twiist Type 2 Diabetes FDA Clearance: Trial Results (2026)

Q: Is twiist approved for type 2 diabetes?

Yes. The FDA cleared twiist for adults 18 and older with insulin treated type 2 diabetes, as reported on October 16, 2026.

Q: How well did twiist work in type 2 diabetes?

In a 13 week trial of 307 adults, HbA1c fell 0.7 percentage points and time in range rose from 57% to 73%, with no severe hypoglycemia.

Q: Who makes twiist?

Sequel Med Tech. twiist was first cleared in March 2024 for people with type 1 diabetes aged 6 and older.

Q: Does twiist work with Libre Duo?

Abbott expects Libre Duo to be compatible with twiist by the end of 2026.

The FDA has expanded Sequel Med Tech’s twiist automated insulin delivery system to adults with type 2 diabetes who use insulin, backed by a trial that lifted time in range from 57 to 73 percent.

Presented By Our Partners

Quick answer, verified October 20, 2026

The FDA has cleared twiist for adults 18 and older with insulin treated type 2 diabetes, Healio reported on October 16, 2026. twiist was already cleared in March 2024 for people with type 1 diabetes aged 6 and older. In a 13 week trial of 307 adults with type 2 diabetes, HbA1c fell 0.7 percentage points and no severe hypoglycemia occurred.

Time in range: rose from 57% to 73% (70 to 180 mg/dL).
Hitting the 70% target: the share of adults above 70% time in range rose from 37% to 60%.
Biggest gains: in people starting with HbA1c of 9% or higher.
Safety: no severe hypoglycemia events in the trial.
Sensor pairing: Abbott expects its glucose and ketone sensor, Libre Duo, to work with twiist by the end of 2026.

The short verdict

Automated insulin delivery has been built around type 1 diabetes, yet far more people with type 2 diabetes take insulin, often through complex multiple daily injection routines. The twiist clearance gives them an automated option backed by a dedicated trial, with meaningful gains in time in range and HbA1c and no severe lows. Coverage and access will decide how quickly it reaches people.

What the trial showed

Participants: 307 adults with insulin treated type 2 diabetes, multicenter, 13 weeks.
HbA1c: down 0.7 percentage points from baseline (P < .001), with the largest drops in people starting at 9% or higher.
Time in range: mean rose from 57% to 73%.
Target achievement: adults with more than 70% time in range rose from 37% to 60%.
Quality of life: improvements in treatment satisfaction and sleep quality.
Safety: no severe hypoglycemia events.

The results were first presented at the American Diabetes Association Scientific Sessions in June 2026.

Featured Partner

Invest in the Infrastructure Behind Modern Medicine

As healthcare expands beyond hospital walls, the buildings and campuses supporting that shift are generating compelling returns for investors who move early. The Healthcare Real Estate Fund offers qualified investors direct access to a curated portfolio of medical office, outpatient, and specialty care facilities.

Learn More →

How twiist works

twiist continuously adjusts basal insulin to match the user’s needs based on glucose readings. Sequel Med Tech says it is the first automated insulin delivery system that directly measures the volume of insulin delivered with every microdose. Endocrinologist Osama Hamdy, MD, PhD, called the results an inflection point for adults with type 2 diabetes who rely on insulin.

Who it is for

Adults 18 and older with type 2 diabetes treated with insulin, especially those not reaching glucose targets on injections.
People with type 1 diabetes aged 6 and older, under the 2024 clearance.

It is not for people with type 2 diabetes who do not use insulin. For them, over the counter glucose sensors such as Dexcom Stelo are the more relevant technology; see also our guide to wearable blood sugar monitoring.

How it fits with sensors and other systems

Abbott has said it expects its new Libre Duo glucose and ketone sensor to be compatible with twiist and Beta Bionics’ iLet by the end of 2026. For the tubeless side of the market, see our coverage of the Beta Bionics Mint patch pump.

Open questions

Coverage: payer policies for automated insulin delivery in type 2 diabetes are still catching up.
Long term data: the trial ran 13 weeks; longer follow up will show whether gains hold.
Training: moving from injections to a pump requires education and support from a diabetes team.

Frequently asked questions

Is twiist approved for type 2 diabetes?

Yes. The FDA cleared twiist for adults 18 and older with insulin treated type 2 diabetes, as reported on October 16, 2026.

How well did twiist work in type 2 diabetes?

In a 13 week trial of 307 adults, HbA1c fell 0.7 percentage points and time in range rose from 57% to 73%, with no severe hypoglycemia.

Who makes twiist?

Sequel Med Tech. twiist was first cleared in March 2024 for people with type 1 diabetes aged 6 and older.

Does twiist work with Libre Duo?

Abbott expects Libre Duo to be compatible with twiist by the end of 2026.

Sources

This article is for general information and is not medical advice. Talk with your diabetes care team before changing insulin delivery.

Free Daily Briefing

The Latest Longevity Science.
Delivered Every Morning.

Join researchers, physicians, and health professionals getting daily breakthroughs in AI-driven medicine, epigenetics, and longevity research.

Support the research that powers this editorial

No spam. Unsubscribe anytime. We respect your inbox.