Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. (DREAM-ICU)
Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU
Main objective:
The goal is to to determine the accuracy of Dexcom G7 Continuous glucose monitor system in critically ill patients, undergoing major abdominal surgery and solid organ transplantation, in the intensive care unit.
On admission to the intensive care unit or at the end of surgery, two Dexcom G7 sensors are placed in the infraclavicular position.
Sensor number 1 will be blinded and will only be active when paired with the receiver, without the ability to monitor glucose levels.
Sensor number 2 is used for continuous glucose monitoring and can be used to adjust the insulin dose.
Patients will wear the continuous glucose monitoring sensor for a maximum of 10 days, including the time spent in the intensive care unit and the immediate care unit. The study will not interfere with any usual care clinical workflows.
Calibration is only performed on an unblinded sensor. The reference method for calibration is the glucose from the blood glucose meter.
Calibrate on the first day of monitoring: 4 times a day after approximately 6 hours, or if the blood glucose reading from the blood glucose meter is not within the estimated error range of the continuous glucose monitor (difference greater than 1,5mmol/L).
Calibration on days 2 and 3 of monitoring: once in the morning, or when the meter's glucose reading is not within the estimated error range of the continuous glucose monitoring (difference greater than 1,5mmol/L) On subsequent days when the blood glucose meter reading is not within the estimated error range of continuous glucose monitoring (difference greater than 1,5mmol/L).
Hypothesis:
- Ho: No difference in mean absolute relative difference (MARD) between calibrated and non-calibrated sensors.
- Ha: Calibrated sensors have lower mean absolute relative difference (δ = 4%, SD = 5%).
Further objectives:
To evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety.
To identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Design:
- Each intensive care unit patient wears two sensors (calibrated + non-calibrated).
- 4 glucose measurements/day × 6 days = 24 measurements/subject.
- Sequential Organ Failure Assessment (SOFA) score recorded daily.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Marek Protus, MD
- Telefonnummer: +420602278062
- E-mail: marek.protus@ikem.cz
Undersøgelse Kontakt Backup
- Navn: Alexander Macek, MD
- Telefonnummer: +421910631876
- E-mail: alexander.macek@ikem.cz
Studiesteder
-
-
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Prague, Tjekkiet
- Rekruttering
- Institute of Clinical and Experimental Medice
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Kontakt:
- Marek Protus, MD
- Telefonnummer: +420602278062
- E-mail: marek.protus@ikem.cz
-
Kontakt:
- Alexander Macek, MD
- Telefonnummer: +421910631876
- E-mail: alexander.macek@ikem.cz
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 18 years or over
- Intensive care unit admission
- Requiring blood glucose monitoring for insulin therapy
Exclusion Criteria:
- High-dose ascorbic acid or acetaminophen > 4g/day
- Physical or mental health condition precluding continuous wear of the continuous glucose monitor, as judged by the physician
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Enhedens gennemførlighed
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Open labeled CGM
Additional calibrations performed on CGM device during monitoring period
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Continuous measurement of glucose from subcutaneous tissue
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Sham-komparator: Control labeled CGM
No additional calibrations performed on CGM device during monitoring period
|
Continuous measurement of glucose from subcutaneous tissue
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Calculate overall mean absolute relative difference between arms
Tidsramme: From enrolment to discharge from ICU care or up-to day 10
|
Analyse the difference in mean absolute relative difference (MARD) of Dexcom G7 continuous glucose monitor between calibrated and uncalibrated sensor, in patients undergoing major abdominal surgery and solid organ transplantation.
|
From enrolment to discharge from ICU care or up-to day 10
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy metrics
Tidsramme: From enrolment to discharge from ICU care or up-to day 10
|
To evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety. To identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU. |
From enrolment to discharge from ICU care or up-to day 10
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- G-25-71
- ID Project No. LX22NPO5104 (Andet bevillings-/finansieringsnummer: MH CZ-DRO (Institute for Clinical and Experimental Medicine-IKEM, IN 00023001)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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