Memorandum

Abbott FreeStyle InsuLinx blood glucose meter receives FDA clearance; no bolus calculator in US version, but up close demo reveals solid touchscreen and software innovations – March 11, 2012

Executive Highlights

  • Abbott announced that its FreeStyle InsuLinx blood glucose meter has received FDA clearance – launch is expected “in the coming months.”

Abbott Diabetes Care announced late last week that the FDA has cleared its FreeStyle InsuLinx blood glucose meter. The touchscreen meter will be made available to US patients “in the coming months.” The US version of the meter is slightly different from the version of the InsuLinx now available in Belgium, France, Germany, the Netherlands, and the UK as of May 2011 and in Canada as of October 2011. The major change is that the US version will not include the built-in bolus calculator that is a highlight of the European system. Instead of calculating a suggested mealtime dose, the US version of the InsuLinx will allow users to manually log both rapid- and long-acting insulin doses. Presumably, this is because getting the built-in bolus calculator (cool as it is) through FDA would have meant a longer review time. The new meter will also use specific test strips branded for the FreeStyle InsuLinx, unlike the European version that uses the FreeStyle Lite branded strips; as we understand it, FDA is requiring all new meters to have strips named for that meter. That said, the new InsuLinx strips are identical in design, look, and compatibility with the FreeStyle Lite line of test strips. We understand that the decision to make the new strip was related to the FDA’s requirement for evaluating BGM/strips as a combined “system” – to us, this seems like an unnecessary regulatory requirement that adds additional costs to an already expensive development process and hyper-competitive BGM industry. This is similar to what was seen last year with the Insulet system, when Abbott had to go through a lengthy review cycle to get the strips officially approved for the Insulet pump. Whether reviews like this represent the best use of FDA resources stands as an unanswered question, for now.

After getting an opportunity to demo the FreeStyle InsuLinx, we believe the product’s major benefits are: (1) an easy-to-use, intuitive touch screen interface; (2) easier recording of insulin dosing for non- pumpers (especially compared to paper logbooks); (3) combined blood glucose and insulin dosing data; and (4) hassle free software that resides on the meter and offers useful reports and data analysis. It’s disappointing that the built-in bolus calculator is not included in the US version of the InsuLinx, though there is still plenty of value in the insulin dose-logging feature, and faster approval is certainly a positive. According to recent research, 51% of insulin users do not log their insulin doses, meaning physicians don’t have all the information they need to make an informed treatment change and patients themselves likely find it harder to recognize patterns. While the benefits of combined data with the InsuLinx hinge on manual patient entry of insulin doses, the mere inclusion of a simple, on-meter dosing log should improve the likelihood that patients actually record their doses.

Broadly speaking, the innovations in this meter seem to be targeted at reducing the hassle factor associated with data input, collection, and analysis – we think these will be positively perceived by patients and providers alike and seem to continue an increasingly common industry trend to simplify data management (on a related note, see our coverage of Dexcom’s recent acquisition of SweetSpot Diabetes Care at bit.ly/wLQMdn). As the future of healthcare information moves into the cloud, we believe patients and providers will begin to demand more connected, mobile, and remote information solutions. The recent approval of Telcare’s meter and Sanofi’s iBGStar suggest that the BGM industry is moving in the this direction, and we’ll be interested to see if the Big 4 will soon follow suit.

  • One of the major highlights of the FreeStyle InsuLinx is an intuitive, touchscreen user interface. In our demo of the device, we found the menus quite easy to navigate through by clicking on the appropriate icons. While it’s not quite as easy as an iPhone to use, it’s easier than the firmer button-pushing required by traditional meters. The home screen includes one major icon – Logbook – and then smaller icons to record an insulin dose; set reminders (e.g., up to 12 can be set, including a reminder to test blood sugar or take insulin); change messaging settings and personalization; and change the meter’s settings. Besides the touchscreen, the meter has a single button with three major functions: turning the meter on/off from the home screen, automatically returning to the home screen from anywhere else on the meter, and activating the port light while testing. We found the touchscreen to be a major plus of the meter and we hope that future versions include a sharper and more readable color LCD display.
  • Testing with the meter was straightforward and incorporated useful meal marking and customizable notes. Inserting a strip turns the meter on and the test result appears in five seconds. We like that patients can tag the reading as pre- or post-meal while the result countdown is occurring – this is very cool and while it sounds like a small thing, we think it’s actually very smart and innovative as it should encourage more patients to add a meal mark (compared to the industry standard of only allowing the patient to mark the result after the test, which takes valuable seconds – if a patient does this after every test, this can add three to six hours a year to the process, assuming 5-10 seconds time for each meal mark). After tagging a reading, notes can also be added (e.g., exercise, illness, etc.). Completely customized notes can be added by using the FreeStyle Auto-Assist software (e.g., riding my bike, ate a burrito, etc.). While the notes do take some time to enter, we think this would be quite helpful to doctors and patients looking at logs, especially when they are trying to optimize their pump settings1.

  • The InsuLinx includes the option to manually log both rapid-acting and long-acting insulin doses. This can be done following a test result or at any time from the home screen by clicking on the pencil icon. Users can adjust whether full or half-units are displayed (tenths are unfortunately not available) and the dose-logging feature can be completely turned off (factory default has it turned on) or configured for only one type of insulin (i.e., only long-acting or only short-acting). When a patient selects the option for rapid-acting insulin, they must increase the logged dose from zero. However, if the patient selects the option for long-acting insulin, the number will start at their last logged long-acting insulin dose. In the future, we’d love to see tenths of units available to log since this is what many pumpers use.
  • The Logbook offers a chronological list of recent blood glucose tests and logged insulin doses. The Logbook can be accessed with one tap of the icon from the meter’s home screen. The interface displays three events at a time and each blood glucose test or insulin-dosing event can be clicked on for more information. When applicable, a big benefit of this three-block design allows patients to see their pre-meal blood sugar, insulin dose, and post-meal blood sugar all on one screen. Of course, this hinges on patients remembering to meal mark each blood glucose, to manually log the insulin dose, and that the three events occurred chronologically. Interestingly, insulin dose events that appear in the Logbook list – denoted by a syringe icon – simply display two dashed lines. For a patient to get more information on the dose they previously took, they must click on the event to open up a more comprehensive summary. As we understand it, this was intended to prevent confusion between rapid-acting and long-acting doses when quickly glancing through the Logbook menu.

  • The InsuLinx will also give patients a number of personalization features. Patients have the option of turning on valuable weekly messages that can be viewed on the meter – these provide a summary of the past week's blood glucose results (in-range, high, and low) along with a message comparing their results to the prior week or their target blood glucose range. The bar chart can also be sorted to show all blood glucose results, or filtered based on pre- or post meal tagging. We are seeing more and more of this sort of feedback in diabetes software and think it’s very useful for patients, especially considering the low rates of data downloading (see pages 27-36 of our Day #3 ATTD 2012 report at bit.ly/zEKWOB for the latest Helmsley data on this front – about 50% of patients reported never downloading CGM and only 2% of patients over 13 years old reported downloading SMBG at least once a week).
  • The InsuLinx will use the new Auto-Assist software, which offers some important innovations in downloading and reporting. The InsuLinx connects to the computer using a provided micro USB cable (commonly used with BlackBerry cell phones and other electronics). Notably, the Auto-Assist software actually resides on the InsuLinx, meaning that reports can be generated at any PC or Mac and settings are saved onto the meter itself. We are very glad to see Mac compatibility and think that there are important patient and provider benefits to software stored on the meter itself: portability between multiple patient computers; less hassle factor associated with software downloads and lost discs; simplified data downloading for time-pressed HCPs (especially in settings without advanced IT or that have a large number of patients using different meters); and automatic program opening when the meter is plugged in (compared to manually locating and opening it on a computer). The Auto-Assist software can generate six different reports, which can be saved as PDFs and either emailed or printed:

    • Snapshot: Provides an overview, at-a-glance report summarizing glucose and insulin information. A major highlight is the ‘Notes’ section, which displays a number of customized, actionable messages based on a patient’s “time in zone” data (e.g., pre-meal blood glucose was within target 95% of the time). Rather than being overly critical, the messaging is intended to have a more positive, informational outlook. As we understand it, this part of the report has been particularly well received by HCPs in European countries where the software has launched. We think patients will also appreciate these more digestible summary takeaways.
    • Modal day: This is a fairly standard report showing blood glucose over time, but the benefit of the InsuLinx is that it includes both glucose and corresponding insulin information.

    • Meal Event Averages: Sorts blood glucose results based on pre- or post-meal tagging.
    • Logbook: The electronic version of the traditional paper logbook.

    • Daily Statistics: Detailed information for a particular day.

    • Meter Settings

  • The FreeStyle InsuLinx is about the size of a deck of cards and uses two CR2032  ‘coin cell’ batteries that last for ~3,000 tests. Of course, the trend is towards rechargeable devices (e.g., Telcare, LifeScan Verio IQ, Tandem’s t:slim insulin pump), though we think patients will appreciate not having to ever charge the InsuLinx. We are interested in seeing how patients weigh the tradeoffs between a rechargeable meter vs. a larger/better screen, wireless connectivity, etc. and will be exploring some of these items in upcoming dQ&A surveys (for more information, contact   richard.wood@d-qa.com)

 

 

1 We are currently researching how optimized pump settings for the average pumper through work with our sister company dQ&A. Specifically, we are interested in views of patients and HCPs regarding the extent to which they believe their pump settings are optimized – we believe there is some significant upside on this front (contact richard.wood@d-qa.com for more information on this front).