en.Wedoany.com Reported - As the American Diabetes Association (ADA) Scientific Sessions approach, several medical device companies, including Insulet, Tandem Diabetes Care, and MiniMed (spun off from Medtronic), are promoting their fully closed-loop automated insulin delivery systems. These systems use glucose sensor data to calculate insulin needs and deliver insulin via a pump. Unlike currently marketed systems, they do not require users to declare meals or count carbohydrates before eating.

Insulet plans to share late-stage data from the next phase of its feasibility study at the ADA Scientific Sessions this weekend. MiniMed will also present posters on the development and clinical validation of its planned algorithm at the conference. Experts note that while the technology has the potential to reduce the burden of diabetes management, it cannot achieve full automation, and device developers must strike a balance between user autonomy and system trust.

Rayhan Lal, an endocrinologist and assistant professor at Stanford Medicine, believes the term "fully closed-loop" is inaccurate. Although these devices eliminate the need for carbohydrate counting, they still require human intervention. For example, exercise or illness can alter insulin sensitivity, requiring users to signal changes in needs to the system. Additionally, if a glucose sensor fails, the device switches to a backup mode that requires user input. Lal himself uses a system developed by the patient-led open-source project OpenAPS to manage his insulin doses without meal declarations. However, he emphasizes: "If I go for a run, I still need to somehow indicate to the system, 'Listen, my insulin needs have suddenly changed, you have to reduce the dose.'" Lal also notes that the system "has greatly reduced the number of inputs I have to provide to the system, which in itself is very good."

Insulet has initiated a pivotal study of its fully closed-loop system without meal declarations and launched related trials in May. Chief Medical Officer Trang Ly stated that the system is suitable for insulin-using type 2 diabetes patients, and physicians do not need to program pump settings at the start of treatment. Results from Insulet's 24-person feasibility study, released in March, showed that users spent 68% of their time in the target glucose range. According to ADA recommendations, most people should aim for approximately 70% time in range, representing a 24% improvement over standard injection therapy. Over 90% of participants wished to continue using the feature and enter an extension study. Insulet plans to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) in 2027 and launch the product in 2028.

MiniMed is developing a system called Vivera, where meal declarations are optional. Chief Product and Technology Officer Ali Dianaty explained that the system is being studied in type 1 and type 2 diabetes patients, with insulin targets lower than the company's current hybrid closed-loop system, and it can help people maintain target glucose ranges during pregnancy. In a 24-person study, participants first used the existing 780G system to establish a baseline, then used the new algorithm with carbohydrate counting for 30 days, followed by 30 days without any meal declarations. After the study, participants more frequently chose to skip meal declarations. MiniMed began recruiting for the Vivera pivotal trial in the U.S. in February and has not yet announced a timeline for FDA submission.

CamDiab, based in Cambridge, UK, has received CE marking for its CamAPS Liberty feature, which is indicated for type 1 diabetes patients aged 13 and older. The feature allows people to choose to skip carbohydrate counting or pre-meal insulin boluses and is planned to launch as an optional feature of the CamAPS FX app. In a 26-person crossover study, CamDiab found that the fully closed-loop feature improved time in range, but the company decided to retain the option for users to administer boluses. CamAPS Liberty is expected to launch around the end of this year in countries where it has received regulatory approval.

Tandem Diabetes Care is developing a fully closed-loop system called Tandem Freedom. Laurel Messer, Vice President of Medical Affairs, stated that feasibility studies have shown promise in safety and glycemic control, with pivotal trials expected to begin later this year. Messer noted that the challenge in developing a system without meal declarations lies in the algorithm's ability to detect meals and deliver appropriate insulin while avoiding the risk of hypoglycemia. "Although fully closed-loop sounds like a simple solution, I am fully convinced that if there are five fully closed-loop devices on the market five years from now, none of them will look the same," Messer said.

Mihail Zilbermint, an endocrinologist at Johns Hopkins Medicine, stated that the primary benefit of the technology will be reducing the mental burden of diabetes, but patients still need backup plans in case of device failure or inaccurate data. He believes, "The best system is not one that makes all decisions for them, but one they are truly willing to wear, can afford, understand, and even troubleshoot when needed."

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