Patient Information

Refer a Patient to start on the twiist™ AID System

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Enter the information below for the patient you are referring to use the twiist AID System.

Training Requested*

Date twiist AID system started*

First Name*

Last Name*

Email*

Date of Birth*

Gender

Diabetes Therapy Details

Language*

Comprehends English

Yes

Mobile Phone*

Home Phone

Address

City

State

Zip code*

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Personal Information

Relationship to Patient

Parent/Guardian/First Name

Parent/Guardian/Last Name

Parent/Guardian/Phone

CGM Sensor

Insulin Therapy

Primary Insurance

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Provider Information

HCP First Name*

HCP Last Name*

HCP Credentials

HCP NPI*

Please enter a valid NPI consisting of exactly 10 numeric digits.

HCP Phone*

HCP Fax

HCP Address

HCP City

HCP State

HCP Zip*

HCP Email

HCP Practice Name

I have consulted with the above patient, reviewed their medical history, and evaluated their diagnosis and care plan. I represent that I intend to prescribe the twiist Automated Insulin Delivery (AID) System for the patient for use in managing the patient’s diabetes in accordance with a prescription and treatment plan. I further represent that the information contained herein is accurate, to the best of my knowledge, and the twiist AID System, which I intend to prescribe, is reasonable and medically necessary for this patient.

Sequel Med Tech (“Sequel”) is a medical device company that distributes the twiist AID System. As a medical device company that provides health care services in relation to diabetes care, Sequel is a health care provider. Under the Health Insurance Portability and Accountability Act (“HIPAA’), Sequel, as a health care provider, is allowed to receive Protected Health Information (“PHI”) without an authorization to facilitate the prescription of the twiist AID System and the provision of training, supplies, and customer support to the patient. The patient has consented to their PHI and personal information being shared with Sequel, its authorized agents, and/or its authorized third-party service providers for treatment purposes.

I certify that I have read and agree to the statements above*

HCP to Type their Full Name*

Date of HCP Signature*

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INDICATIONS FOR USE¹

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.

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 .

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)System Powered by Tidepool User Guide, Sequel Med Tech: DKPI-09233-001-EN 1.72024-10-21
2. Calculation based on a comparison of the following IFUs. The following reported 1 U/hr basal rate: The twiist Automated Insulin Delivery (AID) System Powered by Tidepool User Guide, Sequel Med Tech(DKPI-09233-001-EN 1.7 2024-10-21). Omnipod 5 Technical User Guide (PT-000941-AW Rev07 10/24), MiniMed 780G System User Guide (M036461C001_22023-02-24). iLet Bionic Pancreas System User Guide (LA000081_E 3-19-24). The following reported 2 U/hr basal rate: t:slim X2 Insulin Pump User Guide (AW-1011648_B 2023-Nov-09), Tandem Mobi System User Guide (AW-1012691_A2023-Dec-07.)
3. Omnipod 5 Technical User Guide. Insulet Corporation; PT-000941-AW Rev. 07 10/24
4. MiniMed 780G with the Guardian. Sensor System User Guide, Medtronic: M036461C001_2 2023-02-24.
5. iLet Bionic Pancreas System Quick Reference Guide, Beta Bionics: LA000082_E.
6. t:slim X2 Insulin Pump with Control-IQ Technology User Guide, Tandem Diabetes Care: AW-1011648_B 2023-Nov-09.
7. Tandem Mobi System, Tandem Diabetes Care: AW-1012691_A 2023-Dec-07.
8. 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.
9. Wong JJ, et al. Psychosocial Effects of the Loop Open-Source Automated Insulin Delivery System. J Diabetes Sci Technol 2023;17:1440–7.
10. R. D. Butterfield and N. M. Sims, “Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump with Acoustic Volume and Flow Sensing in Simulated High Consequence Situations,” in IEEE Open Journal of Engineering in Medicine and Biology, doi: 10.1109/OJEMB.2024.3408092.

Product not yet available outside of the U.S.

CONTRAINDICATIONS

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The twiist automated insulin delivery 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.

For full FreeStyle Libre 3 Plus sensor safety information, please visit https://www.freestyle.abbott/us-en/safety-information.html.
The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission.

“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.
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