Tidepool Loop
Beta Bionics iLet Pancreas
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.
The iLet Bionic Pancreas is the first and only commercially-available, automated insulin delivery system that determines 100% of insulin doses without carb counting - offering better results with less work.
The iLet only needs a user's weight to get started. It then learns and adapts to the user's insulin needs based on their meal announcements and CGM data (Dexcom CGM or FreeStyle Libre 3 Plus sensor).
Components
Controller
Smartphone or smartwatch receives CGM readings and automatically adjusts insulin delivery via insulin pump.
Infusion Set
An infusion set contains the thin plastic tubing that delivers insulin from the pump to the body.
Controller
Pump receives CGM readings and automatically adjusts insulin delivery. Data from the pump and CGM viewable on compatible smartphones (iOS and Android)
Sensor
Sensor is inserted underneath the skin, either on the abdomen or arm.
Pump
Pump connects tubing to a small patch called an infusion set that attaches to the body.
Device Details
Overview
Tidepool Loop is the first fully interoperable automated insulin dosing app that originated as a patient-led initiative.
This system requires very little input from the physician or user. It only requires the user to input their weight to get started (glucose targets can be adjusted). Instead of carb counting,* the iLet just needs an estimate of the carbs in your meal – Usual for me, More or Less. The iLet is paired with either a Dexcom CGM or the FreeStyle Libre 3 Plus sensor.
*User must be carb aware.
Affordability and Access
$$$$
Pump and CGM supply information is not yet available. iPhone is not covered and must be set up independently.
$$$$
iLet and sensors are widely covered and provided by DME and pharmacy. Sensor price range $0-$550/month. iLet cost dependant on your insurance for DME or Pharmacy.
Data Monitoring Options
Yes
Compatible with Tidepool - a web-based diabetes data management system.
Yes
iLet Mobile App provides the ability to pull data from an iLet device to share with the Beta Bionics Cloud.
Data View Options
Yes
Data can be viewed on an iPhone.
Yes
Users can view their iLet data directly on the pump or by using the iLet Mobile App. iLet users can share their data with friends, family, and caregivers through the Bionic Circle App.
Duration and Storage
Pump and CGM information not yet available.
3-day pump up to 15 day sensor
Sensors last 10 or 15 days and transmitters last 90 and work at 50ºF – 108ºF. Pump can be used for up to 72 hrs, fully charged iLet will last for 4-5 days, and work between 36°F (2°C) to 86°F (30°C).
Vision / Auditory / Dexterity
NO text to speech
YES vibration alerts
A LOT of dexterity needed
NO text to speech
YES 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 exercise mode. Pump will continue to increase or decrease insulin dosing in response to changing CGM glucose levels as usual. However, insulin can be stopped at user's discretion. Pump is water resistant for up to 12 feet for 30 minutes.
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.
Auto basal and bolus insulin. The iLet makes the corrections for you. If you’re trending high, it will automatically give you more insulin to bring you back in range. If you’re trending low, it will reduce your current insulin dosage.
Comfort
Low-profile mobile app. Dosing and other adjustments can be done directly on the mobile app.
Somewhat comfortable. Low maintenance sensor. Larger pump option.
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.
Meal announcement controller. User must be carb aware. The iLet calculates and doses 100% of the insulin throughout the day and night, allowing the user to focus on other things in their lives. Please note: even when you use the "Meal Announcement." your blood glucose levels could rise above 250 mg/dL for a few hours. You'll need to be comfortable letting the iLet regulate your blood glucose.
Easy to Use
Easy dosing. Software makes most dosing decisions easy to do on the fly.
Easiest to Use. User weight is the only input required to start using the insulin pump. No carb counting *, correction factors, carb ratios, or pre-set basal rates required.
*User must be carb aware.
Fewer Fingersticks
Factory-calibrated sensor. Fingersticks needed for backup only.
Factory-calibrated sensor. Fingersticks needed for backup only.
Privacy
Discreet. Ability to give insulin via watch or phone. Ability to check sugar on phone or watch. Alerts available.
Discreet. Ability to check blood sugar on phone. Minimal pump interaction is required. Pump has tubing but can be clipped to clothing or placed in a pocket to be discreet when needed.