Skip to main content
Clinical Trials/NCT05571397
NCT05571397
Completed
Phase 1

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

Ohio State University1 site in 1 country201 target enrollmentNovember 1, 2023
ConditionsHyperglycemia
InterventionsDexcom G6

Overview

Phase
Phase 1
Intervention
Dexcom G6
Conditions
Hyperglycemia
Sponsor
Ohio State University
Enrollment
201
Locations
1
Primary Endpoint
Percentage of Time in Target Glycemic Ranges
Status
Completed
Last Updated
2 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
September 19, 2024
Last Updated
2 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Dexcom CGM

Dexcom G6

Intervention: Dexcom G6

Historical Controls

Matched historical controls

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Percent of Time in Hypoglycemic Ranges(For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient)

Study Sites (1)

Loading locations...

Similar Trials