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Problems spur FDA caution on insulin pump


4 Star

Problems spur FDA caution on insulin pump

Our Review Summary

First, let’s be clear that this is a review of an Associated Press story as shortened by the St. Paul Pioneer Press.  Some of the flaws commented on were not present in the original AP story.  

The story was about a 10-year retrospective study of adverse events resulting from adolescent use of insulin pumps conducted by the FDA and published in the May issue of the journal Pediatrics.  Insulin pumps are being used more often to deliver insulin to the body through a plastic tube with a small tip that inserts under the skin.  The article provides a good description of the pumps, indicating that they are approximately the size of a cell phone and can be worn on a belt or kept in a pocket.  Insulin pumps have been primarily used by adults but are now being used more often by adolescents because it allows them to lead more normal lives by eliminating the need for them to give themselves insulin injections in public.  The results of adverse events reported by in the FDA study, including 13 deaths and more than 1,500 pump-related injuries over the past decade, were accurately presented.  However, no denominator was given so the numbers lose context and meaning.  Estimated causes of these adverse events – patient misuse, lack of education, and device malfunction – were also described.  A notable omission from the story was the importance of parental supervision as three of the 13 deaths occurred when there was no adult supervision. 

The original AP story provided a good overall summary of the health concerns related to insulin pump use among adolescents and the need for for more study to address safety concerns.

But all for the sake of cutting 290 words, the St. Paul Pioneer Press version lost: 

  • any discussion of cost – something lacking in about 75% of all stories we review.  (And at a time when the US devotes 16% of the GDP to health care spending!)
  • the emphasis on the parental oversight issue
  • the perspectives of two other knowledgeable sources

Yet it left in a defensive comment from the Medtronic company "which makes the top-selling insulin pump."  Why cut out independent perspectives and leave in the Medtronic comment?  Is it because it’s a local Twin Cities company? Not a good reason in our estimation.  


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The original AP story told readers the cost of devices, approximately $6,000, and monthly supplies, approximately $250.  The St. Paul Pioneer Press, in its shortened version of the AP story, left this information out.  So our grade is for the Pioneer Press effort, not the original AP story.  

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


This article fairly communicates the risks and benefits of insulin pump use among adolescents.  It does not overstate the main benefit of allowing young people to live more normal lives by eliminating the need for multiple daily insulin injections.

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


The overall focus of the original research and this article was on the potential harms of insulin pump use by adolescents and the need to address safety concerns.  Potential causes of adverse events related to patient use and education and device malfunction were appropriately described.  This article could have been improved by including the importance of parental oversight in preventing adverse events, particularly since three of the five deaths occurred at times when there was no parental supervision.

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

Not Satisfactory

This article includes the key findings and conclusions reported in the Pediatrics study.  Some of the study methodology, e.g. the 10-year time period of the investigation, was provided.  But there is no mention that this was a retrospective study and what limitations such a study may have.  The story mentions 13 deaths and > 1,500 injuries over 10 years, but fails to give the denominator of subjects involved. In addition, the research study also examined the use of analgesia pump use in adolescents which was not covered in the story.  Why not?

Does the story commit disease-mongering?


This article accurately summarizes the prevalence of adverse events related to insulin pump usage in adolescents and presents this information without sensationalism.  The brief amount of background information on Type 1 diabetes was useful for context.

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

Not Satisfactory

The original AP story included the perspective of an independent expert, the American Diabetes Association’s president for medicine and science.  It also included input from the editor of a patient newsletter.  But the Pioneer Press deleted these perspectives.  Instead, the St. Paul story included a quote from the manufacturer of the top-selling insulin pump. Why?  Because it’s a local Twin Cities company? 

Does the story compare the new approach with existing alternatives?


Multiple daily insulin injections, the standard most widely used treatment option for Type I diabetes, is appropriately referenced.

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


The story establishes availability in its lead sentence when it clearly states that insulin pumps are used by tens of thousands of teenagers worldwide. 

Does the story establish the true novelty of the approach?


This article accurately indicates that insulin pumps have been available and used for many years.

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


There is no evidence that the AP story relied solely or largely on a news release.

Total Score: 7 of 10 Satisfactory


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