iLet device img
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Summary

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).

The twiist AID system was cleared by the FDA for use with CGMs that have received FDA designation as integrated continuous glucose monitors (iCGMs). As the twiist AID system gets closer to commercial availability, Sequel Med Tech will publicize the list of compatible CGM

*Recently FDA approved for people with type 1 diabetes ages 6 and up.

Components

Beta Bionics iLet Pancreas : Pump

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

Beta Bionics iLet Pancreas : Sensor

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

Beta Bionics iLet Pancreas : Controller

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

Beta Bionics iLet Pancreas : Infusion Set

An infusion set contains the thin plastic tubing that delivers insulin from the pump to the body.

twiist  : Pump

twiist : Pump

Pump can be worn with a pump clip, adhesive patch or in a pocket.

twiist  : Controller

twiist : Controller

Pump is controlled by the twiist app on an iPhone. Data from both the pump and CGM are viewable on the twiist app Home Screen.

Twiist  : Infusion Set

Twiist : Infusion Set

An infusion set contains the thin plastic tubing that delivers insulin from the pump to the body.

Device Details

Overview

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.

This system automatically adjusts insulin delivery according to continuous glucose monitor (CGM) readings and predicted blood sugar levels. It is the first FDA-approved AID system with Apple Watch compatibility.

Affordability and Access

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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.

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No insurance coverage data. Anticipated to be provided through Pharmacy.  

Data Monitoring Options

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

Yes
Compatible with Tidepool - a web-based diabetes data management system. 

Data View Options

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.

Yes
Data is stored and can be viewed directly from the twiist app on the mobile device (iPhone), and can be linked to an Apple Watch for viewing data as well.

 

Duration and Storage

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).

3-day pump 10-day sensor
Sensors last 10 days, and transmitters last 90 and work at 50ºF – 108ºF. The reservoir holds 300 units and is disposable, and the pump can be used for up to 3 years.

Vision / Auditory / Dexterity

NO text to speech
YES 
vibration alerts
A LOT 
of dexterity needed

YES text to speech
YES vibration alerts
A LOT of dexterity needed

Patient Considerations

Active Lifestyle

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. 

Waterproof. The pump, when connected to the cassette, has a rating of IP28, indicating protection from continuous immersion in water. The pump can tolerate immersion to depths of up to 12 feet (3.7 m) for 1 hour.

Avoiding Highs and Lows

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.

Automatically adjusts insulin delivery. Increases or decreases insulin delivery to meet glucose targets. Insulin delivery settings can be aggressive or conservative.

Comfort

Somewhat comfortable. Low maintenance sensor. Larger pump option.

Low-profile. Low profile with an adhesive design that prevents the pump from catching on other objects. 

Easy Insulin Dosing

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.

Customizable. Can bolus from phone, smartwatch, or directly from the device without needing to be attached to your phone. The device also directly measures the volume (amount) and flow (speed) of insulin delivered with every micro-dose

Easy to Use

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.

*User must be carb aware.

Watch compatible. The twiist AID system is the first FDA-approved AID system that can be directly controlled from an Apple Watch.

Fewer Fingersticks

Factory-calibrated sensor. Fingersticks needed for backup only.

Factory-calibrated sensor. Fingersticks needed for backup only.

Privacy

Discreet. Ability to check blood sugar on phone. Minimal pump interaction is required. Pump has tubing but can be clipped to clothing or placed in a pocket to be discreet when needed. 

Discreet. The pump is in two pieces - the top (algorithm and battery) and the bottom (insulin chamber and AVS technology)