simplera device
stelo sensor

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.

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

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.

N/A

Device Details

Overview

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

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

To Be Announced 

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. 

To Be Announced 

Duration and Storage

7 Days
Sensors last 7 days. 

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
3 sound sources
SOME dexterity needed

YES text-to-speech
YES vibration alerts
3 sound sources
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 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

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. 

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

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 and low maintenance sensor application.

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

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

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

Real-time data and alerts make dose adjustment easier.

Fewer Fingersticks

Factory-calibrated sensor. Finger sticks needed for backup only.

Factory-calibrated sensor. Finger sticks needed for backup only.

Privacy

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

Small sensor. Discreet and thin sensor that is easy to hide under clothing.