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Hello, JNPMEDI has prepared medical device clinical trial plan approved in March 2025.
Shall we take a closer look? ๐
In March, a variety of medical devicesโincluding digital therapeuticsโreceived clinical trial plan approvals from the Ministry of Food and Drug Safety (MFDS).
Clinical trials targeting a range of indications, including obsessive-compulsive disorder (OCD), depression, heart failure, ADHD, and post-stroke cognitive impairment, have caught attention. Notably, two trials were approved for products classified as neuroscience-related medical software. To date, a total of eight clinical trials in this category have been approved, but no product has yet received regulatory approval.
Additionally, devices intended for chronic disease management, such as personal continuous glucose monitoring (CGM) systems, were also included in this monthโs approval list.
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This month, we will explore continuous glucose monitoring systems (CGM) for diabetes patients.
A personal continuous glucose monitoring system (CGM) measures blood glucose levels in real-time through a sensor inserted into the subcutaneous fat layer of the user. The system transmits these readings to mobile devices, allowing continuous monitoring of glucose fluctuations.
In addition to real-time glucose monitoring, CGM provides features such as alerts for high and low blood sugar levels, as well as trends in blood glucose changes. These features enable more precise self-management of meals, exercise, and insulin administration. Some products are even integrated with insulin pumps, enabling hybrid artificial pancreas functionality.
Since 2020, the National Health Insurance Service has partially covered the cost of CGM sensors for eligible patients in South Korea. This system has expanded the use of CGM not only among children and adolescents with type 1 diabetes but also among some type 2 diabetes patients requiring intensive insulin therapy.
CGMs are considered an effective tool for improving patient compliance and treatment efficiency, as they allow glucose monitoring without blood sampling. Recent studies, both domestic and international, have proven various clinical benefits, including a reduction in HbA1c levels and prevention of hypoglycemia.
The advancement of digital health technologies is enhancing the accessibility and efficiency of treatments while improving patients' quality of life.
The potential applications of digital therapeutics in fields such as mental health and chronic disease are expected to continue expanding in the future.
We will continue to provide valuable information related to clinical trials.
Thank you! ๐
๐ Reference
Hello, JNPMEDI has prepared medical device clinical trial plan approved in March 2025.
Shall we take a closer look? ๐
In March, a variety of medical devicesโincluding digital therapeuticsโreceived clinical trial plan approvals from the Ministry of Food and Drug Safety (MFDS).
Clinical trials targeting a range of indications, including obsessive-compulsive disorder (OCD), depression, heart failure, ADHD, and post-stroke cognitive impairment, have caught attention. Notably, two trials were approved for products classified as neuroscience-related medical software. To date, a total of eight clinical trials in this category have been approved, but no product has yet received regulatory approval.
Additionally, devices intended for chronic disease management, such as personal continuous glucose monitoring (CGM) systems, were also included in this monthโs approval list.
This month, we will explore continuous glucose monitoring systems (CGM) for diabetes patients.
A personal continuous glucose monitoring system (CGM) measures blood glucose levels in real-time through a sensor inserted into the subcutaneous fat layer of the user. The system transmits these readings to mobile devices, allowing continuous monitoring of glucose fluctuations.
In addition to real-time glucose monitoring, CGM provides features such as alerts for high and low blood sugar levels, as well as trends in blood glucose changes. These features enable more precise self-management of meals, exercise, and insulin administration. Some products are even integrated with insulin pumps, enabling hybrid artificial pancreas functionality.
Since 2020, the National Health Insurance Service has partially covered the cost of CGM sensors for eligible patients in South Korea. This system has expanded the use of CGM not only among children and adolescents with type 1 diabetes but also among some type 2 diabetes patients requiring intensive insulin therapy.
CGMs are considered an effective tool for improving patient compliance and treatment efficiency, as they allow glucose monitoring without blood sampling. Recent studies, both domestic and international, have proven various clinical benefits, including a reduction in HbA1c levels and prevention of hypoglycemia.
The advancement of digital health technologies is enhancing the accessibility and efficiency of treatments while improving patients' quality of life.
The potential applications of digital therapeutics in fields such as mental health and chronic disease are expected to continue expanding in the future.
We will continue to provide valuable information related to clinical trials.
Thank you! ๐
๐ Reference