twiist AID systempng
tempo pen 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.

The Tempo system enhances management with multiple daily injections because it tracks data in real-time and offers personalized dosing recommendations. This system combines the Dexcom G6/G7 CGM with smart insulin pens for more time in range. 

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.

Tempo Pen  : Sensor

Tempo Pen : Sensor

Sensor uses a thin, flexible filament inserted just under the skin to measure glucose levels every 5 minutes. Push-button applicator allows sensor to be placed on the body in one step.

Tempo Pen  : Controller

Tempo Pen : Controller

Smart button records daily injections and sends them to the compatible app.

Tempo Pen  : Receiver

Tempo Pen : Receiver

Smart button and sensor readings displays dosage information directly on smart mobile device.

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.

Discreet and modern option for people using multiple daily injections.

Affordability and Access

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

$$$$
Sometimes covered. Tempo is covered by some commercial insurance companies; typically, users pay $35 out-of-pocket copays for the eight-month device. Prices range from $35- $165. For those without any insurance coverage, the button's full price is $165.

Data Monitoring Options

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

Yes
Data can be easily shared with a healthcare provider through the SMART Visit Report. 

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
Dose-related data can be viewed on the TempoSmart mobile app.

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.

8-month button 10-day sensor 
Sensor lasts for 10 days, pen button lasts for up to 8 months. Sensors can be stored between 36°F - 86°F, and pens can be kept at room temperature.

Vision / Auditory / Dexterity

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

NO text to speech
NO 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.

Light on body. Pens are easy to use and do not remain attached to the body, senor is light on the body.

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.

Limited customizability. System integrates the Dexcom G6/G7 CGM for high or low alerts but requires manual dose adjustment and limits the ability to adjust insulin levels throughout the day. 

Comfort

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

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

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

Dosing recommendations. Displays personalized mealtime dosing recommendations.

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.

Simple design. Replaces regular insulin pen. No additional devices to add on. 

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)

Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. View recommendations and data on a smartphone.