device OmniDash5 copy
tidepool loop device

Summary

The first FDA-approved tubeless, waterproof pump that can be controlled entirely from a compatible Android smartphone. The system combines the Omnipod patch pump with the Dexcom continuous glucose monitor (CGM) to automatically adjust insulin delivery in response to glucose trends. It's easy to use and allows bolus dosing directly from a compatible smartphone.

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

Omnipod 5 : Pump

Omnipod 5 : Pump

Pods come with reservoirs and directions for application. They can be applied anywhere on the body that is comfortable.

Omnipod 5 : Sensor

Omnipod 5 : Sensor

Automatic applicator inserts sensor just under the surface of the skin and can be applied to many places on the body.

Omnipod 5 : Controller

Omnipod 5 : Controller

The Controller or a compatible smartphone allows the user to control the Pod using the Omnipod 5 App. Compatible smartphone can be used to view and administer boluses via the Omnipod 5 app.

Tidepool Loop  : Controller

Tidepool Loop : Controller

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

Device Details

Overview

This system includes a wearable, tubeless insulin Pod controlled by the Omnipod App on a compatible smartphone or a smartphone-like Insulet-provided Controller.

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

Affordability and Access

$$$$
Widely covered for insulin-dependent type 1 and 2. Supplies for Pump and Sensor provided by Pharmacy and/or DME suppliers. Projected price range; $5-$1260 to start and 0-$200/month.

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

Data Monitoring Options

Yes
Insulet Provided Glooko® is a data management platform that provides clear, actionable insights. Wireless data uploads directly into Glooko® to support both in-person and remote patient care.

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

Data View Options

Yes
Dexcom sensors permit remote monitoring. Wireless data uploads directly into Glooko® to support both in-person and remote patient care

Yes
Data can be viewed on an iPhone. 

Duration and Storage

3-day pump 10-day sensor
Sensors last 10 days and transmitters last 90 and work at 50ºF – 108ºF. Under normal circumstances, your body temperature keeps the Pod within a range of 73°F and 98.6°F

Pump and CGM information not yet available. 

Vision / Auditory / Dexterity

NO text to speech
YES vibration alerts
SOME dexterity needed

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

Patient Considerations

Active Lifestyle

Activity. Target glucose is set to 150 mg/dl. Automated insulin delivery is decreased ~50%. The maximum insulin delivery is deceased. Activity mode can be run for 1-24 hours. Wear the Pod in the shower, in the pool, or in the ocean. The Controller is not waterproof and must be charged daily.

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

Automated Mode uses insulin delivery history and sensor glucose value and trend to automatically increase, decrease, and pause insulin delivery based on current and predicted glucose values using a customizable glucose target.

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

Comfort

Low profile & no tubing. Low profile sensor and Omnipod has no tubing but may require more adhesive on the body than other pumps.

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

Easy Insulin Dosing

Automatically adjusts dosing. Sensor trends feed into Pods' customizable dose adjustments and there are no interruptions in insulin delivery. You can set a target between 110 mg/dL – 150 mg/dL in 10 mg/dL increments. Basal and bolus in 0.05 increments. Extended bolus unavailable when using automated insulin delivery mode. 

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

Smartphone Integration. Pod has fewer components to deal with than other pumps and can be fully controlled using a compatible smartphone. 

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

Fewer Fingersticks

Factory-calibrated sensor. Fingersticks needed for backup only.

Factory-calibrated sensor. Fingersticks needed for backup only.

Privacy

Discreet. Sensor allows for checking blood glucose on phone/smartwatch. Most discreet pump option with no visible controller required if using an Android smartphone.

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