simplera device
tidepool loop 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.

Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.

Background: A diabetes non-profit called Tidepool decided in 2018 to officially support Loop and shepherd it through the FDA process. Tidepool Loop was cleared by the FDA in January 2023 with plans to launch with Dexcom and other alternate controller-enabled (ACE) pump partners (RileyLink will no longer be necessary).

2023 Updates from Tidepool:

  • Medtronic and Tidepool have decided to discontinue the development of a Medtronic insulin pump system compatible with Tidepool Loop.
  • As Omnipod 5 is now commercially available, Insulet is devoting all available resources to their Omnipod products, including the global launch and further development of Omnipod 5.
  • Future ACE Pumps that will be commercially compatible with Tidepool Loop will need to be FDA-cleared for use with third-party interoperable automated glycemic (iAGC) controllers.

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.

Tidepool Loop  : Controller

Tidepool Loop : Controller

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

Device Details

Overview

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

Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.

Affordability and Access

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

$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.

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. 

Pump and CGM information not yet available. 

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.

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 mobile app. Dosing and other adjustments can be done directly on the mobile app. 

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 or smartwatch and all settings are expected to be customizable. More information on modifications to insulin delivery will be available soon. 

Easy to Use

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

Easy dosing. Software makes most dosing decisions easy to do on the fly.

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.