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Continuous Glucose Monitoring

Continuous glucose monitoring (CGM) arm for Hemodialysis (CONDOR Trial)

N/A

Recruiting

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years old

Type 1 or type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

CONDOR Trial Summary

This trial will compare the use of continuous glucose monitoring (CGM) to regular blood glucose monitoring in patients with diabetes who are undergoing hemodialysis. The trial aims to determine if CGM can improve

Who is the study for?

This trial is for adults over 18 with end-stage kidney disease on hemodialysis and diabetes, who have been checking their blood sugar themselves for at least 4 weeks. They must be willing to wear a continuous glucose monitoring device and have done so with good compliance in the pre-trial period.Check my eligibility

What is being tested?

The study compares two ways of monitoring blood sugar in dialysis patients with diabetes: one group will use continuous glucose monitors (CGM), while the other will stick to self-monitoring. The goal is to see if CGMs can better control blood sugar levels, reduce low blood sugar episodes, and improve overall well-being.See study design

What are the potential side effects?

While not explicitly stated here, potential side effects from using CGM may include skin irritation or infection at the sensor site. Usual care through self-monitoring typically has minimal risks like discomfort or bruising from finger pricks.

CONDOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have diabetes.

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I have been checking my blood sugar levels by myself for at least 4 weeks.

CONDOR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent (%) of time in target glucose range (70-180 mg/dl)

Secondary outcome measures

Diabetes Distress Scale Survey Score

Fructosamine level

Glycated albumin level

+6 more

Other outcome measures

Continuous glucose monitoring compliance during the intervention period

Participant feedback on continuous glucose monitoring training sessions

CONDOR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Continuous glucose monitoring (CGM) armExperimental Treatment1 Intervention

During the intervention period, patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.

Group II: Usual care armActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous glucose monitoring (CGM)

2016

Completed Phase 4

~120

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,921 Total Patients Enrolled

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

2,359 Previous Clinical Trials

4,314,470 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this research study?

"Indeed, as reported on clinicaltrials.gov, this ongoing clinical trial is currently actively seeking eligible participants. The initial posting of the trial was made on February 1st, 2023 and it has been recently updated on December 20th, 2023."

Answered by AI

What is the upper limit on the number of patients who can participate in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The clinical trial was initially posted on February 1st, 2023 and underwent its most recent update on December 20th, 2023. A total of 122 patients will be enrolled at a single location for this study."

Answered by AI

Is the enrollment for this research study open to individuals who are 60 years of age or older?

"To be eligible for enrollment in this study, individuals must be at least 18 years old and there is no upper age limit; patients up to the age of 99 are welcome to participate."

Answered by AI

Which specific individuals meet the eligibility criteria to participate in this research endeavor?

"The trial aims to enroll a total of 122 individuals between the ages of 18 and 99 who are undergoing hemodialysis. Eligible participants must fulfill the following conditions: capability to provide written informed consent, being at least 18 years old, having end-stage kidney disease and receiving in-center hemodialysis for a minimum duration of 4 weeks, diagnosed with either type 1 or type 2 diabetes, actively engaged in self-monitored blood glucose (SMBG) testing for no less than four weeks, displaying at least 70% adherence when wearing continuous glucose monitoring (CGM) device during the pre-trial period"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

Connie Rhee 2023. "Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05509881.

All > Dialysis