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Sequel Med Tech’s twiist offers novel insulin management for people with type 1 diabetes

March 27, 2024

Sequel Med Tech’s twiist, a new automated insulin delivery (AID) system for people with type 1 diabetes ages 6 years and older, was granted FDA 510(k) clearance on March 18. Sequel says twiist is the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose. (Fitch, 2024; Sequel, 2024)

What’s the potential patient impact?

According to the American Diabetes Association, in 2021, more than 38 million Americans, or 11.6% of the population, had diabetes. Roughly 352,000 Americans under age 20 are estimated to have diagnosed diabetes. In 2017-2018, the annual incidence of diagnosed diabetes in youth was estimated at 18,200 with T1D. AID systems like twiist improve glycemic outcomes and quality of life for many people. In a recent meta-analysis, authors found that AID systems were more effective than conventional insulin therapy for children and adolescents with T1D in outpatient settings. (Zeng, 2023)

How does it work?

According to Sequel’s press release, the twiist system incorporates an automated insulin pump, designed by DEKA Research & Development Corp, and the FDA-cleared Tidepool Loop technology, which enables the system to automatically adjust insulin delivery based on continuous glucose monitor (CGM) readings and predicted glucose level. (Sequel, 2024)

The Tidepool Loop was developed by Deka, a company founded by Dean Kamen, inventor of the Segway and the first wearable infusion pump. As the first fully interoperable AID app, Tidepool was developed through patient-led, open-source initiatives. (Hale, 2024; Sequel, 2024)

The twiist system allows users to adjust the amount of insulin proactively or retroactively. The app interface displays food emojis that indicate the amount of carbohydrates ingested. Lollipop emojis represent a small amount of fast-acting carbs for a 30-minute bolus of insulin, a taco for snacks and most meals for a 3-hour bolus, or a pizza for a larger meal with a longer extended 5-hour bolus. Glucose targets can be set as low as 87 mg/dL, considerably lower than the standard target of 110 mg/dL that is pre-specified by other insulin pump companies. (Hale, 2024; Sequel, 2024)

Sources:

(2024, March 18). Globe Newswire. Sequel’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance. 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

Fitch, J. (2024, March 18). Contemporary Pediatrics. Twiist automated insulin delivery system FDA cleared for children 6 years and up with T1D. https://www.contemporarypediatrics.com/view/twiist-automated-insulin-delivery-system-fda-cleared-children-6-years-and-up-t1d

Hale, C. (2024, March 18). Fierce Biotech. Deka-designed, Tidepool-powered automated insulin pump looks to make waves in Type 1 diabetes. https://www.fiercebiotech.com/medtech/deka-designed-tidepool-powered-automated-insulin-pump-looks-make-waves-type-1-diabetes

Zeng B, et al. (2023, December 1). Diabetes Care. Automated Insulin Delivery Systems in Children and Adolescents With Type 1 Diabetes: A Systematic Review and Meta-analysis of Outpatient Randomized Controlled Trials. https://pubmed.ncbi.nlm.nih.gov/38011519/