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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.
This system combines the Tandem t:slim x2 with the Dexcom G6 or G7 continuous glucose monitor (CGM) to automatically adjust insulin delivery in response to glucose trends. It's easy to use and allows bolus dosing directly from a compatible iOS or Android smartphone.
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.

Control IQ with Dexcom : Pump
Touch screen pump connects tubing to a small patch called an infusion set that attaches to the body.

Control IQ : Sensor
Automatic applicator inserts sensor just under the surface of the skin and can be applied to many places on the body.

Control IQ with Dexcom : Controller
t:slim pump receives CGM readings to automatically adjust basal insulin delivery via an infusion set. Compatible smartphone can be used to view and administer boluses via the t:connect app.

Control IQ : 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.
The system automatically adjusts insulin levels from the Tandem t:slim X2 pump based on the Dexcom G6 or G7 readings for more time in range.
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 for insulin-dependent type 1 and 2. Supplies for Pump and Sensor provided by DME suppliers. Price range; $5-$6,995 to start and $0-$200/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
The t:connect mobile app for the t:slim X2 pump wirelessly uploads pump and CGM data to the cloud-based t:connect web application.
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 directly on the pump screen or on the t:connect mobile app (available for both iOS and Android devices).
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. Pump can be used for up to 72 hrs, battery life lasts five days with the use of CGM, and work between 40°F - 99°F.
*CGM transmitter is only required for the Dexcom G6 model.
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.
Exercise Activity. Can manually increase target range to 140-160 mg/dl. Insulin decreases when Control IQ predicts CGM ≤140 mg/dl and increases when ≥ 160 mg/dl within 30 minutes. Autocorrections will still occur. Pump is not waterproof. CGM is 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.
Auto basal and bolus insulin. Responds to CGM data by increasing or decreasing basal insulin delivery to prevent highs and lows and maintain a target blood glucose of 110 mg/dl. Auto-bolus is available once per hour to correct blood sugar above 180 mg/dl.
Comfort
Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body.
Low profile. Low profile/low maintenance sensor. Small tubed pump with the most infusion sets to pick from.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
Automatically adjusts dosing. Sensor integration allows for the pump to automatically adjust insulin doses. More customizable dosing than pens or syringes. Basal in 0.001 increments, bolus in 0.01 increments. Extended bolus available.
Easy to Use
Simple design. One-button device with easy to read display.
Modern & flexible. Rechargeable and touchscreen pump. Sensor integrated with multiple devices in case you change up what you're using.
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 check blood sugar on phone or watch. Ability to bolus on a compatible smartphone. Pump has tubing but can be clipped to clothing or placed in a pocket to be discreet when needed. Dexcom's built-in hypoglycemia safety alarm alerts users when glucose is below 55 mg/dl and is always on.