For those interested in seeing a review of three new glucose meters on the market, I recommend reading this blog post from Adam Brown(diaTribe). He reviews the OneTouch VerioIQ, Telcare, and Freestyle InsuLinx meters. Each of these new meters has different feature sets that try to differentiate it by doing more than “just checking a glucose level.”
There are two ongoing clinical trials to be aware of.
One is at the Univ of Maryland and is using the forementioned Telcare meter. This study is a 6-month pilot study taking 100 patients with diabetes (both types 1 and 2) and randomizing them to either typical glucose meter or the Telcare meter. The outcome measures will be to see if connecting the patients via the Telcare meter will improve self-monitoring of blood glucose (SMBG) compliance, to see if A1c is affected, and to see if patient satisfaction is improved.
The other is being sponsored by a company called Diabetech with a link to the trial information here. This study is using an investigational device designed by Diabetech that attaches a self-contained wireless accessory to a glucose meter, and then transmits data to a centralized data management system. The system then analyzes the data and either sends educational materials to the patient or alerts or reports to the healthcare team. The primary outcome measures in this study are glucose control and patient satisfaction. The secondary outcome measures are HbA1c, self-test frequency of glucoses, and standard deviation of HbA1c and SMBG.
I won’t review this meter, since I haven’t tested one, and there is a very thorough review already here at DiabetesMine. I do want to draw attention to it, however. The draw of this meter is that it purports to find patterns in a user’s glucose data and to then give the user feedback and recommendations about how to make changes based on those patterns. In theory, this sounds wonderful. Give feedback to a patient during a “teachable moment,” ie at the moment when the feedback is relevant and someone is most likely to learn from it. Unfortunately, according to the DiabetesMine review, the actionable recommendations are actually contained in a separate paper book that you have to request. This would significantly detract from the usefulness of the feedback given by the meter.
There is significant medical literature about decision support and how to make it successful. One BMJ systematic review from Kawamoto et al in 2005 noted that four key features are that “(a) decision support provided automatically as part of clinician workflow, (b) decision support delivered at the time and location of decision making, (c) actionable recommendations provided, and (d) computer based.” It sounds like the Verio IQ meter tries to achieve these goals but still falls short…
I don’t have diabetes. But I do think about diabetes a lot, read about diabetes a lot, and certainly talk about diabetes a lot. So, this past week, I decided it was time to walk the walk. I opened up a shiny package for a new glucometer with the plan of monitoring my glucose 3 or 4 times a day for several days. I actually read the instruction manual on how to properly set the time and date, and did so within a few minutes. As long as I was going to do this, I at least wanted my data to be accurate, a true “quantified-self” experiment (of course, choosing a night where I went out for a hamburger and fries was a true test of my pancreas’ abilities!).
Then, like a know-it-all physician, I tried to check my sugar. “Er5” said the screen. Hmmm. Did it again. Punched hole #2 in my finger. Ouch. “Er5.” Maybe I didn’t get a big enough drop of blood. So, I cranked up the dial on the lancet device from “3” to “9” so I could get the deepest finger puncture and guarantee a burgundy nugget for the test strip. This time, “ouch” out loud. “Er5” on the screen again. I did this several times, howling in pain down the hall of my apartment, and said to my fiancee, “this hurts! I can’t believe I ask people to check their sugar multiple times a day! And worse, I can’t even do it right!” At this point, I figured the test strips must be defective so I googled “Er5 onetouch ultramini” to see what was going wrong.
I didn’t have another vial of test strips so I was hopeful that “test strip damage” was not my issue. If it was, my experiment would be over rather quickly. I had to read a little further to find out that an “incompletely filled confirmation window” actually means, “you are not putting the blood on the test strip properly.” It turns out, rather than placing the drop of blood to the side of the test strip for it to be sucked in to a small channel, I had been just plopping the blood on top of the strip. Whoops! Embarrassing!
After discarding nearly a dozen wasted test strips into the garbage, I finally struck gold and got a real, live number on the screen. “86” it read, and though my finger stung, I had finally erased the humiliating sting of “Er5.” For the next 24 hours, I checked my fingerstick on schedule, but noticed that it REALLY hurt and that I had to talk myself into pressing that button on the lancet each time, knowing the pain that would follow. I commented about this to one of our diabetes educators, Catherine, who laughed and spent ten minutes showing me the proper way to use a lancet to get a blood sample, ie using the side of my finger instead of the tip and shaking my hand toward the floor to get blood flowing into it. Turns out, if you do it the right way, you can get a drop of blood with a lot more ease and a lot less pain. Though I consider myself pretty good at helping analyze blood sugar patterns, I finally now, after four years of medical school, three years of Internal Medicine residency, a year as Internal Medicine faculty, and nearly a year of Endocrinology fellowship, actually know the right way to check a blood sugar.
Luckily for me, this experience was only that, and is not something I have to endure on a daily basis. But as I spend my career trying to improve diabetes technology and caring for those of you with diabetes, you can at least know, that I do understand your pain. And if a patient one day asks me why her meter says “Er5,” I hope she will forgive me if I take a moment to laugh at the dozen half-filled-with-blood test strips in my garbage can.
Still not available in US (though finally FDA approved), but now available in the UK, is the iBGStar from Sanofi. This device is similar in spirit to the Glooko iPhone connector dongle that I recently wrote about here.
This is a very exciting device because it will allow patients to electronically capture their blood sugars without any extra work. No more transcribing numbers into a logbook, either a paper one or even a digital logbook. As soon as you check your blood sugar, the number is already captured into a digital logbook with no extra work. This device clearly has an advantage over the Glooko solution in that the data is collected in real-time, rather than needing a connection and download the way the Glooko does. The introduction of real-time data upload brings the possibility of shorter and faster feedback loops between patient and clinician. There is also no extra hardware to potentially lose, since the extra hardware is your glucometer. Glooko’s advantage is that it works with many existing glucose meters, so you can get the one covered by your insurance, and still easily digitize the data. So, they each bring a unique new capability to glucose monitoring that should be welcome.
The new Telcare glucose meter has received a lot of attention in the last few months (including Walt Mossberg in the WSJ and in the blogosphere from DiabetesMine), as well it should. The most important advance that this meter brings is that patients no longer have to do a separate task to record their glucose value in a logbook or to download their meters. Currently, the only way for a provider to see a patient’s glucose values is for either a) the patient to copy them down onto paper from the meter, or b) the patient or physician to download the data off the meter. Both of these steps have proven to be barriers to efficient transmission of information. The Telcare system removes this barrier because there is no extra step required once the patient checks his or her glucose. It is all part of the same, usual workflow. Brilliant.
The drawback is that you have to use Telcare’s hardware. You can’t use your Contour meter or Freestyle meter, etc. This limitation will, in my view, slow adoption of this technology.
But, it is an exciting advance nonetheless.
One other noteworthy fact is that the Telcare system uses Qualcomm’s wireless technology. Qualcomm has established themselves as leaders in mobile health and this certainly won’t be the last innovation that uses their technology.