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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 Medtronic Guardian Connect is a continuous glucose monitoring (CGM) system that provides real-time glucose data on a compatible smartphone. The system offers optional low and high blood sugar notifications and can be inserted on the abdomen or back of the upper arm.
MARD of 9.6%
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.
Guardian Connect : Sensor
Sensor is inserted underneath the skin, either on the abdomen or arm. Push buttons applicator allows sensor to be placed on the body in one step.
Guardian Connect : Transmitter
Seashell-shaped with built-in Bluetooth capability that allows it to send glucose data directly to a smartphone every 5 minutes.
Guardian Connect : Receiver
Trends and alerts are viewed directly on a mobile device. Available for both iOS and Android devices.
Device Details
Overview
Smart cap used for most disposable insulin pens with CGM integration.
One of the larger sensors, may be cumbersome to wear on some parts of the body under clothes.
Affordability and Access
$$$$
Monthly mail-order package includes all the supplies needed, for a regular subscription price or insurance-covered copay with no upfront costs.
$$$$
Sometimes covered. The costs vary depending on individual insurance coverage and how insurance classifies CGMs. Price range $0-$600/month.
Data Monitoring Options
Yes
Data from the iCGM and time-of-dose data from the smart caps are automatically uploaded to the cloud.
Yes
CGM data can be linked to a CareLink account and shared with the user's health care team.
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
The Guardian Connect mobile app allows users to view glucose levels, trends, create customizable alerts, and share blood glucose data with family and friends.
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.
7 Days
Sensors last 7 days, and transmitter battery needs weekly charging and replacement once a year. Both can be stored between 36°F - 86°F.
Vision / Auditory / Dexterity
NO text to speech
NO vibration alerts
A LOT of dexterity needed
YES text to speech
YES vibration alerts
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 transmitter when submerged in up to 2.5 meters of water for 30 minutes and must be within 20 feet of a connected mobile device.
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.
Measures sensor glucose 24/7 and sends alerts when a high or low is detected. 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.
More tape is needed for Medtronic sensors.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
Sensor trends can be used for dose adjustment.
Easy to Use
Simple design. One-button device with easy to read display.
Rechargeable sensor transmitter but has the most steps to change sensor.
Fewer Fingersticks
Factory-calibrated sensor. Finger sticks needed for backup only.
2 daily finger-sticks are needed to calibrate the sensor.
Privacy
Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. Sensor is the smallest option available.
Somewhat discreet. Ability to see sugar on watch or phone. Sensor requires regular meter use.