The second generation of blood glucose meters is beginning to arrive. But it may not be what most people think it is.
It may not be continuous sensors, some of which are already here. They show our blood glucose trends and can warn of us impending hypos or hypers even while we are asleep. But few people with diabetes can afford them, because hardly any health insurance companies will reimburse you for them.
The second generation is certainly not non-invasive meters. They have huge technical hurdles to overcome before any of them come to market.
The second generation is wireless monitoring. These meters will automatically or semi-automatically send your blood glucose results to your doctor or nurse or a separate medical facility. Parents can also monitor their children’s blood glucose levels this way. None of these wireless monitors require using a computer.
But they have had a difficult birth. As is often the case, the technology was ready before people were. And even now few healthcare professionals are anxious to read your blood glucose results as you take them.
More than six years ago I used the first of these devices. An innovative endocrinologist named Dr. Joe Prendergast was perhaps the first to extend his practice into telemedicine. I used a LifeChart Reporter, a modem that connected a LifeScan OneTouch Profile or OneTouch II meter to a phone line without using a computer.
When Dr. Joe enrolled me in his program, I wondered if it would help me to control my type 2 diabetes. It did. The big difference was that I tested much more often. Why? Simply because I know somebody was watching and giving me feedback.
While the LifeChart Reporter is no longer available, its first successor was Diabetech’s GlucoMON. The GlucoMON works with the OneTouch Ultra. The device automatically sends blood glucose levels via a cradle that fits the Ultra and includes its own two-way nationwide wireless network instead of using the patient’s cell phone.
Unlike the LifeChart Reporter, it can send results immediately, rather than once a week as I did in Dr. Joe’s program.
Diabetech started selling the GlucoMON a couple of years ago, and I reviewed it in the August 2004 issue of Diabetes Health. But then the Food and Drug Administration told the company to halt sales until it got 510(k) market clearance.
Meanwhile, Diabetech’s CEO, Kevin McMahon, says that is company is actively recruiting people with diabetes to participate in a large nationwide study using the GlucoMON.
“Our focus for the GlucoMON has been to make it available to patients, physicians, researchers, and health plans within the realm of carefully monitored research and diabetes programs,” he says. “For example, patients can opt-in to our RightNow! Study and start using a GlucoMON typically within a week of enrollment, and this study is approved for up to 1000 patients.
“In addition to managing the internal clock of the OneTouch Ultra blood glucose meter to ensure accurate time stamping, the GlucoMON automatically sends the patient’s data via Diabetech’s nationwide wireless network to the GlucoDYNAMIX care management system in real-time without being tethered to the home,” Kevin tells me. “Since every member (including mom, dad, teachers, nurses, doctors, diabetes supporters, and researchers) has his or her own unique need for information, GlucoDYNAMIX analyzes the data for trends and automatically determines the right information at the right time and in the preferred format for each authorized member of the care team. In addition to collecting the data, managing it so it becomes useful to the team has been the focus of our clinical research and disease management programs.”
Also waiting for FDA approval is the GlucoTel, which will use Bluetooth technology to connect almost any cell phone to transmit your blood glucose data. I reviewed this forthcoming system for the October 2006 issue of Diabetes Health.
I wrote a sidebar to that article saying that the Virtual Tracker was the nearest thing available today to the wireless way the GlucoTel will work. Earlier, in the May 2005 issue of Diabetes Health I had reported my interview with HMD BioMedical CEO Bryan Sowards, who told me about the Virtual Tracker.
This device includes a modem without the need of a computer, just like the LifeChart Reporter did. “This is the first meter that will notify whoever you authorize to let them know if your readings are beyond the parameters you have set,” Bryan told me. “It is real time information.”
I have, however, been trying to test the Virtual Tracker ever since I first wrote about it. I still don’t have one. And then Kevin at Diabetech emailed me after my article about the GlucoTel and the Virtual Tracker came out.
“I’m curious what made you write that the Virtual Tracker is the most comparable to the GlucoTel,” he wrote, “and not the GlucoMON or even the GlucoPack from HealthPia?”
Good question. I didn’t include the GlucoMON because the FDA hasn’t approved it yet. But I don’t know for sure whether the FDA has approved the Virtual Tracker either. And before Kevin brought HealthPia’s GlucoPack to my attention, I wasn’t familiar with that device.
HealthPia America says that its GlucoPack is the world’s first all-in-one blood glucose meter and cell phone and service for managing diabetes remotely. The FDA has given it 510(k) approval. The GlucoPack works with specific LG cell phones on the Sprint and Verizon wireless networks. Kevin understands that Diabetes Centers of America will offer the GlucoPack to their patients.
MedApps is another company that says it has developed a blood glucose monitoring device that will transmit results via cell phone to a server. They call this device the D-PAL.
MedApps initially plans to first market the device to disease-management companies that oversee care for Medicare and Medicaid patients. Eventually, the system could be available for any of us.
As impressive as they are, these wireless systems are only the beginning of the wave. The second generation of wireless blood glucose meters hasn’t even begun to crest yet. You can read about it here as this generation develops.
This article is based on an earlier version of my article published by HealthCentral.
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