Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

University of California, Irvine122 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Hemodialysis Diabete Mellitus Continuous Glucose Monitoring

Interventions

Continuous glucose monitoring (CGM)DEVICE

Patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.

Usual care (Self-monitored blood glucose)DEVICE

Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California, Irvine

Orange, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Ascertained by continous glucose monitoring

Time frame: 12 weeks

Secondary Outcomes

Percent (%) of time spent in hypoglycemia (<70 mg/dl)

Ascertained by continous glucose monitoring

Time frame: 12 weeks

Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)

Ascertained by continous glucose monitoring

Time frame: 12 weeks

Glycemic variability

Ascertained by continous glucose monitoring

Time frame: 12 weeks

Hemoglobin A1c level

Ascertained by blood test

Time frame: 12 weeks

Fructosamine level

Ascertained by blood test

Time frame: 12 weeks

Glycated albumin level

Ascertained by blood test

Time frame: 12 weeks

Short Form 36 Survey Physical Component Summary Score

Ascertained by Short Form 36 Survey; Minimum-Maximum range is 0-100; Higher scores indicate better health-related quality of life

Time frame: 12 weeks

Diabetes Distress Scale Survey Score

Ascertained by Diabetes Distress Scale Survey; Minimum-Maximum range is 1-6; Higher scores indicate higher states of distress

Central Contacts

Connie Rhee

CONTACT

714-456-5142 crhee1@uci.edu

Kamyar Kalantar-Zadeh

CONTACT

714-456-5142 kkz@uci.edu

Data from ClinicalTrials.gov

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