Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

Not Applicable

Recruiting

• Conditions: Diabete Mellitus; Continuous Glucose Monitoring; Hemodialysis

• Registration Number: NCT05509881
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-22
• Study Start: 2023-12-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent (%) of time in target glucose range (70-180 mg/dl)	12 weeks	Ascertained by continous glucose monitoring

Secondary Outcome Measures

Name	Time	Method
Short Form 36 Survey Physical Component Summary Score	12 weeks	Ascertained by Short Form 36 Survey; Minimum-Maximum range is 0-100; Higher scores indicate better health-related quality of life
Hypoglycemia Fear	12 weeks	Ascertained by Hypoglycemia Fear Survey II
Percent (%) of time spent in hypoglycemia (<70 mg/dl)	12 weeks	Ascertained by continous glucose monitoring
Glycemic variability	12 weeks	Ascertained by continous glucose monitoring
Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)	12 weeks	Ascertained by continous glucose monitoring
Hemoglobin A1c level	12 weeks	Ascertained by blood test
Glycated albumin level	12 weeks	Ascertained by blood test
Diabetes Distress Scale Survey Score	12 weeks	Ascertained by Diabetes Distress Scale Survey; Minimum-Maximum range is 1-6; Higher scores indicate higher states of distress
Fructosamine level	12 weeks	Ascertained by blood test

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Orange, California, United States