An observational study in End Stage Kidney Disease (ESKD), Hyperglycaemia and Diabetes, sponsored by Emory University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Emory University · Observational
This study will evaluate whether Continuous Glucose Monitoring (CGM) can identify previously unrecognized diabetes and clinically significant hyperglycemia in adults with end-stage kidney disease (ESKD) receiving hemodialysis who have no known history of diabetes.
Participants will wear a Libre 3 Plus CGM sensor for up to 15 days and undergo standard diabetes assessments, including fasting plasma glucose and hemoglobin.
The primary objectives are to:
Diabetes is a leading cause of kidney failure and contributes substantially to morbidity and mortality among patients receiving dialysis. However, a significant proportion of individuals undergoing hemodialysis may have undiagnosed diabetes or abnormal glucose metabolism. Accurate diagnosis in this population is challenging because traditional glycemic markers can be affected by factors associated with kidney disease and dialysis treatment.
Continuous glucose monitoring (CGM) provides detailed information on glucose patterns throughout daily activities and may detect clinically relevant hyperglycemia that is not readily identified by conventional screening methods. While CGM is widely used for diabetes management, its role as a screening tool for diabetes detection in individuals receiving dialysis has not been well established.
This study seeks to improve understanding of glucose abnormalities in adults receiving hemodialysis who do not have a known diagnosis of diabetes. By examining relationships between CGM-derived glucose patterns and established measures of glucose metabolism, the study aims to evaluate the potential utility of CGM as a screening approach for identifying individuals who may benefit from further diagnostic evaluation.
The findings may help address an important gap in diabetes detection among patients with end-stage kidney disease and provide foundational data for future studies focused on optimizing diabetes screening strategies in the dialysis population.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's planned enrollment of 180 is above the median of 120 across 441 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.
Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study team will recruit patients undergoing hemodialysis at Grady Memorial Hospital and at Emory Dialysis Centers. Individuals without a known diagnosis of diabetes who are undergoing hemodialysis will be eligible to enroll.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Participants with end-stage kidney disease receiving maintenance hemodialysis and without a prior diagnosis of diabetes mellitus.
Other: Continuous Glucose Monitoring (CGM)
Participants will wear a Libre 3 Plus continuous glucose monitoring sensor to collect interstitial glucose measurements throughout the study period. CGM data will be evaluated for glucose patterns and measures of glycemic exposure.
Prevalence of DM based on OGTT
Proportion of participants meeting diagnostic criteria for diabetes mellitus based on fasting plasma glucose ≥126 mg/dL and/or 2-hour plasma glucose ≥200 mg/dL following a 75-g oral glucose tolerance test (OGTT).
Time frame: Baseline through the end of the study (up to 15 days)
Hyperglycemic Events Detected by CGM
Number of hyperglycemic episodes detected by continuous glucose monitoring (CGM) per participant during the monitoring period.
Time frame: Baseline through the end of study (up to 15 study)
Hypoglycemic Events Detected by CGM
Number of hypoglycemic episodes detected by CGM per participant during the monitoring period.
Time frame: Baseline through the end of study (up to 15 study)
Average Daily Glucose
Mean daily glucose concentration measured by CGM during the monitoring period, expressed in mg/dL and compared between participants with and without diabetes mellitus based on OGTT classification.
Time frame: Baseline through the end of the study (up to 15 days)
Time in Range (70-140 mg/dL)
Percentage of valid CGM readings between 70 and 140 mg/dL during the monitoring period, compared between participants with and without diabetes mellitus based on OGTT classification.
Time frame: Baseline through the end of the study (up to 15 days)
Time in Range (70-180 mg/dL)
Percentage of valid CGM readings between 70 and 180 mg/dL during the monitoring period, compared between participants with and without diabetes mellitus based on OGTT classification.
Time frame: Baseline through the end of the study (up to 15 days)
Time Above Range (>140 mg/dL)
Percentage of valid CGM readings exceeding 140 mg/dL during the monitoring period, compared between participants with and without diabetes mellitus based on OGTT classification.
Time frame: Baseline through the end of the study (up to 15 days)
Time Above Range (>180 mg/dL)
Percentage of valid CGM readings exceeding 180 mg/dL during the monitoring period, compared between participants with and without diabetes mellitus based on OGTT classification.
Time frame: Baseline through the end of the study (up to 15 days)
Time Above Range (>250 mg/dL)
Percentage of valid CGM readings exceeding 180 mg/dL during the monitoring period, compared between participants with and without diabetes mellitus based on OGTT classification.
Time frame: Baseline through the end of the study (up to 15 days)
Mean Amplitude of Glycemic Excursions (MAGE)
Mean amplitude of glycemic fluctuations calculated from CGM measurements during the monitoring period, expressed in mg/dL and compared between participants with and without diabetes mellitus based on OGTT classification.
Time frame: Baseline through the end of the study (up to 15 days)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Nov 2027, 11 months later.
Of 125 non-industry observational studies under Kidney Failure, Chronic, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 66. This study's planned 11 months is below that.
Counting every sponsor, half of 144 studies reached it within 30 months; a quarter within 13 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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