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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.
The FreeStyle Libre 2 is the thinnest, all-in-one glucose sensor/transmitter and requires scanning using a handheld reader or compatible smartphone with an app. This sensor lasts for 14 days and only needs fingersticks as backup. Optional low and high blood sugar notifications are available for this system.
FDA approved for insertion on the back of the upper arm (ages 4 years and older).
MARD of 9.3%
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.
Freestyle Libre 2 : Sensor
Sensor uses a thin, flexible filament inserted just under the skin to measure glucose levels every minute. Push-button applicator allows sensor to be placed on the body in one step.
Freestyle Libre 2 : Receiver
Conveniently access glucose readings using a reader, smartphone, or both. Available for both iOS and Android devices.
Device Details
Overview
Smart cap used for most disposable insulin pens with CGM integration.
All-in-one glucose sensor/transmitter with low and high blood glucose alarms can be worn on the upper arm.
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. Provided by pharmacies. Price range; $0-$100/month. Often the cheapest and easier to access sensor.
Data Monitoring Options
Yes
Data from the iCGM and time-of-dose data from the smart caps are automatically uploaded to the cloud.
Yes
After each sensor scan with the mobile app or reader, data is automatically sent to the user’s LibreView account which enables sharing with HCPs and caregivers via the LibreLinkUp app. Data upload is possible with Glooko and Tidepool data-management systems.
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.
Yes
Freestyle Libre 2 app provides glucose readings and alarms, multiple data views, the ability to share glucose data and real-time alarms with LibreLinkUp, and the ability to connect to a clinician's practice through LibreView.
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.
14 Days
Sensors last 14 days and work between 50ºF - 113ºF. They are shipped in orders of 1-3 months at a time - which is 2-6 boxes at a time.
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.
Water-resistant for up to 3 feet deep for 30 minutes and light on the body, does not get in the way of activity. The reader must be within 1.5 inches of the sensor to scan it.
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.
Optional glucose alerts for low and high glucose levels. Trend arrows show the direction glucose is heading, with the rate of change.
Comfort
Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body.
Low profile sensor and small adhesive.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
Scanned sensor trends can be used for dose adjustment.
Easy to Use
Simple design. One-button device with easy to read display.
Requires scanning. Self-application and manual scanning are required. Easy self-application.
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.
Hypoglycemia safety alarm. Discreet size but built-in hypoglycemia safety alarm alerts users when glucose is below 55 mg/dl and is always on.