Trying to calculate your insulin doses for injections, without the help of an insulin pump "wizard"? There's an app for that! (of course)
First came basic insulin dose calculators like RapidCalc. But providing more personalized recommendations in a so-called "insulin titration app" was something of a challenge, because these provide real medical treatment decision support and therefore require FDA approval -- as opposed to so many diabetes logging apps that do not.
The first regulatory breakthrough for a "mobile prescription therapy aid" that analyzes users' past data trends to deliver personalized recommendations came with WellDoc's BlueStar app in 2013. That was followed in 2015 by the Accu-Chek Connect app, that also calculates and recommends insulin amounts. WellDoc just recently snagged an expanded label for its BlueStar app that allows patients to use it without a doctor's prescription -- adding to the accessibility of this mobile tech tool.
The FDA's decision last year to allow a dosing claim for the Dexcom G5 CGM system seems to have helped pave the way for even more smartphone-based decision therapy tools.
And now, two new apps have snagged FDA clearance and are almost ready for prime time:
Lilly's Go Dose
In December, Eli Lilly got FDA clearance on its new mobile app called Go Dose, which can be used for the Lilly-branded Humalog insulin to titrate doses. This is the company's first class II ("moderate-risk") mobile app approved by the FDA. This one is designed for adults with type 2 diabetes, and is focused on meal-time insulin use for Humalog U-100 only.
There is a Go Dose version for patients to use at home, and the Go Dose Pro clinical version for use by healthcare professionals.
As of now, it's only compatible with iOS devices (iPads and iPhones), but hopefully will eventually be compatible with Android as well.
Unfortunately, Lilly is currently not disclosing any details on how the Go Dose app actually works. The FDA letter notes only: "The dose recommendation is based on effectiveness of the individual’s insulin response... algorithm employed by using the current BG to determine that it is safe to dose. Then the last insulin dose, post-dose BG, and glucose target range are utilized for the calculation."
Lilly's not yet publicizing the design or features either, which is disappointing, and a Lilly spokeswoman tells us that availability and pricing details are not yet finalized, as the Pharma company is still "exploring commercialization options" at this time. No word yet on when this might hit the market.
So, how good Go Dose actually is for insulin titration remains to be seen...
The Voluntis Insulia App
Late last year, the startup Voluntis (based in both Paris, France and Cambridge, MA) received FDA clearance for a new insulin titration app called Insulia. This company has been around for many years, fine-tuning its mobile tool long before smartphones were even on the market. It's worked with JDRF and others through the years, getting to a point where it was finally ready to unveil its technology worldwide. Our friends at A Sweet Life have a good background story on the company, btw.
This app is also designed for type 2 PWDs but it focuses on basal (background) insulin dosing, and is classified as a prescription-only device. Aside from insulin titration of long-acting insulin, it also offers educational coaching messages in response to BG values and other inputted data, like food and exercise.
Being that it requires a prescription, a clinician must input all the personalized treatment plan info into the patient's profile -- insulin sensitivity, BG targets, etc., and the patient can then access all of this via the app on an iOS or Android smart devices, or using the web-based portal online. All of this can be shared with the HCP team, of course.
Voluntis has been in the news lately for teaming up with Livongo (read our take on Livongo's offerings here) to develop an "expanded solution that aims to improve medication adherence and optimization" based on the Insulia app. This includes the diabetes coaching services that both companies have weaved into their offerings.
"We know that the three pillars of diabetes management are nutrition, exercise, and medication, but having the right information on how to manage is also critical," says Livongo's Chief Medical Officer Dr. Jennifer Schneider, who lives with type 1 diabetes herself. "By integrating with Insulia, we can give members with type 2 diabetes additional insight and tips for medication optimization -- making managing diabetes easier."
An exact launch date for Insulia has not yet been announced, but we're told that like Lilly's Go Dose, it's expected out at some point before mid-2017.
More Help, Less Math
One of the biggest advantages of an insulin pump is of course that it helps free up PWDs (people with diabetes) from a lot of the math involved in fine-tuning insulin doses. We're thrilled to see that sophisticated algorithms being developed for modern pumps, CGMs and closed loop systems can also be utilized to help those on daily injections too!
These apps, along with new "smart insulin pens" on the horizon, will no doubt be a boon to the many millions of PWDs who may never be candidates for an Artificial Pancreas, even when those go mainstream.
We look forward to exploring these new mobile apps more in-depth before long, and seeing just how well they deliver on the promise of easing the burden of daily insulin therapy.