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

Primary Purpose

Hyperglycemia

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dexcom G6

About this trial

This is an interventional treatment trial for Hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dexcom CGM

Historical Controls

Arm Description

Dexcom G6

Matched historical controls

Outcomes

Primary Outcome Measures

Time in Range

Percent glucose in ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d

Secondary Outcome Measures

Time in hypoglycemia

Percent glucose <70mg/dl and <55mg/dl

Full Information

NCT ID

NCT05571397

First Posted

September 15, 2022

Last Updated

October 4, 2022

Sponsor

Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT05571397

Brief Title

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

Acronym

CGM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 16, 2022 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexcom CGM

Arm Type

Experimental

Arm Description

Dexcom G6

Arm Title

Historical Controls

Arm Type

No Intervention

Arm Description

Matched historical controls

Intervention Type

Device

Intervention Name(s)

Dexcom G6

Intervention Description

Continuous Glucose Monitor

Primary Outcome Measure Information:

Title

Time in Range

Description

Percent glucose in ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d

Time Frame

Daily during MICU admission; MICU length of stay to be determined by patient medical needs

Secondary Outcome Measure Information:

Title

Time in hypoglycemia

Description

Percent glucose <70mg/dl and <55mg/dl

Time Frame

Daily during MICU admission; MICU length of stay to be determined by patient medical needs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

EILEEN FAULDS, PhD

Phone

4199890730

eileen.faulds@osumc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sandra Solove

solove.3@osu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

EILEEN FAULDS, PhD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

EILEEN Faulds, PhD

Phone

419-989-0730

eileen.faulds@osumc.edu

First Name & Middle Initial & Last Name & Degree

Sandra Solove

solove.3@osu.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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