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

NCT ID: NCT05571397

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-09-19

Brief Summary

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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

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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.

Conditions

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Hyperglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

CGM will be used by 100 MICU patients with glycemic control comparison with matched 100 MICU historical controls
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexcom CGM

Dexcom G6

Group Type EXPERIMENTAL

Dexcom G6

Intervention Type DEVICE

Continuous Glucose Monitor

Historical Controls

Matched historical controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexcom G6

Continuous Glucose Monitor

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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EILEEN FAULDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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G220050

Identifier Type: OTHER

Identifier Source: secondary_id

2021H0407

Identifier Type: -

Identifier Source: org_study_id