Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

Study Overview
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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.

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.

Official Title
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Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

Conditions
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Hemodialysis, Diabete Mellitus, Continuous Glucose Monitoring

Intervention / Treatment
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* Device: Continuous glucose monitoring (CGM)
* Device: Usual care (Self-monitored blood glucose)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous glucose monitoring (CGM) arm<br>During the intervention period, patients in the CGM arm will undergo continuous real-time unblinded CGM using Dexcom CGM devices. | Device: Continuous glucose monitoring (CGM)<br>* Patients in the CGM arm will undergo continuous real-time unblinded CGM using Dexcom CGM devices.<br>|
| Active Comparator: Usual care arm<br>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. | Device: Usual care (Self-monitored blood glucose)<br>* Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (%) of time in target glucose range (70-180 mg/dl) | Ascertained by continous glucose monitoring | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (%) of time spent in hypoglycemia (<70 mg/dl) | Ascertained by continous glucose monitoring | 12 weeks | 
| Percent (%) of time spent in relative hypoglycemia (<100 mg/dl) | Ascertained by continous glucose monitoring | 12 weeks | 
| Glycemic variability | Ascertained by continous glucose monitoring | 12 weeks | 
| Hemoglobin A1c level | Ascertained by blood test | 12 weeks | 
| Fructosamine level | Ascertained by blood test | 12 weeks | 
| Glycated albumin level | Ascertained by blood test | 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 | 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 | 12 weeks | 
| Hypoglycemia Fear | Ascertained by Hypoglycemia Fear Survey II | 12 weeks |