October 3, 2017 Read Original Story

AP’s write-up on a new continuous blood sugar monitor–where’s the proof that it works?

Reviewed By

Rating

FDA OKs continuous blood sugar monitor without finger pricks

Our Review Summary

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.

Why This Matters

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.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

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.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the story commit disease-mongering?

Satisfactory

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.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

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.

Does the story compare the new approach with existing alternatives?

Satisfactory

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.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story tells us that “should be available in pharmacies within months.”

Does the story establish the true novelty of the approach?

Not Satisfactory

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.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not appear to rely on new release from either the device maker Abbott or the FDA.

Total Score: 5 of 10 Satisfactory

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