Tidepool Loop
Dexcom Stelo
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.
Dexcom Stelo is the first over-the-counter low-profile, all-in-one glucose sensor/transmitter. This sensor lasts for up to 15 days and sends real-time glucose readings to a compatible smartphone app. No finger pricks or scanning is needed.
*Recently FDA approved for people 18 years or older with type 2 diabetes. Expected availability is summer 2024.
MARD of 9.2%
Components
Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Device Details
Overview
Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.
Small all-in-one sensor/transmitter with a quick warm-up period and can be worn in multiple areas.
Affordability and Access
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
$$$$
No insurance coverage data. Pricing is to be announced in summer 2024. Price expected to be low to allow for over the counter distribution.
Data Monitoring Options
Yes
Compatible with Tidepool - a web-based diabetes data management system.
To Be Announced
Data View Options
Yes
Data can be viewed on an iPhone.
To Be Announced
Duration and Storage
Pump and CGM information not yet available.
15 Days
Sensors last 15 days. They are purchased over the counter. 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.
Waterproof when submerged in 2.4 meters of water and must be within 20 (unobstructed) feet of the receiver or mobile device. This device is intended to help people with non-insulin requiring type 2 diabetes better understand their blood sugar numbers.
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.
Very limited alerts. This device does not provide alarms and alerts for high, low, and rise/fall rates. This device is intended to track and understand the effects of food on blood sugar for people with type 2 diabetes.
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.
No options. Stelo is intended for use by people with type 2 diabetes who do not require insulin to manage their blood sugar levels.
Easy to Use
Easy dosing. Software makes most dosing decisions easy to do on the fly.
Real-time data and alerts make dose adjustment easier.
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.
Small sensor. Discreet and thin sensor that is easy to hide under clothing.