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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

No Placebo-Only Group

Summary

This trial uses a device that constantly tracks blood sugar levels to help prevent low blood sugar in patients with type 2 diabetes and end-stage kidney disease who are on insulin and hemodialysis. This technology has been developed to help patients with diabetes manage their blood sugar levels by providing real-time data, which can prevent both low and high blood sugar.

Eligible Conditions

Type 2 Diabetes
Kidney Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

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

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

Primary study objectives

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 study objectives

% 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

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

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