CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04473430
NCT04473430N/ACompleted
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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)

Emory University·interventional·Posted Jul 16, 2020·Updated Feb 10, 2025

In Brief

A clinical study evaluating Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM) and POC Glucose Testing for End-Stage Renal Disease and Type 2 Diabetes. Completed, enrolled 53 participants across 2 sites.

Detailed Summary

The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated with insulin therapy and receiving hemodialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd-Stage Renal Disease, Type 2 Diabetes
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 16, 2020
Enrollment StartNov 5, 2020
Primary CompletionOct 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.0 years ago

Interventions

Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM)device

Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective "urgent low soon" alarm, with proven prediction of hypoglycemia within 20 minutes in advance. Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the "urgent low soon" alarm (predictive of hypoglycemia \< 55 mg/dL within the preceding 20 minutes). Diagnostic Test: Real-time CGM will be used to collect outcomes variables

POC Glucose Testingdevice

POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations. Diagnostic Test: Professional CGM will be used to collect outcomes variables (including during the POC BG testing).