simplera device
tempo pen 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.

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

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.

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

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

Discreet and modern option for people using multiple daily injections.

Affordability and Access

$$$$
No insurance coverage data. Provided by DME and/or 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
Automatically and continuously sends data to the user’s Care Partner web-based cloud which is accessible by clinicians. 

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

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

Duration and Storage

7 Days
Sensors last 7 days. 

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
3 sound sources
SOME dexterity needed

NO text to speech
NO 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.

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

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. 

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

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.

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

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

Dosing recommendations. Displays personalized mealtime dosing recommendations.

Easy to Use

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

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

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.

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