Introduction

My name is Mary Catherine and my daughter is Amelia. She is currently ten years old and has type 1 diabetes, celiac disease and autoimmune thyroid disease. She was first diagnosed with T1D at age two and then with celiac and thyroid at three and four. Fortunately, there have been no further autoimmune diseases in the last six years and I attribute that to a gluten free diet, but I’ll save that for another post. The topic of this blog will be our experiences with the recently FDA approved FreeStyle Navigator continuous glucose monitoring system (CGMS).

I first heard about CGMS two years ago at the 2006 Friends for Life conference in Orlando FL hosted by Children With Diabetes. The idea of real time monitoring of blood glucose levels without finger sticks was intriguing but we were not ready to consider it at that time for several reasons. Both Amelia and I were still hesitant about trying the insulin pump at that time, she for fear of the insertion process and I worried about the relatively rapid onset of DKA if the pump fails. By the following summer, we both decided to give it a try and are so glad we did. Amelia chose the Deltec Cosmo pump and it really changed both of our lives for the better.

By the time we attended the next FFL conference, I could definitely see how CGMS was the next logical step toward tighter blood glucose control with the pump. By this time, we were testing 7 to 10 times a day and had significantly reduced the rollercoaster of BG levels. But try as we might, we just couldn’t get the basal insulin levels right. I asked the endocrinologist if we should do basal testing and she suggested a one week CGMS trial with the Medtronic Guardian.

Ironically, the CGMS trial this past February worked too well. Because we could see oncoming highs and lows and react to them, Amelia’s BGs remained nearly rock steady the entire week. When the endo looked at the data she asked if we had somehow magically cured her diabetes! We wound up with no usable data for the basal testing but I knew then that we needed CGMS.

The Guardian was great but the researchers at the FFL conference had mentioned the accuracy of the current systems including Dexcom Seven and Medtronic Paradigm and Guardian wasn't as impressive as they had hoped. When compared to finger sticks, a new device - the Navigator still being tested and awaiting FDA approval, was significantly more accurate than the existing devices, at least in the normal and high BG range. There was some concern though that there was not as much consistency in the lowest BG range in the Navigator trials. They were however impressed with the Navigator’s ability to predict rises and falls in BG levels far earlier and more reliably than any of the other devices. With that reliability, you are far less likely to drop so low. We decided to wait for the Navigator to be approved.

Luckily, we did not have to wait long. By mid March the FDA approval had been given and I rushed my request to the endocrinologist to submit the letter of medical necessity along with any other paperwork that would be needed. She agreed to do so but cautioned that the diabetes educators (CDEs) would have to be trained on the device before any approval was given and Abbott Labs had not set up training sessions to teach them yet.

By mid April, I received word that the CDE had been trained and the endo had submitted my request for the Navigator to Abbott Labs. By early May Abbott notified me they had submitted the doctor’s request to Care First Blue Cross/Blue Shield to determine if it would be covered and for how much. It was a long two weeks and I had reconciled myself to the likelihood that no news was bad news. But I was wrong, Amelia had been approved for the device! And because I had PPO coverage instead of HMO or POS, it would be considered in network and would be covered 100% after my $250 annual deductible. That had been met already by the first order of pump supplies this year so we were golden!

But we don’t have the little prize just yet. Abbott is still making arrangements with the durable medical equipment suppliers to distribute the Navigator and supplies, hopefully within two weeks. Amelia and I have a tentative appointment with the CDE June 18th to be rescheduled if we don’t have the device in hand by then.

So that’s where we are at the moment, waiting for the UPS/FedEx package to arrive. I hope my next post will include pictures and a detailed description of the new FDA approved Freestyle Navigator.

Amelia will be posting her thoughts on the Navigator as well. It’s one thing when adult diabetics choose to subject themselves to new medical devices knowing full well that the benefits to their health, both mental and physical, far outweigh any discomfort that they may or may not have. I think it’s important that we parents listen to the thoughts and feelings (and fears) of our children when they are the ones who will be using the devices.