Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Hemodialysis

Treatment

Usual care (Self-monitored blood glucose)

Continuous glucose monitoring (CGM)

Clinical Study ID

NCT05509881

1668

Ages 18-99
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thepre-trial period

Exclusion

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 Design

Usual care (Self-monitored blood glucose)

December 12, 2023

January 31, 2026

Study 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.

Connect with a study center

University of California, Irvine
Orange, California 92868
United States
Active - Recruiting

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