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

Study 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.

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

Conditions
-----------------
Hyperglycemia

Intervention / Treatment
-----------------
* Device: Dexcom G6


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: CGM will be used by 100 MICU patients with glycemic control comparison with matched 100 MICU historical controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexcom CGM<br>Dexcom G6 | Device: Dexcom G6<br>* Continuous Glucose Monitor<br>|
| No Intervention: Historical Controls<br>Matched historical controls | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |