Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-12

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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

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Hemodialysis Diabete Mellitus Continuous Glucose Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous glucose monitoring (CGM) arm

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

Group Type EXPERIMENTAL

Continuous glucose monitoring (CGM)

Intervention Type DEVICE

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

Usual care arm

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.

Group Type ACTIVE_COMPARATOR

Usual care (Self-monitored blood glucose)

Intervention Type DEVICE

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

Interventions

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Continuous glucose monitoring (CGM)

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

Intervention Type DEVICE

Usual care (Self-monitored blood glucose)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No