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Continuous Glucose Monitoring

Continuous Glucose Monitoring for Diabetes in Hemodialysis Patients (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

No Placebo-Only Group

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Diabetes Distress Scale Survey Score

Fructosamine level

Glycated albumin level

+6 more

Other study objectives

Continuous glucose monitoring compliance during the intervention period

Participant feedback on continuous glucose monitoring training sessions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~230

0 / 3Eligibility criteria met