twiist AID systempng
tidepool loop device

Summary

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.

Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.

Background: A diabetes non-profit called Tidepool decided in 2018 to officially support Loop and shepherd it through the FDA process. Tidepool Loop was cleared by the FDA in January 2023 with plans to launch with Dexcom and other alternate controller-enabled (ACE) pump partners (RileyLink will no longer be necessary).

2023 Updates from Tidepool:

  • Medtronic and Tidepool have decided to discontinue the development of a Medtronic insulin pump system compatible with Tidepool Loop.
  • As Omnipod 5 is now commercially available, Insulet is devoting all available resources to their Omnipod products, including the global launch and further development of Omnipod 5.
  • Future ACE Pumps that will be commercially compatible with Tidepool Loop will need to be FDA-cleared for use with third-party interoperable automated glycemic (iAGC) controllers.

Components

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.

Tidepool Loop  : Controller

Tidepool Loop : Controller

Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.

Device Details

Overview

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.

Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.

Affordability and Access

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

$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.

Data Monitoring Options

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

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

Data View Options

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.

 

Yes
Data can be viewed on an iPhone. 

Duration and Storage

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.

Pump and CGM information not yet available. 

Vision / Auditory / Dexterity

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

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

Patient Considerations

Active Lifestyle

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.

Automatic responses. Can set custom blood sugar targets and insulin and carb sensitivities based on type of activity. App automatically responds to blood sugar changes during activity.

Avoiding Highs and Lows

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

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

Comfort

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

Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app. 

Easy Insulin Dosing

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

Customizable. Can bolus from phone or smartwatch and all settings are expected to be customizable. More information on modifications to insulin delivery will be available soon. 

Easy to Use

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

Easy dosing. Software makes most dosing decisions easy to do on the fly.

Fewer Fingersticks

Factory-calibrated sensor. Fingersticks needed for backup only.

Factory-calibrated sensor. Fingersticks needed for backup only.

Privacy

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

Discreet. Ability to give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available.