check_circleStudy Completed
Continuous glucose monitoring, Diabetes mellitus
Bayer Identifier:infoA unique number for a trial given by Bayer.
21972
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
A study to learn how well a monitoring system called Continuous Glucose Monitoring (CGM) which measures glucose on an ongoing basis works and how safe it is in Chinese patients in usual practice
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal info
76The overall number of participants needed for a trial.
Trial Dates info
October 2021 - March 2022Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 4A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Cascade® CGM system (BPI1000070)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, China |
Completed | Many Locations | Many Locations, China |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 20/20% agreement rate with reference valueTo compare CGM values with reference venous blood glucose values and to analyze the agreement ratedate_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
- Percentage of total points found in Zone A +B of Clarke Error GridThe 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.date_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
- Percentage of total points found in Zone A+B of Consensus Error GridThe 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.date_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
- Mean absolute relative difference (MARD%)MARD% requires an absolute relative difference (ARD) for each subject to be calculated, and then gets the mean for all subjects.date_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 15/15% agreement rate with reference valueTo compare CGM values with reference venous blood glucose values and to analyze the agreement ratedate_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
- 30/30% agreement rate with reference valueTo compare CGM values with reference venous blood glucose values and to analyze the agreement ratedate_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
- Scores of questionnaire on Ease of UseA questionnaire on Ease of Use will be used to evaluate the Ease of Use of the study device through user ratings of the study device. 5-point-scale with 1=Very Unsatisfied, 5=Very Satisfied.date_rangeTime Frame:Day 14
- Hyperglycemia or hypoglycemia alarm/alert performance of study devicedate_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
- Number of cases of device failure/defect eventsdate_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
- Pain scoreThe Gracely Box Scale will be used to evaluate the pain level of first CGM sensor insertion, and the pain level of first BGM fingertip blood glucose collection. Gracely Box Scale is a visual analog of 0 (0=No pain sensation) to 20, used by a participant to define the pain intensity experience.date_rangeTime Frame:Day 1
- Performance of user interfaces or patient interactions: Success rate of sensor insertion, sensor displacement rate, and calibrationSensor insertion success is defined as the number of sensors used within 10 hours after the first sensor insertion less than or equal to 2. Sensor displacement is defined as accidental shedding or displacement of the sensor during wearing.date_rangeTime Frame:From successful device-wearing to planned device-removal, up to 14 days
- Number of participants with adverse events/serious adverse eventsdate_rangeTime Frame:From day 1 to follow up (day 17 +- 1)
- AE with special concern: erythema/edema under the adhesive patch or at the insertion siteA Draize score (0 to 3) will be used to assess the degree of erythema and edema, with higher scores representing a higher severity of symptoms.date_rangeTime Frame:From successful device-wearing to device-removal, up to 14 days
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DeviceAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
Supportive CareThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.