Clinical trial NCT06190808: Continuous Glucose Monitoring in the Intensive Care Unit
Official title: Continuous Glucose Monitoring in the Intensive Care Unit: Validation and Implementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: ICU
CGM
Accuracy
Diabetes
Hypoglycemia
Diabetes mellitus
Continuous glucose monitor
Intensive care
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hyperglycemic patients admitted to an intensive care unit will have blood glucose concentration measured using current standard-of-care tests (fingerstick determinations and laboratory assays). Study participants will bel be asked to volunteer to permit concurrent glucose measurement using a Dexcom G7 continuous glucose monitor in order to determine the accuracy and feasibility of the latter. Only standard glucose measurements will be used for patient management.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Clarke Error Grid
timeFrame: 6 months
measure: Mean Absolute Relative Difference (MARD).
timeFrame: 6 months
Secondary outcomes:
measure: Unplanned event frequency
timeFrame: 6 months
measure: Adverse event nature and frequency
timeFrame: 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: John P Mordes, MD
role: PRINCIPAL_INVESTIGATOR
References: