a breakthrough in diabetes management is

coming soon

twiist automated insulin delivery (AID) system powered by Tidepool

Q: what is the twiist AID system powered by Tidepool?

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.

Q: why was Tidepool chosen as the algorithm partner for the twiist AID system?

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.

Q: for what condition has the FDA authorized the use of the twiist AID system?

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.

Q: can the twiist system be used in people with type 2 diabetes?

The twiist AID system is indicated for people with type 1 diabetes.

Q: when and where will the twiist AID system be available?

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.

Q: what CGMs will the twiist AID system be compatible with?

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.

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

personalized settings to match your lifestyle

retroactive adjustable carb entries

the only AID system that allows you to change your original carb entry after a meal to accommodate the unpredictability of real life¹

widest customizable target range of any commercial system

you can select a target glucose range as low as 87 mg/dL and as high as 180 mg/dL^1,3-7

multiple discreet bolus options — including through the Apple Watch

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

compact, lightweight with flexible wear options

weighing less than 2 pencils
(<2 oz), twiist is small enough to be discreet and large enough to hold up to 300 units¹

pre-meal and exercise presets

presets allow you to customize dosing to match the unique demands of your day¹

receive updates from twiist

frequently asked questions

what is the twiist AID system powered by Tidepool?

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.

why was Tidepool chosen as the algorithm partner for the twiist AID system?

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.

for what condition has the FDA authorized the use of the twiist AID system?

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.

can the twiist system be used in people with type 2 diabetes?

The twiist AID system is indicated for people with type 1 diabetes.

when and where will the twiist AID system be available?

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.

what CGMs will the twiist AID system be compatible with?

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

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click here to read our
FDA clearance announcement

*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).

References

1. DEKA R&D Corp. DEKA ACE Pump System with DEKA Loop User Guide. December 2023. 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. 2023.

Indications for Use

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.

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

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.