Tidepool Loop
Guardian Connect
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 Medtronic Guardian Connect is a continuous glucose monitoring (CGM) system that provides real-time glucose data on a compatible smartphone. The system offers optional low and high blood sugar notifications and can be inserted on the abdomen or back of the upper arm.
MARD of 9.6%
Components
Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Receiver
Trends and alerts are viewed directly on a mobile device. Available for both iOS and Android devices.
Transmitter
Seashell-shaped with built-in Bluetooth capability that allows it to send glucose data directly to a smartphone every 5 minutes.
Sensor
Sensor is inserted underneath the skin, either on the abdomen or arm. Push buttons applicator allows sensor to be placed on the body in one step.
Device Details
Overview
Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.
One of the larger sensors, may be cumbersome to wear on some parts of the body under clothes.
Affordability and Access
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
$$$$
Sometimes covered. The costs vary depending on individual insurance coverage and how insurance classifies CGMs. Price range $0-$600/month.
Data Monitoring Options
Yes
Compatible with Tidepool - a web-based diabetes data management system.
Yes
CGM data can be linked to a CareLink account and shared with the user's health care team.
Data View Options
Yes
Data can be viewed on an iPhone.
Yes
The Guardian Connect mobile app allows users to view glucose levels, trends, create customizable alerts, and share blood glucose data with family and friends.
Duration and Storage
Pump and CGM information not yet available.
7 Days
Sensors last 7 days, and transmitter battery needs weekly charging and replacement once a year. Both can be stored between 36°F - 86°F.
Vision / Auditory / Dexterity
NO text to speech
YES vibration alerts
A LOT of dexterity needed
YES 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.
Waterproof transmitter when submerged in up to 2.5 meters of water for 30 minutes and must be within 20 feet of a connected mobile device.
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.
Measures sensor glucose 24/7 and sends alerts when a high or low is detected. Trend arrows show the direction glucose is heading, with the rate of change.
Comfort
Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app.
More tape is needed for Medtronic sensors.
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.
Sensor trends can be used for dose adjustment.
Easy to Use
Easy dosing. Software makes most dosing decisions easy to do on the fly.
Rechargeable sensor transmitter but has the most steps to change sensor.
Fewer Fingersticks
Factory-calibrated sensor. Fingersticks needed for backup only.
2 daily finger-sticks are needed to calibrate the sensor.
Privacy
Discreet. Ability to give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available.
Somewhat discreet. Ability to see sugar on watch or phone. Sensor requires regular meter use.