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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)

NCT04473430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-02-10

Study results available
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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.

Conditions

Interventions

DEVICE

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

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

DEVICE

POC Glucose Testing

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).

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Guillermo Umpierrez, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473430 on ClinicalTrials.gov