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7. Drug and Device Updates


The Breakthrough of Survodutide in Weight Loss

The Breakthrough of Survodutide in Weight Loss

      Survodutide, a novel dual agonist targeting Glucagon and GLP-1 receptors, has emerged as a beacon of hope in the battle against obesity. Developed by Boehringer Ingelheim and Zealand Pharma, this promising compound has recently been the focus of a rigorous clinical trial designed to assess its weight loss efficacy and safety profile.

      In this randomized, double-blind, placebo-controlled, dose-finding study, participants without diabetes, aged 18 to 75 years with a body mass index (BMI) of at least 27 kg/m^2, were enrolled to evaluate the impact of varying doses of survodutide. The study's results have sparked considerable interest, demonstrating significant weight reduction across different dosage levels of survodutide compared to placebo.

      Participants experienced notable weight loss, particularly with the 0.6 mg, 2.4 mg, 3.6 mg, and 4.8 mg doses of survodutide, with changes in body weight ranging from a 6.2% reduction at the lowest dose to a striking 14.9% decrease at the highest dose over 46 weeks. In contrast, the placebo group saw a modest 2.8% weight loss. Additionally, survodutide recipients reported an average six-inch decrease in waist circumference, highlighting the drug's potential in reducing central obesity, a key factor in metabolic health.

      However, the journey to weight loss with survodutide was not without its challenges. Adverse events were reported in 91% of survodutide-treated individuals, predominantly gastrointestinal issues, compared to 75% in the placebo group. This underscores the necessity of weighing the benefits against potential side effects in clinical decisions.

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The Rise of the Fully Closed-Loop Inreda AP System management

The Rise of the Fully Closed-Loop Inreda AP System management

      In an exciting development for individuals with type 1 diabetes, the Inreda AP, a novel Fully Closed-Loop (FCL) system from Inreda Diabetic in the Netherlands, has made significant strides in simplifying diabetes management. This bihormonal FCL system, which utilizes both insulin and glucagon, is designed to alleviate the daily challenges of insulin administration and carbohydrate counting that many patients face.

      The Inreda AP system operates by continuously monitoring glucose levels and automatically adjusting insulin and glucagon delivery based on real-time sensor data and the trends in glucose concentration. This dynamic approach enables the system to closely replicate the natural glucose regulation of the body, providing a proactive defense against the risk of hypoglycemia. Clinical trials have underscored the system's effectiveness in improving glycemic control. Participants using the Inreda AP experienced not only better management of their blood glucose levels but also enjoyed a reduction in the constant decision-making and calculations associated with traditional hybrid closed-loop systems. The EU's approval of the system in 2020 attests to its safety and efficacy.

      Real-world evidence from these trials suggests that the bihormonal FCL system holds the promise of a significant breakthrough in diabetes care. By offering a solution that can autonomously manage blood glucose levels, the Inreda AP system represents a substantial leap forward in empowering patients with type 1 diabetes to live more freely, reducing the mental and physical burdens of their condition.



FDA clears first Over-the-counter Continuous Glucose Monitor

FDA Approves Brenzavvy for People with Type 2 Diabetes

      In a landmark decision, the FDA has approved the Dexcom Stelo Glucose Biosensor System for over the counter (OTC) use, marking the first continuous glucose monitor (CGM) available without a prescription. This innovative integrated CGM (iCGM) system is designed for individuals 18 years and older, catering to non-insulin users, such as those managing diabetes with oral medications, and even individuals without diabetes who wish to monitor the effects of diet and exercise on their blood glucose levels.

      The Dexcom Stelo stands out for its user-friendly design, featuring a wearable sensor that synchronizes with a smartphone or other smart devices via a dedicated app. This system offers continuous glucose tracking, providing real-time data on glucose levels every 15 minutes, allowing users to stay informed about their blood glucoe trends for up to 15 days per sensor. However, it's important to note that the Dexcom Stelo is not recommended for individuals with problematic hypoglycemia, as it does not include alerts for this condition. This delineation underscores the need for potential users to understand the device’s capabilities and limitations thoroughly.

      The FDA's approval of the Dexcom Stelo as an OTC product represents a significant step forward in making glucose monitoring more accessible and convenient, empowering individuals to take proactive control over their health with cutting-edge technology.


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