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Continuous Glucose Monitoring

Dexcom G6 Intervention Study

N/A

Waitlist Available

Led By Guillermo Umpierrez, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during hospitalization (up to 10 days)

Awards & highlights

No Placebo-Only Group

Summary

The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).

Eligible Conditions

Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during hospitalization (up to 10 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during hospitalization (up to 10 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospitalization (up to 10 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Daily Blood Glucose (BG) Concentration While Hospitalized

Number of Clinically Significant Hypoglycemia Events While Hospitalized

Percent of Time With BG Between 70-180 mg/dL While Hospitalized

Secondary study objectives

Count of Participants With Hypoglycemia After Discharge

Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized

Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge

+11 more

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 G6 CGM - Continues Glucose Monitoring sensor systemExperimental Treatment2 Interventions

Patients will wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days. In addition, patients will undergo POC testing before meals and bedtime per hospital protocol. Insulin therapy will be titrated based on daily CGM printouts, which will include BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Patients will wear a CGM in the current approved insertion site, the abdomen, and in the upper arm.

Group II: POC BG - Point-of-Care Blood Glucose monitoringActive Control1 Intervention

Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded in the electronic medical record (EMR) system. The research team together with the PCP team will adjust daily insulin orders based on POC readings (standard of care). In addition, patients will wear a 'blinded' CGM where no results will be visualized by patients, nursing staff, primary care physician (PCP) or research teams.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

POC BG - Point-of-Care Blood Glucose monitoring

2019

N/A

~290

Dexcom G6 CGM - Continues Glucose Monitoring sensor system

2019

N/A

~290