Expanding Use of CGM in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes (CGM)

February 4, 2026 updated by: Ohio State University

Expanding Use of Continuous Glucose Monitoring Beyond COVID in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes

The primary objective of this implementation study is to assess the feasibility of real time continuous glucose monitoring (CGM) implementation using a CGM plus (+) point-of-care (POC) protocol among patients on IV insulin or those with hyperglycemia (>250mg/dl) in the critical care hospital environments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study analyzes the feasibility of inpatient real time CGM implementation through the use of a CGM + POC protocol as routine care for glycemic monitoring among patients on IV insulin or those with hyperglycemia (>250mg/dl). The investigators will examine the effects on medical intensive care (MICU) patient's (N=100) glycemic control compared to matched historical control patients (N=100) from the MICU who received fingerstick POC.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adults >18 years old,
  • admitted to Ohio State University Wexner Medical Center MICU and
  • have hyperglycemia (glucose >250mg/dl) or are currently on IV insulin.

Exclusion Criteria:

  • Current COVID-19 infection,
  • Refractory shock (Levophed dose >0.5 mcg/kg/min or equivalent)
  • Actively being treated for diabetic ketoacidosis (DKA)
  • Actively being treated for hyperosmolar non-ketoacidosis (HONK)
  • Pitting edema, anasarca, blue or purple discoloration to left upper extremity
  • Treated with high dose acetaminophen (>1 gram Q6 hours)
  • Treated with hydroxyurea
  • Are pregnant, patients
  • Using home insulin pump therapy during hospitalization, or
  • Reside in a corrections institution.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexcom CGM
Dexcom G6
Device: Dexcom G6
Continuous Glucose Monitor
No Intervention: Historical Controls
Matched historical controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Time in Target Glycemic Ranges
Time Frame: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient
Percent of time in target glycemic ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d
For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Time in Hypoglycemic Ranges
Time Frame: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient
Percent of time in hypoglycemic ranges <70mg/dl and <55mg/dl
For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: EILEEN FAULDS, PhD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

September 19, 2024

Study Completion (Actual)

September 19, 2024

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021H0407
  • G220050 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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