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 first FDA-approved tubeless, waterproof pump that can be controlled entirely from a compatible Android smartphone. The system combines the Omnipod patch pump with the Dexcom 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 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.
Omnipod 5 : Pump
Pods come with reservoirs and directions for application. They can be applied anywhere on the body that is comfortable.
Omnipod 5 : Sensor
Automatic applicator inserts sensor just under the surface of the skin and can be applied to many places on the body.
Omnipod 5 : Controller
The Controller or a compatible smartphone allows the user to control the Pod using the Omnipod 5 App. Compatible smartphone can be used to view and administer boluses via the Omnipod 5 app.
Device Details
Overview
Smart cap used for most disposable insulin pens with CGM integration.
This system includes a wearable, tubeless insulin Pod controlled by the Omnipod App on a compatible smartphone or a smartphone-like Insulet-provided Controller.
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 Pharmacy and/or DME suppliers. Projected price range; $5-$1260 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
Insulet Provided Glooko® is a data management platform that provides clear, actionable insights. Wireless data uploads directly into Glooko® to support both in-person and remote patient care.
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
Dexcom sensors permit remote monitoring. Wireless data uploads directly into Glooko® to support both in-person and remote patient care
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. Under normal circumstances, your body temperature keeps the Pod within a range of 73°F and 98.6°F
Vision / Auditory / Dexterity
NO text to speech
NO vibration alerts
A LOT of dexterity needed
NO text to speech
YES vibration alerts
SOME 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.
Activity. Target glucose is set to 150 mg/dl. Automated insulin delivery is decreased ~50%. The maximum insulin delivery is deceased. Activity mode can be run for 1-24 hours. Wear the Pod in the shower, in the pool, or in the ocean. The Controller 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.
Automated Mode uses insulin delivery history and sensor glucose value and trend to automatically increase, decrease, and pause insulin delivery based on current and predicted glucose values using a customizable glucose target.
Comfort
Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body.
Low profile & no tubing. Low profile sensor and Omnipod has no tubing but may require more adhesive on the body than other pumps.
Easy Insulin Dosing
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
Automatically adjusts dosing. Sensor trends feed into Pods' customizable dose adjustments and there are no interruptions in insulin delivery. You can set a target between 110 mg/dL – 150 mg/dL in 10 mg/dL increments. Basal and bolus in 0.05 increments. Extended bolus unavailable when using automated insulin delivery mode.
Easy to Use
Simple design. One-button device with easy to read display.
Smartphone Integration. Pod has fewer components to deal with than other pumps and can be fully controlled using a compatible smartphone.
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. Sensor allows for checking blood glucose on phone/smartwatch. Most discreet pump option with no visible controller required if using an Android smartphone.