FDA clears automated insulin delivery system for children and adults with type 1 diabetes
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Key takeaways:
- The twiist automated insulin delivery system utilized Tidepool Loop technology to adjust insulin doses.
- FDA clearance was granted for people aged 6 years and older with type 1 diabetes.
The FDA granted 510(k) clearance for an automated insulin delivery system that can measure the volume and flow of insulin within every micro-dose, according to an industry press release.
The twiist automated insulin delivery system (Sequel Med Tech) was cleared for people aged 6 years and older with type 1 diabetes. Benefiting from the medical device interoperability standards adopted in 2017, the system uses Tidepool Loop technology to automatically adjust insulin delivery based on continuous glucose monitoring readings and predicted glucose levels. Twiist, which was developed by DEKA Research & Development Corp., was designed to offer greater flexibility for users to address individual dosing needs through the direct measurement of insulin volume and flow, according to the release.
“The clearance of the twiist automated insulin delivery system is a pivotal first step in Sequel’s quest to make day-to-day life easier for people with type 1 diabetes,” Alan Lotvin, MD, CEO and co-founder of Sequel Med Tech, said in the release. “The twiist system combines drug delivery technology that directly and precisely measures each dose of insulin, providing the opportunity for better control and flexibility. Sequel is working to simplify living with diabetes by introducing product and process innovation while expanding access for all. It’s why we expect to distribute twiist through the pharmacy channel so more people with type 1 diabetes have a convenient, affordable way to get started on an automated insulin delivery system.”
Lotvin said the company will release more details about initiatives designed to expand access to the system as the launch date for the device approaches.
Perspective
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Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
The diabetes community received a nice surprise with the FDA approval of a new insulin pump called the Sequel twiist. Although this is the fifth FDA-approved automated insulin delivery system, this one will have some notable differences.
While there is still a lot to be learned about the specifics of this new system, what we know so far is that Sequel has partnered with the FDA-cleared Tidepool loop. Tidepool loop is an insulin dosing algorithm based on the open-source loop algorithm that people in the diabetes community have been using without FDA approval for years. It has many features that are more customizable than other automated insulin delivery systems. This includes lower glucose targets and setting different absorption patterns based on the type and composition of the food.
Another notable difference is the mechanism of insulin delivery, which is thought to be more precise and better at quickly detecting occlusions. This could have the potential to reduce hyperglycemia and even diabetic ketoacidosis, although clinical trials are needed to confirm these hypotheses. The system is planned to be available through the pharmacy. This is great news because most insulin pumps are considered durable medical equipment and require a 4-year contract, which is a big commitment. By going through the pharmacy, people can choose to try it out with little to no risk.
I love having different choices available for people with diabetes, and I think the FDA approval of the twiist will shake up the automated insulin delivery market. Diabetes guidelines state that every person with type 1 diabetes should be offered automated insulin delivery, and hopefully with this new option, accessibility to automated insulin delivery systems and choice will continue to increase.
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