New To Insulin Pumps? Twiist Gets FDA-Clearance For Type 2 Diabetes

Sequel, the insulin pump manufacturer of the twiist insulin pump, announced on Friday, October 16, that its insulin pump system has been cleared by the Food and Drug Administration (FDA) for use in adults aged 18 and older with insulin-dependent type 2 diabetes (T2D). 

The majority of adults living with diabetes in the United States live with T2D, which is an estimated 31 million people. Of those, about 5.5 million use insulin. This clearance enables immediate prescribing of the insulin pump for this population, since the pump is already available in the US for those living with type 1 diabetes (T1D) since its national launch in March 2026. 

What does twiist’s FDA clearance mean for people with T2D?

It means adults with T2D who use insulin now have another AID option, and healthcare providers (HCPs) can prescribe it right away. This clearance greatly expands the treatment options available to people living with T2D, especially those wanting a more aggressive automated insulin delivery (AID) algorithm for hyperglycemia and insulin resistance, which the twiist pump offers. 

How does the twiist system work?

The twiist system runs on the Tidepool loop algorithm, which makes automated insulin delivery adjustments based on real-time blood glucose projections. It automatically increases, decreases, or suspends basal insulin in response to continuous glucose monitoring (CGM) blood glucose readings for tighter control. 

What did the twiist type 2 diabetes trial find?

Historically, people living with insulin-dependent T2D had limited treatment options. But a pivotal study found that despite only 11 percent of insulin-dependent type 2 users in a trial having previous carb-counting experience, the majority saw both A1C and time-in-range improvements when using the twiist insulin pump system.

Some other improvements in the trial with T2D participants on twiist include: 

• Mean time-in-target blood glucose range (70 to 180 mg/dL) increased from 57 percent to 73 percent, an improvement of 16 percentage points translating to 3.8 additional hours per day in a healthy glucose range
• The proportion of participants achieving more than 70 percent time-in-range increased from 37 percent at the start of the trial to 60 percent over 13 weeks
• A1C improved across all bolus-frequency groups, with reductions ranging from 0.6 percent to 0.9 percent, regardless of bolus frequency

Using the twiist system, study participants also reported improved diabetes treatment satisfaction and sleep quality. 

Participants switching from a basal-bolus therapy with multiple daily injections to twiist required an average of 19.3 fewer units of insulin per day, showing tighter control. 

“For many adults living with type 2 diabetes, insulin therapy can feel like one more thing to manage in an already busy life,” said Sequel ceo and co-founder Alan Lotvin, MD. “At Sequel, we believe technology should meet people where they are, not the other way around. With twiist, we’re bringing a personalized automated insulin delivery experience to the type 2 community that can help improve outcomes while reducing the day-to-day burden of diabetes management.” 

What features does the twiist pump have?

Additional features of the pump include:

• Low glucose targets. Users can set targets as low as 87 mg/dL (compared to around 110 mg/dL on many other systems) Pre-meal presets: Users can activate presets up to an hour before eating to trigger more accurate insulin delivery in anticipation of carbohydrate intake.
• Micro-dosing and five-minute updates. Every five minutes, using CGM data, the system looks ahead and predicts where your glucose will be in six hours. This allows the pump to fine-tune insulin adjustments.
• Carb flexibility. Users can modify carbohydrates eaten before, during and after eating, and choose specialized food-type settings for faster- or slower-digesting foods (like orange juice versus pizza). 

“What we’re seeing with twiist represents a real inflection point for adults with type 2 diabetes who rely on insulin. Many people intensify therapy, adjust doses, and follow complex regimens but still struggle to reach glucose targets,” said Dr. Osama Hamdy, MD, PHD of Joslin Diabetes Center. “This trial shows how twiist can change that trajectory, where adults with type 2 diabetes can gain better time‑in‑range, lower A1C, and avoid severe hypoglycemia even without the prerequisite of prior pump experience. Twiist is showing they can deliver the kind of burden-free improvement this community has long needed. This combination is exactly what clinicians and patients need from automated insulin delivery.” 

How can you get twiist?

The twiist system is available now with a prescription from your HCP. Learn more about twiist at https://www.twiist.com.

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