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.
Tidepool Loop is thefirst fully interoperableautomated insulin dosing appthat 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 usewith third-partyinteroperable automated glycemic (iAGC) controllers.
Components
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
Automatic applicator inserts sensor just under the surface of the skin and can be applied to many places on the body.
Omnipod 5 : Controller
Smartphone receives CGM readings to automatically adjust basal insulin delivery via a tubeless pod. All insulin delivery can be fully controlled on the OmniPod app via a compatible Android smartphone.
Tidepool Loop : Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Device Details
Affordability and Access
$$$$
Widely covered for insulin-dependenttype 1 and 2. Supplies for Pump and Sensor provided by Pharmacy and/or DME suppliers. Projected price range; $5-$1260 to start and 0-$200/month.
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
Data Monitoring Options
Yes
Dexcom Clarity provides multiple data views and access through theCLARITY ClinicianPortalOmnipod data can be accessed by clinicians onDiasend by Glooko.
Yes
Compatible withTidepool- aweb-based diabetes data management system.
Data View Options
Yes
Dexcom sensors permit remote monitoring. The Omnipod DISPLAY app displays real-time data for the patient. The Omnipod VIEW app allows family and friends to view datafor up to 12 Omnipod users.(iPhone compatible only).
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. Pods can be used for up to 72 hrs and work from 41ºF –104ºF.
Pump and CGM information not yet available.
Vision / Auditory / Dexterity
NOtext to speech
YESvibration alerts
A LOTofdexterity needed
NOtext to speech
YESvibration alerts
A LOTofdexterity needed
Patient Considerations
Active Lifestyle
Exercise mode and waterproof. Can manually increase target to 150 mg/dl and suspend insulin delivery during exercise. Fully waterproof, tubeless, and can be worn for most exercises.
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
Auto-basal featureadjusts insulin delivery every 5-minutes based onDexcom CGM trends to maintain a target blood glucose between 110 mg/dl and 150 mg/dl. This system does not give auto-bolus correction.
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. Basaland 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 onmodifications to insulin delivery will be available soon.
Easy to Use
Fewer components.Pod has fewer components to deal with than other pumps.
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.
