End Stage Kidney Disease (ESKD)NCT07880795
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
An observational study of End Stage Kidney Disease (ESKD) and Hyperglycaemia, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease (ESKD), Hyperglycaemia, Diabetes
- What is being tested?
- Continuous Glucose Monitoring (CGM)
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Dialysis treatment for more than 3 months
- Willing to wear a CGM for at least 10 days and to undergo an OGTT.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Grady Memorial Hospital
Atlanta, Georgia, 30303
Ghada Elshimy, MD, Ghada.elshimy@emory.edu
About this study
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 CGM sensor for up to 15 days and undergo standard diabetes assessments, including fasting plasma glucose and hemoglobin.
The primary objectives are to:
- Determine the prevalence of previously undiagnosed diabetes among dialysis patients using OGTT criteria.
- Compare CGM glucose patterns between participants with and without diabetes as determined by OGTT results.
Read the detailed description
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.
- Conditions
- End Stage Kidney Disease (ESKD), Hyperglycaemia, Diabetes
- Being tested
- Continuous Glucose Monitoring (CGM)
- Keywords
- Oral glucose tolerance test ( OGTT), continuous glucose monitor ( CGM),, Hemoglobin A1C( A1C)
- Medical subject headings
- Kidney Failure, Chronic, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring (CGM)Other
Participants will wear a 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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Participants Without Known Diabetes | Participants with end-stage kidney disease receiving maintenance hemodialysis and without a prior diagnosis of diabetes mellitus. Receives: Other: Continuous Glucose Monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline through the end of the study (up to 15 days)
Secondary outcomes (9)
Hyperglycemic Events Detected by CGM
Number of hyperglycemic episodes detected by continuous glucose monitoring (CGM) per participant during the monitoring period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through the end of the study (up to 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Elshimy, Emory University
- Investigators
- Ghada Elshimy, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880795
- Sponsor's protocol ID
- 2026P000540
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT07880795
- Acronym / sponsor ID
- 2026P000540
- Conditions
- End Stage Kidney Disease (ESKD), Hyperglycaemia, Diabetes
- Keywords
- Oral glucose tolerance test ( OGTT), continuous glucose monitor ( CGM),, Hemoglobin A1C( A1C)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 CGM sensor for up to 15 days and undergo standard diabetes assessments, including fasting plasma glucose and hemoglobin.
The primary objectives are to:
- Determine the prevalence of previously undiagnosed diabetes among dialysis patients using OGTT criteria.
- Compare CGM glucose patterns between participants with and without diabetes as determined by OGTT results.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Participants Without Known Diabetes | – | Other: Continuous Glucose Monitoring (CGM)Participants with end-stage kidney disease receiving maintenance hemodialysis and without a prior diagnosis of diabetes mellitus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Dialysis treatment for more than 3 months
- Willing to wear a CGM for at least 10 days and to undergo an OGTT.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitoring (CGM)Participants will wear a 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. | Other | Hemodialysis Participants Without Known Diabetes |
Primary outcome
Prevalence of DM based on OGTT
Time frame: 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).
9 secondary outcomes
Hyperglycemic Events Detected by CGM
Time frame: Baseline through the end of study (up to 15 study)
Hypoglycemic Events Detected by CGM
Time frame: Baseline through the end of study (up to 15 study)
Average Daily Glucose
Time frame: Baseline through the end of the study (up to 15 days)
Time in Range (70-140 mg/dL)
Time frame: Baseline through the end of the study (up to 15 days)
Time in Range (70-180 mg/dL)
Time frame: Baseline through the end of the study (up to 15 days)
Time Above Range (>140 mg/dL)
Time frame: Baseline through the end of the study (up to 15 days)
Time Above Range (>180 mg/dL)
Time frame: Baseline through the end of the study (up to 15 days)
Time Above Range (>250 mg/dL)
Time frame: Baseline through the end of the study (up to 15 days)
Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: Baseline through the end of the study (up to 15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ghada Elshimy, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Kidney Disease (ESKD) and Hyperglycaemia, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada Elshimy, MD (404.251.8976, Ghada.elshimy@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of DM based on OGTT (time frame: Baseline through the end of the study (up to 15 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.