Continuous Glucose Monitoring in the Intensive Care Unit

Diabetes Mellitus Clinical Trial

Official title:

Continuous Glucose Monitoring in the Intensive Care Unit: Validation and Implementation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06190808
• Other study ID #: STUDY0000138
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of Massachusetts, Worcester
• Contact: John P Mordes, MD
• Phone: 6178884488
• Email: john.mordes[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Diagnostic Test:
• Dexcom G7 Continuous Glucose Monitor
Continuous glucose monitor

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clarke Error Grid	Traditional comparison of glucose concentration results obtained by standard test methods and by newer method	6 months
Primary	Mean Absolute Relative Difference (MARD).	Concordance of glucose concentration results obtained by standard test methods with those obtained by a continuous glucose monitoring device	6 months
Secondary	Unplanned event frequency	Number of occurrences per patient of device failure or or unforeseen device removal	6 months
Secondary	Adverse event nature and frequency	Number of occurrences per patient of device-associated infection, pain, or skin irritation	6 months