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Continuous Glucose Monitoring

Dexcom G6 CGM - Continues Glucose Monitoring sensor system for Diabetes

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

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 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

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

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

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,583,481 Total Patients Enrolled
32 Trials studying Diabetes
16,846 Patients Enrolled for Diabetes
Guillermo Umpierrez, MDPrincipal Investigator - Emory University
Emergency Care of Atlanta Inc, Grady Memorial Hospital
University De Guayaquil (Medical School)
Emory University Hospital (Residency)
33 Previous Clinical Trials
11,336 Total Patients Enrolled
11 Trials studying Diabetes
8,350 Patients Enrolled for Diabetes
~30 spots leftby Sep 2025
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