simplera device
twiist AID systempng

Summary

The Simplera continuous glucose monitor (CGM) is Medtronic’s first disposable, all-in-one CGM. This sensor lasts for 7 days and sends real-time glucose readings to a compatible smartphone app or directly on an Apple Watch. No finger pricks or scanning is needed. 

FDA-approved for people with diabetes ages 2 years and older.

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

Simplera : Sensor

Simplera : 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.

Simplera : Receiver

Simplera : Receiver

Conveniently access glucose readings using a reader, smartphone, or directly on an Apple Watch. Phone app available for both iOS and Android devices.

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

The Simplera is Medtronic's smallest continuous glucose monitor. It's disposable and has a flat, square shape.

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

$$$$
No insurance coverage data. Provided by DME and/or Pharmacy. 

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

Data Monitoring Options

Yes
Automatically and continuously sends data to the user’s Care Partner web-based cloud which is accessible by clinicians. 

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

Data View Options

Yes
Users must download the Simplera app to view and share data. Messages via the simplera app or text messages to notify care partners when glucose is high or low. 

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

7 Days
Sensors last 7 days. 

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

YES text to speech
YES vibration alerts
3 sound sources
SOME dexterity needed

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

Patient Considerations

Active Lifestyle

Waterproof when submerged in water and must be within range of the feet of the receiver or mobile device.

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

Custom alerts can be set for highs, lows, and rapidly rising or falling glucose levels. Trend arrows show the direction glucose is heading, with the rate of change. 

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

Comfort

Smaller size. The sensor is small and flat, and no overtape is required. Simplera’s adhesive is made from an anti-lint material that prevents sweat and water from reaching the sensor.

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

Easy Insulin Dosing

Real-time data and alerts make dose adjustment easier. The device can be integrated with the Medtronic InPen, which offers a bolus calculator based on carb ratios, meal estimations, the amount of insulin on board, and fixed dosing regimens

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

No scanning is required. Readings are sent directly to the mobile app every 5 minutes.

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. Finger sticks needed for backup only.

Factory-calibrated sensor. Fingersticks needed for backup only.

Privacy

Discreet. Small, flat shape and ability to see sugar on a watch or phone.

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