in this wacky world of diabetes never let the facts get in the way of the real issues facing patients.