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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 twiist AID system was cleared by the FDA for use with CGMs that have received FDA designation as integrated continuous glucose monitors (iCGMs). As the twiist AID system gets closer to commercial availability, Sequel Med Tech will publicize the list of compatible CGM
*Recently FDA approved for people with type 1 diabetes ages 6 and up.
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.
twiist : Pump
Pump can be worn with a pump clip, adhesive patch or in a pocket.
twiist : Controller
Pump is controlled by the twiist app on an iPhone. Data from both the pump and CGM are viewable on the twiist app Home Screen.
Twiist : Infusion Set
An infusion set contains the thin plastic tubing that delivers insulin from the pump to the body.
Device Details
Overview
Smart cap used for most disposable insulin pens with CGM integration.
This system automatically adjusts insulin delivery according to continuous glucose monitor (CGM) readings and predicted blood sugar levels. It is the first FDA-approved AID system with Apple Watch compatibility.
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. Anticipated to be provided through Pharmacy.
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 is stored and can be viewed directly from the twiist app on the mobile device (iPhone), and can be linked to an Apple Watch for viewing data as well.
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. The reservoir holds 300 units and is disposable, and the pump can be used for up to 3 years.
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. The pump, when connected to the cassette, has a rating of IP28, indicating protection from continuous immersion in water. The pump can tolerate immersion to depths of up to 12 feet (3.7 m) for 1 hour.
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. Low profile with an adhesive design that prevents the pump from catching on other objects.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
Customizable. Can bolus from phone, smartwatch, or directly from the device without needing to be attached to your phone. The device also directly measures the volume (amount) and flow (speed) of insulin delivered with every micro-dose
Easy to Use
Simple design. One-button device with easy to read display.
Watch compatible. The twiist AID system is the first FDA-approved AID system that can be directly controlled from an Apple Watch.
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. The pump is in two pieces - the top (algorithm and battery) and the bottom (insulin chamber and AVS technology)