For people with type 1 diabetes ages 6 and up,1 twiist™ is the only AID system that combines two of today’s innovative diabetes technologies with simple, personalized settings designed to match your unique lifestyle.
Tidepool Loop enables the system to automatically adjust insulin delivery based on continuous glucose monitor (CGM) readings, your personalized settings, and predicted glucose levels. Designed for and by people living with diabetes, it provides a high degree of customization, including the widest target range.1-7
Innovative technology precisely measures the volume and flow of each microdose of insulin 4 times to make sure that you get the insulin you need when you need it.1,8 This technology also allows the twiist system to alert you to blockages up to 9 times faster than other AID systems.*,1,3-7
the only AID system that allows you to change your original carb entry after a meal to accommodate the unpredictability of real life1
twiist is the only AID system that allows you to bolus using the on-device bolus button, Apple iPhone, and through direct control from the Apple Watch1
weighing less than 2 pencils
(<2 oz), twiist is small enough to be discreet and large enough to hold up to 300 units1
presets allow you to customize dosing to match the unique demands of your day1
The twiist AID system, which will be commercialized by Sequel Med Tech, LLC, is the first drug delivery system that directly measures the volume and flow of insulin delivered with every microdose. Cleared for people ages 6 and up with type 1 diabetes, the twiist AID system offers the capability and flexibility to address each patient’s individual dosing needs, while providing precise insulin delivery to help achieve tighter glucose control.
The twiist system incorporates FDA-cleared Tidepool Loop technology, which enables the system to automatically adjust insulin delivery based on continuous glucose monitor (CGM) readings and predicted glucose levels. The technology was developed by Tidepool, a diabetes-focused non-profit organization. Sequel chose to partner with Tidepool because the technology is community driven, designed for and by people living with diabetes, provides individuals with a high degree of customization and, most importantly, delivers the clinical results patients are looking for. For more information about Tidepool, please visit www.tidepool.org.
The twiist system has been cleared for people ages 6 and up with type 1 diabetes. The twiist AID system is intended for single-patient use and requires a prescription.
The twiist AID system is indicated for people with type 1 diabetes.
Sequel is currently preparing for a US commercial launch and is expected to distribute twiist through the pharmacy channel so more people with type 1 diabetes have a convenient, affordable way to get started on an AID system. Sequel will share launch updates as they become available. In the meantime, patients with type 1 diabetes, their caregivers, and healthcare providers are encouraged to sign up at www.twiist.com for updates on the twiist AID system and availability.
The twiist AID system was cleared by the FDA for use with CGMs that have received FDA designation as integrated continuous glucose monitors (iCGMs). As the twiist AID system gets closer to commercial availability, Sequel Med Tech will publicize the list of compatible CGMs.
“The twiist AID system reimagines how insulin is measured and delivered for more personalization with a simpler design. I believe twiist will set a new standard for precise, dependable insulin delivery going forward.”
Dean Kamen
inventor of the first wearable insulin pump for diabetes and the twiist AID system
*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).
The twiist™ Automated Insulin Delivery (AID) system is intended for the continuous subcutaneous (under the skin) delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages six and above.
The device 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 device is intended for single-patient home use and requires a prescription.
The Tidepool Loop algorithm is intended for use with compatible integrated continuous glucose monitors (iCGM) and the twiist device 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. Tidepool Loop is intended for the management of type 1 diabetes mellitus in persons six years of age and greater. Tidepool Loop is intended for single-patient use.
The Tidepool Loop 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.
The twiist AID system with the Tidepool Loop is Rx – For Prescription Use Only.
The twiist AID system with the Tidepool Loop is not intended for anyone unable or unwilling to:
The user must not:
The twiist™ AID system is a product of Sequel™. “Tidepool” and the Tidepool logo are registered trademarks of Tidepool Project, a fully-qualified 501(c)(3) nonprofit organization.
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