FDA Grants Clearance to twiist Automated Insulin Delivery System for T1D


The FDA has granted 510(k) clearance to the twiist Automated Insulin Delivery System, the first drug delivery system that measures both insulin volume and flow with each micro-dose, according to a company press release.1 The system is cleared for use in individuals aged 6 years and older with type 1 diabetes.

The twiist Automated Insulin Delivery System will be commercialized by Sequel Med Tech, LLC; clearance was granted to Sequel’s partner DEKA Research and Development Corp.

Twiist utilizes the FDA’s medical device interoperability standards to help patients more effectively tailor their diabetes management to their individual needs. Specifically, twiist uses FDA-cleared Tidepool Loop technology that allows the automated insulin delivery system to automatically adjust insulin delivery based on continuous glucose monitoring readings and predicted glucose levels.

The twiist Automated Insulin Delivery System utilizes the FDA's medical device interoperability standards. | Image credit: natali_mis - stock.adobe.com

The twiist Automated Insulin Delivery System utilizes the FDA's medical device interoperability standards. | Image credit: natali_mis - stock.adobe.com

According to the press release, Sequel chose to partner with Tidepool due to the community-driven nature of the technology “designed for and by people living with diabetes” which gives individuals living with type 1 diabetes a high degree of customization alongside positive clinical results. Tidepool is a diabetes-focused non-profit organization.

“There’s been a real need for continued innovation in insulin delivery, and the twiist [Automated Insulin Delivery] system powered by Tidepool represents a substantial leap forward,” said Tidepool president and CEO Howard Look in a press release. “The twiist [Automated Insulin Delivery] system takes advantage of the Tidepool Loop algorithm, the first and only FDA-cleared glycemic controller that originated as a patient-led initiative.”

Tidepool Loop was granted FDA clearance in January 2023.2

DEKA Research and Development developed the drug delivery technology of the twiist Automated Insulin Delivery system.

READ MORE: FDA Gives 510(k) Clearance to App That Controls Insulin Delivery System for Type 1 Diabetes

“The FDA’s clearance marks a transformative moment, and we would like to thank the FDA for their vision of interoperability in insulin delivery that will help improve diabetes therapies for years to come,” said Dean Kamen, DEKA founder and the inventor and entrepenuer who commercialized the first wearable insulin pump. “The twiist system was designed from the start to integrate with the latest available innovation and it represents the next generation of insulin delivery.”

Kamen continued, “The twiist [Automated Insulin Delivery] system reimagines how insulin is measured and delivered for more personalization with a simpler design.”

Earlier this year, researchers from the T1D Exchange Quality and Improvement Collaborative published results of a study on insulin pump utilization in a large, multicenter, observational, cohort study of adults and children with type 1 diabetes between 2017 and 2021.3 Although insulin pump use has increased over time, that use differs by sex, insurance type, and patient race and ethnicity. However, the positive outcomes of insulin pump use—including more optimal HbA1c, increased use of continuous glucose monitoring technology, and lower rates of diabetic ketoacidosis and severe hypoglycemia—underscore the need to improve diabetes technology access.

Nearly 2 million Americans, including 304,000 children and adolescents, are living with type 1 diabetes.4 The total cost of diagnosed diabetes in the US topped $412.9 billion in 2022, with $306.6 billion spent on direct medical costs and $106.3 billion spent on indirect medical costs.

READ MORE: Continuous Glucose Monitoring Resource Center

  1. Sequel’s twiist automated insulin delivery system receives FDA 510(k) clearance. News release. Sequel. March 18, 2024. Accessed March 18, 2024. https://www.globenewswire.com/news-release/2024/03/18/2847675/0/en/Sequel-s-twiist-Automated-Insulin-Delivery-System-Receives-FDA-510-k-Clearance.html
  2. Look H. Tidepool Loop has received FDA clearance! Tidepool. January 24, 2023. Accessed March 18, 2024. https://www.tidepool.org/blog/tidepool-loop-has-received-fda-clearance
  3. Ghandi K, Ebekozien O, Noor N, et al; and the T1D Exchange Quality Improvement Collaborative. Insulin pump utilization in 2017-2021 for more than 22,000 children and adults with type 1 diabetes: A multicenter observational study. Clin Diabetes. 2024;42(1):56-64. doi:10.2337/cd23-0055
  4. Statistics about diabetes. American Diabetes Association. Accessed March 18, 2024. https://diabetes.org/about-diabetes/statistics/about-diabetes
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