The twiist Automated Insulin Delivery System Receives FDA Clearance

On March 18, 2024, Sequel Med Tech announced that its partner—DEKA Research & Development Corp.—received FDA clearance for the twiist Automated Insulin Delivery (AID) system.

Using the FDA-cleared Tidepool Loop technology, the twiist is the first drug-delivery system that directly measures the:

• Volume (amount) of insulin delivered with every micro-dose, and
• Flow (speed) of insulin delivered with every micro-dose.

“The clearance of the twiist AID system is a pivotal first step in Sequel’s quest to make day-to-day life easier for people with type 1 diabetes,” said Sequel CEO and Co-Founder, Alan Lotvin, MD. “The twiist system combines drug-delivery technology that directly and precisely measures each dose of insulin, providing the opportunity for better control and flexibility.”

Cleared for people ages 6 and up with type 1 diabetes, the twiist AID system, which will be commercialized by Sequel Med Tech, offers the capability and flexibility to address each patient’s individual dosing needs.

The AID system is able to automatically adjust insulin delivery according to continuous glucose monitor (CGM) readings and predicted blood-sugar levels.

The twiist AID system is also the first FDA-approved AID system with Apple Watch compatibility.

What is an AID?

AID systems are made up of:

• An insulin pump
• A smart algorithm that links the two devices together—allowing them to “talk” to each other, and
• A compatible CGM system

In the case of the twiist AID system, the three components will be:

• The Deka insulin pump
• The Tidepool Loop algorithm
• A compatible CGM sensor.

Also known as a closed-loop or “artificial pancreas” system, AIDs have transformed the management of type 1 diabetes.

When Will The twiist Be Available?

Sequel does not have a timeline for launch, and the twiist website only says “coming soon.”

Lotvin states that Sequel expects to distribute the device through the pharmacy channel so more people with type 1 diabetes have a “convenient, affordable way to get started on an AID system.”