Tidepool Loop

Discover personalized and transparent algorithmic decisions powering diabetes management.

Revolutionizing Diabetes Care with User-Centric Design

Experience the first Automated Insulin Delivery (AID) system built on an algorithm created by and for people with diabetes. With Tidepool Loop at its core, twiist offers your patients a truly adaptive and intelligent AID system, marking a new era in personalized diabetes care.

Predictive Power

Every 5 minutes, Loop makes 72 sequential glucose predictions to create a 6-hour glucose forecast based on therapy settings, recent history of insulin delivery, recent history of carb entries and recent CGM readings

Dynamic Adjustments

Basal Delivery
Automatically fine-tunes insulin delivery every 5 minutes to meet user-specified correction target.

Bolus Recommendations 
Utilizes the six-hour glucose forecast and the user-specified correction target to calculate precise bolus amounts for carbohydrate and glucose corrections.

*Adhesive options for on-body wear are currently being developed

Continuous Optimization

The algorithm recalculates its six-hour forecast every five minutes, integrating the latest insulin dosing, carbohydrate, and continuous glucose monitor data to ensure the most up-to-date and accurate diabetes management.

Clinically meaningful improvements across efficacy and psychosocial metrics^8,9*

In a sub-analysis of new users, prior versions of the Loop algorithm demonstrated clinically meaningful improvements across efficacy and psychosocial metrics^8,9*

6% Improvement in TIR⁸

Patients spend more time within target glucose levels, reducing the risk of long-term complications.

90% Reduction in severe hypoglycemia⁸

Dramatically decreasing the occurrence of dangerous low blood sugar episodes.

20% Decrease in diabetes distress⁹

Alleviating the emotional and mental burden associated with diabetes management.

21% Improvement in sleep quality⁹

Promoting better rest and overall well-being for patients.

*Results obtained with the DIY Loop algorithm using a non-twiist™ device. DIY Loop was a predecessor to Tidepool Loop without the added guardrails, in-app education, and safety features added by Tidepool.

Centralized Data Dashboard

Experience seamless diabetes management with our all-in-one status screen, displaying real-time data from an insulin pump, continuous glucose monitor, and blood glucose meter.

Intuitive User Experience

Enjoy a user-friendly interface featuring food emojis, customizable pre-meal and workout presets, and integrated in-app training, simplifying diabetes management.

Personalized Tracking and Insights

Monitor meals, exercise sessions, and daily activities with ease. Our advanced features provide valuable insights, empowering those with diabetes to make informed health decisions based on unique patterns and trends.

Apple Watch Integration for Discreet Management

Unlike many AID systems, twiist offers compatibility with most Apple Watch models, providing a convenient and discreet method to check glucose levels, log carbohydrates, and administer insulin boluses directly from the wrist.

INDICATIONS FOR USE

The twiist™ system is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages six and above. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The twiist system is intended for single patient, home use and requires a prescription.

Loop Indications for Use
Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and the twiist alternate controller enabled(ACE) insulin infusion pump to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend, and with the user’s confirmation, deliver correction boluses when glucose values are predicted to exceed user configurable thresholds. Loop is intended for the management of type 1 diabetes mellitus in persons six years of age and greater, and is intended for single-patient use. The twiist automated insulin delivery system is for prescription use only.

Bolus Calculator
Indications for Use
The simple bolus calculator, available when Loop is off, is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator-entered blood glucose, insulin sensitivity, carbohydrate ratio, correction range, and current active insulin.

REFERENCES

1. The twiist Automated Insulin Delivery (AID) System Powered by Tidepool User Guide, Sequel Med Tech: DKPI-09233-001 1.3 2024-02-23.
2. Calculation based on the following sources, reporting 1 U/hr basal rate: Omnipod 5 Technical User Guide (PT-001716-AW Rev03 03/24,) MiniMed 780G System User Guide (M036461C001 2). iLet Bionic Pancreas System User Guide (LA000081_D). Calculation based on the following sources, reporting 2 U/hr basal rate: t:slim X2 Insulin Pump User Guide (AW-1011648_B), Tandem Mobi System User Guide (AW-1012691_A 2023-Dec-07.)
3. Omnipod 5 Technical User Guide. Insulet Corporation: PT-001716-AW Rev. 03 03/24.
4. MiniMed 780G with the Guardian. Sensor System User Guide, Medtronic: M036461C001_2 2023-02-24.
5. t:slim X2 Insulin Pump with Control-IQ Technology User Guide, Tandem Diabetes Care: AW-1011648_B 2023-Nov-09.
6. Tandem Mobi System, Tandem Diabetes Care: AW-1012691_A 2023-Dec-07.
7. iLet Bionic Pancreas System Quick Reference Guide, Beta Bionics: LA000082_E.
8. Lum JW, Bailey RJ, Barnes-Lomen V, et al. A real-world prospective study of the safety and effectiveness of the Loop open source automated insulin delivery system. Diabetes Technol Ther. 2021;23(5):367-375.
9. Wong JJ, et al. Psychosocial Effects of the Loop Open-Source Automated Insulin Delivery System. J Diabetes Sci Technol 2023;17:1440–7.
10. R. D. Butterfield and N. M. Sims, “Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump with Acoustic Volume and Flow Sensing in Simulated High Consequence Situations,” in IEEE Open Journal of Engineering in Medicine and Biology, doi: 10.1109/OJEMB.2024.3408092.

CONTRAINDICATIONS

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The twiist automated insulin delivery system is not intended for anyone unable or unwilling to:

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Test blood glucose (BG) levels as recommended by their healthcare provider.
Maintain sufficient diabetes selfcare skills.
See their healthcare provider regularly.
Demonstrate adequate carbohydrate-counting skills (preferred, not required).

The user must not:

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Have difficulty seeing.
Have difficulty hearing.
Have deficient cognitive capabilities.
Have physical impairments that would make operating the pump or iPhone difficult.

“twiist,” “iiSure,” and the twiist logo are licensed trademarks of Sequel Med Tech, LLC. “Tidepool” and the Tidepool logo are trademarks of Tidepool Project, a fully-qualified 501(c)(3) nonprofit organization.
© 2024 Sequel Med Tech, LLC. All rights reserved.