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OpenTrials
Completed

NCT Number: NCT05571397

Expanding Use of CGM 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.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexcom G6

Device

Continuous Glucose Monitor

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Acronym: CGM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2022
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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