Comparing the Libre2 and Dexcom G6 as RT-CGM using #WeAreNotWaiting software was written by Tim Street on his website, Diabettech – Diabetes and Technology, 24 February 2020. This is a GREAT, in-depth comparison of the new Abbott Libre2 with the current Dexcom G6 CGM, particularly for those using DIY, #WeAreNotWaiting AIDs. Thank you, Tim, for such careful analysis!
The conclusion: The Libre2 data had a much better accuracy profile than I was expecting to see, and it also had a potentially safer profile for use in an AID, with a negative bias as opposed to a positive one. It’s worth noting that the number of data points, and the fact that this is an n=1 observation introduce a reasonable amount of uncertainty in relation to this output.
The main question for me in relation to Libre2 data being accessed via xDrip is “Would I loop with it?”. What’s come from this test of one sensor has been pleasantly surprising, given my expectations from Libre1. It appears that Libre2 sensors with poor data issues may just die rather than continuing to produce bad data, unlike the Libre1. Having said that, the first two days of data were pretty horrible, which raises different concerns relating to usability.
At this stage, I’d cautiously consider using the Libre2 for looping, pending checking whether there were noticeable differences between sensors, as we’ve seen with Libre1, and whether the issues I saw with the first 36 hours could be mitigated.
I was pleased that the data this sensor produced was, in general, considerably better than I’ve seen from Libre1 and looks like it could present a reasonable alternative to Dexcom, if you are someone who isn’t waiting.
Read the details of the study: Comparing Libre2 and Dexcom G6 as RT-CGM, for Looping
FDA Support for AID Systems Grows with Backing of New Questionnaires was reported by Sara Seitz for InsulinNation.com, 9 July 2020. INSPIRE questionnaires to determine psychosocial effects of AID systems signal growing support for quality-of-life in advanced diabetes tech.
In 2017, the FDA introduced the Medical Device Development Tools (MDDT) program to help better evaluate and regulate decisions surrounding novel medical devices. According to the FDA’s website, an MDDT is a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device.
Since the program’s debut, only six tools have qualified for this special designation. Now, with the recent addition of the INSPIRE questionnaire set to this shortlist, the FDA has signaled support for the growing field of automated insulin delivery (AID) systems.
INSPIRE Questionnaires: What Are They?
Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) questionnaires were developed to help quantify the psychosocial impacts of automated insulin dosing systems on people living with type 1 diabetes and their caregivers.
Unlike traditional safety and efficacy testing which is largely focused on physical complications and improvements, this questionnaire is meant to measure the mental impact of AID systems and process this information to help the FDA evaluate and regulate new devices entering the market place.
These questionnaires focus specifically on the areas of psychosocial functioning and quality of life and how these measures change after the adoption of an AID management system.
Quality of Life Focus: A Growing Trend: The inclusion of such a tool in the MDDT by the FDA falls in line with a growing trend within the diabetes tech industry to focus on devices that aim to improve more than just blood sugar control. The ability of AID systems to improve the quality of life of a person living with diabetes was a huge talking point at this year’s ADA Scientific Sessions.
YES, FINALLY … this is sooooo important for the betterment of our day to day living!
Read more: INSPIRE questionnaires to determine psychosocial effects of AID systems
I hope the FDA follows through with this approach of looking at quality of life issues. Perhaps it will link into interoperability and cost of use.
As for the Libre’ 2, I will believe it when I see it. The libre’ 1 has been most inaccurate for my use. I cannot imagine dosing off of it.