twiist
Dexcom Stelo
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.
Dexcom Stelo is the first over-the-counter low-profile, all-in-one glucose sensor/transmitter. This sensor lasts for up to 15 days and sends real-time glucose readings to a compatible smartphone app. No finger pricks or scanning is needed.
*Recently FDA approved for people 18 years or older with type 2 diabetes. Expected availability is summer 2024.
MARD of 9.2%
Components
Infusion Set
An infusion set contains the thin plastic tubing that delivers insulin from the pump to the body.
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.
Pump
Pump can be worn with a pump clip, adhesive patch or in a pocket.
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.
Small all-in-one sensor/transmitter with a quick warm-up period and can be worn in multiple areas.
Affordability and Access
$$$$
No insurance coverage data. Anticipated to be provided through Pharmacy.
$$$$
No insurance coverage data. Pricing is to be announced in summer 2024. Price expected to be low to allow for over the counter distribution.
Data Monitoring Options
Yes
Compatible with Tidepool - a web-based diabetes data management system.
To Be Announced
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.
To Be Announced
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.
15 Days
Sensors last 15 days. They are purchased over the counter. Works at 50ºF – 108ºF
Vision / Auditory / Dexterity
YES text to speech
YES vibration alerts
A LOT of dexterity needed
YES text-to-speech
YES vibration alerts
3 sound sources
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.
Waterproof when submerged in 2.4 meters of water and must be within 20 (unobstructed) feet of the receiver or mobile device. This device is intended to help people with non-insulin requiring type 2 diabetes better understand their blood sugar numbers.
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.
Very limited alerts. This device does not provide alarms and alerts for high, low, and rise/fall rates. This device is intended to track and understand the effects of food on blood sugar for people with type 2 diabetes.
Comfort
Low-profile. Low profile with an adhesive design that prevents the pump from catching on other objects.
Low profile and low maintenance sensor application.
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
No options. Stelo is intended for use by people with type 2 diabetes who do not require insulin to manage their blood sugar levels.
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.
Real-time data and alerts make dose adjustment easier.
Fewer Fingersticks
Factory-calibrated sensor. Fingersticks needed for backup only.
Factory-calibrated sensor. Finger sticks 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)
Small sensor. Discreet and thin sensor that is easy to hide under clothing.