Medtronic Simplera Sync
Tidepool Loop
Summary
This is a disposable, all-in-one CGM sensor integrated with Medtronic’s pump systems (e.g., MiniMed 780G). Typical wear time is 6 days, plus a 24-hour “grace period.” No routine fingersticks are required when the device is in closed-loop/SmartGuard mode.
FDA approved for ages 7+ on the back of the upper arm
MARD of ~9%
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
Sensor
Sensor uses a thin, flexible filament beneath the skin to continuously measure glucose every 5 minutes. Simple, one-step applicator makes insertion fast and easy.
Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Device Details
Overview
Disposable, all-in-one CGM sensor integrated with Medtronic’s pump systems
Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.
Affordability and Access
$$$$
Coverage depends on region and insurance; supplied via DME or specialty pharmacy.
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
Data Monitoring Options
Yes
Data streams directly to the pump; users and clinicians can view trends and logs via Medtronic’s platforms.
Yes
Compatible with Tidepool - a web-based diabetes data management system.
Data View Options
Yes
Data view directly on your connected pump or smart device.
Yes
Data can be viewed on an iPhone.
Duration and Storage
6 Days
Sensors last 6 days, with a 24-hour grace period, and need about 2 hours to warm up. They work between 41°F – 104°F and should be stored between 36°F – 86°F. They are usually shipped in 1–3 month supplies, which is about 5–15 sensors at a time.
Pump and CGM information not yet available.
Vision / Auditory / Dexterity
YES text to speech
YES vibration alerts
Multiple sound sources
Moderate dexterity needed
NO text to speech
YES vibration alerts
A LOT of dexterity needed
Patient Considerations
Active Lifestyle
Compact and integrated. Reducing bulk; compatibility with daily activities depends on the adhesive and body movement. Water-resistant up to 8 feet (2.4 m) for 30 minutes.
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
SmartGuard closed-loop. Pump adjustments use sensor data continuously to reduce highs and lows.
Automatically adjusts insulin delivery. Increases or decreases insulin delivery to meet glucose targets. Insulin delivery settings can be aggressive or conservative.
Comfort
Low profile. No overtape needed and one-hand insertion.
Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app.
Easy Insulin Dosing
SmartGuard technology. When paired with the MiniMed 780G, it automatically adjusts basal and gives correction boluses based on sensor readings. In manual mode, glucose values can guide dosing decisions, but fingersticks are required for confirmation.
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
All-in-one. Eliminates the need for a separate transmitter, simplifying sensor changes (although more frequent due to the 6-day wear).
Easy dosing. Software makes most dosing decisions easy to do on the fly.
Fewer Fingersticks
Calibration is optional. Perfect if you like having that choice.
Factory-calibrated sensor. Fingersticks needed for backup only.
Privacy
Small and integrated, but visible on the back of the arm. No separate transmitter reduces the number of visible parts. Alerts and alarms can be adjusted for discretion.
Discreet. Ability to give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available.