Diabetes and New Devices
Today, after perusing this site, I learned about a new system for blood glucose downloading. David Mendosa wrote about the new "Glooko system" in which one downloads an Apple app onto an iphone, ipad, or iPod Touch, as well as a cable from the software company, and voila, you are ready to download your blood sugars into your Apple device. The system may be found on the web at www.glooko.com/product/logbook/.
My understanding is that the cable sells for $39.95 and the software application from the Apple store is free. The meters that are compatible with the software include Bayer's Contour®, FreeStyle Freedom Lite®, FreeStyle Lite®, OneTouch® Ultra®2, OneTouch® UltraLink,® and OneTouch® UltraMini®. The company is currently working to include the Accuchek meters as well. The software only allows blood sugars to be presented in a logbook form (see David's blog for illustration) but blood sugars are placed in "time buckets" allowing for better pattern interpretation by patient, family, and healthcare providers. The logbook can then be sent electronically to the healthcare provider in advance of the appointment or to diabetes educators intermittently. My understanding is that the Glooko software company is working on software to include glucose trends and graphics, such as model days, daily trends, etc.
Please understand that I am not recommending one blood glucose monitoring system over another; but rather highlighting another means of record-keeping. The key is for the person with diabetes to both perform self-glucose monitoring and be able to analyze the results to make informed choices! However, because so many people have smart phones and our children and teens are native to this form of technology, I believe it may have a better chance of success.
Please let me know your thoughts about this new system if you decide to try it!
Another cool gadget, a new insulin pump called the "Gizmodo," was recently approved by the FDA for people with diabetes aged 12 and older. The major changes include a "touch" screen and a sleek look that resembles a smart phone. A concern which will most likely be addressed is how to avoid making errors with a touch screen however, I suspect there will be a means to lock the data on the pump.
As you all probably know by now, there was a major announcement by the FDA, which issued guidelines to help speed up the development of the artificial pancreas. The FDA's approach of issuing these new guidelines will enable increased flexibility in the design and testing of the devices to prove efficacy and safety. There will be more flexibility in the choice of clinical trial outcomes, number of patients needed for inclusion and the length of trials. My understanding is that the initial trials will include only those with type 1 diabetes 18 years or older. According to the FDA, upon starting clinical trials, the initial study population will also have the following requirements:
1. Experience with pump more than 6 months
2. Willing to perform 4 or more blood glucose checks daily
3. Willing to perform required sensor calibrations
4. Willing to wear the system 6 days or more per week
5. Willing to keep a minimum log of sick days, days with exercise, and
symptoms of low and high blood glucose results
The FDA also notes that, "the guidance recommends a three-phase clinical study progression so that studies may move to an outpatient setting as quickly as possible. To further streamline clinical studies, the guidance suggests ways sponsors may leverage existing safety and effectiveness data for components that may make up an artificial pancreas system, as well as data gathered from clinical studies conducted outside of the U.S." Thus, the FDA will be able to apply data already garnered from Europe.
The study endpoints are such that there should be meaningful clinical outcomes that are evidenced-based and reflect objective variables relating to patients' quality of life as well as safety. Primary endpoints will be looking at the safety and effectiveness of the Artificial Pancreatic Device System. The FDA is suggesting measurement of the hb A1c as the primary endpoint. Secondary endpoints are then used for additional support for increased application of the device.
It looks like major devices will be evolving quickly in the near future that will assist in the day-to-day management of diabetes!