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Powerful Evidence

Empowering healthcare providers with robust clinical data to support informed treatment decisions for patients with type 1 diabetes.

Pioneering Innovation in Diabetes Management

The twiist™ Automated Insulin Delivery (AID) System represents a groundbreaking advancement in diabetes care, uniquely combining the innovative iiSure™ Technology with the integrated twiist Loop algorithm, an unparalleled synergy that marks a new chapter in precision diabetes management. This fusion of cutting-edge technologies offers healthcare providers a powerful tool to optimize patient outcomes.
Real World Evidence

The Loop algorithm, at the heart of the twiist AID system, has demonstrated significant clinical benefits in real-world studies. Healthcare providers can confidently prescribe twiist, knowing it's backed by evidence-based technology designed to enhance glycemic control and improve quality of life for patients with type 1 diabetes.

Loop demonstrated real-world evidence of clinically meaningful benefits over 6 months in people with type 1 diabetes (N=175).1


The Loop Observational Study Design
The Jaeb Center for Health Research, in collaboration with Stanford University and Tidepool conducted an open-enrollment, observational study to collect data on the Loop System (ClinicalTrials.gov Identifier: NTC03838900).This study collected and analyzed data on the efficacy, safety, usability, and quality of life/psychosocial effects of the Loop System in patients diagnosed with type 1 diabetes (T1D) who were using insulin (pump therapy or multiple daily injections) and were using Loop or had plans to begin using Loop. Tidepool Loop is based on the same algorithm as Loop. Results obtained using Tidepool guardrails on a non-twiist™ device..

Intended User Population
‍Study population (n=175) was limited to the intended user population (ages 6 and up, use of Humalog or Novolog, settings within allowable Tidepool guardrails at least 90% of the time).

Unparalleled Occlusion Detection with iiSure™ Technology2

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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

‍

The twiist automated insulin delivery system is not intended for anyone unable or unwilling to:

‍

  • 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.
“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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