MeduGate LMS;

16th Oct, 2026 12:00 AM

Test

Automated Insulin Delivery in T2D: Latest System FDA Cleared

The FDA has cleared the twiist Automated Insulin Delivery (AID) System (Sequel Med Tech) for use in adults aged 18 years and older with insulin-treated type 2 diabetes (T2D).

The twiist continuously adjusts basal insulin delivery to accommodate individual dosing needs and is unique in its direct measurement of insulin volume delivered. The system has a 300-unit capacity and is changed every three days. It is compatible with the Abbott FreeStyle Libre 3 Plus and Senseonics' Eversense 365 continuous glucose monitors, but not Dexcom's.

It uses a "proprietary iiSure Technology, which includes checkpoints to ensure accurate delivery and detect blockages up to nine times faster than other AID systems," according to a Sequel statement.

The twiist was FDA-cleared in 2024 for use in people aged 6 years and older with type 1 diabetes. Clearance for T2D was supported by data from a multicenter pivotal trial

Article Key Points

FDA cleared twiist AID for adults ≥18 with insulin-treated T2D.
System continuously adjusts basal insulin; direct insulin volume measurement.
300-unit reservoir; infusion set changed every 3 days.
Pivotal trial: A1c 8.1%→7.4% at 13 weeks; TIR 57%→73%.
No severe hypoglycemia reported; greatest A1c benefit with baseline ≥9%.

Dive Deeper

How does AID compare with basal-bolus therapy in T2D?

Which T2D patients benefit most from AID initiation?

What long-term outcomes follow AID in insulin-treated T2D?

of the system in 307 adults with insulin-treated T2D. At 13 weeks, mean A1c levels dropped from a baseline 8.1% to 7.4% (P < .001). Those with baseline A1c of 9% or greater showed the most improvement. Mean time in range rose from 57% to 73% (P < .001), with no reports of severe hypoglycemia.

SUGGESTED FOR YOU

The twiist now joins the Omnipod 5, the Tandem Control-IQ+ algorithm, and the Minimed 780G in availability for use in T2D.

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR's Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and BlueSky @miriametucker.bsky.social

Dive Deeper

Commonly Asked by HCPs

Q: How do automated insulin delivery systems fit into guideline-based escalation for poorly controlled type 2 diabetes?

A: Automated insulin delivery is typically positioned as an advanced option for insulin-treated type 2 diabetes when standard insulin regimens and CGM-guided management are insufficient. Physicians often research where AID fits relative to basal-bolus insulin, GLP-1 receptor agonists, and other intensification strategies, along with practical issues such as training, coverage, and follow-up.

Read full answer

Q: Which adults with type 2 diabetes are appropriate candidates for continuous glucose monitoring with insulin therapy?

A: Continuous glucose monitoring is most helpful in insulin-treated type 2 diabetes when glucose patterns are variable, hypoglycemia is a concern, or treatment intensification is being considered. Clinicians generally research which patients benefit from CGM-guided titration, how often data should be reviewed, and how CGM supports safer insulin adjustments.

Read full answer

Q: What monitoring and safety issues are important after starting automated insulin delivery in type 2 diabetes?

A: After starting automated insulin delivery, monitoring usually centers on CGM metrics, hypoglycemia frequency, insulin delivery interruptions, infusion-site problems, and overall adherence. Research commonly addresses device troubleshooting, alarm burden, calibration or sensor compatibility, and how to assess whether glycemic improvements are sustained over time.

Read full answer

Q: How do automated insulin delivery systems compare with standard insulin pump therapy in type 2 diabetes?

A: Compared with standard pump therapy, automated insulin delivery can improve time in range and reduce glycemic variability by adjusting basal insulin in response to CGM data. Physicians usually look for evidence on A1c change, hypoglycemia risk, usability, and whether algorithm-driven insulin delivery adds benefit beyond conventional pump settings.

Read full answer

Q: When should adults with insulin-treated type 2 diabetes consider automated insulin delivery?

A: Automated insulin delivery is generally considered for adults with insulin-treated type 2 diabetes who need more precise basal insulin adjustment and improved glycemic control. Research typically focuses on how insulin requirement, hypoglycemia risk, self-management capacity, and access to CGM-integrated technology influence candidacy and expected benefit.

Read full answer