Tidepool Loop
Dexcom G6
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.
This sensor lasts for 10 days and only needs finger sticks as a backup. Dexcom G6 has 3 parts - sensor, transmitter, and receiver. Data can be viewed on a compatible mobile device or a separate receiver. Optional low and high blood sugar notifications are available for this system.
FDA approved for insertion on the abdomen (indicated for patients age 2 years and older) or the upper buttocks (ages 2-17 years).
MARD of 9%
Components
Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Receiver
Receives data automatically from the transmitter. Can be substituted by compatible smartphone and smartwatch. Available for both iOS and Android devices.
Transmitter
Sends readings from sensor to device, clips into sensor. Can be used for 90 days.
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.
Device Details
Overview
Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.
Small sensor can be worn in multiple areas.
Affordability and Access
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
$$$$
Widely covered. Provided by DME and/or Pharmacy. Price range; $0-$500/month.
Data Monitoring Options
Yes
Compatible with Tidepool - a web-based diabetes data management system.
Yes
Automatically and continuously sends data to the user’s Dexcom Clarity web-based cloud which is accessible by clinicians. Data upload is possible with Glooko and Tidepool data-management systems.
Data View Options
Yes
Data can be viewed on an iPhone.
Yes
Users must download the Dexcom G6 and Dexcom Clarity apps to view and share data. Both apps provide multiple data views, sharing options, and access through the clinician portal using a code from the user's device. Caregivers can use the Dexcom Follow app to view data. Glooko and Tidepool can also be used to view data.
Duration and Storage
Pump and CGM information not yet available.
10 Days
Sensors last 10 days, and transmitters last 90 days. They are shipped 3 boxes at a time every 3 months – 9 sensors and 1 transmitter. Works at 50ºF – 108ºF
Vision / Auditory / Dexterity
NO text to speech
YES vibration alerts
A LOT of dexterity needed
YES text to speech
YES vibration alerts
3 sound sources
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.
Water-resistant when submerged in 2.4 meters of water and must be within 20 (unobstructed) feet of the receiver or 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.
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.
Comfort
Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app.
Low profile and low maintenance sensor application.
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.
Real-time data and alerts make dose adjustment easier.
Easy to Use
Easy dosing. Software makes most dosing decisions easy to do on the fly.
Flexible pump integration. Can be paired with multiple different types of pumps which gives flexibility for how to use the data.
Fewer Fingersticks
Factory-calibrated sensor. Fingersticks needed for backup only.
Factory-calibrated sensor. Finger sticks needed for backup only.
Privacy
Discreet. Ability to give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available.
Hypoglycemia safety alarm. Discreet but built-in hypoglycemia safety alarm alerts users when glucose is below 55 mg/dl and is always on.