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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

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

CGM Trial 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.Check my eligibility

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.See study design

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.

CGM Trial 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.

CGM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily during micu admission; micu length of stay to be determined by patient medical needs

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time in Range

Secondary outcome measures

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%

Study treatment Arm

Insulin and CGM Intervention

CGM 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,520 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort participating in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this research is recruiting participants since the original posting on August 16th 2022 and most recently updated on October 4th 2022. Currently, one hundred people are being recruited from a single site."

Answered by AI

Are there any vacancies in this medical trial for volunteers?

"Affirmative. According to clinicaltrials.gov, this experiment is presently searching for participants and was initially posted on August 16th 2022 with the latest update being made October 4th 2022. The study requires 100 individuals at a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Expanding Use of CGM in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05571397.