Tidepool Loop
Medtronic InPen
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 InPen system enhances management with multiple daily injections because it tracks data in real-time and offers personalized dosing recommendations. This system combines the Guardian Connect 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.
Controller
Inpen connects to a mobile app and displays dosage information directly on a smart mobile device.
Cartridge
InPen is compatible with Humalog, Novolog, and Fiasp U-100 3.0 mL insulin cartridges.
Sensor
Sensor is inserted underneath the skin, either on the abdomen or arm. InPen is compatible with the Medtronic Guardian Connect sensor (left) or the Dexcom G6 sensor (right).
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
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
$$$$
Widely covered. InPen is covered by many insurance companies, typically users pay $50-$60 out-of-pocket copays for the one-year device. Prices range from $0- $549. For those without any insurance coverage, the pen's full price is $549.
Data Monitoring Options
Yes
Compatible with Tidepool - a web-based diabetes data management system.
Yes
Data can be easily shared with a healthcare provider or family members directly through the InPen app.
Data View Options
Yes
Data can be viewed on an iPhone.
Yes
Data can be viewed on the InPen mobile app with dosage recommendations, glucose readings, and glucose trends.
Duration and Storage
Pump and CGM information not yet available.
12-month pen 7-day sensor
Sensor lasts for 7 days, insulin pen lasts for up to 12 months with refillable cartridges, transmitter is rechargeable. Sensor 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, sensor is waterproof.
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 Guardian Connect 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 InPen and pen needles. CGM is attached to the body and requires more tape than other 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.
Dosing recommendations. Displays dosing recommendations and reminders for long-acting insulin.
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.
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.
Hideable. Pens are portable but visible when in use. Frequent injections are unavoidable. View recommendations and data on a smartphone.