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| ID | Type | Description | Link |
|---|---|---|---|
| FoUI-960993 | Other Grant/Funding Number | Region Stockholm (ALF project) |
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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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This is an investigator-initiated, prospective, observational accuracy-study. The aim of the study is to test the feasibility, safety, and accuracy of a subcutaneous continuous glucose monitoring system (the Dexcom G6 glucose monitoring system) in critically ill patients. A total of 40 adult patients admitted to the intensive care unit requiring intravenous insulin infusion to maintain blood glucose within target range will be enrolled. Subcutaneous glucose readings will be compared with routine arterial blood glucose measurements to determine accuracy.
The primary endpoint of the study is the mean absolute relative difference (MARD) in percent between CGM and arterial glucose values. Calculations show that 40 patients are required for a 95% confidence interval for the mean to have a range of ±1.7%, meaning that MARD can be estimated with high precision. Calculations of confidence intervals were done using normal approximation, assuming an SD of 5.5 percentage units.
The following variables will be collected from the electronic medical record (Take Care), from the ICU-specific patient data management system (Clinisoft) and/or from the handheld Dexcom G6 monitor:
Patient-related variables:
Clinical variables:
Treatment variables:
Continuous Glucose Monitoring (CGM)-related variables:
Exact date and time of sensor insertion will be manually recorded in a case report form at the bedside. Every time an arterial blood gas is obtained, the arterial blood glucose value and the corresponding CGM glucose value will be manually recorded along with date and time in the case report form. At the end of the study period, after removing the CGM sensor, CGM-data will be downloaded from the handheld Dexcom G6 monitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill adults requiring insulin | Other | Patients admitted to the intensive care unit requiring insulin infusion to maintain blood glucose within target range |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous continuous glucose sensor | Device | Dexcom G6 continuous glucose monitoring system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute relative difference (MARD) | MARD in percent between subcutaneous sensor glucose values and arterial blood glucose values | From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute difference (MAD) | MAD between subcutaneous sensor glucose values and arterial blood glucose values | From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
| Numerical accuracy according to ISO criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Number of interrupted sensor readings (Feasibility outcome) | Number of interrupted sensor readings | From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
| Duration of interrupted sensor readings (Feasibility outcome) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan MÃ¥rtensson, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25233297 | Background | Matuleviciene V, Joseph JI, Andelin M, Hirsch IB, Attvall S, Pivodic A, Dahlqvist S, Klonoff D, Haraldsson B, Lind M. A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes. Diabetes Technol Ther. 2014 Nov;16(11):759-67. doi: 10.1089/dia.2014.0238. Epub 2014 Sep 18. |
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Numerical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined according to the International Organization for Standardization (ISO) criteria from 2013 (ISO 15197:2013) |
| From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
| Numerical accuracy according to CLSI standard | Numerical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined according to the Clinical and Laboratory Standards Institute (CLSI) Point of Care Testing 12-A3 (POCT12-A3) standard | From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
| Clinical accuracy determined by Clarke error grid analysis | Clinical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined by Clarke error grid analysis | From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
| Clinical accuracy determined by surveillance error grid analysis | Clinical accuracy between subcutaneous sensor glucose values and arterial blood glucose values determined by surveillance error grid analysis | From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
| Correlation | Correlation between arterial blood glucose levels and subcutaneous sensor glucose values | From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
Duration of interrupted sensor readings (hours) |
| From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |
| Adverse events (safety and tolerability) | Local reactions (e.g. allergic skin reactions, bruising) related to sensor insertion/sensor adhesives | From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days |