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Image via MannKind Corp.

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 a user’s data.

California-based MannKind Corp began showcasing early prototypes in 2017 of BluHale, a small electro-acoustic device that snaps onto the dry powder inhaler and tracks the amount of insulin taken. It measures the sound generated during use, which indicates the pressure of inhalation, and flashes a green light if the Afrezza is inhaled properly and a red light if it’s not.

The initial version is being used as a training tool for healthcare professionals, allowing doctors to view the tracked data (compatible with Android, iPhone and Microsoft devices) and then offer their patients advice on how to best use Afrezza.

Soon, an updated version will allow Afrezza users to track their own doses and timing. It will work with a companion app for smartphones and other devices, bringing a data-sharing connectivity function to make Afrezza more compatible with modern diabetes tech like continuous glucose monitors (CGMs).

“Patients won’t have to look at any software or look at an app — just look for the green or red light,” MannKind CEO Michael Castagna told DiabetesMine. “It’s very simple and user-friendly for them.”

This development ought to spark a vote of confidence, given the lower-than-expected sales of Afrezza through the years. But things are looking up as the company’s financial picture improves and this data-tracking add-on becomes more of a reality.


DiabetesMine first encountered this BluHale tech on the expo floor at the American Diabetes Association’s Scientific Sessions back in 2016, and later Castagna tweeted a picture of two colorful BluHale inhaler adapter samples, when the company first launched these prototypes at the end of 2017.

The adapters attach to the top of the current Dreamboat inhaler where the Afrezza powder cartridge fits inside. The cartridges are color-coded to indicate dose amounts: blue for 4 unit, green for 8 unit, and yellow for 12 unit.

The company has long said that it is also exploring building the connectivity directly into the base inhaler itself, or whether it’s best to keep the inhaler and BluHale accessory separate. Manufacturing capabilities, 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 each cartridge used, so the system would automatically know which cartridges are being used more, along with data integration with existing apps and platforms.

That is, MannKind does not intend to create its own mobile app or platform for Afrezza users, but instead wants to partner with existing solutions 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 insulin injection icon as exists now.

Originally, MannKind had planned to launch a consumer-focused version of BluHale in 2019, but delays pushed that back to 2020. Then, the COVID-19 pandemic hit and delayed clinical trial work even more, according to Castagna, and they hoped to bring this to fruition for 2021.

Pandemic-related delays and a change in administration at the Food and Drug Administration (FDA) have slowed the regulatory process even further, and a global computer chip shortage — hitting many industries from automotive to consumer technology and medical devices — have impacted MannKind’s development of BluHale.

As of July 2021, Castagna says they are waiting on more feedback from the FDA and hope to get BluHale finalized so it can become available in 2022.

Of course, existing Afrezza users can continue using the regular Dreamboat inhaler without BluHale.

MannKind is exploring the best ways to sell BluHale alongside Afrezza — perhaps for $20 on Amazon, or maybe through a subscription or different model. Nothing’s been finalized yet, 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 not to do that over patients’ privacy concerns. (Thank you for listening, MannKind!)

MannKind expects to soon 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.

“We have to start putting our money where our mouth is,” Castagna said.

We at DiabetesMine are 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.