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

University of California Irvine (UCI)

Status: Enrolling

Conditions: Hemodialysis; Diabete Mellitus; Continuous Glucose Monitoring

Treatments: Device: Usual care (Self-monitored blood glucose); Device: Continuous glucose monitoring (CGM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05509881

1668

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Continuous glucose monitoring (CGM) arm

Experimental group

Description:

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

Treatment:

Device: Continuous glucose monitoring (CGM)

Usual care arm

Active Comparator group

Description:

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:

Device: Usual care (Self-monitored blood glucose)