bigfootunity new
afrezza device

Summary

Connected smart caps that recommend insulin doses for people using multiple daily injections. This system combines the FreeStyle Libre 2 CGM with insulin pen smart caps to provide daily dose recommendations.

Participating in the Bigfoot Unity program requires an agreement between Bigfoot Biomedical and the health care provider. After establishing a contract, the prescribed Bigfoot supplies are delivered in a "one-stop-shop" directly to the patient's door each month. Information about the Bigfoot Unity program can be found on the Bigfoot Biomedical website. 

Inhalable regular human insulin. Cartridges come in three doses: 4, 8, and 12-unit doses.

Components

Bigfoot Unity  : Sensor

Bigfoot Unity : Sensor

Sensor uses a thin, flexible filament inserted just under the skin to measure glucose levels every minute.

Bigfoot Unity  : Controller

Bigfoot Unity : Controller

Smart cap displays dosing recommendations for manual insulin delivery through multiple daily injections.

Bigfoot Unity  : Receiver

Bigfoot Unity : Receiver

Smartcap is used to scan the sensor and displays dosage information directly on the screen and smart mobile device.

Afrezza : Inhaler

Afrezza : Inhaler

Small refillable inhaler contains a compartment for powdered insulin containing cartridges.

Afrezza : Cartridge

Afrezza : Cartridge

Cartridges come in three doses: 4, 8, and 12-unit doses. All color coded.

Device Details

Overview

Smart cap used for most disposable insulin pens with CGM integration. 

Nothing on the body when not in use. Visible when dosing. 

Affordability and Access

$$$$
Monthly mail-order package includes all the supplies needed, for a regular subscription price or insurance-covered copay with no upfront costs. 

$$$$
Widely covered. Price range; 0-$99/month, depending on insurance coverage. $35/month for medicare and commercial insurance plans. 

Data Monitoring Options

Yes
Data from the iCGM and time-of-dose data from the smart caps are automatically uploaded to the cloud.

No Options

Data View Options

Yes
Data can be viewed on the Bigfoot Unity mobile app but dosage recommendations, glucose readings, and glucose trends will display directly on the smart cap.

No Options

Duration and Storage

28-day pen 14-day sensor 
Sensor lasts for 14 days, insulin pen lasts for up to 28 days, smart cap is rechargeable. Sensor works between 50ºF - 113ºF and pens can be kept at room temperature for up to 28 days. 

10 Days
Open cartridges last up to 10 days. Sealed cartridges may be stored in a refrigerator at 36°F - 46°F until the expiration date.

Vision / Auditory / Dexterity

NO text to speech
NO vibration alerts
A LOT of dexterity needed 

NO text to speech
NO 
vibration alerts
LITTLE
 dexterity needed

Patient Considerations

Active Lifestyle

Light on body. Pens are easy to use and do not remain attached to the body, senor is light on the body.

Body free of devices. Does not remain attached to the body.

Avoiding Highs and Lows

Limited customizability. System integrates the FreeStyle Libre 2 CGM for high/low alerts but requires manual dose adjustment and limits the ability to adjust basal insulin throughout the day. 

Very short-acting. Absorbs quickly through the lungs to correct high blood sugar but requires attention to prevent lows. 

Comfort

Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body. 

Many components. Have to carry multiple cartridges that can be bulky. 

Easy Insulin Dosing

Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin. 

Less precise but easy dosing. Dosing may be less precise due to the inhaled method of dosing, but color-coded cartridges make dosing easier. Dosing can also be done based on small, medium, or large meals and can be administered 1-2 hours post meals. 

Easy to Use

Simple design. One-button device with easy to read display.

Simple design. Whistle-like device for inhaling insulin.

Fewer Fingersticks

Factory-calibrated sensor. Finger sticks needed for backup only. 

Frequent finger-sticks are required. 

Privacy

Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. Sensor is the smallest option available. 

Hideable. Small, discreet, and portable device that's not as noticeable as injections.