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

NCT05571397 | Completed Phase 1 Results DMC FDA Device

• 2 other identifiers: 2021H0407G220050
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Time in Target Glycemic Ranges

  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 Outcomes (1)

• Percent of Time in Hypoglycemic Ranges

  For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient

Study Arms (2)

Dexcom CGM

EXPERIMENTAL

Dexcom G6

Device: Dexcom G6

Historical Controls

NO INTERVENTION

Matched historical controls

Interventions

Dexcom G6 DEVICE

Continuous Glucose Monitor

Dexcom CGM

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Eileen Faulds
• Organization: The Ohio State University

faulds.10@osu.edu

419-989-0730

Study Officials

• EILEEN FAULDS, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CGM will be used by 100 MICU patients with glycemic control comparison with matched 100 MICU historical controls

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 7, 2022
• Study Start: November 1, 2023
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)