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Medtronic insulin pump beats injections in study

Rating

1 Star

Medtronic insulin pump beats injections in study

Our Review Summary

It touts benefits of insulin pumps and blood glucose sensors without mentioning potential harms. It fails to tell readers that the trial included only a subset of patients and thus the results may not necessarily apply to people with diabetes in general. It implies that the improvement seen in the intermediate endpoint measured (A1C blood sugar levels) will actually reduce the risk of eye, kidney, heart and other diseases without making clear that this trial was not designed to reveal differences in actual health outcomes. It makes no mention of the financial ties between the researchers and insulin pump manufacturers, even though the researchers’ published conflict of interest disclosure summary was substantially longer than the news story itself.

 

Why This Matters

This thumbnail sketch of medical device trial results that may suit the needs of investors trying to predict stock performance fails to meet the needs of people who need relevant information about ways to manage diabetes. But does it really even give investors the true nitty-gritty they need?

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention that the devices cost thousands of dollars and their use requires ongoing purchases of supplies and services. These costs may or may not be covered by health care insurance.

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

Not Satisfactory

As mentioned above, the story implies that the degree of improvement in the control of blood sugar levels reported by the researchers will reduce the risk of eye, kidney and heart disease, even though these health outcomes were not measured. Although control of blood sugar levels is a widely accepted target of diabetes treatment, the trial did not measure whether or not there were any noticeable improvements in real health outcomes.

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

Not Satisfactory

The story does not mention any potential harms of insulin pumps, even though the researchers reported that two patients were hospitalized because of infections at the site of the pump insertion.

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

Not Satisfactory

The story fails to report any of the limitations or qualifications reported by the researchers in their article in New England Journal of Medicine. These include:

– the trial included only people who were able to adequately control their blood sugar levels and the results may not necessarily apply to people who are able to manage their diabetes by other methods;

– the researchers were not blinded, that is, they knew whether patients were using the study devices or multiple daily insulin injections;

– that the motivation of participants and support by health care providers in a clinical trial may not be replicated in regular clinical practice.

And as mentioned above, the story implies that the improved control of one measure of blood sugar control (A1C) would lead to reductions in eye, kidney and heart disease, even though this trial did not measure those outcomes.

Does the story commit disease-mongering?

Not Satisfactory

Although diabetes and complications from the disease are serious and common, the story fails to note that this trial reported only changes in one measure of blood glucose control, not hard health outcomes. While the story says that, “Lowering A1C levels helps reduce the risk of long-term complications from diabetes such as eye, kidney and heart disease,” it fails to point out that this study did not measure whether participants who used the pump and senor devices had lower rates of these diseases.

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

Not Satisfactory

Not only does this story lack an independent source, it makes no mention of the ties between the researchers and manufacturers of insulin pumps and blood glucose sensors. Indeed, the disclosure summary included in the New England Journal of Medicine is 30 percent longer than the news report about the study. The story does note that the trial was sponsored by Medtronic, which manufactures the pump used by researchers.
(Disclosures are summarized at the end of the article posted online at: http://content.nejm.org/cgi/content/full/NEJMoa1002853
Disclosure statements provided by each auther are available at: http://content.nejm.org/cgi/content/full/NEJMoa1002853/DC3

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Although the story does mention that people with diabetes can manage blood glucose levels with multiple daily injections of insulin, without a pump, it leaves out a critical piece of information. Patients who could successfully manage their blood sugar levels without a pump were excluded from the study. Readers should be told how often people with diabetes can achieve treatment targets without using a pump. This story does not make clear that the trial results apply only to people who are unable to achieve treatment goals by using multiple daily insulin injections.

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

Satisfactory

The story points out that these results are from a post-market study, thus indicating the device is already available. However, an editorial in the New England Journal of Medicine accompanying the research article made an important point that was not included in the study: devices are not enough, effective glucose management requires effective management… and the “expert training and guidance received by patients in clinical trials cannot be readily duplicated in a busy clinical practice.” In other words, the results of this trial may not necessarily be achieved in general clinical practice because while the devices tested are widely available, expert support services are not.

Does the story establish the true novelty of the approach?

Not Applicable

The novelty of insulin pumps and monitoring sensors was not part of this story.

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

Not Applicable

Not applicable because we can’t be sure of the extent to which the story relied on a news release. The quote used in this story does not appear in the news releases available for review. However, the story fails to include any information beyond that provided by Medtronic in its news release: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1277813641618⟨=en_US

Total Score: 1 of 8 Satisfactory

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