Continuous Glucose Monitoring SystemNCT03120091
Assessment of the Accuracy,Feasibility,Safety of Continuous Glucose Monitoring System
An observational study of Continuous Glucose Monitoring System and Accuracy, run by West China Hospital at 1 site in China.
Trial summary
Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU, but its feasibility, accuracy and confounding factors are controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Glucose Monitoring System, Accuracy, Feasibility
- What is being tested?
- Real-time continuous blood glucose monitoring system(CGMS)
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2014to 31 Jan 2015
- 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
- Adult, Older adult
Study population: Patients were screened in a 52-bed general ICU of West China Hospitaland enrolled if they were at least 18 years old and had an anticipated stay in ICU for more than 48 hours.
Who may be able to join
- Inclusion criteria: Critically ill patients who were older than 18 years old and expected length of ICU stay longer than 48 hours
Who cannot join
- 1) they were pregnant.2) had broken skin. 3) had a platelet count of less than 30 × 109/L 4) had participated in another trial.5) diabetic ketoacidosis or hyperosmotic coma.6) judged to be improper to complete this trial by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy, Feasibility, Safety and Confounding Factors of Real-time Continuous Glucose Monitoring System
Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU, but its feasibility, accuracy and confounding factors are controversial.
Read the detailed description
Acute glucose metabolic disorder (hyperglycemia, hypoglycemia and high glucose variability) is common during critical illness and associated with poor prognosis.Continuous glucose monitoring system (CGMS), which providing continuous glucose values, is promising to overcome these problems mentioned above and finally optimize glucose control.But its feasibility, accuracy and confounding factors are controversial.The aims of this study is to assess the accuracy, feasibility and safety of CGMS in daily routine in a general ICU in comparison with simultaneous laboratory arterial blood glucose (ABG) values
- Conditions
- Continuous Glucose Monitoring System, Accuracy, Feasibility, Safety
- Being tested
- Real-time continuous blood glucose monitoring system(CGMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time continuous blood glucose monitoring system(CGMS)Device
A total of 20 patients were enrolled for the place of CGMS.CGMS were placed on the right chest wall of each patients and recorded the interstitial glucose. Arterial blood glucose (ABG) were recorded every four hours. The duration of monitoring set was 5 days.CGMS were compared with ABG at the same time point. A total of 600 pairs of glucose level were collected
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Patients | A total of 20 patients were enrolled for the place of CGMS. Arterial blood glucose (ABG) were recorded every four hours. The duration of monitoring set was 5 days.CGMS were compared with ABG at the same time point. A total of 600 pairs of glucose level were collected Receives: Device: Real-time continuous blood glucose monitoring system(CGMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Spearman correlation analysis
correlation coefficient (between 0.3 and 0.5):low correlation;(between 0.5 and 0.8);moderate correlation;(above 0.8):high correlation
Measured: CGMS will be used up to 5 days
Bland-altman analysis
more than 95% CGMS-arterial blood glucose(ABG) data pairs should be within the agreement range.
Measured: CGMS will be used up to 5 days
The International Standardization Organization (ISO) criteria
more than 95% of CGMS readings should be within 0.83mmol/L( of the reference values when the reference value is ≤5.56mmol/L and within 15.0% of the reference values when the reference value is >5.56mmol/L
Measured: CGMS will be used up to 5 days
Mean absolute relative difference(MARD) and possible confounding factors
The MARD in critical ill patients should not be more than 14%.Stratified MARD according to 7 factors(history of diabetes, blood glucose variability （determined using standard deviation of blood glucose）, glucose ranges(<4.4mmol/L,4.4-10mmol/L,>10mmol/L）, vasoactive drugs,continuous renal replacement therapy(CRRT), glucocorticoids, enteral nutrition(EN) and parenteral nutrition(PN) will be calculated and made a comparison.
Measured: CGMS will be used up to 5 days
Clarke error grid analysis
More than 98% data pairs should locate in "accuracy zone(Zone A)" and "clinically acceptable zone(Zone B)"
Measured: CGMS will be used up to 5 days
Surveillance error grid
There is no definite data field.The results will be analyzed comprehensively
Measured: CGMS will be used up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Jul 2014
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose Monitoring SystemStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Yan, West China Hospital
- Investigators
- Yan Kang, MD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120091
- Sponsor's protocol ID
- accuracy-ky65
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy, Feasibility, Safety and Confounding Factors of Real-time Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT03120091
- Acronym / sponsor ID
- accuracy-ky65
- Conditions
- Continuous Glucose Monitoring System, Accuracy, Feasibility, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 19 Apr 2017 (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.
Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU, but its feasibility, accuracy and confounding factors are controversial.
Detailed description
Acute glucose metabolic disorder (hyperglycemia, hypoglycemia and high glucose variability) is common during critical illness and associated with poor prognosis.Continuous glucose monitoring system (CGMS), which providing continuous glucose values, is promising to overcome these problems mentioned above and finally optimize glucose control.But its feasibility, accuracy and confounding factors are controversial.The aims of this study is to assess the accuracy, feasibility and safety of CGMS in daily routine in a general ICU in comparison with simultaneous laboratory arterial blood glucose (ABG) values
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Patients | – | Device: Real-time continuous blood glucose monitoring system(CGMS)A total of 20 patients were enrolled for the place of CGMS. Arterial blood glucose (ABG) were recorded every four hours. The duration of monitoring set was 5 days.CGMS were compared with ABG at the same time point. A total of 600 pairs of glucose level were collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients were screened in a 52-bed general ICU of West China Hospitaland enrolled if they were at least 18 years old and had an anticipated stay in ICU for more than 48 hours.
Key inclusion criteria (1 listed)
- Inclusion criteria: Critically ill patients who were older than 18 years old and expected length of ICU stay longer than 48 hours
Key exclusion criteria (1 listed)
- 1) they were pregnant.2) had broken skin. 3) had a platelet count of less than 30 × 109/L 4) had participated in another trial.5) diabetic ketoacidosis or hyperosmotic coma.6) judged to be improper to complete this trial by the investigator
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 |
|---|---|---|
| Real-time continuous blood glucose monitoring system(CGMS)A total of 20 patients were enrolled for the place of CGMS.CGMS were placed on the right chest wall of each patients and recorded the interstitial glucose. Arterial blood glucose (ABG) were recorded every four hours. The duration of monitoring set was 5 days.CGMS were compared with ABG at the same time point. A total of 600 pairs of glucose level were collected | Device | Enrolled Patients |
Primary outcome
The Spearman correlation analysis
Time frame: CGMS will be used up to 5 days
correlation coefficient (between 0.3 and 0.5):low correlation;(between 0.5 and 0.8);moderate correlation;(above 0.8):high correlation
Bland-altman analysis
Time frame: CGMS will be used up to 5 days
more than 95% CGMS-arterial blood glucose(ABG) data pairs should be within the agreement range.
The International Standardization Organization (ISO) criteria
Time frame: CGMS will be used up to 5 days
more than 95% of CGMS readings should be within 0.83mmol/L( of the reference values when the reference value is ≤5.56mmol/L and within 15.0% of the reference values when the reference value is >5.56mmol/L
Mean absolute relative difference(MARD) and possible confounding factors
Time frame: CGMS will be used up to 5 days
The MARD in critical ill patients should not be more than 14%.Stratified MARD according to 7 factors(history of diabetes, blood glucose variability （determined using standard deviation of blood glucose）, glucose ranges(<4.4mmol/L,4.4-10mmol/L,>10mmol/L）, vasoactive drugs,continuous renal replacement therapy(CRRT), glucocorticoids, enteral nutrition(EN) and parenteral nutrition(PN) will be calculated and made a comparison.
Clarke error grid analysis
Time frame: CGMS will be used up to 5 days
More than 98% data pairs should locate in "accuracy zone(Zone A)" and "clinically acceptable zone(Zone B)"
Surveillance error grid
Time frame: CGMS will be used up to 5 days
There is no definite data field.The results will be analyzed comprehensively
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 19 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Yan Kang, MD study director
West China Hospital
1 site 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 System and Accuracy, run by West China Hospital at 1 site 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 1 inclusion and 1 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The Spearman correlation analysis (time frame: CGMS will be used up to 5 days). The study lists 6 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 19 Apr 2017.