NCT05509881

Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis
• Diabete Mellitus
• Continuous Glucose Monitoring

Interventions

Type	Name	Description
DEVICE	Continuous glucose monitoring (CGM)	Patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.
DEVICE	Usual care (Self-monitored blood glucose)	Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day.

Timeline

• Start date: 2023-12-12
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2022-08-22
• Last updated: 2024-02-28

Locations

1 site across 1 country: United States