FDA Clears Twiist Automated Insulin Delivery System by April Hopcraft for diaTribe.org, 18 March 2024.

In the latest victory for type 1 diabetes management, the FDA cleared the Twiist AID system, the first automated insulin pump to precisely measure each dose of insulin delivered.  Specifically, the Twiist AID system measures both the volume (amount) and flow (speed) of each micro-dose of insulin. This allows for more personalization of insulin dosing, which could allow for more precise glycemic control and better health outcomes.  

What does the Twiist AID system consist of? All AID systems consist of three parts: an insulin delivery device, insulin delivery algorithm, and a continuous glucose monitor (CGM). The Twiist AID system includes the following components: 

      • An automated insulin pump, developed by Deka Research & Development, that measures each microdose of insulin 
      • The Tidepool Loop algorithm, which automatically adjusts insulin delivery based on CGM readings
      • A compatible CGM sensor

Tidepool is the only FDA-approved algorithm to have begun as a patient-led project, rather than by diabetes technology companies. Tidepool Loop enables users to build their own AID system by combining their preferred CGM and insulin delivery devices. 

“The Twiist AID system reimagines how insulin is measured and delivered for more personalization with a simpler design,” said Dean Kamen, president and founder of Deka, who is also well known for developing the first insulin pumps. “I believe the Twiist AID system will set a new standard for precise, dependable insulin delivery going forward,” Kamen said.

What’s unique about the Twiist AID system?  The Twiist AID system allows for microdosing, which means insulin could be given in fractions of a unit, allowing for more precise glucose control. 

Bellini highlighted several innovative aspects of the Twiist AID system, including the ability to set targets as low as 87 mg/dL and distinguish the type of carbs consumed to change bolus delivery. For example, the setting of “lollipop” for rapid-acting carbs, “taco” for moderate carb, fat, and protein foods, and “pizza” for higher fat and protein carbs.  

While most insulin pumps involve a four or five-year commitment, patients have the option to try the Twiist AID system without committing for the full period, Bellini noted.

More about the Sequel Twiist system  Sequel designed its Twiist AID system to take advantage of FDA medical device interoperability standards. The company says it helps patients better tailor their insulin therapy to their own unique needs. Incorporating Tidepool Loop technology enables automatic adjustments to insulin delivery based on CGM readings and predicted glucose levels.

Read more: 

Below are some wonderful “impressions” from well-respected attendees at ATTD 2024


PhD/Nurse Researcher (Italy was fun and the conference was good!)

  • There is some interesting science behind using ketone sensors along with CGM to detect early DKA. This needs more development because it is too expensive right now but I do think this might be an advancement down the road.
  • Interesting session on brain health but I didn’t learn anything new. More research has been done on those with Type 2 diabetes than Type 1 diabetes. Both hyper and hypoglycemia are contributors to changes in brain health.  It is important to keep glucose levels <7% and to exercise regularly. Everyone should be screened yearly for cognitive impairment since early intervention can reverse some of the causes of dementia. Nobody is doing this screening.
  • Dr. Medha Munshi (Harvard/Joslin) was able to put together a whole session on Sarcopenia, Frailty, and Diabetes. Sarcopenia is the loss of muscle mass. We heard about how to measure and monitor sarcopenia and frailty and about the current treatment options- resistance training and other exercises, and increase protein intake (etc).
  • Lastly, there was a presentation that talked about GLP-1 might decrease the risk of dementia. Novo is now researching this.


T1D/Pediatric Endocrinologist/Looper (I want one – a continuous ketone meter!)

The continuous ketone meter data from Abbott provided by Dr. Jen Sherr is going to help us better understand type 1 diabetes physiology. Do we need to set a lower ketone threshold for intervention? Or do people with type 1 diabetes have elevated ketones more often than we realize, because we are only checking when blood sugars are high or when someone is sick?

T1D/Loop-iAPS Developer/Loop and Learn Admin: The key takeaways for me (next to networking, meeting VCs, meeting various folks, seeing a lot of new tech, etc.):

  • AID is on everyone’s mind and FCL (fully closed loop) will be a reality in commercial pumps in the next 3-5 years; research already shows the massive results that can be received and – not really a shocker – open-source-driven AIDs are still ahead
  • T2s are the focus group for industry; it’s the bigger market and they want the $$
  • Multiple sessions and talks on:
    • CGMs need to become standard of care for every diabetic, T1, T2, T3, everyone.
    • Similar was voiced for GLP-1/SLGT-2s but there’s growing concern that long-term use might have downsides and when PwDs stop using them they often see far greater issues than before going on them
  • HCPs and industry are becoming more and more aware of the psychological and mental issues diabetics of all colors go through and realize that therapy and devices need to be supporting in that, not just treating
  • Diabetics are being heard, but not yet loud enough; the rudeness we’ve faced on multiple occasions when asking uncomfortable questions was quite shocking at times


Share This
Skip to content