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Continuous Glucose Monitoring System

Dexcom real-time G6 Continuous Glucose Monitoring System (CGM) for Type 2 Diabetes

N/A
Waitlist Available
Led By Rodolfo Galindo, 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 up to 3 months
Awards & highlights

Study Summary

This trial will help researchers learn if real-time CGM data can prevent hypoglycemia in patients with type 2 diabetes and end-stage kidney disease who are treated with insulin therapy and receiving hemodialysis.

Eligible Conditions
  • Type 2 Diabetes
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).
Secondary outcome measures
% time in hyperglycemia (>180 mg/dL)
% time in hyperglycemia (>250 mg/dl)
% time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)Experimental Treatment2 Interventions
Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks.
Group II: Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)Experimental Treatment2 Interventions
Patients with type 2 DM treated with insulin and receiving hemodialysis will use POC BG for 4 weeks, then 2 weeks of wash-out period, and cross over to use a real-time/personal CGM for 4 weeks (Control-Intervention Group).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)
2020
N/A
~70
POC BG
2020
N/A
~70

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,509 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,002 Total Patients Enrolled
Rodolfo Galindo, MDPrincipal Investigator - Emory University
Emory University
1 Previous Clinical Trials
145 Total Patients Enrolled

Media Library

Dexcom real-time G6 Continuous Glucose Monitoring System (CGM) (Continuous Glucose Monitoring System) Clinical Trial Eligibility Overview. Trial Name: NCT04473430 — N/A
Type 2 Diabetes Research Study Groups: Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group), Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)
Dexcom real-time G6 Continuous Glucose Monitoring System (CGM) (Continuous Glucose Monitoring System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04473430 — N/A

Frequently Asked Questions

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

Is participation in this trial open to those below the age of thirty?

"To be eligible for this trial, patients must fall within the 18 to 80 age range. Alternatively, there are 251 studies targeting those under 18 and 1638 specifically designed for senior citizens aged 65 or higher."

Answered by AI

What criteria must people meet in order to be selected for this trial?

"To be eligible for inclusion in this medical trial, patients must have type 2 diabetes and should fall within the ages of 18 to 80. This research initiative is currently recruiting a total of 45 participants."

Answered by AI

How many people are actively participating in this clinical experiment?

"That is correct. As detailed on the clinicaltrials.gov website, this medical trial opened for enrollment on November 5th 2020 and was most recently updated February 18th 2022. 45 patients are being sought between two different sites of study."

Answered by AI

What is the objective of this experiment?

"The primary endpoint of this study, to be monitored over a period of three months, is the distinction in mean percentage time-in-hypoglycemia (< 70 mg/dL) between intervention and control phases. Additionally, secondary endpoints include: Proportion of CGM values within %15/15 of reference glucose values <70 mg/dL; Rate of asymptomatic and nocturnal CGM-detected hypoglycemia (<70 mg/dl); and Proportion of CGM values within ±20% or ±20 mg/dL (%20/20) of reference glucose values >250 mg/dL."

Answered by AI

Is this examination currently seeking participants?

"Per the information available on clinicaltrials.gov, this trial is actively recruiting participants at this time. It was initially made public on November 5th 2020 and last updated a few days ago, February 18th 2022."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)
Rodolfo Galindo 2020. "Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04473430.
~14 spots leftby Apr 2025
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