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
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.
Loop is a DIY (do-it-yourself) system. It takes some work to set up but allows people to think about diabetes less by automating basal insulin delivery based on predicted glucose levels. This system can be used with the Dexcom G6 and the Omnipod or Medtronic pumps. Information about DIY Loop can be found on the Loop or Riley Link websites.
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.
Loop : Pump
The system is compatible with Omnipod (left) or Medtronic (right) pumps. Both options can be applied anywhere on the body that is comfortable.
Loop : Sensor
Automatic applicator inserts sensor just under the surface of the skin and can be applied to many places on the body.
DIY Loop : Transmitter
RileyLink allows the pump and sensor to communicate. It is only required if a Medtronic pump is used.
Loop : Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via an Omnipod or Medtronic pump.
Device Details
Overview
Smart cap used for most disposable insulin pens with CGM integration.
This is a DIY (do-it-yourself) system that needs significant setup. It has the most flexibility in settings and device options. It also depends on a third device called a "Riley Link" to communicate between sensor, phone, and pump.
Affordability and Access
$$$$
Monthly mail-order package includes all the supplies needed, for a regular subscription price or insurance-covered copay with no upfront costs.
$$$$
Supplies can be covered for Omnipod or Medtronic pumps and Dexcom. Price range; $0-$8,574 to start and 0-$300/month. iPhone, app, and Riley link are not covered and must be set up independently. Riley link price range; $135-$165.
Data Monitoring Options
Yes
Data from the iCGM and time-of-dose data from the smart caps are automatically uploaded to the cloud.
Yes
Compatible with Tidepool - a web-based diabetes data management system.
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
Data can be viewed on an iPhone.
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.
3-day pump 10-day sensor
Sensors last 10 days and transmitters last 90, and work at 50ºF – 108ºF. Pods or pump reservoirs last for up to 72 hrs and work from 40ºF – 104ºF.
Vision / Auditory / Dexterity
NO text to speech
NO vibration alerts
A LOT of dexterity needed
NO 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.
Automatic responses. Can set custom blood sugar targets and insulin and carb sensitivities based on type of activity. App automatically responds to blood sugar changes during activity. *Medtronic option is not waterproof. Omnipod option is fully waterproof.
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.
Automatically adjusts insulin delivery. Increases or decreases insulin delivery to meet glucose targets. Insulin delivery settings can be aggressive or conservative.
Comfort
Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body.
Low-profile but extra device. Low profile/low maintenance sensor. The RileyLink is an extra device that must be carried.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
All settings are completely customizable. Can bolus from phone or smartwatch. Can operate “open-loop” where the user must enact insulin delivery based on recommendations or “closed-loop” where modifications to insulin delivery are automatically delivered.
Easy to Use
Simple design. One-button device with easy to read display.
Difficult set-up but easy to use. Software makes most dosing decisions. Requires many parts. Can be difficult to set up.
Fewer Fingersticks
Factory-calibrated sensor. Finger sticks needed for backup only.
Factory-calibrated sensor. Fingersticks needed for backup only.
Privacy
Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. Sensor is the smallest option available.
Discreet. Ability to give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available. *Medtronic pump has tubing. Omnipod is most hideable pump option (no tubes or separate controller needed).