simplera device
libre2 tslim device

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.

This system is the first automated insulin delivery system that combines the Tandem t:slim x2 with the Freestyle Libre 2 Plus continuous glucose monitor (CGM) to automatically adjust insulin delivery in response to glucose trends. It's easy to use and allows bolus dosing directly from a compatible iOS or Android smartphone. 

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.

Control IQ with Freestyle Libre  : Pump

Control IQ with Freestyle Libre : Pump

Touch screen pump connects tubing to a small patch called an infusion set that attaches to the body.

Control IQ with Freestyle Libre  : Sensor

Control IQ with Freestyle Libre : Sensor

Automatic applicator inserts sensor just under the surface of the skin and can be applied to many places on the body.

Control IQ with Freestyle Libre  : Controller

Control IQ with Freestyle Libre : Controller

t:slim pump receives CGM readings to automatically adjust basal insulin delivery via an infusion set. Compatible smartphone can be used to view and control insulin delivery using the t:connect app.

Control IQ with Freestyle Libre  : Infusion Set

Control IQ with Freestyle Libre : 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 levels from the Tandem t:slim X2 pump based on the Libre 2 Plus readings for more time in range.

Affordability and Access

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

$$$$
Widely covered for insulin-dependent type 1 and 2. Supplies for Pump and Sensor provided by DME suppliers. Price range; $5-$6,995 to start and $0-$200/month.

Data Monitoring Options

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

Yes
The t:connect mobile app for the t:slim X2 pump wirelessly uploads pump and CGM data to the cloud-based t:connect web application.

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 can be viewed directly on the pump screen or on the t:connect mobile app (available for both iOS and Android devices).

Duration and Storage

7 Days
Sensors last 7 days. 

3-day pump 15-day sensor
Sensors last 14 days, and transmitters last 90 and work at 50ºF - 113ºF. Pump can be used for up to 72 hrs, battery life lasts five days with the use of CGM, and work between 40°F - 99°F. 

Vision / Auditory / Dexterity

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

NO 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.

Exercise Activity. Can manually increase target range to 140-160 mg/dl. Insulin decreases when Control IQ predicts CGM ≤140 mg/dl and increases when ≥ 160 mg/dl within 30 minutes. Autocorrections will still occur. Pump is not waterproof. CGM is waterproof. 

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. 

Auto basal and bolus insulin. Responds to CGM data by increasing or decreasing basal insulin delivery to prevent highs and lows and maintain a target blood glucose of 110 mg/dl. Auto-bolus is available once per hour to correct blood sugar above 180 mg/dl.

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/low maintenance sensor. Small tubed pump with the most infusion sets to pick from.

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

Automatically adjusts dosing. Sensor integration allows for the pump to automatically adjust insulin doses. More customizable dosing than pens or syringes. Basal in 0.001 increments, bolus in 0.01 increments. Extended bolus available.

Easy to Use

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

Modern & no scanning required. Rechargeable and touchscreen pump. Sensor does not require scanning and sends minute-by-minute readings directly to the pump.

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. Ability to check blood sugar on phone or watch. Ability to bolus on a compatible smartphone. Pump has tubing but can be clipped to clothing or placed in a pocket to be discreet when needed. CGM has a built-in hypoglycemia safety alarm that alerts users when glucose is below 55 mg/dl and is always on.