Diabetes is a life-threatening chronic disease that requires ongoing life-long treatment, which can put pressure on patients and their caregivers, especially when the patient is a child.The unique challenge faced by people with diabetes is the all-weather blood glucose monitoring.Recently, the FDA has approved two diabetes management devices in a row, one for children with diabetes, and the other using digital new technologies to help better manage diabetes.

　　FDA approves first continuous blood glucose monitoring system with sensors and app

　　Recently, the US FDA approved the Senseonics Eversense Continuous Blood Glucose Monitoring (CGM) system for patients with diabetes over 18 years of age.This is the first FDA-approved CGM system that contains a fully implanted, 90-day blood glucose detection sensor.

　　People with diabetes cannot make enough insulin (type 1 diabetes) or cannot use insulin correctly (type 2 diabetes). Glucose accumulates in the blood when the body does not have enough insulin or it cannot be used effectively.High blood sugar levels can lead to heart disease, stroke, blindness, kidney failure, and amputation of the toes, feet or legs.People with diabetes must regularly monitor their blood sugar levels as part of disease management.Most current blood glucose sensors require regular replacement of diabetes management accessories (usually every seven days) to ensure that the overall CGM system is functioning properly.

　　The small sensors used in the Eversense CGM system can implant skin in hospitals.After implantation, the sensor periodically measures glucose levels in diabetic patients for up to 90 days.Implantable sensors use new light technology to measure blood glucose levels and send information to mobile applications to alert users when blood sugar levels are too high (high blood sugar) or too low (low blood sugar).Every five minutes, the measurement results are sent to the mobile application (smartphone or tablet).

　　The FDA evaluated data from 125 clinically-researched diabetic patients aged 18 years and older and compared the data from the Eversense CGM system to laboratory blood glucose analyzers to evaluate the effectiveness and safety of the device.The study confirmed that fewer than 1% of the population had serious adverse events using implanted sensors.

　　FDA approves automated insulin delivery and monitoring system for pediatric patients

　　Recently, Medtronic's MiniMed 670G hybrid closed-loop system has also been approved by the US FDA to extend its use to patients with type 1 diabetes between the ages of 7 and 13.The system is a diabetes management device that automatically monitors blood glucose and injects the appropriate amount of basal insulin into the body.The FDA previously approved the device in September 2017 for patients with type 1 diabetes aged 14 and over.

　　The human pancreas provides basal insulin to maintain daily activities. The ability of the body of a diabetic patient to produce or use insulin is impaired.The pancreas of Type 1 diabetics cannot produce insulin, so the patient must continuously monitor blood glucose levels in the body and inject insulin to avoid hyperglycemia.Type 1 diabetes, also known as juvenile diabetes, usually occurs in children and young people.

　　The MiniMed 670G Hybrid Closed Loop System measures blood glucose levels in the body every five minutes and automatically adjusts insulin input by turning it on or off.The system includes a sensor that measures blood glucose levels, an insulin pump, and an infusion patch that is connected to the pump via a catheter for delivery of insulin.When the device automatically adjusts the insulin level, the user needs to manually request the insulin dose to offset the carbohydrate consumption during the meal.

　　The MiniMed 670G Hybrid Closed Loop System was clinically tested in 105 patients aged 7 to 11 years. Study participants wore the device for approximately 3.5 months and participated in the three phases of the study to assess the effects of home use and remote use.The study did not find any serious adverse events associated with the use of the MiniMed 670G. The device is safe for patients with type 1 diabetes aged 7 to 13 years.

　　Risks associated with using the system may include hypoglycemia, hyperglycemia, and skin irritation or redness around the device infusion patch.The FDA requires product developers to conduct post-marketing studies to evaluate the performance of children aged 7 to 13 in real environments. The device is not approved for use in children under 6 years of age and patients requiring less than 8 units of insulin per day.

     We congratulate these two products for approval, hoping that they can more easily control blood sugar and improve the condition for the majority of people with diabetes.