A Prospective Observational Study to Evaluate the Effectiveness and Safety of Cascade® Continuous Glucose Monitoring System in China: A Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Mean absolute relative difference (MARD%)
研究概览
简要总结
Researchers are looking for a better way to help Chinese people who have diabetes to monitor their blood sugar (blood glucose) situation.
There are 2 types of diabetes. In people with type 1 diabetes, the body's immune system attacks and destroys cells in the pancreas that produce a hormone called insulin. In people with type 2 diabetes, the body does not make enough insulin or does not use insulin well. This results in high blood glucose levels. Over time, high blood glucose levels can cause damage to certain parts of the body. These include the eyes, the kidneys, the nerves, and the heart.
There are tests and devices available for doctors and patients to measure blood glucose levels. Repeated measurements of blood glucose levels are needed to see whether the treatments that prevent blood glucose levels from becoming too high work well and to notice when the blood glucose is decreasing too much. Such tracking of the blood glucose is also called blood glucose monitoring. Blood glucose monitoring tests and devices can however be difficult to use, and one test or device may not work for all patients. Researchers think that better monitoring systems would help patients improve the control of their blood glucose levels. This could help stop their diabetes from getting worse.
In this study, the researchers want to learn more about how well a new monitoring system called CGM works in Chinese patients with diabetes. CGM is a continuous glucose monitoring system. It regularly measures the level of glucose in the tissue throughout the day and night. CGM is made up of a small sensor that patients apply in the belly region where it is placed just under the skin, into the so-called subcutaneous tissue. The sensor measures the level of glucose in the fluid that surrounds cells in the subcutaneous tissue. It also has a transmitter which attaches to the sensor and sends via Bluetooth the results to a device, which can instantly display the glucose level. The glucose levels can then be used to adjust the treatment.
The main purpose of this study is to learn how well CGM monitors glucose levels in Chinese patients when used in usual practice. To answer this question, the researchers will compare the glucose levels collected with the CGM monitor to the blood glucose levels collected with another type of monitoring called "venous blood glucose testing". This is where a blood sample is taken from the veins, and then the level of glucose in the blood sample is measured.
The study will include adult Chinese patients who have type 1 or type 2 diabetes and who the study doctors think need to monitor their diabetes using CGM and venous blood glucose testing.
There will be no treatments given as part of this study. The device will be worn up to a maximum of 14 days. The patients will get training on how to use the CGM monitor and will attach it to their belly on Day 1 of the study.
The researchers will then collect the information about their glucose levels. The study doctors will also take blood samples and measure blood glucose levels using venous blood glucose testing. They will compare the glucose levels recorded from the blood samples to the glucose levels recorded by CGM at the closest time points. After wearing CGM for 14 days, the study doctors will remove it from the patients' bellies. About 3 days later, the researchers will call the patients to check if they have any swelling or areas of rash where CGM was worn. The patients may also take photos of the area and send these to the study doctors.
During the study, the study staff will:
- take blood samples as part of the usual care
- compare glucose levels recorded by CGM to the levels recorded from the venous blood glucose tests
- check the skin for any swelling or areas of rash where CGM was worn
- record any instances of CGM errors or alarms for when glucose levels are too high or too low
- check the patients' overall health
- ask the patients about how they are feeling and what medical problems they are having.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult female or male (18 years of age or older)
- •Diagnosed with type 1 or type 2 diabetes mellitus
- •Decision to initiate venous blood glucose testing and CGM as per investigator's routine treatment practice;
- •Signed informed consent
排除标准
- •Patients with moderate or more serious anemia defined as hemoglobin < 90g/L
- •Patients with moderate or more serious subcutaneous edema: grading can be referred to: mild edema (a visible mild depression of eyelid, soft tissues below the orbit, subcutaneous tissue of the anterior tibia or subcutaneous tissue of the ankle after finger pressure); moderate (all the sparse tissues of the whole body have visible edema with obvious or deeper tissue depressions after finger pressure and slow subsidence); severe (severe edema of tissues all over the body, the skin of the low hanging part of the body is tense and shiny, and there may even be fluid exudation, sometimes accompanied by fluid accumulation in the thoracic cavity, abdominal cavity and sphincter cavity)
- •Pregnant women
结局指标
主要结局
Mean absolute relative difference (MARD%)
时间窗: From successful device-wearing to device-removal, up to 14 days
MARD% requires an absolute relative difference (ARD) for each subject to be calculated, and then gets the mean for all subjects.
20/20% agreement rate with reference value
时间窗: From successful device-wearing to device-removal, up to 14 days
To compare CGM values with reference venous blood glucose values and to analyze the agreement rate
Percentage of total points found in Zone A +B of Clarke Error Grid
时间窗: From successful device-wearing to device-removal, up to 14 days
The distribution of measurement points in each zone was analyzed for A, B, C, D, and E. Zone A is clinically accurate; zone B is clinically uncritical decision; and the remaining zones C, D, and E are inaccurate to varying degrees. Analyze the sum of zone A and zone B.
Percentage of total points found in Zone A+B of Consensus Error Grid
时间窗: From successful device-wearing to device-removal, up to 14 days
The distribution glucose level points in each zone was analyzed for A, B, C, D, and E. Zone A is no effect on clinical action; zone B is altered clinical action or little or no effect on clinical outcome; Zone C is altered clinical action-likely to affect clinical outcome; and the remaining zones D, E are altered clinical action-could have significant medical risk or dangerous consequences. Analyze the sum of zone A and zone B.
次要结局
- Hyperglycemia or hypoglycemia alarm/alert performance of study device(From successful device-wearing to device-removal, up to 14 days)
- Number of participants with adverse events/serious adverse events(From day 1 to follow up (day 17 +- 1))
- 15/15% agreement rate with reference value(From successful device-wearing to device-removal, up to 14 days)
- 30/30% agreement rate with reference value(From successful device-wearing to device-removal, up to 14 days)
- Performance of user interfaces or patient interactions: Success rate of sensor insertion, sensor displacement rate, and calibration(From successful device-wearing to planned device-removal, up to 14 days)
- AE with special concern: erythema/edema under the adhesive patch or at the insertion site(From successful device-wearing to device-removal, up to 14 days)
- Scores of questionnaire on Ease of Use(Day 14)
- Pain score(Day 1)
- Number of cases of device failure/defect events(From successful device-wearing to device-removal, up to 14 days)