discover the future of automated insulin delivery (AID)

introducing twiist

personalized diabetes management for flexible control

Powered by Tidepool, the twiist™ system is a revolutionary advancement that will bring precision insulin delivery to people living with type 1 diabetes.

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and discover what makes the twiist system different:

simplified Access

expanded platform options

twiist will be the first commercially available AID system that will support the use of Tidepool Loop, expanding looping options beyond the DIY community^1-6

pharmacy availability

expected availability via pharmacy to streamline prescribing and patient access

personalized Control

only AID system with integrated Tidepool Loop algorithm

an FDA-cleared algorithm delivers real-world evidence of clinically meaningful benefits in severe hypoglycemia, A1C, and time in range (TIR)^1-7

widest target glucose range

from 87 mg/dL, the lowest of any AID system, to 180 mg/dL for greater personalization and tighter control^1-6

multiple discreet bolus options

using the on-device bolus button, Apple iPhone, and through the Apple Watch¹

flexible wear options

large enough to hold up to 300 units, small enough to be discreet (< 2 oz)¹

retroactive meal adjustments

the only AID system that allows carb entries not only before a meal, but also after a meal, to accommodate the unpredictability of real life¹

advanced Technology

fastest occlusion detection: detects occlusions up to 9x faster than other AID systems^1-6*

precision insulin dosing: measures each dose of insulin at 4 checkpoints to help ensure accurate delivery^1,8

1 advanced AID system

2 innovative technologies

real-world evidence of clinically meaningful benefits in severe hypoglycemia, A1C, and time in range^1,7

positive psychosocial and quality of life outcomes associated with the use of DIY Loop¹

*Calculation based on 1 U/hr basal rate and the following sources: Omnipod 5 Automated Insulin Delivery System. t:slim X2 Insulin Pump User Guide (AW-1011648_B; listed at 2 U/hr). Tandem Mobi 510(k) Substantial Equivalence Determination Decision Summary (listed at 2 U/hr) July 2023. MiniMed 780G System User Guide (M036461C001 2). iLet Bionic Pancreas System User Guide (LA000081_D).

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REFERENCES

1. DEKA R&D Corp. DEKA ACE Pump System with DEKA Loop User Guide. February 2024. 2. Insulet Corporation. Omnipod^® 5 Automated Insulin Delivery System User Guide (PDM-H001-G-XX PT-000369-AW Rev. 012). November 2022. 3. Medtronic. MiniMed™ 780G with the Guardian™ 4 Sensor System User Guide (M036461C001 2). February 2023. 4. Tandem™ Diabetes Care. t:slim X2 Insulin Pump With Control-IQ Technology User Guide (AW-1011648_B). June 2023. 5. Tandem Diabetes Care. Tandem Mobi System User Guide (AW-1012691_A). December 2023. 6. Beta Bionics. iLet Bionic Pancreas System User Guide (LA000081_D). May 2023. 7. 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. 8. Data on file. Sequel Med Tech, LLC. 2023.

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 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.

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, insulin to carbohydrate ratio, correction range, and current active insulin.

Contraindications

The twiist AID system with the Tidepool Loop 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

The user must not:

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

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