INDICATIONS FOR USE¹

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
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, deliver 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, and is intended for single-patient use. The twiist automated insulin delivery system is for prescription use only .

‍Bolus Calculator
The twiist automated insulin delivery system 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) SystemPowered 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 SystemUser Guide (M036461C001 2). iLet Bionic Pancreas System User Guide(LA000081_D). Calculation based on the following sources, reporting 2 U/hrbasal rate: t:slim X2 Insulin Pump User Guide (AW-1011648_B), Tandem MobiSystem User Guide (AW-1012691_A 2023-Dec-07.) 3. Omnipod 5 Technical UserGuide. Insulet Corporation: PDM-H001-G-MG; PT-001716-AW Rev. 03 03/24 4.MiniMed 780G with the Guardian 4 Sensor System User Guide, Medtronic:M036461C001_2 2023-02-24 5. t:slim X2 Insulin Pump with Control-IQ TechnologyUser Guide, Tandem Diabetes Care: AW-1011648_B 2023-Nov-09 6. Tandem MobiSystem, Tandem Diabetes Care: AW-1012691_A 2023-Dec-07 7. iLet Bionic PancreasSystem User Guide, Beta Bionics: LA000081_E 8.Lum JW, et al. A Real-WorldProspective Study of the Safety and Effectiveness of the Loop Open SourceAutomated Insulin Delivery System. Diabetes Technol Ther 2021;23(5):367–75. 9.Data on file. Sequel Med Tech, LLC. 2023. 10. Wong JJ, et al. PsychosocialEffects of the Loop Open-Source Automated Insulin Delivery System. J DiabetesSci Technol 2023; 17(6):1440–7. 11. Butterfield RD, et al. Performance of aContinuous Subcutaneous Insulin Infusion (CSII) Pump with Acoustic Volume andFlow Sensing in Simulated High-Consequence Situations. IEEE Open J Eng Med Biol2024;PP(99):1–7.

*To be eligible for the twiist Savings Program, participants must have commercial insurance and not be enrolled in programs that pay for prescriptions in whole or in part by Medicare, Medicaid or any other federal or state programs. It is only valid in the United States, and not valid for cash-paying participants, in Puerto Rico or U.S. Territories, or where prohibited by law. The pay no more than $50 offer is applicable to most participants on commercial insurance, based on copay and coinsurance averages across all tiered cost sharing plan designs, but may not be applicable to participants on high-deductible plans who have not yet reached their deductible. Max benefit per month for covered claims is $200.

† Adhesive options for on body wear are currently being developed.

‡Results obtained with the Tidepool Loop algorithm used a non-twiist device ; twiist Loop is substantially equivalent to the predicate device, Tidepool Loop, as cleared in K203689

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