Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial (CONDOR)

February 27, 2024 updated by: Connie Rhee, University of California, Irvine
This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a parallel, two-arm randomized controlled trial comparing real-time CGM using Dexcom devices vs. usual care (self-monitored blood glucose 4-times/day) among 122 in-center hemodialysis patients with diabetes mellitus over a 12-week period. Our primary objective will be to determine the effects of CGM vs. usual care on glycemic control, defined by percent (%) of time in target glucose range (70-180 mg/dl). Our main and exploratory secondary objectives will be to determine the effects of CGM on CGM-indices of hypoglycemia, blood-based glycemic markers (HbA1c, glycated albumin, fructosamine), and patient-reported outcomes (health-related quality of life, diabetes distress, hypoglycemia fear). We will also evaluate feasibility endpoints by measuring CGM compliance during the intervention period and success/ease of implementing CGM training sessions among patients.

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kamyar Kalantar-Zadeh
  • Phone Number: 714-456-5142
  • Email: kkz@uci.edu

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to provide written informed consent
  • Age ≥18 years old
  • End-stage kidney disease status receiving in-center hemodialysis ≥4 weeks
  • Type 1 or type 2 diabetes
  • Actively performing self-monitored blood glucose (SMBG) testing for ≥4 weeks
  • ≥70% compliance wearing continuous glucose monitoring (CGM) device during the pre-trial period

Exclusion Criteria:

  • Inability to provide informed consent or comply with the study protocol
  • Limited visual acuity
  • Inability to wear CGM device
  • Prior use of CGM
  • Active pregnancy or planning a pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care arm
During the intervention period, patients in the usual care arm will conduct self-monitored blood glucose (SMBG) at least 4 times/day. At Weeks 6 and 12 of the intervention period, usual care arm patients will also undergo 10-days of blinded CGM data collection.
Device: Usual care (Self-monitored blood glucose)
Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day.
Experimental: Continuous glucose monitoring (CGM) arm
During the intervention period, patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.
Device: Continuous glucose monitoring (CGM)
Patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent (%) of time in target glucose range (70-180 mg/dl)
Time Frame: 12 weeks
Ascertained by continous glucose monitoring
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent (%) of time spent in hypoglycemia (<70 mg/dl)
Time Frame: 12 weeks
Ascertained by continous glucose monitoring
12 weeks
Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)
Time Frame: 12 weeks
Ascertained by continous glucose monitoring
12 weeks
Glycemic variability
Time Frame: 12 weeks
Ascertained by continous glucose monitoring
12 weeks
Hemoglobin A1c level
Time Frame: 12 weeks
Ascertained by blood test
12 weeks
Fructosamine level
Time Frame: 12 weeks
Ascertained by blood test
12 weeks
Glycated albumin level
Time Frame: 12 weeks
Ascertained by blood test
12 weeks
Short Form 36 Survey Physical Component Summary Score
Time Frame: 12 weeks
Ascertained by Short Form 36 Survey; Minimum-Maximum range is 0-100; Higher scores indicate better health-related quality of life
12 weeks
Diabetes Distress Scale Survey Score
Time Frame: 12 weeks
Ascertained by Diabetes Distress Scale Survey; Minimum-Maximum range is 1-6; Higher scores indicate higher states of distress
12 weeks
Hypoglycemia Fear
Time Frame: 12 weeks
Ascertained by Hypoglycemia Fear Survey II
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous glucose monitoring compliance during the intervention period
Time Frame: 12 weeks
CGM compliance will be ascertained by two metrics; 1) wearing the CGM device ≥6 days/week, and 2) % of time CGM is active, which is an automatically captured/reported metric on the Dexcom G6 device
12 weeks
Participant feedback on continuous glucose monitoring training sessions
Time Frame: 12 weeks
Survey graded on a 5-point Likert scale; participants' qualitative feedback
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1668

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodialysis

Clinical Trials on Usual care (Self-monitored blood glucose)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe