Rumors are flying that the Abbott Navigator, a continuous glucose monitor (CGM), will be discontinued even before it receives FDA approval. Layoffs at the company are said to be in the works, according to a Reuters news release.
Abbott denies the rumors, according to a second Reuters story.
And an Abbott representative told me, "We are absolutely not pulling out of the market. Inaccurate information regarding Abbott's commitment to the FreeStyle Navigator Continuous Glucose Monitoring System has been circulated."
In June, the Navigator received approval for use in Europe. Abbott says it plans a U.S. launch "very soon." But they've been saying that for several years, and the release date always seems to be next year.
At the current time, there are two other CGMs on the U.S. market: the DexCom Seven, and the Medtronic MiniMed Guardian REAL-Time CGM System, and some analysts speculate that the Navigator won't be able to keep up with the rapidly moving technology because the Dex and the MiniMed have a head start in capturing market share.
Some insurance policies will cover the considerable expense of the CGMs for type 1 patients, but others won't. I suspect none of them will cover the devices for the average type 2.
For example, Medicare thinks that people using insulin need only 100 test strips a month, or about three strips a day, at a cost of about $3 a day. The sensors for the CGMs cost about $10 a day. However, as with the strips, exceptions will most likely be made for people who really need the devices.
In my case, even if I have to pay for a CGM and sensors myself, I think it would be cheaper in the long run than dealing with the aftermaths of a heart attack.
But because many patients won't get insurance approval and many people can't or won't use medical devices or drugs that aren't covered by their insurance, some analysts see the market as limited to type 1 patients, especially those with so-called brittle diabetes (diabetes that is very difficult to control), or those who are no longer able to sense when they are hypoglycemic. The CGMs can be literally lifesaving in such patients.
No one will say why it is taking Abbott so long to get FDA approval for their CGM. They initially asked the FDA to approve the devices as replacements for regular BG meters. In other words, you wouldn't need to confirm the readings with your regular meter.
They didn't get that approval, so they reapplied for approval as an "adjunct" to the regular meters, which is the same type of approval that the MiniMed and Dex have received. Patients are told to confirm any high or low readings with regular blood glucose meters before adjusting insulin doses or taking steps to bring up lows.
I had the opportunity to try two different CGMs, a MiniMed and a Dex, as part of a clinical study and a generous loan from a friend, and I think these monitors have the potential to have a tremendous impact on type 2 patients as well as saving the lives of type 1s and giving the parents of type 1 toddlers some peace of mind during the night (the CGMs have alarms that go off when you go too low [or too high]).
