Continuous Glucose Monitoring in the Intensive Care Unit

NCT06190808 | Completed Results FDA Device

• 1 other identifier: STUDY00001138
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

ICU; CGM; Accuracy; Diabetes; Hypoglycemia; Diabetes mellitus; Continuous glucose monitor; Intensive care

Outcome Measures

Primary Outcomes (2)

• Mean Absolute Relative Difference (MARD).

  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

  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

Secondary Outcomes (1)

• Unplanned Event Frequency

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

All members of the arm will have a CGM place and glucose concentration downloaded.

Diagnostic Test: Dexcom G7 Continuous Glucose Monitor

Interventions

Dexcom G7 Continuous Glucose Monitor DIAGNOSTIC_TEST

Continuous glucose monitor

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

A limitation of the study was the small number of subjects, due principally to the difficulty of obtaining informed consent from either the critically ill patient or their Legally Authorized Representative, many of whom were unavailable in a timely manner. Another limitation is that all subjects were enrolled in respiratory ICUs at a single medical center. CGM use in other kinds of ICUs needs to be investigated separately.

Results Point of Contact

• Title: John P Mordes, MD, PI, Professor Emeritus of Medicine
• Organization: UMass Medical School

john.mordes@umassmed.edu

5088563291

Study Officials

• John P Mordes, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 5, 2024
• Study Start: February 20, 2024
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: September 29, 2026
• Results First Posted: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year
• Access Criteria: Publication

Locations

US (1)