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Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU, but its feasibility, accuracy and confounding factors are controversial.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | 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)" | CGMS will be used up to 5 days |
| Surveillance error grid | There is no definite data field.The results will be analyzed comprehensively |
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| Measure | Description | Time Frame |
|---|---|---|
| Continuous data display/Total monitoring time | CGM should continuously measure glucose and display in real time >95% of the time for the duration of total study period. | CGMS will be used up to 5 days |
| device-related data gaps |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yan Kang, MD | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care unit of West China Hospital | Chengdu | Sichuan | 610000 | China |
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| CGMS will be used up to 5 days |
Skips in data acquisition should not exceed 30 minutes at a time
| CGMS will be used up to 5 days |
| Reasons for early disconnection of CGMS | the number of each disconnection reason(3 categories:Accidentally,poor signal and early discharge) | CGMS will be used up to 5 days |
| Number of Participants With Local complications, such as infection, bleeding, bruises and redness | Number of Participants With Local complications, such as infection, bleeding, bruises and redness | CGMS will be used up to 5 days |