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Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).

NCT04094064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-21

Study results available
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Summary

Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread. CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. Patients with end stage renal disease (ESRD) who are on intermittent hemodialysis (iHD) or peritoneal dialysis (PD) undergo fluid shifts between the interstitial fluid and intravascular space during dialysis treatments.These fluid shifts, uremia, acidosis, and volume overload (increase in interstitial fluid volume due to ESRD) have the potential to impact the performance of the most advanced and commercially available CGMs; however, use of CGM in these patients has not yet been studied.Use of CGM, and potentially hybrid closed loop insulin delivery systems that are dependent on accurate continuous glucose monitoring, has the potential to improve glucose control and quality of life in these patients (7). This study team feels that this study will be valuable in collecting preliminary data needed with the goal of validating the use of CGM in this patient population. The specific aim is to conduct a pilot study to evaluate the accuracy of continuous glucose monitors (CGM) in End Stage Renal Disease (ESRD) patients on intermittent hemodialysis (iHD).

Conditions

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Continuous Glucose Monitor

Use of a continuous glucose monitor during study period.

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Meaghan Stumpf, MD · University of Virginia

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2021-09-29
Completion
2021-09-29
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 NCT04094064 on ClinicalTrials.gov