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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.
Insulin pens make insulin delivery more convenient than traditional vial/syringe options. Pens are small, portable, and more discrete to use in public.
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.
Insulin Pen : Bolus Insulin
Bolus (fast-acting) insulin pen for meal time or high blood sugar correction.
Insulin Pen : Basal Insulin
Basal (long-acting) insulin pen for steady release of insulin that helps control blood sugar between meals, and overnight.
Insulin Pen : Needles
Disposable needle attaches to insulin pen for daily injections.
Device Details
Overview
Smart cap used for most disposable insulin pens with CGM integration.
Nothing on the body when not in use. Noticeable when dosing.
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. Price range; 0-$1260/month depending on insurance coverage.
Data Monitoring Options
Yes
Data from the iCGM and time-of-dose data from the smart caps are automatically uploaded to the cloud.
No Options
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.
No Options
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.
28 Days
Can be kept at room temperature (not above 80º F) when in use for 28 days. Unopened insulin pens should be stored in the refrigerator (36ºF - 46ºF).
Vision / Auditory / Dexterity
NO text to speech
NO vibration alerts
A LOT of dexterity needed
NO text to speech
NO 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.
No attachments to the body. Insulin pens are easy to use and do not remain attached to the body, allowing for a flexible and active lifestyle.
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.
Limited customizability. Pens require manual dose adjustment and limit the ability to adjust basal insulin throughout the day.
Comfort
Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body.
Many components. Have to carry pen and pen needles but nothing attached to the body.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
More precise than syringes. Ability to measure doses using a dial, increasing accuracy.
Easy to Use
Simple design. One-button device with easy to read display.
Simple but many steps. Attach a new needle, dial the correct dose, inject, and dispose of needle.
Fewer Fingersticks
Factory-calibrated sensor. Finger sticks needed for backup only.
Frequent finger-sticks are required.
Privacy
Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. Sensor is the smallest option available.
Hideable. Pens can be hidden when not in use but visible when in use. Frequent injections are unavoidable.