Continue glucosemonitoring op de intensive care
Continue glucosemonitoring op de intensive care: validatie en implementatie
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Worcester, Massachusetts, Verenigde Staten, 01605
- UMass Memorial Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Single Arm
All members of the arm will have a CGM place and glucose concentration downloaded. |
Continuous glucose monitor |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean Absolute Relative Difference (MARD).
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Unplanned Event Frequency
Tijdsspanne: 6 months
|
Number of occurrences per patient of device failure or or unforeseen device removal |
6 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: John P Mordes, MD, UMass Chan Medical School
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00001138
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Study design and deidentified aggregate glucose concentration data will be shared. No individual patient data will be shared.
IPD-tijdsbestek voor delen
One year
IPD-toegangscriteria voor delen
Publication
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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