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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.

The twiist Loop algorithm 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, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. The twiist Loop algorithm is intended for the management of type 1 diabetes mellitus in persons six years of age and greater. The twiist Loop algorithm is intended for single-patient use and requires a prescription.

The twiist Automated Insulin Delivery System includes a simple bolus calculator available when Loop is off. It 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, insulin to carbohydrate ratio, target glucose values, and current insulin on board.

CONTRAINDICATIONS

The twiist AID System is not intended for anyone unable or unwilling to:

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

The user must not:

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

Product not yet available outside of the U.S.

REFERENCES

1. Sequel Med Tech - twiist Automated Insulin Delivery (AID) System Powered by Tidepool User Guide.
2. Calculation based on a comparison of the following IFUs. The following reported 1 U/hr basal rate: Sequel Med Tech - twiist Automated Insulin Delivery (AID) System Powered by Tidepool User Guide; lnsulet - Omnipod 5 Automated Insulin Delivery System User Guide; Medtronic - MiniMed 780G system User Guide; Beta Bionics - iLet Bionic Pancreas System User Guide. The following reported 2 U/hr basal rate: Tandem Diabetes Care - t:slim X2 Insulin Pump User Guide; Tandem Diabetes Care - Tandem Mobi System User Guide.
3. lnsulet - Omnipod 5 Automated Insulin Delivery System User Guide.
4. Medtronic - MiniMed 780G system User Guide.
5. Beta Bionics - iLet Bionic Pancreas System User Guide.
6. Tandem Diabetes Care - t:slim X2 Insulin Pump User Guide.
7. Tandem Diabetes Care - Tandem Mobi System User Guide.
8. Lum JW, 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. Klonoff DC, et al. Time to Moderate and Severe Hyperglycemia and Ketonemia Following an Insulin Pump Occlusion. J Diabetes Sci Technol. 2024;18(6):1472-1479.
10. Wong JJ, et al. Psychosocial Effects of the Loop Open-Source Automated Insulin Delivery System. J Diabetes Sci Technol. 2023;17(6):1440-1447.
11. Butterfield RD, et al. Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump With Acoustic Volume and Flow Sensing in Simulated High-Consequence Situations. IEEE Open J Eng Med Biol. 2024;5:593-599.

*The twiist™ Savings Program is available to individuals with a valid prescription and commercial insurance that covers twiist. Eligible participants can receive a Starter Kit for $0 and pay no more than $50 for Refill Kits. This offer is not valid for individuals enrolled in Medicare, Medicaid, or any other federal or state programs, or for cash-paying patients and non-covered claims. It is available only in the U.S. and is not valid in Puerto Rico, U.S. Territories, or where prohibited by law. While most commercially insured participants qualify for the $50 Refill Kit offer, those with high-deductible plans who haven't met their deductible may pay more than $50 per Refill Kit until their deductible is met. The maximum benefit is $200 per Refill Kit for covered claims. Terms are subject to change. Call us at 1-877-489-4478 or contact your insurance provider to confirm coverage.  

^†Sequel is working on adhesive options for on-body wear. Alternative adhesive options are available through third-party providers.

^‡Results obtained with the Loop algorithm using a non-twiist device.

Product for prescription only, for Important Safety Information please visit FreeStyleLibre.us
‍The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission.

The Eversense 365^® Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to one year in people (18 years and older) with diabetes. For important safety information, see bit.ly/eversensesafety.

“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. © 2026 Sequel Med Tech, LLC. All rights reserved.

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