Tidepool + Data Platform

INDICATIONS FOR USE‍

The twiist™ Automated Insulin Delivery (AID) 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 automated insulin delivery system is not intended for anyone unable or unwilling to:

• 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).

Product not yet available outside of the U.S.

‍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.

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. Wong JJ, et al. Psychosocial Effects of the Loop Open-Source Automated Insulin Delivery System. J Diabetes Sci Technol. 2023;17(6):1440-1447.
10. 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.
11. Klonoff DC, et al. Time to Moderate and Severe Hyperglycemia and Ketonemia Following an Insulin Pump Occlusion. J Diabetes Sci Technol 2024.
12. Snow K, Aleppo G, Mitri J. (2026, March). Early Clinical Performance in the twiist™ AID System. [Poster Presentation] ATTD, Barcelona, Spain.
13. Study Design: Approved by the Institutional Review Board of the JAEB Center for Health Research (ClinicalTrials.gov Identifier: NCT03838900), Wong et al conducted a prospective, observational, real-world study including a subset of 239 adults with T1D to evaluate the psychosocial and quality of life outcomes of using DIY Loop. Patients initiated the DIY Loop either on their own, or with community-developed resources, and used the DIY Loop algorithm with a non-twiist insulin pump over 3 months.

*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

For full FreeStyle Libre 3 Plus sensor safety information, please visit https://www.freestyle.abbott/us-en/safety-information.html. 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.
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