Kontinuierliche Glukoseüberwachung auf der Intensivstation
Kontinuierliche Glukoseüberwachung auf der Intensivstation: Validierung und Implementierung
The aim of the proposed clinical trial is to study the use of the Dexcom G7 continuous glucose monitor (CGM) within the intensive care unit (ICU) environment. The overall goal is to validate the accuracy and practicality of the Dexcom G7 when used to assess glycemia in critically ill patients.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The specific goals are 1) to work with intensive care unit (ICU) staff, in a respiratory ICU setting, to determine how best to place and maintain Dexcom G7 continuous glucose monitors (CGMs) on patients and how to place recording devices and chargers in that environment, 2) download CGM readings to the Dexcom Dashboard in an analyzable format, and 3) to compare simultaneous CGM readings with glucose measurements obtained in the course of routine care as recorded in the electronic medical record. The primary analytical goal is the correlation of CGM glucose measurements with those obtained in the course of routine care. A secondary goal is to determine the frequency of device malfunctions that occur either as a result of device failure (e.g. it falls off) or adverse events (e.g. removal due to skin irritation).
Study subjects will be patients admitted to the 6-ICU UMass Memorial Medical Center (UMMMC) University Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized. All enrolled volunteers will have a Dexcom G7 CGM place on the skin according to manufacturer's specifications. The devices will remain in place for 10 days or until discharge from the ICU
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Massachusetts
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Worcester, Massachusetts, Vereinigte Staaten, 01605
- UMass Memorial Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized.
- Persons with either type 1 or type 2 diabetes.
- Persons of either sex.
- Persons of any age over 18.
- Persons able to give informed consent or cognitively impaired adults whose legally authorized representative (LAR) can give informed consent.
- English or Spanish speaking adults.
Exclusion Criteria:
- Persons unable to provide informed consent.
- Cognitively impaired persons whose LAR declines to provide informed consent.
- Patients receiving hydroxyurea, which interferes with sensor function.
- Patients receiving high dose acetaminophen (> 4 gm/day), which interferes with sensor function.
- Anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy.
- Severe cachexia with absence of subcutaneous fat at preferred sensor placement sites, which might interfere with sensor accuracy.
- Persons who are pregnant.
- Prisoners.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Single Arm
All members of the arm will have a CGM place and glucose concentration downloaded. |
Continuous glucose monitor |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean Absolute Relative Difference (MARD).
Zeitfenster: 6 months
|
Concordance of glucose concentration results obtained by standard test methods with those obtained nearly simultaneously by a continuous glucose monitoring device was assessed by Mean Absolute Relative Difference (MARD). The MARD is the average percentage difference between the continuous glucose monitor readings measured over 6 months and glucose concentration results obtained by near simultaneous (+/- 5 minutes) standard test methods was used to gauge the accuracy of the CGM in the ICU setting. Typical MARD values reported for CGMs in the outpatient setting average approximately 8%. Typical MARD values reported for CGMs other than the one used in this study n the ICU setting average approximately 12%. |
6 months
|
|
Clarke Error Grid
Zeitfenster: 6 months
|
Concordance of glucose concentration results obtained by standard test methods with those obtained nearly simultaneously by a continuous glucose monitoring device was assessed by Clarke Error Grid. The Clarke Error Grid plots of reference glucose values obtained by point-of-care fingerstick or laboratory determination (x-axis) against CGM values (y-axis). The grid is divided into 5 zones (A-E) that indicate clinical implications of CGM glucose measurements when compared to a "gold standard" Region A: Clinically accurate. Region B: Benign measurement error. Region C: Overcorrection error region CGM values suggest unnecessary treatment. Region D: Serious hypo- or hyperglycemia detection error region. Region E: Erroneous treatment region. CGM fails to detect potentially dangerous hypo- or hyperglycemia Ideally, all values are in Regions A and B. We report the percentage of correlated values that fall in each region. |
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Unplanned Event Frequency
Zeitfenster: 6 months
|
Number of occurrences per patient of device failure or or unforeseen device removal |
6 months
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: John P Mordes, MD, UMass Chan Medical School
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY00001138
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Study design and deidentified aggregate glucose concentration data will be shared. No individual patient data will be shared.
IPD-Sharing-Zeitrahmen
One year
IPD-Sharing-Zugriffskriterien
Publication
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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