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iiSure™ Technology directly measures the volume of insulin delivered and includes 4 checkpoints along the way to help ensure accurate delivery.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 twiist AID system, which will be commercialized by Sequel Med Tech, LLC, is the first drug delivery system that directly measures the volume of insulin delivered and includes 4 checkpoints along the way to help ensure accurate delivery. The twiist AID System is cleared for people ages 6 and up with type 1 diabetes and offers the capability and flexibility to address each patient’s individual dosing needs, while providing accurate 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.”
*Calculation based on 1 U /hr basal rate and the following sources: Omnipod 5 Automated Insulin Delivery System User Guide. PDM-H001-G-XX PT-000369-AW Rev. 012. t:slim X2 Insulin Pump User Guide AW-1011648_B (listed at 2 U/hr). Tandem Mobi user guide AW-1012691_A (listed at 2 U/hr). MiniMed 780G System User Guide M036461C001 2. iLet Bionic Pancreas System User Guide, LA000081_D.
1. DEKA R&D Corp. DEKA ACE Pump System with DEKA Loop User Guide. February 2024. 2. 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. 3. Insulet Corporation. Omnipod® 5 Automated Insulin Delivery System User Guide (PDM-H001-G-XX PT-000369-AW Rev. 012). November 2022. 4. Medtronic. MiniMed™ 780G with the Guardian™ 4 Sensor System User Guide (M036461C001 2). February 2023. 5. Tandem™ Diabetes Care. t:slim X2 Insulin Pump With Control-IQ Technology User Guide (AW-1011648_B). June 2023. 6. Tandem Diabetes Care. Tandem Mobi System User Guide (AW-1012691_A). December 2023. 7. Beta Bionics. iLet Bionic Pancreas System User Guide (LA000081_D). May 2023. 8. Data on file. Sequel Med Tech, LLC. 2023.
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.
The twiist AID system with the Tidepool Loop is not intended for anyone unable or unwilling to:
The user must not:
“twiist,” “iiSure,” and the twiist logo are 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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