Continuous Glucose MonitoringCareMinsNCT05038761
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
An observational study of Continuous Glucose Monitoring and Diabetes Mellitus, run by Bayer at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Glucose Monitoring, Diabetes Mellitus
- What is being tested?
- CGM System and Standard Venous Blood Glucose Test
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 76 participants
- Where
- 2 sitesChina
- Study dates
- 8 Oct 2021to 21 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Female and/or male patients with a diagnosis of type 1 or type 2 diabetes mellitus will be enrolled after the decision to initiate venous blood glucose testing and CGM as per investigator's routine treatment practice.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Many locations
Multiple Locations, Many Locations
Many Locations
Multiple Locations
About this study
Official title: A Prospective Observational Study to Evaluate the Effectiveness and Safety of Cascade® Continuous Glucose Monitoring System in China: A Real World Study
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.
Read more
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.
- Conditions
- Continuous Glucose Monitoring, Diabetes Mellitus
- Being tested
- CGM System, Standard Venous Blood Glucose Test
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM SystemDevice
Following the manner of observational study, no intervention will be used for the study.
Participants will wear the CGM on abdomen or lower area for no longer than 14 days.
Standard Venous Blood Glucose TestProcedure or surgery
Necessary venous blood glucose testing will be performed during the study as clinically required as comparator.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 or type 2 diabetes mellitus participants | Participants will be enrolled after the decision to initiate venous blood glucose testing and Continuous Glucose Monitoring (CGM) system as per investigator's routine treatment practice. Receives: Device: CGM System; Procedure: Standard Venous Blood Glucose Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
20/20% agreement rate with reference value
To compare CGM values with reference venous blood glucose values and to analyze the agreement rate
Measured: From successful device-wearing to device-removal, up to 14 days
Percentage of total points found in Zone A +B of Clarke Error Grid
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.
Measured: From successful device-wearing to device-removal, up to 14 days
Percentage of total points found in Zone A+B of Consensus Error Grid
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.
Measured: 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.
Measured: From successful device-wearing to device-removal, up to 14 days
Secondary outcomes (9)
15/15% agreement rate with reference value
To compare CGM values with reference venous blood glucose values and to analyze the agreement rate
Measured: From successful device-wearing to device-removal, up to 14 days
30/30% agreement rate with reference value
To compare CGM values with reference venous blood glucose values and to analyze the agreement rate
Measured: From successful device-wearing to device-removal, up to 14 days
Scores of questionnaire on Ease of Use
A 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.
Measured: Day 14
Hyperglycemia or hypoglycemia alarm/alert performance of study device
Measured: From successful device-wearing to device-removal, up to 14 days
Number of cases of device failure/defect events
Measured: From successful device-wearing to device-removal, up to 14 days
Pain score
The 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.
Measured: Day 1
Performance of user interfaces or patient interactions: Success rate of sensor insertion, sensor displacement rate, and calibration
Sensor 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.
Measured: From successful device-wearing to planned device-removal, up to 14 days
Number of participants with adverse events/serious adverse events
Measured: From day 1 to follow up (day 17 +- 1)
AE with special concern: erythema/edema under the adhesive patch or at the insertion site
A 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.
Measured: From successful device-wearing to device-removal, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start8 Oct 2021
- Primary completion29 Jan 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038761
- Sponsor's protocol ID
- 21972
- Acronym
- CareMins
- Status last verified
- Mar 2023
- First submitted
- 1 Sep 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate the Effectiveness and Safety of Cascade® Continuous Glucose Monitoring System in China: A Real World Study
- ClinicalTrials.gov ID
- NCT05038761
- Acronym / sponsor ID
- CareMins / 21972
- Conditions
- Continuous Glucose Monitoring, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 or type 2 diabetes mellitus participants | – | Device: CGM System, Procedure: Standard Venous Blood Glucose TestParticipants will be enrolled after the decision to initiate venous blood glucose testing and Continuous Glucose Monitoring (CGM) system as per investigator's routine treatment practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female and/or male patients with a diagnosis of type 1 or type 2 diabetes mellitus will be enrolled after the decision to initiate venous blood glucose testing and CGM as per investigator's routine treatment practice.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM SystemFollowing the manner of observational study, no intervention will be used for the study. Participants will wear the CGM on abdomen or lower area for no longer than 14 days. | Device | Type 1 or type 2 diabetes mellitus participants |
| Standard Venous Blood Glucose TestNecessary venous blood glucose testing will be performed during the study as clinically required as comparator. | Procedure or surgery | Type 1 or type 2 diabetes mellitus participants |
Primary outcome
20/20% agreement rate with reference value
Time frame: 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
Time frame: 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
Time frame: 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.
Mean absolute relative difference (MARD%)
Time frame: 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.
9 secondary outcomes
15/15% agreement rate with reference value
Time frame: From successful device-wearing to device-removal, up to 14 days
30/30% agreement rate with reference value
Time frame: From successful device-wearing to device-removal, up to 14 days
Scores of questionnaire on Ease of Use
Time frame: Day 14
Hyperglycemia or hypoglycemia alarm/alert performance of study device
Time frame: From successful device-wearing to device-removal, up to 14 days
Number of cases of device failure/defect events
Time frame: From successful device-wearing to device-removal, up to 14 days
Pain score
Time frame: Day 1
Performance of user interfaces or patient interactions: Success rate of sensor insertion, sensor displacement rate, and calibration
Time frame: From successful device-wearing to planned device-removal, up to 14 days
Number of participants with adverse events/serious adverse events
Time frame: From day 1 to follow up (day 17 +- 1)
AE with special concern: erythema/edema under the adhesive patch or at the insertion site
Time frame: From successful device-wearing to device-removal, up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Continuous Glucose Monitoring and Diabetes Mellitus, run by Bayer at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20/20% agreement rate with reference value (time frame: From successful device-wearing to device-removal, up to 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.