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

Phase 1

Completed

• Conditions: Hyperglycemia
• Interventions: Device: Dexcom G6

• Registration Number: NCT05571397
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Study Start: 2023-11-01
• Primary Completion: 2024-09-19
• Study Completion: 2024-09-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dexcom CGM	Dexcom G6	Dexcom G6

Primary Outcome Measures

Name	Time	Method
Time in Range	Daily during MICU admission; MICU length of stay to be determined by patient medical needs	Percent glucose in ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d

Secondary Outcome Measures

Name	Time	Method
Time in hypoglycemia	Daily during MICU admission; MICU length of stay to be determined by patient medical needs	Percent glucose \<70mg/dl and \<55mg/dl

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States