People with diabetes using Afrezza inhaled insulin will hopefully soon have access to a new Bluetooth accessory called BluHale that will help them know if they're taking the medication properly and getting the full dose. The idea is to build this out to eventually track and share all of the user's Afrezza data.

California-based MannKind Corp. is currently conducting a limited pilot rollout of prototypes of BluHale, a small electro-acoustic device that snaps on the dry powder inhaler and measures the amount of insulin taken via the sound generated during use, which indicates the pressure of inhalation.

Currently, BluHale's main function is to flash a green light if the Afrezza is inhaled properly and a red light if it's not. It's being used as a training tool, where doctors can view the tracked data (compatible with Android, iPhone and Microsoft devices) and then offer their patients advice on how to best use Afrezza.

"Patients don't have to look at any software or look at an app -- just look for the green or red light," Castagna says. "It's very simple and user-friendly for them."

We first encountered this on the expo floor at the ADA Scientific Sessions back in 2016, when MannKind was demo'ing a first-gen prototype. At the time, MannKind execs told us the company was still toying with the idea of whether to launch a next-gen BT-enabled Dreamboat inhaler with full data-tracking capabilities.

Flash forward to early 2018, and the first step is actually happening.

This ought to spark a vote of confidence, given that many have questioned the company's future and how long it can survive. But with the recent hire of Dr. David Kendall as Chief Medical Officer, the company's stronger financial footing and now this BluHale tech being used in real-world settings, things appear to be looking up.

Late last year, MannKind CEO Mike Castagna tweeted a picture of two new colorful BluHale inhaler adapter samples.

The adapters attach to the top of the current Dreamboat inhaler where the Afrezza cartridge fits inside. (To us, it kinda looks like someone glued a Dexcom CGM transmitter to the top of an Afrezza inhaler!)

MannKind has a training pilot program in place now, with a few sales reps taking the adapters into clinics for doctors to have their patients try out. Currently it's just an 8 to 10-week program that's starting out small, but Castagna hopes to bring more providers into the program before long.

As BluHale's currently an adapter, the company is also exploring whether it could build the connectivity into the base inhaler itself, or whether it's best to keep the inhaler and BluHale accessory separate. Manufacturing, access and affordability all play into that decision.

Eventually, Castagna's vision for this BluHale tech -- especially if they're able to add fiber-optics recognition -- would be to enable full Afrezza dose tracking and recognition of the color of a cartridge to know which are being used more, and data integration with existing apps and platforms.

That is, MannKind does not intend to create their own mobile app or platform for Afrezza users, but instead wants to work within the D-Size now so that Afrezza data becomes sharable via other platforms and apps. Castagna would like to see a day where an Afrezza inhaler icon could appear on a Dexcom CGM app, for example instead of just an injection icon as exists now.

Much of this is a few years out, but Castagna says it's a working plan in action.

On the question of whether MannKind would need separate FDA approval for this BluHale technology, Castagna says they are still exploring that. "It's not all black and white on regulatory," he says, adding: "A rushed timeline doesn't make sense for us."

Of course, any Afrezza users not interested in these tracking capabilities can continue using the regular Dreamboat inhaler without BluHale.

Meanwhile, MannKind is exploring the best ways to sell BluHale alongside Afrezza -- such as $20 on Amazon, or maybe a subscription or different model. Nothing's been finalized, Castagna says.

Originally, MannKind mulled the idea of automatically sharing tracked dosing data with payers in order to better monitor prescription filling patterns, but after consideration and talking to patients, they opted to not do that as many might not be comfortable sharing that kind of information with insurers or suppliers. (Thank you for listening, MannKind!)

MannKind plans to hire a digital data expert to examine all the aspects of data collection and what opportunities do exist for using anonymized data to impact insurance coverage and so on.

"We have to start putting our money where our mouth is," he said. 

From our side, we're encouraged to see dose tracking on MannKind's radar -- making Afrezza much more useful in the context of digital tools -- and we're eager to see what comes next.