Tidepool Loop
Tempo Pen
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 Tempo system enhances management with multiple daily injections because it tracks data in real-time and offers personalized dosing recommendations. This system combines the Dexcom G6/G7 CGM with smart insulin pens for more time in range.
Components
Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Receiver
Smart button and sensor readings displays dosage information directly on smart mobile device.
Controller
Smart button records daily injections and sends them to the compatible app.
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.
Discreet and modern option for people using multiple daily injections.
Affordability and Access
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
$$$$
Sometimes covered. Tempo is covered by some commercial insurance companies; typically, users pay $35 out-of-pocket copays for the eight-month device. Prices range from $35- $165. For those without any insurance coverage, the button's full price is $165.
Data Monitoring Options
Yes
Compatible with Tidepool - a web-based diabetes data management system.
Yes
Data can be easily shared with a healthcare provider through the SMART Visit Report.
Data View Options
Yes
Data can be viewed on an iPhone.
Yes
Dose-related data can be viewed on the TempoSmart mobile app.
Duration and Storage
Pump and CGM information not yet available.
8-month button 10-day sensor
Sensor lasts for 10 days, pen button lasts for up to 8 months. Sensors can be stored between 36°F - 86°F, and pens can be kept at room temperature.
Vision / Auditory / Dexterity
NO text to speech
YES vibration alerts
A LOT of dexterity needed
NO text to speech
NO 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.
Light on body. Pens are easy to use and do not remain attached to the body, senor is light on the body.
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.
Limited customizability. System integrates the Dexcom G6/G7 CGM for high or low alerts but requires manual dose adjustment and limits the ability to adjust insulin levels throughout the day.
Comfort
Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app.
Many components. Have to carry pens and pen needles. CGM is attached to the body.
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.
Dosing recommendations. Displays personalized mealtime dosing recommendations.
Easy to Use
Easy dosing. Software makes most dosing decisions easy to do on the fly.
Simple design. Replaces regular insulin pen. No additional devices to add on.
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.
Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. View recommendations and data on a smartphone.