Device Finder - Bigfoot Unity vs Beta Bionics iLet Pancreas

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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 iLet Bionic Pancreas is the first and only commercially-available, automated insulin delivery system that determines 100% of insulin doses without carb counting - offering better results with less work.

The iLet only needs a user's weight to get started. It then learns and adapts to the user's insulin needs based on their meal announcements and CGM data (Dexcom CGM or FreeStyle Libre 3 Plus sensor).

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.

Beta Bionics iLet Pancreas : Pump

Pump connects tubing to a small patch called an infusion set that attaches to the body.

Beta Bionics iLet Pancreas : Sensor

Sensor is inserted underneath the skin, either on the abdomen or arm.

Beta Bionics iLet Pancreas : Controller

Pump receives CGM readings and automatically adjusts insulin delivery. Data from the pump and CGM viewable on compatible smartphones (iOS and Android)

Beta Bionics iLet Pancreas : 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.

This system requires very little input from the physician or user. It only requires the user to input their weight to get started (glucose targets can be adjusted). Instead of carb counting,* the iLet just needs an estimate of the carbs in your meal – Usual for me, More or Less. The iLet is paired with either a Dexcom CGM or the FreeStyle Libre 3 Plus sensor.

*User must be carb aware.

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.

$$$$
iLet and sensors are widely covered and provided by DME and pharmacy. Sensor price range $0-$550/month. iLet cost dependant on your insurance for DME or Pharmacy.

Data Monitoring Options

Yes
Data from the iCGM and time-of-dose data from the smart caps are automatically uploaded to the cloud.

Yes
iLet Mobile App provides the ability to pull data from an iLet device to share with the Beta Bionics Cloud.

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
Users can view their iLet data directly on the pump or by using the iLet Mobile App. iLet users can share their data with friends, family, and caregivers through the Bionic Circle App.

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 up to 15 day sensor
Sensors last 10 or 15 days and transmitters last 90 and work at 50ºF – 108ºF. Pump can be used for up to 72 hrs, fully charged iLet will last for 4-5 days, and work between 36°F (2°C) to 86°F (30°C).

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.

No exercise mode. Pump will continue to increase or decrease insulin dosing in response to changing CGM glucose levels as usual. However, insulin can be stopped at user's discretion. Pump is water resistant for up to 12 feet for 30 minutes.

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. The iLet makes the corrections for you. If you’re trending high, it will automatically give you more insulin to bring you back in range. If you’re trending low, it will reduce your current insulin dosage.

Comfort

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

Somewhat comfortable. Low maintenance sensor. Larger pump option.

Easy Insulin Dosing

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

Meal announcement controller. User must be carb aware. The iLet calculates and doses 100% of the insulin throughout the day and night, allowing the user to focus on other things in their lives. Please note: even when you use the "Meal Announcement." your blood glucose levels could rise above 250 mg/dL for a few hours. You'll need to be comfortable letting the iLet regulate your blood glucose.

Easy to Use

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

Easiest to Use. User weight is the only input required to start using the insulin pump. No carb counting *, correction factors, carb ratios, or pre-set basal rates required.