tidepool loop device
pen Device

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.

Insulin pens make insulin delivery more convenient than traditional vial/syringe options. Pens are small, portable, and more discrete to use in public. 

Components

Tidepool Loop  : Controller

Tidepool Loop : Controller

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

Insulin Pen : Bolus Insulin

Insulin Pen : Bolus Insulin

Bolus (fast-acting) insulin pen for meal time or high blood sugar correction.

Insulin Pen : Basal Insulin

Insulin Pen : Basal Insulin

Basal (long-acting) insulin pen for steady release of insulin that helps control blood sugar between meals, and overnight.

Insulin Pen : Needles

Insulin Pen : Needles

Disposable needle attaches to insulin pen for daily injections.

Device Details

Overview

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

Nothing on the body when not in use. Noticeable when dosing. 

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. Price range; 0-$1260/month depending on insurance coverage. 

Data Monitoring Options

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

No Options

Data View Options

Yes
Data can be viewed on an iPhone. 

No Options

Duration and Storage

Pump and CGM information not yet available. 

28 Days 
Can be kept at room temperature (not above 80º F) when in use for 28 days. Unopened insulin pens should be stored in the refrigerator (36ºF - 46ºF).

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.

No attachments to the body. Insulin pens are easy to use and do not remain attached to the body, allowing for a flexible and active lifestyle. 

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. Pens require manual dose adjustment and limit the ability to adjust basal insulin 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 pen and pen needles but nothing attached to the body. 

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. 

More precise than syringes. Ability to measure doses using a dial, increasing accuracy. 

Easy to Use

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

Simple but many steps. Attach a new needle, dial the correct dose, inject, and dispose of needle. 

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.

Hideable. Pens can be hidden when not in use but visible when in use. Frequent injections are unavoidable.