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Select Device Freestyle Lingo Freestyle Libre 3 Freestyle Libre 2 Freestyle Libre 14 Day Dexcom G7 Dexcom G6 Dexcom Stelo Guardian Connect Medtronic Simplera Eversense Meter Omnipod Omnipod Dash Medtronic 780G Medtronic 630G Tandem t:slim X2 Bigfoot Unity Medtronic InPen Tempo Pen NovoPen 6/NovoPen Echo Insulin Pen Afrezza CeQur Simplicity Patch V-Go Patch Omnipod GO Patch Syringe and Vial Beta Bionics iLet Pancreas Control IQ with Dexcom Control IQ with Freestyle Libre Medtronic 780G with Smart Guard Omnipod 5 Tandem Mobi Tidepool Loop twiist DIY Loop Apple Series 6/7/8/9/10/SE (2nd Generation) Garmin vívosmart 5™ Garmin Venu Sq 2 Garmin Venu 3 Garmin vivoactive 5 Garmin Fenix 8 Garmin vivofit jr 3 Garmin Forerunner 165/265/965 Garmin epix (Gen 2) Garmin Enduro 3 Fitbit Ace LTE Fitbit Charge 6 Fitbit Inspire 3 Fitbit Versa/Versa 2/4/Versa Lite Fitbit Sense 2 Fitbit Luxe Google Pixel 2/3 Samsung Galaxy 4/5 Xiaomi Mi Band 9 Oura Ring Whoop 4.0 Withings ScanWatch 2 Withings ScanWatch Lite Pedometer 3D Pedometer
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.
Dexcom Stelo is the first over-the-counter low-profile, all-in-one glucose sensor/transmitter. This sensor lasts for up to 15 days and sends real-time glucose readings to a compatible smartphone app. No finger pricks or scanning is needed.
*Recently FDA approved for people 18 years or older with type 2 diabetes. Expected availability is summer 2024.
MARD of 9.2%
Components
Bigfoot Unity : Sensor
Sensor uses a thin, flexible filament inserted just under the skin to measure glucose levels every minute.
Bigfoot Unity : Controller
Smart cap displays dosing recommendations for manual insulin delivery through multiple daily injections.
Bigfoot Unity : Receiver
Smartcap is used to scan the sensor and displays dosage information directly on the screen and smart mobile device.
Device Details
Overview
Smart cap used for most disposable insulin pens with CGM integration.
Small all-in-one sensor/transmitter with a quick warm-up period and can be worn in multiple areas.
Affordability and Access
$$$$
Monthly mail-order package includes all the supplies needed, for a regular subscription price or insurance-covered copay with no upfront costs.
$$$$
No insurance coverage data. Pricing is to be announced in summer 2024. Price expected to be low to allow for over the counter distribution.
Data Monitoring Options
Yes
Data from the iCGM and time-of-dose data from the smart caps are automatically uploaded to the cloud.
To Be Announced
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.
To Be Announced
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.
15 Days
Sensors last 15 days. They are purchased over the counter. Works at 50ºF – 108ºF
Vision / Auditory / Dexterity
NO text to speech
NO vibration alerts
A LOT of dexterity needed
YES text-to-speech
YES vibration alerts
3 sound sources
A LOT of 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.
Waterproof when submerged in 2.4 meters of water and must be within 20 (unobstructed) feet of the receiver or mobile device. This device is intended to help people with non-insulin requiring type 2 diabetes better understand their blood sugar numbers.
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 limited alerts. This device does not provide alarms and alerts for high, low, and rise/fall rates. This device is intended to track and understand the effects of food on blood sugar for people with type 2 diabetes.
Comfort
Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body.
Low profile and low maintenance sensor application.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
No options. Stelo is intended for use by people with type 2 diabetes who do not require insulin to manage their blood sugar levels.
Easy to Use
Simple design. One-button device with easy to read display.
Real-time data and alerts make dose adjustment easier.
Fewer Fingersticks
Factory-calibrated sensor. Finger sticks needed for backup only.
Factory-calibrated sensor. Finger sticks needed for backup only.
Privacy
Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. Sensor is the smallest option available.
Small sensor. Discreet and thin sensor that is easy to hide under clothing.