Summary
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.
Connected smart caps that recommend insulin doses for people using multiple daily injections. Thissystem 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.
Components
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
Smartphone receives CGM readings to automatically adjust basal insulin delivery via a tubeless pod. All insulin delivery can be fully controlled on the OmniPod app via a compatible Android smartphone.
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.
Device Details
Affordability and Access
$$$$
Widely covered for insulin-dependenttype 1 and 2. Supplies for Pump and Sensor provided by Pharmacy and/or DME suppliers. Projected price range; $5-$1260 to start and 0-$200/month.
$$$$
Monthly mail-order package includes all the supplies needed, for a regular subscription price or insurance-covered copay with no upfront costs.
Data Monitoring Options
Yes
Dexcom Clarity provides multiple data views and access through theCLARITY ClinicianPortalOmnipod data can be accessed by clinicians onDiasend by Glooko.
Yes
Data from the iCGM and time-of-dose data from the smart caps are automatically uploaded to the cloud.
Data View Options
Yes
Dexcom sensors permit remote monitoring. The Omnipod DISPLAY app displays real-time data for the patient. The Omnipod VIEW app allows family and friends to view datafor up to 12 Omnipod users.(iPhone compatible only).
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.
Duration and Storage
3-day pump 10-day sensor
Sensors last 10 days and transmitters last 90 and work at 50ºF –108ºF. Pods can be used for up to 72 hrs and work from 41ºF –104ºF.
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.
Vision / Auditory / Dexterity
NOtext to speech
YESvibration alerts
A LOTofdexterity needed
NOtext to speech
NOvibration alerts
A LOTofdexterity needed
Patient Considerations
Active Lifestyle
Avoiding Highs and Lows
Auto-basal featureadjusts insulin delivery every 5-minutes based onDexcom CGM trends to maintain a target blood glucose between 110 mg/dl and 150 mg/dl. This system does not give auto-bolus correction.
Limited customizability. System integrates the FreeStyle Libre 2 CGM for high/low alerts but requires manual dose adjustmentand limits the ability to adjust basal insulin throughout the day.
Comfort
Low profile & no tubing.Low profile sensor and Omnipod has no tubing but may require more adhesive on the body than other pumps.
Many components. Have to carry pens, smart caps, pen needles,and CGM is attached to the body.
Easy Insulin Dosing
Automatically adjusts dosing.Sensor trends feed into Pods' customizable dose adjustments and there are no interruptions in insulin delivery. Basaland bolus in 0.05 increments. Extended bolus unavailable when using automated insulin delivery mode.
Dosing recommendations.Displaysdosing recommendations and reminders for long-acting insulin.
Easy to Use
Fewer components.Pod has fewer components to deal with than other pumps.
Simple design. One-button devicewith easy to read display.
Fewer Fingersticks
Factory-calibrated sensor.Fingersticks needed for backup only.
Factory-calibrated sensor. Finger sticks needed for backup only.
Privacy
Discreet. Sensor allows for checking blood glucose on phone/smartwatch. Most discreet pump option with no visible controller required if using an Android smartphone.
Hideable. Pens are portable but visible when in use.Frequent injections are unavoidable.Sensor is the smallest option available.
