Comparison of Continuous Glucose Monitoring and Point-of-Care Measurements on the Intensive Care Unit: An exploratory study

Comparison of Continuous Glucose Monitoring and Point-of-Care Measurements on the Intensive Care Unit: An exploratory study - Continuous Glucose Monitoring on the Intensive Care Unit

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57040

Enrollment

100

Registered

2024-10-07

Start date

2024-12-17

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high blood sugar Hyperglycemia hypoglycemia low blood sugar

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients admitted to the ICU - Insulin-dependent as defined in local protocol - Age: >= 18 y - Expected length of stay in ICU > 2 days

Exclusion criteria

Exclusion criteria: - Pregnancy - No informed consent - Therapeutic hypothermia (4 g/day

Design outcomes

Primary

Measure	Time frame
The first main study parameter is the discrepancy, in exact values, between glucose levels measured with CGM and POC in insulin-dependent ICU patients. The other main study parameter is the variation of the potential difference in glucose levels between CGM and POC among different patient-related factors	—

Secondary

Measure	Time frame
Six secundary study parameters are defined: 1. The difference in absolute discrepancy between the glucose levels measured with CGM and POC when the CGM sensor is placed in the abdomen versus the upper arm. 2. The reported adverse events, such as infections, bleeding, and decubitus, linked to the CGM. In case of a suspected infection originating from the CGM or decubitus, the CGM will be removed. 3. The number and percentage of hypo- and hyperglycemia episodes shown by the CGM which were not detected by POC interval measurements will be recorded. A hypoglycemia in this study is defined as a glucose level 10,0 mmol/L. 4. The time between the onset of a hypo- or hyperglycemia and its detection via POC testing. The time is described in minutes between the first CGM measurement below 4,0 mmol/L or above 10,0 mmol/L and the time of the POC testing below 4,0 mmol/L or above 10,0 mmol/L. 5. The duration of time, in minutes, it takes for the CGM to reliably measure after the sensor is inserted. Duration of time, in hours, the CGM reliably measures after the sensor is inserted. 6. The difference in discrepancy between the glucose levels measured with CGM and POC after radiologic procedure.	—

Measure

Time frame

Six secundary study parameters are defined: 1. The difference in absolute discrepancy between the glucose levels measured with CGM and POC when the CGM sensor is placed in the abdomen versus the upper arm. 2. The reported adverse events, such as infections, bleeding, and decubitus, linked to the CGM. In case of a suspected infection originating from the CGM or decubitus, the CGM will be removed. 3. The number and percentage of hypo- and hyperglycemia episodes shown by the CGM which were not detected by POC interval measurements will be recorded. A hypoglycemia in this study is defined as a glucose level 10,0 mmol/L. 4. The time between the onset of a hypo- or hyperglycemia and its detection via POC testing. The time is described in minutes between the first CGM measurement below 4,0 mmol/L or above 10,0 mmol/L and the time of the POC testing below 4,0 mmol/L or above 10,0 mmol/L. 5. The duration of time, in minutes, it takes for the CGM to reliably measure after the sensor is inserted. Duration of time, in hours, the CGM reliably measures after the sensor is inserted. 6. The difference in discrepancy between the glucose levels measured with CGM and POC after radiologic procedure.

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Countries

Netherlands

Outcome results