simplera device
loop device v4

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.

Loop is a DIY (do-it-yourself) system. It takes some work to set up but allows people to think about diabetes less by automating basal insulin delivery based on predicted glucose levels. This system can be used with the Dexcom G6 and the Omnipod or Medtronic pumps. Information about DIY Loop can be found on the Loop or Riley Link websites.

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.

Loop : Pump

Loop : Pump

The system is compatible with Omnipod (left) or Medtronic (right) pumps. Both options can be applied anywhere on the body that is comfortable.

Loop : Sensor

Loop : Sensor

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

DIY Loop : Transmitter

DIY Loop : Transmitter

RileyLink allows the pump and sensor to communicate. It is only required if a Medtronic pump is used.

Loop : Controller

Loop : Controller

Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via an Omnipod or Medtronic pump.

Device Details

Overview

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

This is a DIY (do-it-yourself) system that needs significant setup. It has the most flexibility in settings and device options. It also depends on a third device called a "Riley Link" to communicate between sensor, phone, and pump. 

Affordability and Access

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

$$$$
Supplies can be covered for Omnipod or Medtronic pumps and Dexcom. Price range; $0-$8,574 to start and 0-$300/month. iPhone, app, and Riley link are not covered and must be set up independently. Riley link price range; $135-$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
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 can be viewed on an iPhone. 

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. Pods or pump reservoirs last for up to 72 hrs and work from 40ºF – 104ºF.

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.

Automatic responses. Can set custom blood sugar targets and insulin and carb sensitivities based on type of activity. App automatically responds to blood sugar changes during activity. *Medtronic option is not waterproof. Omnipod option is fully 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. 

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 but extra device. Low profile/low maintenance sensor. The RileyLink is an extra device that must be carried.

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

All settings are completely customizable. Can bolus from phone or smartwatch. Can operate “open-loop” where the user must enact insulin delivery based on recommendations or “closed-loop” where modifications to insulin delivery are automatically delivered.

Easy to Use

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

Difficult set-up but easy to use. Software makes most dosing decisions. Requires many parts. Can be difficult to set up. 

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 give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available. *Medtronic pump has tubing. Omnipod is most hideable pump option (no tubes or separate controller needed).