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

The Ohio State University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hyperglycemia

Treatments: Device: Dexcom G6

Study type: Interventional

Funder types: Other

Identifiers

NCT05571397

2021H0407

G220050 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Dexcom CGM

Experimental group

Description:

Dexcom G6

Treatment:

Device: Dexcom G6

Historical Controls

No Intervention group

Description:

Matched historical controls