A New Hope for Type 1 Diabetes Management: Deka’s Automated Insulin Pump Gets FDA Approval

This article highlights a significant advancement in diabetes management with the FDA approval of Deka Research & Development’s novel automated insulin pump, the twiist. Designed specifically for those living with Type 1 diabetes, the twiist promises to revolutionize insulin delivery through its innovative features and ease of use.

Innovation by a Renowned Figure

The mastermind behind the twiist is Dean Kamen, a celebrated inventor known for creating the Segway and credited as the pioneer of wearable infusion pumps. His company, Deka, has a rich history in developing personal mobility solutions and prosthetic limbs, alongside other drug delivery devices.

Key Features of the twiist

Sequel Med Tech, the firm established by Kamen to commercialize the twiist, emphasizes two key aspects of this device. Firstly, the twiist boasts the ability to directly measure the volume and flow of insulin delivered with each tiny dose. This level of precision offers unparalleled control over insulin administration.

Secondly, the twiist integrates seamlessly with Tidepool Loop, a previously FDA-approved software program that functions as an artificial pancreas system. This program allows users to connect various continuous glucose monitors (CGMs) to the twiist, enabling real-time blood sugar readings and automatic insulin adjustments based on those readings.

A Turning Point for Insulin Delivery

The significance of this FDA approval is emphasized by both Kamen and Howard Look, CEO of Tidepool. Kamen views the twiist as a transformative technology, redefining how insulin is measured and delivered for a more personalized experience. Look highlights the twiist’s potential to set a new standard for insulin delivery due to its precision and reliability.

Building on Past Developments

Deka previously collaborated with Eli Lilly on a similar AID system, but that partnership ended in 2020. Following the discontinuation of Lilly’s internal insulin pump efforts and collaborations with other developers, Deka submitted the twiist for FDA review in late 2021.

After receiving initial approval in July 2023, the twiist gained further clearance earlier this month, expanding its authorized use to children as young as 6 years old (previously 13) and receiving nods for the bundled Loop software and administration tubing sets.

Focus on Patient Accessibility

Sequel Med Tech aims to make the twiist readily available to patients by distributing it through pharmacies. This approach intends to provide a convenient and affordable way for those with Type 1 diabetes to access an advanced AID system. Sequel’s CEO, Dr. Alan Lotvin, emphasizes the company’s commitment to simplifying the lives of diabetic patients through product innovation and expanded access. He promises to share further details about initiatives designed to achieve these goals as the launch date approaches.

In conclusion, the FDA approval of Deka’s twiist represents a significant leap forward in insulin delivery for Type 1 diabetics. The device’s innovative features, coupled with Tidepool’s Loop software, offer a new level of precision and personalization in blood sugar management. Sequel Med Tech’s focus on patient accessibility through pharmacy distribution holds promise for making this life-changing technology widely available.

Posted March 2024.


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