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Approval granted for Medtronic's MiniMed 780G system in diabetes management, according to CE Mark certification

European regulatory approval granted to Medtronic for expanded application of MiniMed 780G system

Diabetes management system MiniMed 780G from Medtronic obtains CE Mark approval
Diabetes management system MiniMed 780G from Medtronic obtains CE Mark approval

Approval granted for Medtronic's MiniMed 780G system in diabetes management, according to CE Mark certification

The National Health Service (NHS) England has unveiled a five-year plan to roll out Automated Insulin Delivery (AID) systems to most people with type 1 diabetes, prioritizing children up to the age of 18 years old. This move is part of an effort to improve diabetes management and quality of life for individuals with the condition.

In a significant development, the MiniMed 780G system, designed to advance access to automated insulin delivery technology for a broader and more diverse population, has shown promising results. In a European study, women using the MiniMed 780G system during pregnancy achieved an average Time in Range (TIR) of 66.5%, a significant improvement over traditional insulin therapy.

The benefits of the MiniMed 780G system extend beyond pregnancy. Participants in the LENNY trial achieved a 0.6% lower HbA1C and 9.9% higher TIR when the system was used in auto mode compared to manual mode. The system's ability to provide better overnight glucose control and reduce nighttime hypoglycemia is also noteworthy. With the use of the MiniMed 780G system, time below range (70 mg/dL; 3.9 mmol/L) was under 0.5%.

The MiniMed 780G system has received FDA approval in Europe for use in people with type 2 diabetes. Medtronic, the manufacturer, is actively working with the FDA to expand the indications for the MiniMed 780G system, including its use for individuals with type 2 diabetes in the U.S. A submission to expand the use of the MiniMed 780G system for type 2 diabetes is currently under review by the FDA.

The MiniMed 780G system has also been shown to be safe and effective in children aged 2-6 years old with type 1 diabetes, as demonstrated in the LENNY trial. Parents and caregivers of children using the MiniMed 780G system in auto mode reported improved sleep quality and lower fear of hypoglycemia.

The 2024 ISPAD guidelines strongly recommend AID systems to improve time in range, reduce hypo- and hyperglycemia, enhance quality of life, and ease the burden of care. The German Diabetes Association guidelines advise offering AID to all pediatric patients, provided they or their caregivers can use the technology safely. In England and Wales, NICE guidelines recommend hybrid closed-loop systems for all children and adolescents with type 1 diabetes.

These outcomes align with a growing body of evidence supporting the use of AID systems. A recent Clinical Practice Guideline jointly published by the European Society of Endocrinology and the U.S. Endocrine Society supports the use of AID systems with the goal of improving maternal and fetal health outcomes during pregnancy.

As the use of AID systems continues to expand, it is clear that these technologies have the potential to revolutionize diabetes management, offering improved glucose control, reduced hypoglycemia, and higher treatment satisfaction.

  1. Science and technology are advancing in the health and wellness sector, with the focus on improving chronic diseases like diabetes.
  2. The workplaces are now emphasizing wellness, and diabetes management is a significant aspect of that.
  3. Medical conditions such as diabetes require constant attention and good management for better quality of life.
  4. With advancements in science, treatments like the MiniMed 780G system are promising solutions for people with diabetes.
  5. This system has been designed to be accessible and effective for a diverse population affected by chronic diseases.
  6. In a European study, women using the MiniMed 780G system during pregnancy achieved significant improvements in Time in Range (TIR).
  7. The LENNY trial demonstrated that the MiniMed 780G system in auto mode led to lower HbA1C and higher TIR, facilitating better overnight glucose control.
  8. The MiniMed 780G system, approved in Europe for type 2 diabetes, is awaiting FDA approval in the U.S. for a broader use.
  9. Children aged 2-6 years old with type 1 diabetes have shown safety and effectiveness utilizing the MiniMed 780G system.
  10. Parents and caregivers of children using the MiniMed 780G system noted improved sleep quality and reduced fear of hypoglycemia.
  11. Clinical practice guidelines support the use of Automated Insulin Delivery (AID) systems, aiming to improve time in range and ease the burden of care.
  12. Professional associations like the German Diabetes Association advocate for the use of AID systems for pediatric patients when they can use the technology safely.
  13. The National Institute for Health and Care Excellence (NICE) guidelines recommend hybrid closed-loop systems for children and adolescents with type 1 diabetes in England and Wales.
  14. A growing body of evidence backs the effectiveness of AID systems, offering improved glucose control, reduced hypoglycemia, and higher treatment satisfaction.
  15. Diabetes management is critical in addressing chronic diseases, and advancements in science and technology can play a significant role in improving outcomes.
  16. Alongside diabetes management, other factors like fitness, exercise, nutrition, and weight management are essential for overall health and wellness.
  17. Mental health, including conditions like anxiety and depression, are also linked to chronic diseases and must be addressed for holistic wellness.
  18. Men's health, sexual health, and skin care are important aspects of health and wellness, given their impact on overall quality of life.
  19. The aging population presents unique challenges related to eye health, hearing, and neurological disorders, requiring attention from the medical industry.
  20. Industries such as manufacturing, finance, energy, retail, entrepreneurship, and transportation must prioritize health and wellness, recognizing their impact on employees' productivity and mental health.
  21. Medications, therapies, and treatments for various medical conditions require ongoing research and innovation, supported by investments from the venture capital, pharmaceutical, and biotech industries.
  22. Cardiovascular health, cancer, respiratory conditions, and digestive health are common chronic diseases that require continuous medical attention and intervention.
  23. When implementing wellness programs, diversity and inclusion must be a priority to ensure equal access and opportunities for all.
  24. Small businesses and financial institutions can play a crucial role in promoting health and wellness in their employees, investing in wellness programs, and offering benefits like health insurance, telemedicine, and mental health resources.
  25. Innovations like hybrid closed-loop systems and Clinical Practice Guidelines are geared towards improving health outcomes and quality of life for individuals battling chronic diseases.
  26. Organizations, governments, and industry leaders must collaborate to prioritize health and wellness in public policy, focusing on sectors like climate change, environmental science, and healthcare reform.
  27. As the world evolves, so should our approach to health and wellness, incorporating emerging technologies like Artificial Intelligence, Personalized Medicine, and Telemedicine to deliver better, more accessible healthcare.
  28. Ultimately, investing in health and wellness is an investment in our future, fostering a healthy, productive workforce and promoting a better quality of life for all.

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