Materials Collection
Several days ago, I got a call, seemingly out of the blue, from a company called ASM Clinical, asking me about my diabetes testing habits. It turns out they are the referred "salesperson" from Simple Diagnostics, regarding my application for a free Clever Chek monitor. ASM Clinical is not a point of retail sale -- they are a point of insurance-based delivery, much like Liberty Medical. When we came to the understanding that I was not looking to switch my delivery service (my insurance covers supplies 100% and I can pick them up at the local CVS), they did try to sell me on their add-ons: (insert short plug) they provide free logs, syringes (with insulin prescription), prep packets, sharps containers, and a 6-pack of Glucerna free with each order (end plug).
That much being that much -- no free Clever Chek. And I've not found where to purchase the one with the integrated blood pressure cuff (which also allows for data download). Therefore, sadly, the Clever Chek is off my list of monitors for testing.
So far, I've received my order from Hock's, and expect to receive my order from American Diabetes Wholesale by the end of the week. While I haven't seen a shipping confirmation, I expect I should see the order from Diabetic Express arrive about the same time. This means, if all goes according to plan, I should have everything available to test six monitors against the current monitor starting next week.
The six monitors, for those who have not been counting, are:
- Abbott Diabetes Care Freestyle Lite, a no-code monitor with back-light and port-light, and 3.5mm stereo phono plug data port;
- Accu-Chek Aviva, a key-coded monitor and infrared data port, with provided Multi-Clix lancet device;
- Agamatrix/Wavesense Keynote, a manually-coded monitor with backlight and advanced in-meter data analysis capabilities, and lower-cost supplies;
- Diabetic Supply of Suncoast, Inc. Advocate Duo, a combination glucometer and blood pressure cuff with low-cost supplies, with spoken instructions in English and Spanish, and data management capabilities for both tools;
- Lifescan One Touch Ultra2, a manually-coded meter with backlight, 3.5mm stereo phono plug data port, and some extended on-meter data management capabilities;
- Lifescan OneTouch UltraMini with Data Port, a manually-coded basic meter with 3.5mm phono plug data port.
Unfortunately, I forgot that I have two One Touch meters to test, and only ordered a total of 50 One Touch strips. Which means that either I'll have to run fewer tests on one, or both, meters, or I'll have to pay retail for another 50 strips. *sigh*
Test Protocols
Initial Set-up
How easy is it to set-up these meters and test -- to what degree do I need to use the manual to set up time, alerts, and so on, and to bring the meter to the point of a first useful test? This is going to be an anecdotal assessment, scale with comments.
How effective are the extra features? Will it be a pain in the butt to enter meal information in the Ultra2? Are the Advocate's spoken instructions clear, correct, and adequate? Can the alarms be heard through the case in a quiet room? Through a backpack in a relatively noisy environment? Again, this is going to need to be somewhat anecdotal, but comments only.
Meter Responses (Accuracy)
Given that my test subjects are pretty much limited to me and my Other Half (I don't expect any of my real-life friends with diabetes to volunteer for this -- and again, I only have 50 strips per meter for testing), and both of us have a pretty narrow range of blood glucose levels (neither of us has ever gone over 200 that I know of, and I rarely drop below 70), I'm going to have to accept that the manufacturers' pre-FDA-approval tests for accuracy came out reasonable. I know this is not going to be useful for those of you who routinely have to handle high spikes and low dips -- but then again, since I'm testing for my own information, I'm not going to apologize. (Now I'm wondering if I can create an artificial "high glucose" using some of the gels available in the pharmacy department???)
I am concerned with accuracy within my normal range, so I want to compare my highs, lows, and averages across all the meters -- including my present, known-good, Freestyle Flash -- to see if they come up with the same/similar, or wildly different, readings.
- This will require setting up and testing all the meters at once from the same sample, or from samples taken at the same time from the same area of the body.
- I'm a bit concerned about the accuracy of either method, as blood may dry between drops and I'm not sure how well seven lances to the same couple square inches of skin are going to feel.
- I guess I can try it both ways to see.
I should probably also check with all meters when I should be in a period of rapid change, to see how rapidly they respond to the change. This is probably going to require serial testing the meters, in a consistent order, using fingertip readings.
I am concerned with how well the meters respond to common contaminants, such as orange juice, balsamic vinegar, rubbing alcohol, sweat, and soap. I should probably add one or two kid-friendly items in there as well (parents, any suggestions?) Because simple handwashing (with soap) does not always remove the contaminants completely, I'm looking at a three-fold test, across all meters, for each contaminant under test. Except for sweat, I believe my best method will be to proceed as follows:
- With clean, dry hands, and stable blood sugar, assign one fingertip to each meter under test and test across all meters to create a set of baseline readings.
- Handle the contaminant with all fingers for a period of 30-60 seconds.
- Test again, using the assigned fingertip for each meter.
- Wash hands thoroughly
- Test again, using the assigned fingertip for each meter.
- Test each contaminant separately, preferrably on separate days.
I am also concerned with getting accurate readings when my hands are cold and when I am cold, but I can't think of a good protocol for this during summertime (unless I can hang out for a few hours in a place which is significantly over-air-conditioned, and in which people will not have any issue with me running multiple blood-based tests). The comparisons here would be fingertip to forearm, as I find my fingertip readings tend to 20 points below forearm whenever my fingers are cold (the forearm reading is the more accurate reading in that case).
Data Management
Having dropped the Clever Chek from this consideration, all of the meters under test have data ports. I've gone ahead and purchased the data cables for the One Touch (the connector looks identical to the Freestyle, but the software only comes with the cable), the Advocate, and the Keynote. I did not purchase the Accu-Chek cable since I had been led to believe that Accu-Chek monitors should sync to a standard infrared port.
Set-up is going to have to be an anecdotal comparison, since I already have Abbott's Co-Pilot software installed. I did take a look at Accu-Chek's Diabetes Assistant setup: it requires a serial port between COM1 and COM4. My system only has USB ports, my USB-based infrared cable does not map to any COM ports, and my USB-based port replicator assigns its serial port to COM6. I've spoken with Roche technical support regarding this. From what the technician told me, the infrared connection cable uses a proprietary infrared protocol to protect the security of the information being transferred. This cable is a serial-only cable and requires a proprietary serial-to-USB adapter (at separate cost) to function correctly (this adapter automatically assigns itself to a free COM port between COM1 and COM4). The computer-hosted version of the program is still a third separate purchase. The upcoming repackaging of the Compact Plus will use the same connections for data transfer -- and as of now, there are no plans to upgrade to a direct USB connection.
Physical connections are important. While the name-brand monitors appear each to have proprietary interfaces, some of the lesser-known manufacturers have incorporated standard USB connections.
Software and hardware installation: how "plug-and-play" is the hardware? Does the installation require Web access and/or a CD to download drivers? Is there support for legacy operating systems? Is there stated support for Windows Vista? Is there stated support for other operating systems? If the software is Web-based, does it require Internet Explorer, or will it work in Firefox, Maxthon, Safari, Flock, Opera, etc? Will Norton Internet Security shut it down before it starts up?
What information is gathered? Co-Pilot downloads the meter, its serial number, the batch code of the strips, the reading, time of day, and whether or not it was a control reading. How much information is kept in the One Touch UltraMini that is not displayed on-meter? Does the Advocate upload both blood pressure and blood glucose readings at the same time, or do I need to go through two different passes?
How easy is it to expand upon the information? Co-Pilot assigns meal-periods to readings based on settings I assign in the software, and does not like it if I manually change the meal-period for a reading. Many of the other parameters it records must be manually entered, one at a time, rather tediously. Are any of the other programs better at this?
What sense is made of the information? What sort of reports can I generate? Does a diet function count only carbs, or does it account for all micro- and macro-nutrients? What is the underlying database?
Can the data be exported from the data management program? If so, in what formats? What are the fields called? What order are they in? Can they be published to a private site for doctor access?
[Note: the Advocate's software manual suggests that the blood pressure and blood glucose information runs as two separate modules in a single program. I'd much prefer the information be integrated. Then again, that's a good reason to take a good look at the whole thing...]
I'm sure I'm forgetting something here -- but then again, this whole thing is more personal interest than scientific investigation. Any thoughts? Comments?