tidepool loop device
Omnipod DASH Insulin Management System Personal Diabetes Manager PDM and Pod with the 1

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.

A tubeless, waterproof pump loved by kids and all who don't want tubes. A touchscreen smartphone-like Personal Diabetes Manager (PDM) is used to give insulin doses to the pod, which remains attached to the body. This pump is one of few that is completely waterproof. 

Components

Tidepool Loop  : Controller

Tidepool Loop : Controller

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

Omnipod DASHv2 : Pump

Omnipod DASHv2 : Pump

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

Omnipod Dash : Reservoir

Omnipod Dash : Reservoir

Fill reservoir is enclosed with the Pod and used to manually fill the Pod with insulin.

Omnipod Dash : Controller

Omnipod Dash : Controller

Separate Android-like is used for manual insulin delivery via a tubeless pod. Data and notifications from the PDM are viewable on a compatible smartphone.

Device Details

Overview

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

This system includes a wearable, tubeless insulin Pod that's controlled by a smartphone-like Personal Diabetes Manager (PDM). 

Affordability and Access

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

$$$$
Widely covered for insulin-dependent type 1 and 2. Supplies for Pump and Sensor provided by Pharmacy and/or DME suppliers. Price range; $5-$1260 to start and 0-$200/month. Touch-screen controller available in the starter kit at no additional cost.

Data Monitoring Options

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

Yes
Omnipod data can be accessed by clinicians on Diasend by Glooko.

Data View Options

Yes
Data can be viewed on an iPhone. 

Yes
The Omnipod DISPLAY app displays real-time data for the patient. The Omnipod VIEW app allows family and friends to view data for up to 12 Omnipod users. (iPhone compatible only)

Duration and Storage

Pump and CGM information not yet available. 

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.

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.

Waterproof. Wear the Pod in the shower, in the pool, or in the ocean. The PDM is not waterproof and must be charged daily. Data monitoring allows others to track your data during physical activity. 

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.

Personalized dosing. Pods can deliver personalized doses of rapid-acting insulin based on the rates programmed into the Personal Diabetes Manager (PDM) device to avoid highs and the ability to set zero basal rates to avoid lows. 

Comfort

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

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

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. 

Manually adjusting dosing. Omnipod DASH System allows the user to manually input their blood glucose (BG) readings from any BGM or CGM device of their choice. Basal and bolus in 0.05 increments.

Easy to Use

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

Fewer components. Pod has fewer components to deal with than other pumps and a touchscreen controller. 

Fewer Fingersticks

Factory-calibrated sensor. Fingersticks needed for backup only.

Frequent finger-sticks are required. 

Privacy

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

Discreet. Sensor allows for checking blood glucose on phone/smartwatch. The pod is the most discreet pump option but requires a visible controller to bolus.