tempo pen device
tidepool loop device

Summary

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. 

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.

Components

Tempo Pen  : Sensor

Tempo Pen : 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.

Tempo Pen  : Controller

Tempo Pen : Controller

Smart button records daily injections and sends them to the compatible app.

Tempo Pen  : Receiver

Tempo Pen : Receiver

Smart button and sensor readings displays dosage information directly on smart mobile device.

Tidepool Loop  : Controller

Tidepool Loop : Controller

Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.

Device Details

Overview

Discreet and modern option for people using multiple daily injections.

Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.

Affordability and Access

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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.

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Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.

Data Monitoring Options

Yes
Data can be easily shared with a healthcare provider through the SMART Visit Report. 

Yes
Compatible with Tidepool - a web-based diabetes data management system. 

Data View Options

Yes
Dose-related data can be viewed on the TempoSmart mobile app.

Yes
Data can be viewed on an iPhone. 

Duration and Storage

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.

Pump and CGM information not yet available. 

Vision / Auditory / Dexterity

NO text to speech
NO vibration alerts
A LOT of dexterity needed

NO text to speech
YES 
vibration alerts
A LOT 
of dexterity needed

Patient Considerations

Active Lifestyle

Light on body. Pens are easy to use and do not remain attached to the body, senor is light on the body.

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.

Avoiding Highs and Lows

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. 

Automatically adjusts insulin delivery. Increases or decreases insulin delivery to meet glucose targets. Insulin delivery settings can be aggressive or conservative.

Comfort

Many components. Have to carry pens and pen needles. CGM is attached to the body.

Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app. 

Easy Insulin Dosing

Dosing recommendations. Displays personalized mealtime dosing recommendations.

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. 

Easy to Use

Simple design. Replaces regular insulin pen. No additional devices to add on. 

Easy dosing. Software makes most dosing decisions easy to do on the fly.

Fewer Fingersticks

Factory-calibrated sensor. Finger sticks needed for backup only. 

Factory-calibrated sensor. Fingersticks needed for backup only.

Privacy

Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. View recommendations and data on a smartphone. 

Discreet. Ability to give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available.