The article describes one man’s experience using a new combination glucose sensor and insulin pump for diabetes. The article explained some of the expenses (although it never gave the cost of the device itself), described the device and how this compared to the rest of the options, and described harms or disadvantages, at least those experienced by this one person. The story could be improved by describing published harms or side effects. What was actually found in the clinical trials? Because the story describes one man’s experience, much of the information is anecdotal and could be biasing. The story is lacking any description of the evidence to support using this new device or this level of monitoring (how do we know this works?) and what it can actually do (will it improve A1C–average blood sugar over the past 2 to 3 months–or will it improve the number of severe low blood sugar episodes experienced or something else?). No independent source was obtained to discuss the new device, another problem with this purely anecdotal approach.
The story does describe monthly testing supply costs for the new device ($350). However, the article could be improved by telling readers how much the actual device costs and/or comparing this to typical blood glucose testing monitors and supplies.
There is no discussion about clinical outcomes, such as by how much it might improve A1C levels, or on average, how many severe low blood sugar episodes were avoided by using this device compared to traditional devices.
Through one man’s story-telling, harms are described and included malfunctions with the machine leading to recalibration or inserting new catheters, trouble relying on machine recommendations for insulin dosages, potential for infection at the injection site, and inconvenience of being awakened or disturbed by the beeping or buzzing alarm. Of course, it’s not clear whether these are the only harms, but they seem reasonable. The story could be improved by reporting on actual harms reported in clinical trials.
The article does not describe the evidence (trial, observational, or otherwise) supporting effectiveness of the new device. It does tell readers that this new device may be inaccurate in its blood sugar readings by as much as 18%, but there is no discussion about outcomes, such as by how much it might improve A1C levels, or on average, how many severe low blood sugar episodes were avoided by using this device compared to traditional devices.
The level of monitoring and use of injections as described in this article are beyond what has been tested in randomized controlled trials.
No independent sources of information were obtained. In fact, the only information is related anecdotally by only one man, which could be biasing.
The story describes alternative options, including traditional blood glucose monitoring devices and insulin pumps (minus the glucose sensors). The story also describes other similar devices that may be on the market soon.
The story states the “Paradigm Real-Time” combination insulin pump and glucose sensor was approved by the FDA, implying it is available to consumers. It was a little confusing to hear one man’s story about traveling to another city for a “test-period” in which the manufacturer paid for supplies, which sounded a bit like a study scenario or a special promotional deal. And, it’s still not clear whether this is available everywhere or only at certain locations. But, the article also tells readers that insurance won’t pay for the supplies as yet (even though the anecdotal story-teller felt it was worth it to him to start paying this), adding to the idea that if one wanted to pay the out-of-pocket expense, one could obtain this device.
The story tells readers that the device was approved in June, which lets people know this is new to the market.
We can’t be sure if the story relied largely on a news release. No sources are quoted anywhere in the story.