By: Jennifer Kaae
Products come and go. Usually the reasons are relatively obvious, but once in a great while, a seemingly successful product vanishes into thin air.
According to many people with diabetes, this is precisely what happened to the Sleep Sentry.
The Sleep Sentry, which was originally patented in the early ’80s, was a watch-like device that could be worn on either the wrist or ankle and served as a night alarm for people with diabetes. Using changes in perspiration and temperature as indicators, the Sleep Sentry would wake the patient when blood sugar levels became low. In the original studies, it successfully sounded the alarm 92.3 percent of the times that the patient’s glucose was under 60 mg/dl.
Based upon these findings, the U.S. Food and Drug Administration approved the product in 1984, and Teledyne Avionics of Charlottesville, Va. (now known as Avionics Specialties Inc.) began production and distribution. Ten-thousand Sleep Sentries were manufactured.
According to Dr. Eric A. Orzeck, who later purchased the existing stock and distribution rights for the product, Teledyne’s marketing techniques left something to be desired.
“There were problems in educating the dealers as to the appropriate manner that the Sleep Sentry should be used, and some dealers experienced a 90 percent return rate,” Orzeck said.
Under Orzeck’s management, sales increased, and by 1992 the original stock had begun to run low. Today, the device is completely unavailable. Both Orzeck, as an individual, and Diabetes Supplies, a mail order company, have considered having the product remanufactured under license from the patent holder, Avionics Specialties. But because the Sleep Sentry hasn’t been built or clinically tested since 1983, the costs are high.
In order to produce the product in accordance with the original FDA approval, the manufacturers would have to use outdated circuitry, and this would require an extremely expensive re-tooling process for the manufacturer. Michael J. Diroff of Diabetes Supplies has approached the Juvenile Diabetes Foundation, the American Diabetes Association, and the National Institute of Health for funding support without success.
This is not to say that reproducing the Sleep Sentry or a similar apparatus would not be a profitable or well-received idea. Since the results of the Diabetes Control and Complications Trial (DCCT) were published in 1993, the demand for such a device has increased. The DCCT proved that serious complications are associated with long term elevated blood sugar levels. Doctors and patients now understand these risks, and diabetes educators are continually stressing the importance of tight glycemic control. As people with diabetes successfully lower their average glucose levels, the risk of night time insulin shock becomes greater.
Diabetes Supplies receives several calls a day requesting the Sleep Sentry. One DIABETES HEALTH reader, Donna Jo Scott, wrote to us with the testimony that “after 10 years and many nights that my Sleep Sentry has awakened me, I’m still an advocate of the device.” She hopes that increased publicity will help to get it remanufactured.
For people like Candace Southerland, who is on medication that causes her blood sugar to drop and masks the warning signs of hypoglycemia, the device is a lifesaver.
“The unavailability of the Sleep Sentry scares me,” she wrote. “When mine breaks down and I am not able to purchase another one, I will die.”
Despite the fact that it has been over ten years since its original development, both Orzeck and Diroff believe that the existing product needs no technological advancements or functional changes. They want to build an exact duplicate. Of course the Sleep Sentry, like any apparatus, “is not perfect and without fail,” to quote the still-faithful Scott.
Those who use the device are aware that the clinical studies demonstrated a failure rate of about eight percent. This means that there might be times when a patient’s blood sugar is low and the alarm does not sound. It is also possible for the alarm to be activated when hypoglycemia is not present. Some might find these “false positives” inconvenient, but for a great many people who use the device properly, the Sleep Sentry has provided both lifesaving technology and peace of mind.
Research has shown that the time is right for a night time alarm like the Sleep Sentry to be redeveloped. The letters of testimony and the floods of calls prove that there is a demand, and scientific developments have shown that there is a need.