Tidepool Loop

Created by people with diabetes for people with diabetes

The twiist™ AID System is the first automated insulin delivery system that includes Tidepool Loop. This intuitive, smart technology was designed by people with diabetes and their caregivers for people with diabetes!

Predictive Power

Every 5 minutes, Loop makes glucose predictions to create a six-hour glucose forecast based on therapy settings, recent history of insulin delivery, recent history of carb entries and recent CGM readings.¹

Dynamic Adjustments

Basal Delivery
Automatically adjusts insulin delivery every 5 minutes to meet your personal Correction Target.

Bolus Recommendations 
Uses the six-hour glucose forecast and your 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 smart technology recalculates its six-hour forecast every five minutes, integrating the latest insulin dosing, carbohydrate, and sensor data to ensure the most up-to-date and accurate diabetes management.

The twiist App with Tidepool Loop is your diabetes management companion

Your All-in-One Diabetes Dashboard

No more juggling multiple devices or apps. The twiist home screen gives you a clear view of all your essential data in one place, including your insulin pump status, continuous glucose monitor (CGM) readings, and 6 hour glucose prediction. Get the full picture of your diabetes management at a glance, anytime, anywhere.¹

User-Friendly Design for a Smooth Experience

The twiist App includes an intuitive interface that's easy to navigate, fun food emojis to simplify carbohydrate logging, customizable Pre-meal and Workout Presets, and built-in tutorials to help you get started quickly.¹

Next Generation Diabetes Management Features

The twiist App helps you log meals, exercise, and daily activities with ease. Change your mind about what you are going to eat after you enter the carbohydrate information? With the twiist App you can easily edit your meal entry and Tidepool Loop will adjust accordingly.¹

Seamless Apple Watch Integration

The twiist AID System takes wearable tech to the next level. How? With most Apple Watch models, you can discreetly check your numbers without pulling out your phone. Best yet, enter carbs and deliver insulin right from your wrist. Manage type 1 diabetes on the go without missing a beat in your daily routine.

Redefining Diabetes Management

In other analyses of the Loop Observational Study, prior versions of the Loop technology demonstrated clinically meaningful improvements across efficacy and psychosocial metrics.^8,10‡

6% Improvement in TIR⁸

Loop users 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 distress¹⁰

Alleviating the emotional and mental burden associated with diabetes management.

21% Improvement in sleep quality¹⁰

Promoting better rest and overall well-being for people with diabetes.

^‡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.

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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CONTRAINDICATIONS¹

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The twiist AID 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.