This Associated Press story describes a newly FDA-approved device — a continuous glucose monitor that does not require any blood testing. The story does a great job describing the convenience and the potential for better blood sugar monitoring, and therefore, better regulation of insulin levels in people with diabetes. However, the story doesn’t evaluate the evidence for these claims. How well does the device work in real patients compared to existing systems? It’s a pretty key question that goes unanswered.
More than 29 million Americans have diabetes, according the CDC. The disease requires that patients check their glucose levels throughout the day and self-administer insulin to keep those levels within a normal range. Improvements in medical technology over the past few decades have meant blood sugar monitoring and insulin delivery that is both more accurate and more convenient, helping people with diabetes maintain steadier glucose levels and have fewer crisis events. Eliminating the need for finger pricks to test one’s blood has the potential to optimize this process even more.
The story does not put a number to the cost of the two-part device, saying the device-maker is not yet disclosing that info.
The benefits of the new continuous blood sugar monitor are not quantified in any way. At the very least, we’d like to know how accurate the sensor is compared to the current method of blood testing.
The story does not consider any potential harms of the system. Is there a failure risk (which might mean patients have to go back to finger pricks to do blood testing). And, since we don’t how good the accuracy is (see benefits), is there a risk that errant blood sugar readings might lead to improper insulin dosing, and the risks that lie therein?
We would also need to know under what conditions the device may not function properly. For example, if the person is sweating profusely, or very chilled, etc. The consequences of poor accuracy under suboptimal conditions are not explored.
The story provides no evidence for benefits or harms, so there’s no qualitative assessment. A discussion of what evidence the FDA used to base their decision upon would be very useful, since medical devices often receive lower scrutiny from the FDA.
The story does not engage in disease-mongering. Diabetes is common and problematic. Notably, however, most people with Type 2 diabetes who are not on insulin do not need to monitor their blood glucose.
The one quoted source in the story is a paid consultant for a number of diabetes device companies. We think an outside perspective, a diabetes doctor or research who does not stand to profit from blood sugar monitoring device sales, is crucial here.
The story describes well the current methods that people with diabetes use to monitor their blood sugar: Standard glucose meters and continuous glucose monitoring devices, both which require two or more finger pricks each day. The story also mentions another product, from a different device maker and new this year, that directly links to a personal insulin pump.
The story tells us that “should be available in pharmacies within months.”
The story makes clear what is new and different about this device — it does not require daily finger pricks to calibrate the readings.
However, it is clear there is a competing product, which begs the question: Why is this so interesting if something similar is already out? That should have been explored more.