bigfootunity new
tandem mobi

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 Tandem Mobi is the smallest durable automated insulin delivery system available in the U.S. that can be fully controlled by a mobile device. The pump is equipped with an on-pump button for users to bolus insulin directly from the pump if they don’t want to do it from their phone. This system is combined with the Dexcom continuous glucose monitor (CGM) to automatically adjust insulin delivery in response to glucose trends. 

*Compatiblilty with Dexcom G7 now available 

Components

Bigfoot Unity  : Sensor

Bigfoot Unity : Sensor

Sensor uses a thin, flexible filament inserted just under the skin to measure glucose levels every minute.

Bigfoot Unity  : Controller

Bigfoot Unity : Controller

Smart cap displays dosing recommendations for manual insulin delivery through multiple daily injections.

Bigfoot Unity  : Receiver

Bigfoot Unity : Receiver

Smartcap is used to scan the sensor and displays dosage information directly on the screen and smart mobile device.

Tandem Mobi : Pump

Tandem Mobi : Pump

Small pump connects tubing to a 5 inch tubing patch called an infusion set that attaches to the body.

Tandem Mobi : Sensor

Tandem Mobi : Sensor

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

Tandem Mobi : Controller

Tandem Mobi : Controller

Mobi pump receives CGM readings to automatically adjust basal insulin delivery via an infusion set. Compatible smartphone can be used to view and control insulin delivery.

Tandem Mobi : Infusion Set

Tandem Mobi : 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. 

Tandem Mobi is the smallest insulin delivery system to be fully controlled by a smartphone.

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. 

$$$$
Pump coverage is not yet available. Sensor is widely covered and provided by DME and/or Pharmacy. Sensor price range; $0-$500/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. Pump supports wireless charging.

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.

Waterproof. The pump and CGM are waterproof and can be worn for most exercises.

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 set blood glucose target. 

Comfort

Many components. Have to carry pens, smart caps, pen needles, and CGM is attached to the body. 

Shorter tubing option. A shorter 5-inch tubing option for comfort on body. 

Easy Insulin Dosing

Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin. 

Automatically adjusts dosing. Sensor integration allows the pump to automatically adjust insulin doses. More customizable dosing than pens or syringes. Manual bolus button is available for quick dosing without a phone. 

Easy to Use

Simple design. One-button device with easy to read display.

Easy Dosing. Full control from a smartphone, with the option to manually bolus if needed.

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 attached to local area with an armband or adhesive sleeve 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.