What are the emotional costs that result when there is a major campaign to promote a potentially lifesaving device? Over the last few days I have received multiple emails and messages in regard to the recent JDRF ad posted in both the NY Times and The Washington Post. The ad stated that:
This figure represents a large number of people with diabetes that will die secondary to hypoglycemia and related events. Is this a true statistic? Anecdotally (which means in my 3o years experience of pediatric practice taking care of children with diabetes), I can think of only one young adult who passed away from hypoglycemia (due to lack of self blood glucose monitoring). That is not to say I can predict what will happen after our emerging adults leave our diabetes program.
However, in response to the many concerns voiced by the parents of our children with T1DM, what should I say?
I found an excellent source on the Children with Diabetes website that lists multiple scholarly references.
According to this source, it is indeed correct that young children and adults have been discovered dead in the morning without explanation or indications of hyperglycemia, hypoglycemia, or other illnesses. In terms of statistics, the number of deaths (called Dead in Bed Syndrome) per 10,000 patient years has been estimated to 2-6.4. Thus, considering a population of 100,000 persons with diabetes, this represents 20-60 deather year or approximately 6 percent of all deaths in persons with diabetes aged less than 40 years. According to sources, the relationship to human insulin or intensive insulin therapy has been questioned but seems less likely.
Why were these statistics meant to be of shock value?
The JDRF’s vice president, Aaron Kowalski, a prominent researcher and proponent of the Artificial Pancreas Project wanted to alert the public of the urgent need for FDA approval of the current technology that is available to markedly decrease the incidence of hypoglycemia. He is referring to artificial pancreas technologies that have demonstrated “predictive algorithms that can minimize hypoglycemic events by up to 80 percent.” According to Dr. Kowalski, JDRF ran the ad to get the attention of the general population about the significant benefits of this technology. In Europe, the Medtronic VEO is available, but not FDA approved in the United States. The pump, like the current minimed “Revelation,” approved in the United States has an additional significant feature that stops the existing insulin delivery (based on predictive algorithms) for 2 hours when the blood glucose goes below a certain level (low glucose suspend feature).
According to information from the Medtronic VEO website, the Paridigm Veo can recognize falling blood glucose levels and will sound a warning alert that will prompt user action. If you have not responded to this alert and the Continuous Glucose Monitor recognizes a significant low blood sugar, another warning will sound. Once again if you do not respond, the VEO will act quickly to suspend the delivery of insulin for 2 hours. The goal will be, of course, to develop an automatic combination of pump/sensor that will monitor glucose levels and determine the correct amount of insulin delivery without the intervention of the user (artificial pancreas). The Minimed VEO is the first iteration of the attempt to “close the loop.” Of note, the “low glucose suspend” feature is only available if one uses the Continuous Glucose Monitoring system that accompanies the Medtronic VEO insulin pump.
I have decided to include the above information about the VEO so you know about the availability about all devices whether FDA approved or not. I do believe, however, that the VEO clearly has merit and I await FDA approval eagerly as do all healthcare providers that care for children and adults with type 1 diabetes. It does not mean, having stated my above opinion, that I necessarily approve “shock value” approaches to gain the attention of the public and perhaps scare already stressed caregivers even further. The goal is to empower our families and patients as much as possible by providing current, accurate, and as much non-sensationalized information as possible