Calibra Finesse – Elegant and Easy to use
Recently Abi Basu, the Marketing VP at Calibra Medical gave me a detailed run through of their recently approved Finesse Insulin Patch-Pen. I'd been waiting to learn more about it since the FDA announcement on January 20th, because Calibra Medical doesn't have a web site.
In a nutshell the Finesse is a simple to use and elegant insulin dispensing device. It doesn't contain any electronics, so it takes almost no time to learn how to use it. And the Calibra Medical folks have really thought about design and usability carefully in the Finesse.
The design itself is slim enough that it should be invisible under most clothing. It contains a reservoir that holds 200 units of insulin.
To dispense insulin you simply squeeze the two small buttons on both sides of the Finesse, the unit clicks with each press so you can count the number of units delivered. There's an interlocking mechanism, so both buttons must be pressed before any insulin is bolused, this is designed to avoid accidental dispensing of insulin. It's a bolus-only device, so users will still need shots of long-acting insulin.
You fill the Finesse reservoir with a supplied syringe, they've got a window on the back to see any bubbles - you click the buttons several times to get rid of these. Priming the internal tubing takes about 8 units of insulin and then whatever is needed to fill the 6 or 9 mm cannula.
Depending on the Finesse model, each press will bolus 1 unit or 2 units of insulin. They hope to develop a model that will bolus 5 units per press, but that's in the future.
When designing the Finesse, Calibra Medical looked at some unmet needs in the diabetes space. They found that one major barrier to better blood glucose control is the need to carry syringes and insulin, or pens, at all times. The Finesse can be worn for 2-3 days and ensures that you'll always have the needed insulin with you. Currently Calibra estimates that only 6% of insulin users are on pumps, leaving a whopping 94% of folks with diabetes who might benefit from their product.
They've tested it under extreme cold conditions ("Minnesota-like") and determined that the dispensing mechanism continues to work well. The buttons lock when the reservoir is empty or the cannula is occluded. Currently there's no way to determine how close to empty you might be, they're hoping to have a window in a future version. They're also planning a pediatric version that dispenses 0.5 units with each click.
Calibra has developed a simple sticker system to remind you when you've been wearing the Finesse for 2-3 days. This was in response to the FDA's concern that people wouldn't know when to change it. Each box of 10 Finesse patch pumps comes with a sheet of stickers to remind you which day to change it on, and whether to do this in the morning or evening. And they've made sure that those stickers don't come off, once they're in place.
I was on a conference call with Ellen Ullman of Kids R Pumping and she asked about teenagers and the 200 unit limitation, because some teenagers might go through that much insulin in less than 3 days. (They eat a lot!) Here's the neat thing, you can load another Finesse and put it on but not start using it until the first is empty, so you already have a replacement ready to go.
Calibra Medical has talked with most of the major insurance companies and believe that they'll get coverage for this almost immediately and it won't be counted as durable medical equipment. Costs will be 'more expensive' than an insulin pen, they'll probably have a Tier 3 copay.
The gauge of the Finesse inserter needle for the cannula is 27 gauge, which is on the chunky side. But Calibra Medical claims that the design is such that it's almost painless.
Calibra Medical didn't give a definite date when the Finesse patch-pen would be available, they're currently finalizing some design and supply issues.
Why no website? Abi Basu points out that if they had a website (it appears they currently own the domain CalibraMedical.com) most of his time would have been spent responding to inquiries and demands from potential customers.
My opinion? Calibra Medical has addressed a real need in the marketplace. Their patch-pen is really easy to use, extremely discreet and ensures that the wearer always has insulin for boluses with them. It's one less thing to carry around. The design is as elegant as it can be, and it's something that will probably have an off-label use for Symlin and other drugs. I'm looking forward to trying one out!
Kris Freeman Interview
Kris Freeman, is the reigning US National cross-country champion. Recently he was selected to compete as a part of the US Ski Team in the 2010 Olympic Games this February, which puts him in a very elite club. He was diagnosed with type 1 diabetes in 2000, before his first Winter Olympics in 2002. He also competed in the 2006 Winter Olympics.
What sets Kris apart from others with type 1 diabetes is that he competes in endurance sports: the 15 kilometer freestyle cross-country (XC) race lasts about 45 minutes. Kris will also compete in the 30k pursuit race, the 50k mass start classic, and the individual and team sprints.
I was given a chance to ask Kris some questions and he kindly answered all of them. I've only edited these to add some hyperlinks.
Q: Your diabetes story: How did you first find out you had diabetes? Had you been ill before this and how did you feel at the time of your diagnosis?
A: I was training full time with the US Ski Team in Park City Utah. Every two months I had a blood test to see how well I was handling the training and to screen for any abnormalities. The tests always included iron levels, cholesterol, red-blood cell counts etc. One screening included a glucose test as well and mine came back at 240. I was sent to an endocrinologist in Salt Lake City who diagnosed me with type 1 in five minutes.
Q: If you remember it, what was your initial BG value?
A: My initial BG levels were low for a new diagnosis because my abnormal blood sugar was discovered very early in the "honeymoon" phase. I had only mild symptoms of diabetes including frequent urination, feeling light-headed and occasional blurry vision. I didn't notice the extent of the symptoms until after the diagnosis.
Q: At the time, your doctors seemed to think that your skiing days were over, what made you sure you could continue?
A: I was crushed when I was first diagnosed and told that my Olympic aspirations were over. I immediately started studying the disease and the history of its treatment. I learned that many breakthroughs in diabetes care had been made recently. Glucose monitors were getting faster and more accurate and pump technology was improving rapidly. The invention of Lilly's Humalog fast-acting insulin excited me most though. With these breakthroughs being so recent, I realized that no one could know what was possible for a diabetic athlete using them, especially when they were told not to try.
Q: What preparation, if any, did you make to return to training with diabetes? How did you change your approach to training to accommodate diabetes?
A: I trained the afternoon of my diagnosis. I went for a kayak with tears in my eyes. I was not going to give up. I didn't change my training at all. I changed my diet and learned the nutritional values of every food I had been eating. I studied the glycemic index and stocked up low index carbs. Over the years I have gotten to the point where I can glance at a plate and know how many carbs are on it where they fall on the index. I prepare for training and racing through a strict diet of what my body needs not what it is most appetizing. Whole grains, lean protein and lots of fruit and vegetables are essential. I try to eat all my food in as close to its natural form as possible. I avoid processed foods like the plague.
Q: Before you started using an insulin pump, how many shots were you taking a day? What changes did you make so you could still exercise while on shots?
A: I used injections for the first seven years I was diabetic. I used Lantus as a basal and Humalog as a bolus. I took my basal at 9:00 PM and the Humalog injections with my five daily meals. I eat about 5000 calories a day when I am in heavy training. I would also take correctional Humalog shots if my sugar was too high after eating. Some days I would take six shots others I would take over a dozen. I do whatever I have to do keep my sugar near normal levels at all times. Diet and a strict insulin regimen make it possible for me to train and race like any other athlete.
Q: For attending a race, what kind of diabetes-related things did you bring with you?
A: I always bring two Lifescan Mini Glucose monitors. I keep one in my water-bottle belt which I keep warm with two chemical hand-warmers. The second monitor I keep in my backpack which I always leave in a heated building. I keep my Personal Diabetes Manager (PDM) for controlling my OmniPod in my waterbottle belt as well. I also bring a vial of insulin and an extra pod in my backpack in case of a freak accident.
Q: Why did you choose an Omnipod over other insulin pumps?
A: In international XC ski races the minimum temperature for holding an event is -4 degrees fahrenheit (-20 C). At that temperature my doctor and I were concerned that the exposed tubing on the infusion set of a traditional pump would freeze. The OmniPod adheres to the skin with the delivery tube going directly into the body. The direct placement allows my body heat to keep the pump from freezing at any legal racing temperature. Also there are occasional high speed crashes in XC ski racing. I have crashed in races going well over 30 mph. Destroying an OmniPod in a crash is not a huge loss since it is replaced every three days anyway. Destroying a traditional pump would be a serious financial and logistical problem.
Q: How has your race preparation and racing changed because of the Omnipod?
A: The OmniPod has allowed me to use only Humalog insulin which is much more predictable than basal insulins. I am able to change the basal drip of Humalog at any time using the PDM. This has allowed me to experiment with different basal rates in training and racing to find the ideal dose for each of my events. My initial testing was done rollerskiing on a huge treadmill at US Ski Team's gym, The Center of Excellence. I was hooked up to an oxygen monitoring helmet and had my glucose and lactate levels monitored at different exertions.
Q: Have you considered using a continuous glucose monitor to reduce time needed to test and correct your blood glucose levels during races?
A: My doctor and I have not learned of a continuous glucose monitor that would work reliably enough to use during a race. I am anxious for the technology to develop though.
Q: It's usually cold where you're training or racing, how do you overcome temperature issues with your Omnipod and testing?
A: The chemical hand-warmers that I mentioned previously keep my glucose monitor and PDM warm while I am skiing so I can make on the fly tests and adjustments. Before a race I always try to make my final tests and adjustments in a heated location for maximum reliability.
Q: Has there been a time when having diabetes helped you in some way? Can you give us some insight into that?
A: Having diabetes has forced me to learn about diet and nutrition. I have also learned more about my physiology than I ever would have without the diagnosis. I am more aware of how I am feeling at all times.
Q: Have you a general message for our readers?
A: The technology exists to treat diabetes in a way that it does not have to have a negative impact on any goal or dream you may have. Be diligent with your diabetes care and there are no limits to what you can achieve.
Type 1 diabetes hasn't stopped Kris from getting to the top of this tough sport. The Winter Olympics in Vancouver start on February 12th. The first cross-country race with Kris is the 15k freestyle on February 15th. You can also find Kris on Twitter.
Bayer Contour USB meter big step forward for design
Bayer USA sent me one of their Contour USB blood glucose meters to review some time ago. For me the summary is easy: this is a great meter with slim design that's easy to use. I like it a lot. Read on for the details and lots of pictures.
LifeScan created a buzz when they released the OneTouch UltraMini a few years ago. Given their sizes, looking at the two meters together is a good way to get a quick comparison point. In the picture both meters have a strip inserted and are prompting for a blood sample. Note the Contour uses standard strips that need a 0.6 microliter drop of blood, by comparison the OneTouch needs 1.0 microliters. Both meters provide results in 5 seconds. The Contour meter is auto calibrated with each strip, while you have to calibrate the OneTouch meters each time you get a new batch of strips.
I'm comparing the readings with my WaveSense Jazz meter, and they are usually within about 10% of each other. So I believe the Contour USB accuracy is good. I need to use the meter over several A1C tests, to do a real comparison.
The color is really eye catching, and the text is very readable. Here's a picture of the Contour USB meter showing a low blood sugar reading of mine.
The designers have used this high resolution screen and color very effectively. When your BG is lower or higher than a range that you set, the result is displayed in an salmon color.
One the right hand side of the meter are three buttons, in the picture above they're between the column reading Reminder|Notes and the Bayer symbol. You can press the button to set a reminder for a later test, or to add some basic notes from a small selection list.
The next picture shows the meter immediately after you apply a blood sample. You're prompted to mark the reading as before or after a meal, or just to continue on to the results. While you're doing this, the result is being calculated. So this step makes the whole thing seem faster.
And don't worry, if your blood glucose is out of range the meter won't wait longer than 5 seconds (time to calculate result) for you to make a choice, it will just display the value.
In case you're wondering where the USB part of this meter is, here's a picture.
The meter has a rechargeable battery that gets powered up whenever you connect it to a standard USB port. They also provide a standalone charger you can plug into an standard outlet (which also works for charging an iPod).
One last picture. If you're testing in the dark, it's really easy to see the results on the screen. But you know how difficult it can be to get the strip into the meter and a sample on the strip. If you click the button at the top of the meter (not visible in my photos) twice, then the area to insert the strip lights up. Note I deliberately took this picture in low light conditions to show you the overall results.
Bayer arranged for me to talk with Rick Case, the project director, and Eric Nelson. These folks were leading the design team, which was completely within Bayer. We had an interesting discussion about product design and some technical issues.
Their target audience for this meter was people in their late teens or early 20s. (Which means that folks like Bennet and me can't get too excited about it!)
They wanted to get the product into the market, so initially it's only in black. But they're considering different meter colors and hope to have these available before too long.
If you use the GlucoFacts software that's provided on the meter itself, it doesn't actually remove the readings off the Contour USB. As the meter holds 2000 readings, you'll get almost a year's worth of readings if you're testing 6 times a day.
You can register at the Bayer site and download a different version of the GlucoFacts software that does take the readings off the meter. The built-in software doesn't allow you to manually enter new values, or A1C readings, but the installed version does. Both pieces of software are written in Java and run on Windows and Mac operating systems.
Because of speed to market, they purchased an off the shelf charger. When you use it, the meter is facing away from you, a minor annoyance. They plan to fix this in later models.
They are reading the sites of many diabetes bloggers, so they're taking note of suggestions and complaints for future versions of their products. One suggestion from me is to enable me to download the readings in some standard format (CSV), so I can look at them using other software. I hope the next version will also include an ability to upload readings to a central server like the MyGlucoHealthMeter.
For the first meter from this team, I think Bayer have done a superb job, and I'd recommend having a good look at this meter.
FYI: The User Guide(PDF) is available.
Final pictures:
A graph from the GlucoFacts software showing blood glucose readings over several days.
Summary of blood glucose readings with some statistics below it.
Summary of readings with a pie chart.
Bayer Contour USB meter big step forward for design
Bayer USA sent me one of their Contour USB blood glucose meters to review some time ago. For me the summary is easy: this is a great meter with slim design that's easy to use. I like it a lot. Read on for the details and lots of pictures.
LifeScan created a buzz when they released the OneTouch UltraMini a few years ago. Given their sizes, looking at the two meters together is a good way to get a quick comparison point. In the picture both meters have a strip inserted and are prompting for a blood sample. Note the Contour uses standard strips that need a 0.6 microliter drop of blood, by comparison the OneTouch needs 1.0 microliters. Both meters provide results in 5 seconds. The Contour meter is auto calibrated with each strip, while you have to calibrate the OneTouch meters each time you get a new batch of strips.
I'm comparing the readings with my WaveSense Jazz meter, and they are usually within about 10% of each other. So I believe the Contour USB accuracy is good. I need to use the meter over several A1C tests, to do a real comparison.
The color is really eye catching, and the text is very readable. Here's a picture of the Contour USB meter showing a low blood sugar reading of mine.
The designers have used this high resolution screen and color very effectively. When your BG is lower or higher than a range that you set, the result is displayed in an salmon color.
One the right hand side of the meter are three buttons, in the picture above they're between the column reading Reminder|Notes and the Bayer symbol. You can press the button to set a reminder for a later test, or to add some basic notes from a small selection list.
The next picture shows the meter immediately after you apply a blood sample. You're prompted to mark the reading as before or after a meal, or just to continue on to the results. While you're doing this, the result is being calculated. So this step makes the whole thing seem faster.
And don't worry, if your blood glucose is out of range the meter won't wait longer than 5 seconds (time to calculate result) for you to make a choice, it will just display the value.
In case you're wondering where the USB part of this meter is, here's a picture.
The meter has a rechargeable battery that gets powered up whenever you connect it to a standard USB port. They also provide a standalone charger you can plug into an standard outlet (which also works for charging an iPod).
One last picture. If you're testing in the dark, it's really easy to see the results on the screen. But you know how difficult it can be to get the strip into the meter and a sample on the strip. If you click the button at the top of the meter (not visible in my photos) twice, then the area to insert the strip lights up. Note I deliberately took this picture in low light conditions to show you the overall results.
Bayer arranged for me to talk with Rick Case, the project director, and Eric Nelson. These folks were leading the design team, which was completely within Bayer. We had an interesting discussion about product design and some technical issues.
Their target audience for this meter was people in their late teens or early 20s. (Which means that folks like Bennet and me can't get too excited about it!)
They wanted to get the product into the market, so initially it's only in black. But they're considering different meter colors and hope to have these available before too long.
If you use the GlucoFacts software that's provided on the meter itself, it doesn't actually remove the readings off the Contour USB. As the meter holds 2000 readings, you'll get almost a year's worth of readings if you're testing 6 times a day.
You can register at the Bayer site and download a different version of the GlucoFacts software that does take the readings off the meter. The built-in software doesn't allow you to manually enter new values, or A1C readings, but the installed version does. Both pieces of software are written in Java and run on Windows and Mac operating systems.
Because of speed to market, they purchased an off the shelf charger. When you use it, the meter is facing away from you, a minor annoyance. They plan to fix this in later models.
They are reading the sites of many diabetes bloggers, so they're taking note of suggestions and complaints for future versions of their products. One suggestion from me is to enable me to download the readings in some standard format (CSV), so I can look at them using other software. I hope the next version will also include an ability to upload readings to a central server like the MyGlucoHealthMeter.
For the first meter from this team, I think Bayer have done a superb job, and I'd recommend having a good look at this meter.
FYI: The User Guide(PDF) is available.
Final pictures:
A graph from the GlucoFacts software showing blood glucose readings over several days.
Summary of blood glucose readings with some statistics below it.
Summary of readings with a pie chart.
MyGlucoHealth Blood Glucose Meter
Recently I was given the MyGlucoHealth blood glucose meter for review. It's made by Entra Health Systems a new entrant to this enormous market.
I considered giving a summary up front, but it’s not that easy with this meter. It has some good points and ways in which it can be improved, I don’t think a summary would do justice to these.
The meter arrived in an elegant white box somewhat like an Apple product. I was really pleased to see the meter picture on the front had a blood glucose reading of 157 mg/dL. Finally, a manufacturer that’s not scared to show a more realistic reading.
The box contained the meter and the usual accessories (lancing device, lancets, some test strips, a carrying case, a USB cable, and an instruction manual). Two AAA batteries were included. I'm glad to see that is uses these instead of the more expensive button batteries used on many other small meters. The cost of this kit is $89.95 on the http://www.myglucohealthstore.com site. I was also given 50 test strips, which are worth an additional $49.95.
While small, the meter is not compact. Here’s a picture of the myglucohealth meter (on the right) beside a OneTouch UltraMini (on top), a WaveSense Jazz on the left and a Bayer Breeze2 Meter in the middle.
From this picture you can see that the blood glucose readings are large and easily readable. Unfortunately there’s no backlight, so using the meter in low light levels is really not an option
The strips require a 0.3µL drop of blood and results are shown in about 3 seconds, which is fairly standard features on the better meters available today. The meter is self coding, when you insert a strip the code is read off it and displayed, so you save a little time on each new vial of strips.
You can use the meter straight out of the box, though MyGlucoHealth strongly suggests you read the manual. I didn’t do this and wasted several strips until I talked with MyGlucoHealth support. Here’s the problem, after you insert the strip and the code is displayed you have to select an activity code before you can add a blood sample. This is not obvious and completely different to the many other meters that I’ve used.
Even after learning this I continued to waste strips because I’d apply blood after the code disappeared but before I chose an ‘activity’. There are four activities to choose from: before a meal; after a meal; after sports; after taking drugs. This is a very limited set of options: what about sickness or fasting options? What if I didn't want to add an activity code?
I think the need to choose the activity before testing is a poor design choice and I’m surprised this wasn’t fixed when the meter was being field tested before release.
The meter has a neat little slider at the top which makes it easier to extract the used strip.
The supplied kit also comes with a 3-month MyGlucoHealth.net subscription. This is the site where you can upload your readings, add other health information and share these with your healthcare providers. I don’t know what the annual costs are for an ongoing subscription.
I did hit a snag when trying to upload readings from my meter. I had chosen a password that contained invalid characters, so it wasn’t accepted. Unfortunately I didn’t get a warning about this and had to contact MyGlucoHealth support to resolve this problem.
To upload readings you create an account, logon and press the big blue Get Readings button on the home page of the web site. This launches an application from the web site that asks you to connect your meter. (Firefox users, you’ll need to install the Microsoft .NET Framework Assistant before doing this.)
The first time you do this, you’ll need to fill in a short form so this application can connect with the web site to send the data from your MyGlucoHealth meter.
Then go back to the Meter tab on this application
Now you need to connect your meter. You can either plug in the standard USB cable that’s provided, or you can connect directly if you’ve got Bluetooth on your PC. I tried both approaches and they worked equally well.
After all the readings are downloaded the Meter tab will change to show the most recent blood glucose reading. You can add a comment to go with this reading, or use the arrows to add comments to any other readings. (You can also add comments to readings on the web site.) Press the Continue button and all your data is on the MyGlucoHealth.net website.
On the website you can view your readings as a chart
Or as a table
You can also add other readings, such as my HbA1c line in the middle of the above table. And you can export your readings to an Excel spreadsheet from this page
If your doctor is registered on the MyGlucoHealth site then they can review your readings and exchange messages with you through this secure site. It’s not clear to me how healthcare providers register, currently there are less than 30 doctors listed on the My Doctors tab.
The site allows you to set reminders when your testing frequency is below a specified level, or when the supply of test strips is below a certain amount, and other options. You can also setup alerts when your blood sugar is out of range and have these sent as email or text messages to several people.
Summary
For the first meter from a new company in this space I think the MyGlucoHealth meter scores about 70 out of 100. These days I assume that meters will be full featured and well designed, unfortunately the meter doesn't score top marks for either of these.
It can calculate averages, store up to 250 results, and remind you when you need to test. But the lack of any backlight is surprising. The user manual is barely adequate and really needs improvement. For example the explanation for setting alarms and average results were very hard to follow.
The ability to upload readings directly to a website is innovative. With electronic health records (EHR) and personal health records (PHR) I think many new meters are going to have a feature like this. This is forward thinking.
The Bluetooth connectivity and the use of a completely standard USB cable is nice (WaveSense take note). However you need to install a serial driver if you’re going to use the USB cable, which is irritating even if other meter companies do the same thing.
The website is nicely interactive using Adobe Flash technology appropriately. But the upload software is Microsoft .NET based, so I don’t think it will work on non-Windows machines. These days, all diabetes device makers should be building software that runs on Windows, Mac OS and Linux.
There’s no way to take readings off the meter without the software from the website, which means you need internet access to use the meter effectively. I’d believe there should b separate download software than can be used without the need to be online, but I know this won't be important for everyone.
I hope that Entra Health Systems succeeds with this meter and the website, so that more manufacturers follow this integrated approach.
