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

Hyperglycemia Clinical Trial

— CGM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571397
• Other study ID #: 2021H0407
• Secondary ID: G220050
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: EILEEN FAULDS, PhD
• Phone: 4199890730
• Email: eileen.faulds[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Device:
• Dexcom G6
Continuous Glucose Monitor

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in Range	Percent glucose in ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d	Daily during MICU admission; MICU length of stay to be determined by patient medical needs
Secondary	Time in hypoglycemia	Percent glucose <70mg/dl and <55mg/dl	Daily during MICU admission; MICU length of stay to be determined by patient medical needs