Tidepool Loop
CeQur Simplicity Patch
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.
Cequr Simplicity is a thin and simple insulin delivery patch for mealtime and correction insulin. The 3-day wearable patch doses two units of insulin with every squeeze of the buttons on either side of the device. Users can fill their CeQur Simplicity patch with 100-200 units of rapid-acting insulin. This device is a hybrid between injections and an insulin pump to allow for discreet dosing without the need for programming or multiple injections.
FDA-approved for both type 1 and type 2 diabetes in people 21 years of age and older.
Components
Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Applicator
Patch uses a thin, flexible cannula inserted just under the skin to deliver insulin. Push-button applicator allows patch to be placed on the body in one step.
Reservoir
Fill reservoir is enclosed with the Patch and used to manually fill the Patch with insulin.
Patch
Wearable insulin patches come with reservoirs and directions for application. They can be applied on the abdomen.
Device Details
Overview
Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.
Convenient, discreet, and simple to use.
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 provided by DME or pharmacy. Price range; $0-$500/Month. When covered, most patients have a co-pay of $50 or less a month. Insurance plans and pharmacy benefits may vary.
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.
3 Days
Patch can be worn for up to 72 hours and works in most temperatures (not for use in hot tubs, saunas, or freezing conditions). Does not require batteries or recharging.
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.
Limited Adjustability. No way to adjust long-acting insulin for higher activity on the fly, but the device is water resistant.
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 requires manual dose adjustment and limits the ability to adjust insulin levels throughout the day. If you need basal (background) insulin, you’ll still need to take it in addition to wearing the CeQur Simplicity.
Comfort
Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app.
Free of tubing. Patches do not have tubing and they're less bulky than traditional insulin pumps but it must be worn in areas that are easy to reach for insulin dosing.
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.
Easy to Use. Squeezing the buttons on either side of the device delivers insulin in two-unit increments for dosing insulin for meals and correction.
Easy to Use
Easy dosing. Software makes most dosing decisions easy to do on the fly.
Simple with few steps. Patch is replaced every 3 days with insulin administered at the click of a button.
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. Thinnest and lightest patch pump that's not as noticeable as injections.