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.
The OmniPod is the only tubeless pump option. A Personal Diabetes Manager (PDM) is used to give insulin doses to the pod, which remains attached to the body. This pump is one of few that is completely waterproof.
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.
Omnipod : Pump
Pods come with reservoirs and directions for application. They can be applied anywhere on the body that is comfortable.
Omnipod : Reservoir
Fill reservoir is enclosed with the Pod and used to manually fill the Pod with insulin.
Omnipod : Controller
Personal Diabetes Manager (PDM) is used to give insulin doses to the pod.
Device Details
Overview
Smart cap used for most disposable insulin pens with CGM integration.
This is a discreet pump option without tubing but will require a controller to dose.
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. Pump can be provided by pharmacy or DME. Price range; 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
Pump data can be accessed by clinicians on Diasend by Glooko.
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.
3 Days
Pod can be worn for up to 72 hours and work from 41ºF – 104ºF.
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.
Waterproof. Wear the Pod in the shower, in the pool, or in the ocean. The PDM is not waterproof and must be charged daily.
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.
Personalized dosing. Pods can deliver personalized doses of rapid-acting insulin based on the rates programmed into the Personal Diabetes Manager (PDM) device. The ability to set zero basal rates is not available.
Comfort
Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body.
Free of tubing. Pods do not have tubes like traditional insulin pumps, allowing for more freedom of movement.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
Customizable dosing. Basal and Bolus in 0.05 increments. No interruption in insulin delivery (pods stay on during bathing and swimming).
Easy to Use
Simple design. One-button device with easy to read display.
Fewer parts. The PDM has button navigation. Pod has fewer parts than tubed pumps.
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.
Somewhat discreet. The pod attaches directly to the body with no tubing, but the pod is bigger than an infusion set. Pod does not have vibrate option.