Twiist automated insulin delivery system FDA cleared for children 6 years and up with T1D
Integrated data from a continuous glucose monitoring device (CGM) and an insulin pump to automate insulin delivery allow AID systems to manage patient blood sugar levels more "effectively," according to Sequel.
Twiist automated insulin delivery system FDA cleared for children 6 years and up with T1D | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.
The twiist Automated Insulin Delivery (AID) system (DEKA Research & Development Corp.) has received a 510(k) clearance from the FDA as the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose for people aged 6 years and older with type 1 diabetes, according to a press release from Sequel Med Tech, LLC.
The device offers the flexibility and capability to address individualized dosing needs.
Integrated data from a continuous glucose monitoring device (CGM) and an insulin pump to automate insulin delivery allow AID systems to manage patient blood sugar levels more "effectively," according to Sequel.
FDA-cleared Tidepool Loop Technology is incorporated into the twiist system, which allows it to automatically adjust insulin delivery based on CGM readings and predicted glucose levels, stated Sequel. Tidepool is a non-profit organization focused on diabetes. According to Sequel, the underlying technology was "community driven" and designed "for and by people living with diabetes."
"The twiist system combines drug delivery technology that directly and precisely measures each dose of insulin, providing the opportunity for better control and flexibility," said Alan Lotvin, MD, CEO, founder, Sequel, who added, "[W]e expect to distribute twiist through the pharmacy channel..."
The lifelong condition that destroys cells in the pancreas that create insulin, impacts approximately 2 million Americans.
The system will be commercialized by Sequel Med Tech, LLC.
Reference:
Sequel's twiist Automated Insulin Delivery system receives FDA 510(k) clearance. Sequel Med Tech, LLC. Press release. March 18, 2024. Accessed March 18, 2024. https://twiist.com/wp-content/uploads/sequel_twiist_510k-post-clearance-release-03182024-with-image.pdf
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