Tidepool Loop
MiniMed Flex
Summary
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.
The MiniMed Flex is a tubed insulin pump system designed to automate insulin delivery using SmartGuard™ technology and the Simplera Sync sensor. Boluses can be delivered directly through the MiniMed app, while customizable settings help support glucose management throughout the day.
Components
Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Controller
Pump receives CGM readings and automatically adjusts insulin delivery. Data from the pump and CGM viewable on compatible smartphones.
Infusion Set
An infusion set contains the thin plastic tubing that delivers insulin from the pump to the body. Optional Medtronic Extended™ Infusion set (up to 7-day wear) available.
Reservoir
Tubed insulin pumps contain a plastic reservoir or cartridge that is manually filled with insulin and locked into the pump. ExtendedTM Reservoir MMT-342, 10PK. 3.0 ml (300 units).
Pump
Pump connects tubing to a small patch called an infusion set that attaches to the body.
Device Details
Overview
Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.
A tubed insulin pump system that works with the Simplera Sync sensor and SmartGuard™ technology to automatically adjust insulin delivery.
Affordability and Access
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
Widely covered for insulin-dependent type 1 and type 2. Pump can be provided by pharmacy or DME. Price range; $0-$8,574 to start and $0-$300/Month. Price range varies depending on insurance coverage.
Data Monitoring Options
Yes
Compatible with Tidepool - a web-based diabetes data management system.
Yes
Pump data can be viewed by your healthcare team on the CareLink therapy management software.
Data View Options
Yes
Data can be viewed on an iPhone.
Yes
Data is viewed on the phone app.
Duration and Storage
Pump and CGM information not yet available.
2-3 Days. Infusion site and pump reservoir last up to 72 hours and works between 41ºF - 93ºF.
Vision / Auditory / Dexterity
NO text to speech
YES vibration alerts
A LOT of dexterity needed
NO text to speech
YES vibration alerts
A LOT of dexterity needed
Patient Considerations
Active Lifestyle
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.
Exercise mode. Optional settings for exercise to adjust treatment ranges for activity with the press of a button. Pump is waterproof for up to 8 feet for 105 minutes.
Avoiding Highs and Lows
Automatically adjusts insulin delivery. Increases or decreases insulin delivery to meet glucose targets. Insulin delivery settings can be aggressive or conservative.
Precise dosing. Pumps allow different amounts of basal insulin at different times of day and very precise dosing.
Comfort
Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app.
Small tubed pump. Small patch called an infusion set consists of a complete tubing system that attaches to the body. Tubed pumps have the most infusion sets to pick from.
Easy Insulin Dosing
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.
Customizable dosing. Bolus calculator available to help figure out doses. Basal and bolus in 0.05 increments.
Easy to Use
Easy dosing. Software makes most dosing decisions easy to do on the fly.
Pump has a rechargeable battery that takes 30 minutes to charge, and lasts about a week.
Fewer Fingersticks
Factory-calibrated sensor. Fingersticks needed for backup only.
Frequent fingersticks are still required.
Privacy
Discreet. Ability to give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available.
Discrete. The MiniMed Flex is small with visible tubing. Can be clipped to clothing or placed in a pocket to be discrete when needed.