← Back to Search

Continuous Glucose Monitoring Device

Continuous Glucose Monitoring for High Blood Sugar (CGM Trial)

Phase 1 & 2
Recruiting
Led By EILEEN FAULDS, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with hyperglycemia (glucose >250mg/dl) or currently on IV insulin
Adults >18 years old admitted to Ohio State University Wexner Medical Center MICU
Must not have
Actively being treated for hyperosmolar non-ketoacidosis (HONK)
Refractory shock (Levophed dose >0.5 mcg/kg/min or equivalent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily during micu admission; micu length of stay to be determined by patient medical needs
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how well a new system for monitoring blood sugar works in patients in the hospital.

Who is the study for?
This trial is for adults over 18 in the MICU at Ohio State University Wexner Medical Center with high blood sugar or on IV insulin. It's not for those with severe shock, current COVID-19, high acetaminophen use, pregnancy, incarceration, DKA or HONK treatment, home insulin pump use during hospitalization, or certain skin conditions.
What is being tested?
The study tests if using a Dexcom G6 continuous glucose monitor (CGM) plus point-of-care testing can be feasibly implemented in critical care and how it affects nurse work patterns and patient outcomes compared to standard practices.
What are the potential side effects?
While CGMs like Dexcom G6 are generally safe and well-tolerated, potential side effects may include skin irritation where the device attaches to the body and inaccurate readings that could affect treatment decisions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have high blood sugar or am on IV insulin.
Select...
I am over 18 and admitted to the Ohio State University Wexner Medical Center MICU.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently receiving treatment for HONK.
Select...
I am experiencing severe shock requiring high doses of medication.
Select...
I am currently infected with COVID-19.
Select...
I am currently taking hydroxyurea.
Select...
I use an insulin pump at home and will continue to use it in the hospital.
Select...
I am currently receiving treatment for diabetic ketoacidosis.
Select...
I have swelling, skin discoloration, or severe swelling all over my body.
Select...
I have been taking more than 1 gram of acetaminophen every 6 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily during micu admission; micu length of stay to be determined by patient medical needs
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily during micu admission; micu length of stay to be determined by patient medical needs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time in Range
Secondary study objectives
Time in hypoglycemia

Side effects data

From 2020 Phase 4 trial • 10 Patients • NCT03670641
70%
Hypoglycemia
60%
Signal Loss with Continuous Glucose Monitor (CGM)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Insulin and CGM Intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dexcom CGMExperimental Treatment1 Intervention
Dexcom G6
Group II: Historical ControlsActive Control1 Intervention
Matched historical controls
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexcom G6
2020
Completed Phase 4
~210

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,061 Total Patients Enrolled
EILEEN FAULDS, PhDPrincipal InvestigatorOhio State University

Media Library

Dexcom G6 (Continuous Glucose Monitoring Device) Clinical Trial Eligibility Overview. Trial Name: NCT05571397 — Phase 1 & 2
High Blood Sugar Research Study Groups: Dexcom CGM, Historical Controls
High Blood Sugar Clinical Trial 2023: Dexcom G6 Highlights & Side Effects. Trial Name: NCT05571397 — Phase 1 & 2
Dexcom G6 (Continuous Glucose Monitoring Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05571397 — Phase 1 & 2
~50 spots leftby Nov 2025