Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring

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.

• Continuous Glucose Monitoring (CGM) (Other): 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.

Primary outcomes

• Prevalence of DM based on OGTT [Baseline through the end of the study (up to 15 days)]: 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).

Secondary outcomes

• Hyperglycemic Events Detected by CGM [Baseline through the end of study (up to 15 study)]: Number of hyperglycemic episodes detected by continuous glucose monitoring (CGM) per participant during the monitoring period.
• Hypoglycemic Events Detected by CGM [Baseline through the end of study (up to 15 study)]: Number of hypoglycemic episodes detected by CGM per participant during the monitoring period.
• Average Daily Glucose [Baseline through the end of the study (up to 15 days)]: 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 in Range (70-140 mg/dL) [Baseline through the end of the study (up to 15 days)]: 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 in Range (70-180 mg/dL) [Baseline through the end of the study (up to 15 days)]: 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 Above Range (>140 mg/dL) [Baseline through the end of the study (up to 15 days)]: 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 Above Range (>180 mg/dL) [Baseline through the end of the study (up to 15 days)]: 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 Above Range (>250 mg/dL) [Baseline through the end of the study (up to 15 days)]: 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.
• Mean Amplitude of Glycemic Excursions (MAGE) [Baseline through the end of the study (up to 15 days)]: 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.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Dialysis treatment for more than 3 months
* Willing to wear a CGM for at least 10 days and to undergo an OGTT.

Exclusion Criteria

* History of diabetes or use of insulin or any diabetes treatment in the past
* Pregnant or planning to become pregnant during the study
* Allergy to medical-grade adhesives

• Ghada Elshimy, MD, Principal investigator, Emory University