Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
Phase: NA
Conditions: End Stage Kidney Disease
Sponsor: Emory University

Protocol 
 
Title: Continuous Glucose Monitoring in Patients With End-Stage Kidney 
Disease and Burnt-Out Diabetes 
 
NCT Number: NCT05741489 
 
Protocol date: January 05, 2023 

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PROTOCOL TITLE:  Continuous Glucose Monitoring in Patients with End-Stage Kidney Disease 
and Burnt-Out Diabetes
Short Title: Burnt-Out Diabetes  
Discovery Project: 
 
Students: 
1 Candice Kaminski, M4 Student, Emory University School of Medicine 
 
PRINCIPAL INVESTIGATOR/MENTOR: 
2Guillermo Umpierrez, MD, CDE, FACE, MACP 
Professor of Medicine 
Division of Endocrinology, Metabolism & Lipids 
Emory University School of Medicine 
69 Jesse Hill Drive, SE -Glenn Building 
Atlanta, GA 30303 
(404) 778-1665 
geumpie@emory.edu 
 
Co-investigators/Mentors: 
2Rodolfo J. Galindo, MD 
Postdoctoral Fellows/Coordinators: 
2Dr. Amany Gerges, MD
2Dr. Bobak Moazzami, MD
2Dr. Zohyra Zabala, MD
Statistician:
3Dr. Limin Peng, PhD
 
1Emory University School of Medicine, Discovery Program.
2Division of Endocrinology, Department of Medicine, Emory University School of Medicine. 
3Rollins School of Public Health, Emory University.
VERSION: 3.0
FUNDING SOURCE: Internal funding.

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Table of Contents
1.
Study Summary....................................................................................................................5
2.
Objectives ............................................................................................................................5
3.
Background..........................................................................................................................5
4.
Study Endpoints...................................................................................................................5
5.
Study Intervention/Investigational Agent ...........................................................................6
6.
Procedures Involved ............................................................................................................6
7.
Statistical Analysis Plan........................................................................................................7
8.
Data and/or Specimen Banking ...........................................................................................7
9.
Sharing of Results with Participants ....................................................................................7
10.
Study Timelines....................................................................................................................8
11.
Inclusion and Exclusion Criteria...........................................................................................8
12.
Population ...........................................................................................................................8
13.
Vulnerable Populations .......................................................................................................9
14.
Local Number of Participants ..............................................................................................9
15.
Recruitment Methods........................................................................................................10
16.
Withdrawal of Participants................................................................................................10
17.
Risk to Participants ............................................................................................................11
18.
Potential Benefits to Participants......................................................................................11
19.
Compensation to Participants ...........................................................................................11
20.
Data Management and Confidentiality .............................................................................11
21.
Plans to Monitor the Data to Ensure Safety of Participants and Data Integrity................12
22.
Provisions to Protect the Privacy Interest of Participants .................................................13
23.
Economic Burden to Participants ......................................................................................14
24.
Informed Consent..............................................................................................................14
25.
Setting................................................................................................................................16
26.
Resources Available...........................................................................................................17
27.
Multi-Site Research When Emory is the Lead Site.............................................................17
28.
References.........................................................................................................................18
29.
Protocol Checklist ..............................................................................................................18

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1. Study Summary
Project Title
Continuous Glucose Monitoring in Patients with End-Stage 
Kidney Disease and Burnt-Out Diabetes
Project Design
Observational cross-sectional study. 
Primary Objective

To determine if utilizing Continuous Glucose Monitor (CGM) 
devices is superior to HbA1c for assessing glycemic control in 
patients with end-stage kidney disease on dialysis. 
Secondary Objective(s)

Compare  daily mean glucose values between patients with 
burnt-out diabetes and  non-diabetic subjects with ESKD.
Research 
Intervention(s)/Interactions

Continuous glucose monitoring (CGM) compared to glycemic 
metrics including CGM and HbA1c. 
Study Population
Individual with and without diabetes on hemodialysis and with 
HbA1c < 6.5% on no diabetes therapy will be eligible to enroll.
Sample Size
40 patients.  20 patients with burnt-out diabetes and 20 non-
diabetic subjects with ESKD
Study Duration for 
individual participants
10 days
Study Specific 
Abbreviations/ Definitions 
POC, Bedside point-of-care; CGM, Continuous glucose 
monitoring; T2D, Type 2 diabetes; BG, blood glucose; OAD, Oral 
antidiabetic; MARD, mean absolute relative difference; CBG, 
capillary blood glucose 
Funding Source (if any)
N/A
2. Objectives
Diabetes is the number one cause of end stage kidney disease (ESKD) and need for dialysis. It is 
estimated that diabetes affects up to 40% of patients with ESKD3.  Glycosylated hemoglobin 
(HbA1c) is the gold standard to assess glycemic control in patients with diabetes and indicates 
the average glycemia during the past 2-3 months. In subjects with ESKD; however, the accuracy 
of HbA1c is reduced because of anemia, shortened erythrocyte lifespan, erythropoietin therapy, 
among others factors. To overcome the limitations of HbA1c, continuous glucose monitoring 
(CGM) technology has been shown to provide a comprehensive glycemic control in patients with 
diabetes and may overcome the limitations of these methods in the ESKD population; however, 
the accuracy of CGM in ESKD has not been established.
About one fourth of patients with diabetes on dialysis therapy experience resolution of their 
hyperglycemia, as defined by an HbA1c less than 6.5%, without antidiabetic therapy. This 

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phenomenon is known as “burnt-out diabetes”.  Because HbA1c may be falsely low in ESKD, we 
will use CGM to assess glycemic control and confirm whether patients with burnt-out diabetes 
have normoglycemia or not.   We hypothesize that the use of CGM may represent a better tool 
to assess glycemic control than HbA1c in patients with ESKD on dialysis.  To prove this hypothesis, 
we will compare glycemic metrics including CGM and HbA1c, in 20 patients with burnt-out 
diabetes and in 20 non-diabetic subjects with ESKD.
II.        Specific Aims:  
Study Aim.  Compare glycemic metrics including CGM and HbA1c in patients with burnt-out 
diabetes and in non-diabetic subjects with ESKD.
Hypotheses: 
1. The use of CGM represents a better tool to assess glycemic control than traditional 
markers (HbA1c) in patients with ESKD and renal replacement therapy (dialysis).  Patients 
with burnt-out diabetes will show higher mean daily glucose values and higher time-
above range (TAR > 180 mg/dl) compared to non-diabetic subjects with ESKD.
3. Background
Diabetes and chronic kidney disease.  More than 37 million adults, or 14.7% of all Americans 
aged 18 and older, are living with diabetes. Controlling hyperglycemia is foundational to diabetes 
management and is necessary to reduce the risks of chronic diabetes complications and death. 
Diabetic nephropathy accounts for great morbidity, as diabetes is the number one cause of 
chronic kidney disease (CKD) and end stage kidney disease (ESKD) in the US2. It is estimated that 
diabetes affects up to 40% of patients with ESKD3.
Assessment of glucose control in patients with advanced CKD/ESKD is complex due to 
changes in glucose homeostasis, potential effects on assays of glycemia, and altered 
pharmacokinetics of diabetes medications2.  Glycosylated hemoglobin (HbA1c) has been the gold 
standard to assess glycemic control in patients with diabetes.  HbA1c reflects the average 
glycemic value over approximately 3 months.  Although HbA1c is associated with chronic 
complications of diabetes in patients with normal kidney function, its predictive value is uncertain 
in patients with increased red cell turnover (hemolysis) and in subjects with ESKD or eGFR <30 
ml/min. HbA1c reliability in ESKD is reduced because of anemia, shortened erythrocyte lifespan, 
protein-energy wasting, and malnutrition-inflammation cachexia syndrome, among others4,5. 
To overcome the limitations of HbA1c, alternative methods to assess long-term glycemic 
control have been proposed including fructosamine and glycated albumin2.  Fructosamine 
measures ketoamines formed by non-enzymatic glycation of serum proteins. It is a useful index 
for glycemic control over the prior 2 to 4 weeks, and some studies have reported that 
fructosamine more accurately reflects blood glucose control than HbA1c in anemic patients with 
ESKD on dialysis. However, there may be falsely low readings in the presence of 
hypoalbuminemia due to protein-energy wasting and in peritoneal dialysis due to dialysate 

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protein loss. Glycated albumin is a useful marker reflecting glycemic control over the prior 2 to 4 
weeks.  In patients with ESKD, glycated albumin more rapidly reflects the status of blood glucose 
control than HbA1c.  Like frucotsamine, there is potential for falsely low readings in patients with 
peritoneal dialysis with dialysate protein losses and hypoalbuminemia2,5-8.
Continuous glucose monitoring (CGM) technology in the outpatient setting has 
transformed glucose monitoring for diabetes self-management, providing more comprehensive 
glycemic control data than intermittent point-of-care capillary blood glucose monitoring and 
HbA1c. Although the accuracy of CGM in ESKD has not been established, a recent prospective 
study in hospitalized patients with type 1 and type 2 diabetes reported good accuracy of CGM in 
patients with CKD9.
Burnt-out diabetes.   Once progressed to ESKD, up to one fourth of patients experience 
resolution of their hyperglycemia, as defined by an HbA1c level of less than 6.5%, and 
consequently are no longer on antidiabetic agents and insulin. This phenomenon is known as 
“burnt-out diabetes” which is likely due to various underlying factors, including but not limited 
to, malnutrition, reduced clearance and degradation of insulin, decreased kidney 
gluconeogenesis, and accumulation of uremic toxins10. These patients are likely at a greater risk 
of morbidity and mortality and an increased risk of hypoglycemic episodes4. There is a need for 
further research in patients with ESKD to establish what is the most appropriate tool to assess 
glycemic control in those with ‘burnt-out diabetes’.  
Our study will use CGM to measure patients’ glucose with real-time levels as opposed to 
relying on surrogate markers like A1c. These results can give insight into the reality of glycemic 
control in these patients and can impact the best monitoring and treatment for patients with 
burnt-out diabetes. It is not known if patients with burnt-out diabetes have complete 
normoglycemia or if they may have episodes of (untreated) hyperglycemia, which may be 
associated with poor outcome.  Accordingly, we will compare glycemic control by CGM in patients 
with burnt-out diabetes and non-diabetic patients with ESKD.
4. Study Endpoints
Primary safety and efficacy endpoints:
1) Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by Dexcom G6 CGM (safety 
endpoint) 52. 
2) Glycemic control, as measured by mean daily glucose concentration between groups by 
Dexcom G6 CGM (efficacy endpoint). 
5. Study Intervention/Investigational Agent 
The proposed CGM to be used in this study is the Dexcom G6, a factory-calibrated CGM system, 
that is innovative in many aspects: 1) it does not require finger stick glucose testing for 
calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several 
substance and drugs, and 4) effective glucose measures every 5 minutes (288 glucose measures 
per day).   

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6. Procedures Involved
Visit 1: All consenting subjects, with and without diabetes, will have a blinded Dexcom G6 CGM 
placed for up to 10 days (study duration). Consent procedure will be conducted during/after their 
hemodialysis sessions after explaining all study procedures. After providing informed consent, 
patients will have a sensor inserted by the study team. Insertion of the CGM sensor will be 
performed per manufacturer instructions and following an aseptic technique. After insertion of 
the sensors, providers will ensure proper hemostasis is achieved. Sensors will be removed if 
prolonged bleeding or severe pain occurs. Patients will be educated on study procedures and 
sensor care. The participants will be instructed to wear the CGM with the display off for 10 days 
while continuing regular, routine dialysis sessions. They will be instructed that the device will be 
removed at a future dialysis session after 10 days of wear. 
Patients will be consented- after explanation of the procedure- for withdrawing about 5 ml of 
blood prior to dialysis to measure glycated albumin as well as fructosamine to assess glycemic 
control in dialysis patients with and without diabetes.
Visit 2: The CGM sensor will be removed after 10 days, and data will be downloaded at this time. 
HbA1c will be collected from patient medical record.  In addition, we will collect information on 
clinical characteristics (age, sex, duration of diabetes and ESKD, dialysis, history diabetes 
treatment, duration of burn-out period, time off diabetes medications, comorbidities 
(hypertension, coronary heart disease, heart failure, COPD).  
Clinical trial materials will be labeled and should be handled and stored according to the 
respective hospital’s regulatory requirements. 
For the safety outcome (primary outcome), a “hypoglycemia episode” is defined as a glucose < 
70 mg/dl, “clinically significant hypoglycemia” is defined as a glucose <54 mg/dl, and “severe 
hypoglycemia” is defined as a glucose < 40 mg/dl by POC testing or by CGM for > 15 
minutes.  An episode is not counted as being “new event” unless the sensor glucose is above 
70 mg/dL or above 54 mg/dL at least once following an episode of hypoglycemia.  A 
“hypoglycemic event rate” is defined as the number of hypoglycemic events per patient per 
day. 
 
For the efficacy outcome, the “mean daily glucose concentration” is defined as the mean daily 
and fasting glucose concentration during the hospital stay up to first 10 days of therapy by POC 
testing and by CGM. A “nocturnal” hypoglycemia episode or a “nocturnal” clinically significant 
hypoglycemia episode is defined as an episode occurring during the time interval of 00:01 to 
05:59. 
7. Statistical Analysis Plan
Data Analysis.  Data will be entered into REDCap to keep track of all results and to meet HIPAA 
and confidentiality regulations, provided by the Emory Research Information Technology 
Department. A p-value less than 0.05 will be considered significant. The data will be presented 

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as means ± SD. Statistical analysis will be performed using the SAS (version 9.2; SAS Institute, 
Cary, NC). All statistical analysis will be performed by Limin Peng, PhD, from Emory University.
Limin Peng, PhD, Professor of Statistics at the School of Public Health will assist with data 
analysis. We will measure outcomes such as average daily glucose, time in range between 70-
140 mg/dl, time in range between 70-180 mg/dl, fasting, premeal, 2 hours post meal, and 
nocturnal (10 PM-6:00 AM) glucose values, time (%) in hyperglycemia (>180 mg/dL, >250 
mg/dl). In addition, we will collect information on glycemic variability by CGM. 
Sample Size.  This study will be a pilot study, as there is no preliminary data available for this 
patient population utilizing the Dexcom G6 CGM. Currently, there are 850 patients undergoing 
Hemodialysis at Emory Dialysis Centers. Up to 40% of these cases should be due to diabetes 
mellitus, and anywhere from ~25-35% of these patients should meet the definition of burnt-out 
diabetes, resulting in ~100 patients who should qualify as participants. Currently, we have 
identified ~20 patients with burnt-out diabetes on hemodialysis. 
8. Data and/or Specimen Banking
Data collection records with personal identifiers will be stored in locked file cabinets. 
Presentation of the study results at regional or scientific meetings or in publications will not 
identify subjects. Access to research and confidential records will be limited to clinical 
investigators, research coordinators, and the IRB at Emory University.
9. Sharing of Results with Participants
Study results will be shared with the subjects at their request, including laboratory values, 
blood pressure measurements, and physical exam measurements.
10. Study Timelines
All consenting subjects, with and without diabetes, will have a Dexcom G6 CGM placed for up to 
10 days (study duration).  The CGM sensor will be removed after 10 days. 
The anticipated time required to complete primary analysis of results is 6 -9 months
11. Inclusion and Exclusion Criteria
Inclusion Criteria
1. Be at least 18 years old
2. Dialysis treatment for more than 3 months
3. HbA1c less than 6.5% at the first clinic visit 
4. Willing to wear a CGM for 10 days
Exclusion criteria 
1. Have used insulin or any diabetes treatment during the last 3 months
2. Be pregnant or plan to become pregnant during the study 
3. Known allergy to medical-grade adhesives

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4. Taking acetaminophen (more than 1 gram every six hours) or hydroxyurea (may interfere 
with sensor membrane)
5. Current or anticipated use of stress steroid doses (prednisone </= 5 mg or its equivalent is 
allowed)
Most participants will not be of child-bearing age. However, pregnancy may impact the 
accuracy of the CGM device. We will ask all women of their menopausal status. If a woman is of 
child-bearing age, we will administer a pregnancy test before enrolling in the trial. 
12. Population
This study will be a pilot study, as there is no preliminary data available for this patient population 
utilizing the Dexcom G6 CGM. Patients qualify for the burnt-out diabetes group if they have 1. 
Been diagnosed with diabetes in the past, 2. Now have last A1c of <6.5%, and 3. Are no longer on 
any diabetic medications, and meet all other inclusion and exclusion criteria. Patients may qualify 
for the control group if they have never been diagnosed with diabetes in the past and meet all 
other inclusion and exclusion criteria. 
Currently, there are 850 patients undergoing HD. ~40% of these cases should be due to diabetes 
mellitus, and anywhere from ~25-35% of these patients should meet the definition of burnt-out 
diabetes, resulting in ~100 patients who should qualify as participants. Currently, we have 
identified ~20 patients with burnt-out diabetes on hemodialysis. 
13. Vulnerable Populations
This study does not involve a vulnerable population.
14. Local Number of Participants
A total of 40 subjects will be invited to participate from Emory dialysis centers.
15. Recruitment Methods
Recruitment will involve identification of hospitalized patients at Emory dialysis centers who 
meet the study eligibility criteria. Screening for eligibility will be performed from medical 
records prior to informed consent being signed. There will be no specific efforts to promote 
recruitment other than making hospital staff aware of the study. All eligible participants will be 
included without regard to sex, race, or ethnicity. Participation in this study is voluntary. 
Recruitment:  The study team will perform pre-screening on subjects scheduled for their clinic 
visit and will approach potential candidates during the dialysis session. If potential candidate 
expresses interest and qualifies for study participation, full consent procedure will be 
conducted during/after their hemodialysis sessions. All consenting subjects, with and without 
diabetes, will have a Dexcom G6 CGM placed for up to 10 days (study duration). 
16. Withdrawal of Participants
1. The subject may withdraw at will at any time.

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2. The subject may be withdrawn from the trial at the discretion of the investigator 
because of a safety concern or if judged non-compliant with trial procedures or included 
in contravention to the inclusion and/or exclusion criteria.
3. Subject requiring hospital admission.
4. Pregnancy or intention to become pregnant.
Subject replacement.  There will be no replacement of subjects in this trial.
17. Risk to Participants
1. Sensor Insertion: We will use a commercially available (FDA approved) glucose sensor 
Dexcom CGM. We will use an aseptic technique following manufacturer recommendations. 
After insertion of the sensors, providers will ensure proper hemostasis is achieved. Sensors will 
be removed if prolonged bleeding or severe pain occurs. It’s uncommon but inserting the 
sensor could cause infection (<1%), bleeding or pain (~10%), and wearing the adhesive patch 
can irritate the skin (~10% on prior studies). We will avoid insertion over irritated or damage 
skin, exclude subjects who are sensitive to adhesive and use an aseptic technique to avoid this. 
The principal investigator and our study team is experienced in performing studies using CGM 
in high-risk population (hospitalized, acutely ill patients), with minimal risk involved.  
2. Skin allergy to adhesive material may be developed in <5% of subjects.  This will usually do 
not require treatment and goes away a few days later.  
Sensors Contraindication: Sensors will be removed before MRI, CT, diathermy procedures, per 
manufacture instructions. 
Sensor precautions: Avoid using sunscreen or insect repellents from having contact with sensor. 
18. Potential Benefits to Participants
1. Participation in the study may determine the presence of hyperglycemia in subjects with so 
called burnout diabetes.  If so, intervention with antidiabetic drugs may be indicated at the 
discretion of their treatment provider.
 The study may help in the management of patients with diabetes on dialysis. In addition, the 
main goal of the intervention study is to prevent hypoglycemia.  
19. Risk of anticipated benefit. Compensation to Participants
Participation in this study is voluntary.  Subjects will receive twenty-five dollars ($25) after CGM 
removal on the second visits.
Information from medical records, interviews and tests that are part of this research will be 
collected. 

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20. Data Management and Confidentiality
Data collection
To assure each subject’s confidentiality, data collected under this protocol will be coded and 
stored in a secure locked file cabinet with access limited to those directly related to the conduct 
of this study. Electronic versions of these data will be stored on a limited access, password 
protected, secure server with coded patient identifiers. Study participants will be assigned a code 
number that will be linked to their name. Only study personal will have access to the linked name-
code key. Except for the informed consent form, data will be marked solely with the participant’s 
code number. 
Statistical analysis
The primary endpoint in this study is to compare glycemic metrics including CGM and HbA1c in 
patients with burnt-out diabetes and in non-diabetic subjects with ESKD. We will first compare 
clinical characteristics including demographics, duration of diabetes and dialysis between 
patients with and without DR using two-sample t-tests or nonparametric Wilcoxon tests. We will 
perform multivariate linear regression to evaluate the group difference while accounting other 
possible confounders (patient age, type of dialysis) for the primary outcome. The secondary 
endpoints include compare  daily mean glucose values between patients with burnt-out diabetes 
and  non-diabetic subjects with ESKD, most recent HbA1c, comorbidities (hypertension, 
cardiovascular disease, heart failure, peripheral neuropathy, autonomic/GI neuropathy, 
cerebrovascular disease, peripheral vascular disease, depression, anxiety, cognitive 
impairment/dementia), adherence and barriers to screening recommendations, we will analyze 
continuous secondary outcomes in the same way that we propose for the primary endpoint. A p-
value less than 0.05 will be considered significant. The data will be presented as means ± SD.  
Statistical analysis will be performed using the SAS (version 9.2; SAS Institute, Cary, NC).  
Confidentiality
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. The Principal investigator and other study 
personnel will not use data or PHI for any purpose other than conduction of the study. All PHI 
used will be de-identified and coded by the Principal investigator or designee. The code will be 
kept in a password protected computer file. PHI will be disclosed when required for audit by 
regulatory agency.
The personal information will be kept private and confidential. Absolute confidentiality cannot 
be guaranteed. Personal information may be disclosed if required by law. The results of this study 
may be shown at meetings or published in journals to inform other doctors and health 
professionals. Subject identity will be kept private in any publication or presentation about the 
study. People and organizations that may inspect and/or copy research records to assure the 
quality of the data and to analyze the data include: 

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
Medical staff who are directly or indirectly involved in your care related to this research.

People who oversee or evaluate research and care activities at Emory University. 

People from agencies and organizations that perform independent accreditation and 
oversight of research;
o
Emory offices that are part of the Human Research Participant Protection 
Program and those that are involved in study administration and billing.  These 
include the Emory IRB, the Emory Research and Healthcare Compliance Offices, 
and the Emory Office for Clinical Research 
o
Government agencies that regulate the research
o
Public health agencies
o
Research monitors and reviewer
o
Accreditation agencies
21. Plans to Monitor the Data to Ensure Safety of Participants and Data Integrity
The safety of interventions and treatments associated with this protocol will be under continuous 
review by the investigative team. As this study is unicentric and  observational trial,  it is felt that 
a formal Data Safety Monitoring Board is not necessary to insure the prompt implementation of 
patient safeguards. 
Select one of the following (do not delete this table; review the guidance document 
for definitions):
☐ Medium Complexity
☐ High Complexity Category A
☒ High Complexity Category B
If choosing this category for a study under an IND or IDE because you believe the 
study intervention does not significantly impact morbidity or mortality, please 
provide your rationale: : We will use a commercially available (FDA approved) 
glucose sensor Dexcom CGM. No major risks are expected with the use of the 
CGM device. Pain and bleeding with insertion is minimal.

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Monitoring Table 3 
DSMP Requirement 
How this Requirement is 
Met  
Frequency 
Responsible Party(ies) 
Real-time review of 
participant data during 
initial data collection. 
 
 Review on real-time by 
CRC every time 
information is obtain
Expectation is that this 
happens every time you 
obtain information. 
CRC 
100% review of 
regulatory files 
Review at study initiation 
by CRC and when the 
requests
Reviewed at a minimum of 
first and close-out visits 
CRC 
Principal Investigator 
100% review of 
consent forms 
Review at study initiation 
and every time a new 
patient is added to the 
study
When modifications apply. CRC 
Principal Investigator 
Review of credentials, 
training records, the 
delegation of 
responsibility logs (if 
applicable) 
Review at study initiation 
per PI
Reviewed at a minimum of 
first and close-out visits 
CRC 
Principal Investigator 
Comparison of case 
report forms (CRF) to 
source documentation 
for accuracy and 
completion 
Review first chart with 
the PI and once a month 
throughout study
Reviewed at a minimum of 
first and close-out visits 
CRC 
Principal Investigator 
Review of 
documentation of all 
adverse events 
Review and report once 
the adverse effect is 
noted
At the time the AE been 
reported 
CRC 
Principal Investigator 
Monitoring of critical 
data points (eligibility, 
study endpoints, etc.) 
Review when a new 
patient is added to the 
study 
Reviewed at a minimum of 
first and close-out visits 
CRC 
Principal Investigator 
Laboratory review of 
processing and 
storage of specimens 
 N/A 
Reviewed at first and close-
out visits and at least 
biannually 
N/A 
Assessment 
of 
laboratory specimens 
stored locally 
 N/A -
 N/A
N/A 

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Test article 
accountability review 
Will keep inventory sheet 
throughout study
Reviewed at first and close-
out visits and at least 
biannually 
CRC 
Principal Investigator 
Accountability logs, 
dispensing records, 
and other participant 
records  
Will keep accountability 
log throughout study
At least biannually 
CRC 
Principal Investigator 
For FDA regulated 
studies, the following 
requirements apply: 
N/A - not FDA study 
 
Monitoring methods 
(may include 
centralized, on-site, 
and self-assessment) 
N/A - not FDA study 
*For international studies, you are required to engage a CRO that is working in the site country and/or 
to consult with Emory’s legal counsel regarding compliance with the country’s clinical research 
regulations. 
Subject safety:
Any AEs will be reported in the Emory REDCap computerized database, within 15 days of the 
event and any SAEs will be reported to the Emory IRB within 24-48 hours of the event. The 
standard Emory IRB reporting guidelines for AE and SAE reporting will also be followed. The 
investigators and staff will enter all AEs into the REDCap database, and evaluate the SAEs, in 
close coordination with the Emory IRB. The investigators and staff will track and summarize AE 
frequency, severity, and relatedness at a frequency appropriate to ensure subject safety.
A periodic (annual unless otherwise specified) report of AE with a frequency > 5% will be 
provided for this clinical trial 1-2 months prior to IRB annual review. The Emory IRB reporting 
guidelines for UP, AE and SAE reporting should also be followed. Risks include local infection, 
inflammation, lightheadedness, pain or discomfort, bleeding at the CGM insertion site, bruising, 
itching, scarring or skin discoloration, hematoma (also known as a black and blue mark) caused 
by the leakage of blood under the skin, CGM Sensor or needle breakage during insertion, wear 
or removal.
Sensors may fracture or be retained in situ on rare occasions. In these rare instances when this 
has occurred in the past, consulting physicians and surgeons have recommended not to remove 
the wire fragment from beneath the skin as long as there are no symptoms of infection or 
inflammation. In the event that signs and/or symptoms of infection or inflammation arise such 
as redness, swelling, and pain participants should consult with the investigator or prescribing 
physician for the best course of action. If there is no portion of the broken sensor wire fragment 

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or retained sensor wire visible above the skin, attempts to remove it without medical guidance 
are not advised. 
Pregnancy will be an exclusion criterion. Pregnancy test will be performed prior to study 
procedures and thereafter at investigator’s discretion. Women of childbearing age will be 
considered pregnant as demonstrated by a positive βHCG PT (Pregnancy Test) to be performed 
during study visits (blood draw) per investigator discretion. Investigators will follow Emory IRB 
protocol for reporting.
 
22. Provisions to Protect the Privacy Interest of Participants
All participant data will be kept confidential and de-identified. Access to research will be limited 
to clinical investigators, research coordinators, and the IRB at Emory University. Clinical data 
will be stored in a secure web-based database that requires password access.
For security and confidentiality purposes, participants will be assigned an identifier that will be 
used instead of their name. All data and records generated during this study will be kept 
confidential in accordance with Institutional policies and HIPAA on subject privacy. The Principal 
investigator and other study personnel will not use data or PHI for any purpose other than 
conduction of the study. All PHI used will be de-identified and coded by the Principal 
investigator or designee. The code will be kept in a password protected computer file. PHI will 
be disclosed when required for audit by regulatory agency.  
The personal information will be kept private and confidential. Absolute confidentiality cannot 
be guaranteed. Personal information may be disclosed if required by law. The results of this 
study may be shown at meetings or published in journals to inform other doctors and health 
professionals. Subject identity will be kept private in any publication or presentation about the 
study.
23. Economic Burden to Participants
No additional cost to subjects 
24. Informed Consent 
After identification of eligible subjects these individuals will be provided basic information 
regarding the study and, if interested, they will then be screened by research staff using the 
inclusion/exclusion criteria delineated elsewhere in this protocol.  The consent form, potential 
risks and benefits, and the rights of research participants will be explained to the participant by 
the investigators or research coordinator.  Individuals will be asked if they have any questions, 
and research staff will answer these questions.  The principal investigator will also be available 
to answer questions that participants may have during the consent procedure or during the 
time a participant is enrolled in the study.  The consent form will be completed in accordance 
with the IRB guidelines of Emory University.  A signed copy of the consent form will be provided 

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to the participant and a copy will be placed in the file that is maintained for each participant in 
the study office.  
Non-English-Speaking Participants  
Adults who speak any of the following languages (English, Russian, Spanish and Arabic) will be 
approached for participation in the study. 
Participants who are not yet adults (infants, children, teenagers)  
No subjects under the age of 18 will be recruited in this study.
Cognitively Impaired Adults  
No subjects with cognitively Impaired Adults will be recruited in this study.
Adults Unable to Consent  
No subjects Adults Unable to Consent will be recruited in this study.
25. Setting
This study will be conduct at Emory dialysis centers. Screening for eligibility will be performed 
from electronic medical records.  
26. Resources Available
Emory University and Grady Hospital have combined ~1300 patients with ESKD on hemodialysis. 
Emory University Dialysis Center is a comprehensive dialysis service with 5 clinics located across 
the health system to provide services to over 800 patients, including 51% of patients with 
diabetes, ~ 88% on hemodialysis. In addition, Grady Dialysis Unit provides care for over 500 
patients/year with 50% of patients with diabetes. This large number of patients will facilitate the 
recruitment and will generate important clinical information. We have put together a team of 
endocrinologists, and statistician to support and guide the discovery student. Given the 12 month 
period and the cross-sectional study design, we expect to recruit the adequate number of 
subjects. We will also work with our colleagues in the Division for assistance in identifying 
patients for this study.  
Dr. Umpierrez, a Professor of Medicine at Emory University, will serve as the principal 
investigator and student’s lead mentor. With Dr. Umpierrez’ oversight, student will learn about 
the use of CGM, and best practices in obtaining consent and recruitment of participants.   In 
addition, the student will learn on data acquisition, use of REDCap research dataset, entering 
data, and help with data analysis.  Limin Peng, PhD, Professor of Statistics at the School of 
Public Health will assist with data analysis. The student will present the results in regional and 
national scientific meetings.
27. Multi-Site Research When Emory is the Lead Site

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N/A
28. References
1.  CDC. Diabetes Data & Statistics. Diabetes Atlas. Division of Diabetes Translation, Centers 
for Disease Control and Prevention, U.S. Dept of Health and Human Services. 
https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html#. Published 2022. Accessed April 
5, 2022.
2. Galindo, R. J., Beck, R. W., Scioscia, M. F., Umpierrez, G. E., & Tuttle, K. R. (2020). Glycemic 
monitoring and management in Advanced Chronic Kidney Disease. Endocrine Reviews, 
41(5), 756–774. https://doi.org/10.1210/endrev/bnaa017 
3. Centers for Disease Control and Prevention. (2021, March 4). CKD related health 
problems. Centers for Disease Control and Prevention. Retrieved April 10, 2022, from 
https://www.cdc.gov/kidneydisease/publications-resources/annual-report/ckd-related-
health-problems.html   
4. Rhee, C. M., Leung, A. M., Kovesdy, C. P., Lynch, K. E., Brent, G. A., & Kalantar-Zadeh, K. 
(2014). Updates on the management of diabetes in dialysis patients. Seminars in Dialysis, 
27(2), 135–145. https://doi.org/10.1111/sdi.12198  
5. Park, J., Lertdumrongluk, P., Molnar, M. Z., Kovesdy, C. P., & Kalantar-Zadeh, K. (2012). 
Glycemic control in diabetic dialysis patients and the burnt-out diabetes phenomenon. 
Current Diabetes Reports, 12(4), 432–439. https://doi.org/10.1007/s11892-012-0286-3 
6. Kovesdy, C. P., Park, J. C., & Kalantar-Zadeh, K. (2010). Glycemic control and burnt-out 
diabetes in ESRD. Seminars in Dialysis, 23(2), 148–156. https://doi.org/10.1111/j.1525-
139x.2010.00701.x  
7. Abe, M., Hamano, T., Hoshino, J., Wada, A., Inaba, M., Nakai, S., & Masakane, I. (2017). Is 
there a “burnt-out diabetes” phenomenon in patients on hemodialysis? Diabetes 
Research 
and 
Clinical 
Practice, 
130, 
211–220. 
https://doi.org/10.1016/j.diabres.2017.06.012
8. Vos, F. E., Schollum, J. B., & Walker, R. J. (2011). Glycated albumin is the preferred 
marker for assessing glycaemic control in advanced chronic kidney disease. Clinical 
Kidney Journal, 4(6), 368–375. https://doi.org/10.1093/ndtplus/sfr140  
9. Davis, G. M., Faulds, E., Walker, T., Vigliotti, D., Rabinovich, M., Hester, J., Peng, L., 
McLean, B., Hannon, P., Poindexter, N., Saunders, P., Perez-Guzman, C., Tekwani, S. S., 
Martin, G. S., Umpierrez, G., Agarwal, S., Dungan, K., & Pasquel, F. J. (2021). Remote 
continuous glucose monitoring with a computerized insulin infusion protocol for 
critically ill patients in a COVID-19 medical ICU: Proof of concept. 
https://doi.org/10.2337/figshare.13570862.v2 
10. Kalantar-Zadeh, K., Kopple, J. D., Regidor, D. L., Jing, J., Shinaberger, C. S., Aronovitz, J., 
McAllister, C. J., Whellan, D., & Sharma, K. (2007). A1C and survival in maintenance 
hemodialysis patients. Diabetes Care, 30(5), 1049–1055. https://doi.org/10.2337/dc06-
2127 

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29. Protocol Checklist
 
Protocol Section 
Added to the 
protocol? 
External Collaborators- if applicable, add each external collaborator information and 
indicate whether that institution’s IRB will review (or has already reviewed) that individual’s 
engagement in human participants research activities)   
☒ Yes 
Funding Source*: Include the information for the funding entity for this study.  Please 
explain if this study is covered by a sub-award or other pertinent information. Say 
“department” if you do not have any other funding. 
☒ Yes 
Objectives*: Describe the purpose, specific aims, or objectives and state the hypotheses to 
be tested 
☒ Yes 
Background*: Describe the relevant prior experience and gaps in current knowledge. 
Describe any relevant preliminary data. Provide the scientific or scholarly background for, 
the rationale for, and significance of the research based on the existing literature and how 
will it add to existing knowledge 
☒ Yes 
Study Endpoints*: Describe the primary and secondary study endpoints. Describe any primary
or secondary safety endpoints.  
☒ Yes 
Study Intervention/Investigational Agent*: Describe the study intervention and/or 
investigational agent (e.g., drug, device) that is being evaluated.   
☒ Yes 
Drug/Device Handling: If the research involves drugs or devices, describe your plans to store, 
handle, and administer those drugs or devices so that they will be used only on participants 
and be used only by authorized investigators. 
If using a drug, explain if the control of the drug is managed by IDS (or VA/Grady/CHOA 
research pharmacies). If not, provide IDS exemption document. 
If a device, explain how the device is being stored and managed. 
☒ Yes 
If the drug is under an FDA REMS, plan to complete the REMS checklist found here, on the 
IRB website. 
☒ Yes 
If the drug is considered a controlled substance, make sure you have filled out this form. 
☒ Yes 
 
If applicable, identify the holder of the IND/IDE/Abbreviated IDE. An Emory investigator who 
holds an IND or IDE is considered to be a Sponsor-Investigator (S-I). If the study is under an S-I, review
this section of our website for additional requirements. 
☒ Yes 
Procedures involved*: Describe and explain the study design and include a study 
schema.  Describe all research procedures being performed and when they are performed, 
including procedures being performed to monitor participants for safety or minimize risks 
☒ Yes 
Procedures-Minimizing risk*: describe the procedures performed to lessen the probability or 
magnitude of risks. 
☒ Yes 
Procedures- Drug/Device Use: describe all drugs and devices used in the research and the 
purpose of their use and their regulatory approval status 
☒ Yes 

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Procedures-Source Records*: describe source records that will be used to collect data about 
participants. Attach all surveys, scripts, and data collection forms to the submission. 
☒ Yes 
Procedures-Data collection*: describe what data will be collected during the study and how 
that data will be obtained 
☒ Yes 
Procedures- Long Term Follow Up*: once all research-related procedures are complete, what
data will be collected during this period.  If no data is collected after procedures are 
completed, please state in the submission. 
☒ Yes 
Data and Specimen Banking: describe where the specimens will be stored, how long they will
be stored, how the specimens will be accessed, and who will have access to the 
specimens.  Depending on the volume and nature of the collection, this may require a 
separate repository-specific IRB submission. The VA Data Repository SOP is required if the 
study is creating a data repository at the Atlanta VA. 
List the data to be stored or associated with each specimen. 
Describe the procedures to release data or specimens, including the process to request a 
release, approvals required for release, who can obtain data or specimens, and the data to be
provided with specimens. 
☒ Yes 
Sharing of Results with Participants*: Describe whether results (study results or individual 
subject results, such as results of investigational diagnostic tests, genetic tests, or incidental 
findings) will be shared with participants or others (e.g., the participant’s primary care 
physicians) and if so, describe how the results will be shared If applicable (e.g. for studies 
involving scans and/or panels of exploratory testing on specimens) 
Plan for managing the types of findings that might arise. This should include any secondary 
findings that are being sought actively, findings that might be anticipatable, and findings that 
might be un-anticipatable.  
Plan for recognizing, analyzing, and handling incidental findings and how incidental findings 
will be communicated to participants during the consent process. If the plan is not to disclose 
any findings, then this should be included. This plan might include the option for participants 
to opt-out of receiving incidental findings. 
Description of the research team’s responsibilities following disclosure of a finding. This 
should detail educational information about the nature of the finding, how to seek care from 
a clinician or specialist, obtaining health insurance to secure treatment, and/or referral to a 
clinical specialist, if one is required.  
Reminder to include language in the consent form to let the participants know your plans for 
this – see Modular Language for Informed Consent Forms on IRB website) 
☒ Yes 
Study timelines*: describe the duration of an individual participant’s participation in the 
study; anticipated time to enroll all study participants and the estimated date for the 
investigators to complete this study (complete primary analyses) 
☒ Yes 
Inclusion and Exclusion Criteria*: describe how individuals will be screened for eligibility and 
the criteria that define who will be included or excluded in your final study sample  
☒ Yes 
Population*: describe the study popualation and indicate specifically whether you will 
include or exclude each of the following special populations:  

Adults unable to consent 

Individuals who are not yet adults (infants, children, teenagers) 
☒ Yes 

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
Pregnant women 

Prisoners 
Note: you cannot exclude people with limited English proficiency unless you can demonstrate
the scientific need for such exclusion. 
Community Participation: For studies aimed at addressing issues that affect a certain 
community or group: How, if at all, will this study involve people from the target community 
in the design of the study? Conduct of the study? How will the results of the research be 
shared with the participants and/or the target community/ies?   
 
If studying Race or Ethnicity, have you defined these terms, and explained their proposed 
mechanism of action if these characteristics will be used in an explanatory model? 
 
Research with pregnant women, fetuses, or neonates: review this checklist to verify you 
have provided enough information to ensure the safety and well-being of this population. 
☒ Yes 
Research with neonates of uncertain viability: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population. 
☒ Yes 
Research involving prisoners: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population. 
☒ Yes 
Research involving children: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population. 
☒ Yes 
Research involving cognitively impaired adults: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population. 
☒ Yes 
Research involving economically or educationally disadvantaged persons: describe the 
additional safeguards that have been included in the study to protect the rights and welfare 
of these subjects 
☒ Yes 
Local Number of Participants*: Indicate the total number of participants to be accrued 
locally. If applicable, distinguish between the number of participants who are expected to be 
enrolled and screened, and the number of participants needed to complete the research 
procedures (i.e., numbers of participants excluding screen failures.)  
Provide your projected enrolling goals, including the percentage of participants according to 
sex and race.    
☒ Yes 
Recruitment Methods*: Describe when, where, and how potential participants will be 
recruited.  Describe the source of participants. Describe the methods that will be used to 
identify potential participants.  Describe materials that will be used to recruit participants. 
Attach copies of these documents with the application.  
If including advertisements, attach the final copy of them. When advertisements are taped 
for broadcast, attach the final audio/videotape. You may submit the wording of the 
advertisement before taping to preclude re-taping because of inappropriate wording, 
provided the IRB reviews the final audio/videotape. Describe the amount and timing of any 
payments to participants. Reimbursement for expenses/travel? 
If using contests or raffles as incentive, you must offer entry to all potential participants, not 
just those who enroll in the study/complete study-related procedures, per Georgia State 
Law. 
☒ Yes 

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All research recruitment through social media needs to follow this guidance, which does not 
allow the use of personal social media accounts for some recruitment activities. 
Withdrawal of Participants*: Describe anticipated circumstances under which participants 
will be withdrawn from the research without their consent. Describe any procedures for 
orderly termination. Describe procedures that will be followed when participants withdraw 
from the research, including partial withdrawal from procedures with continued data 
collection. 
☒ Yes 
Risk to Participants*: List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the participants related to the participant's participation in the research. 
Include as may be useful for the IRB’s consideration, a description of the probability, 
magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks. 
If applicable, indicate which procedures may have risks to the participants that are currently 
unforeseeable. 
If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant. 
If applicable, describe risks to others who are not participants. 
☒ Yes 
Potential Benefits to Participants*: Describe the potential benefits that individual 
participants may experience from taking part in the research. Include as may be useful for the
IRB’s consideration, the probability, magnitude, and duration of the potential benefits. 
Indicate if there is no direct benefit. Do not include benefits to society or others. 
☒ Yes 
Compensation to Participants*: Describe if/how subjects will be compensated for 
participation in this study. Indicate what method compensation will be delivered (e.g. cash, 
gift card, school credit). Describe the amount and timing of any payments to 
participants.  How much?  What kind?  Is tax information required? (if so, must be reflected 
in the informed consent form). Will payments be pro-rated if a participant withdraws early? 
☒ Yes 
Data Management and Confidentiality*: Describe the data analysis plan, including any 
statistical procedures or power analysis. Describe the steps that will be taken to secure the 
data (e.g., training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and data) during storage, 
use, and transmission. Describe any procedures that will be used for the quality control of 
collected data.  
☒ Yes 
Describe how data or specimens will be handled study-wide*: What information will be 
included in that data or associated with the specimens? 

Where and how data or specimens will be stored? 

How long the data or specimens will be stored? 

Who will have access to the data or specimens? 

Who is responsible for receipt or transmission of the data or specimens? 

How data or specimens will be transported? 
☒ Yes 
Data Monitoring and Participants Safety (if this study is more than minimal risk, this section
is required):  
☒ Yes 

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Ensure that you review our Data and Safety Monitoring plan guidance for specific details 
about this section, and examples of what the IRB will be requiring according to the level of 
risk. 
If a DSMB is needed, please describe the composition of the board (if not already detailed in 
the protocol).  Review this guidance for more information.  If the sponsor protocol does not 
contain all required information, please in this section.  
Describe the plan to periodically monitor the data at the site level according to risk level. 
Include the appropriate completed monitoring table, if applicable.  
Description of the plan for notifying the IRB of reportable events, whether the sponsor 
requires reporting above and beyond the Emory IRB reporting requirements, and if so, a 
description of the requirements and plan for meeting them.  
Please address the specific details below. If deemed not applicable, please provide 
rationale: 
Subject safety: 

Specific subject safety parameters  

Frequency of subject safety observations 

Individual responsible for safety monitoring 

Subject stopping rules – under what conditions will a subject be removed 
from study participation and who will make the decision? 

Study stopping rules - under what conditions will the study be modified or 
stopped and who will make the decision? 

Reporting mechanisms (i.e. Deviations, adverse events, UPs) 
Data Integrity: 

Specific data elements to be reviewed 

Frequency of monitoring data, points in time, or after a specific number of 
participants 

Individual responsible for data monitoring 
Additional considerations for FDA regulated trials  
Depending on the procedures affecting risks to participants, the site monitoring plan should 
specify: 

Categorization of activities done centrally and those on-site if applicable 

Monitoring methods (may include centralized/remote, on-site, and self-
monitoring) 

Reference to any tools used (i.e. checklists) 

Identification of events that may trigger changes 

Identification of deviations or failures that would be critical to study integrity 
Provisions to Protect the Privacy Interests of Participants*:  

Describe the steps that will be taken to protect participants’ privacy interests. 
“Privacy interest” refers to a person’s desire to place limits on whom they interact 
with or whom they provide personal information. 

Describe what steps you will take to make the participants feel at ease with 
the research situation in terms of the questions being asked and the procedures 
being performed. “At ease” does not refer to physical discomfort, but the sense of 
☒ Yes 

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intrusiveness a participant might experience in response to questions, examinations, 
and procedures. 

Indicate how the research team is permitted to access any sources of 
information about the participants. 
Economic Burden to Participants*: Describe any costs that participants may be responsible 
for because of participation in the research. 
☒ Yes 
Consent Process*: Describe where the consent process will take place, any waiting period 
available between informing the prospective subject and obtaining the consent; and the 
process to ensure ongoing consent. 
Describe the role of the individuals listed in the application as being involved in the consent 
process; the time that will be devoted to the consent discussion; steps that will be taken to 
minimize the possibility of coercion or undue influence; and steps that will be taken to ensure
the participants’ understanding. 
Note: If you are planning to obtain consent via electronic signature, please review this 
document. Additional guidance on consent documentation and process can be found on our 
website, under the consent toolkit. 
☒ Yes 
Consent Process-Non-English-Speaking Participants*:  
Indicate what language(s) other than English are understood by prospective participants or 
representatives. 
If participants who do not speak English will be enrolled, describe the process to ensure that 
the oral and written information provided to those participants will be in that language. 
Indicate the language that will be used by those obtaining consent. 
If you checked N/A, please provide reasoning of why subjects with limited English proficiency 
are excluded.  
Note: if you stated that subjects with LEP will be enrolled, you are approved for the use of 
the Emory IRB short forms.  Please read the guidance about the use of short forms here. 
☒ Yes 
Consent Process-Children: After determining if the subject is a child per GA law (or if enrolled
outside GA, per state/country law), please describe whether parental permission will be 
obtained from: 

Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the care and 
custody of the child. 

One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child. 
Describe whether permission will be obtained from individuals other than parents, and if so, 
who will be allowed to provide permission.  Describe the process used to determine these 
individuals’ authority to consent to each child’s general medical care. 
When assent of children is obtained describe whether and how it will be documented per 
Emory Policies and Procedures 
☒ Yes 
Consent Process-Cognitively Impaired Adults:  describe the process to determine whether 
an individual is capable of consent. The IRB allows the person obtaining assent to document 
assent on the consent document and does not routinely require assent documents and does 
not routinely require children to sign assent documents. 
☒ Yes 

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Consent Process-Adults Unable to Consent:  List the individuals from whom permission will 
be obtained in the order of priority. (E.g., durable power of attorney for health care, a court-
appointed guardian for health care decisions, spouse, and adult child.) 
For research conducted in the state, review “46 LEGALLY AUTHORIZED REPRESENTATIVES 
AND SURROGATE CONSENT” to be aware of which individuals in the state meet the definition
of “legally authorized representative.” 
For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective subject 
to their participation in the procedure(s) involved in this research.  
Describe the process for the assent of the participants. Indicate whether: 

Assent will be required of all, some, or none of the participants. If some, 
indicated, which participants will be required to assent and which will not. 

If assent will not be obtained from some or all participants, an explanation of 
why not. 
Describe whether the assent of the participants will be documented and the process to 
document assent. The IRB allows the person obtaining assent to document assent on the 
consent document and does not routinely require assent documents and does not routinely 
require participants to sign assent documents 
☒ Yes 
Waiver or Alteration of Consent Process (consent will not be obtained, required 
information will not be disclosed, or the research involves deception)  
Review the Emory IRB waiver document to ensure you have provided sufficient information 
for the IRB to make these determinations. 
If the research involves a waiver of the consent process for planned emergency research, 
please review the “CHECKLIST: Waiver of Consent for Emergency Research (HRP-419)” to 
ensure you have provided sufficient information for the IRB to make these determinations. 
☒ Yes 
Setting*: Describe the sites or locations where your research team will conduct the research 
including where the subject will be identified and recruited, where the research procedures 
will be performed, and if you will involve a community advisory board.  For research 
conducted outside the organization and its affiliates describe the site-specific regulations or 
customs affecting the research outside the organization and the local scientific and ethical 
review structure outside the organization. 
☒ Yes 
Resources Available*: Describe the resources available to conduct the research such us the 
feasibility of recruiting the required number of suitable participants within the agreed 
recruitment period; describe the time that you will devote to conducting and completing the 
research; describe the availability of medical or psychological resources that participants 
might need as a result of an anticipated consequences of the human research; describe your 
process to ensure that all persons assisting with the research are adequately informed about 
the protocol, the research procedures, and their duties and functions. 
☒ Yes 
Multi-Site Research when Emory is the Lead Site: 
Study -Wide Number of Participants: indicate the total number of participants to be accrued 
across all sites. 
☒ Yes 

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Study-Wide Recruitment Methods: If this is a multicenter study and participants will be 
recruited by methods not under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.   
Describe when, where, and how potential participants will be recruited. 
Describe the methods that will be used to identify potential participants. 
Describe materials that will be used to recruit participants.  
Describe the processes to ensure communication among sites. See “WORKSHEET: 
Communication and Responsibilities (HRP-830).” All sites have the most current version of 
the protocol, consent document, and HIPAA authorization. 
All required approvals (initial, continuing review and modifications) have been obtained at 
each site (including approval by the site’s IRB of record). 
All modifications have been communicated to sites and approved (including approval by the 
site’s IRB of record) before the modification is implemented. 
All engaged participating sites will safeguard data, including secure transmission of data, as 
required by local information security policies. 
All local site investigators conduct the study in accordance with applicable federal regulations
and local laws.  
All non-compliance with the study protocol or applicable requirements will reported in 
accordance with local policy 
Describe the method for communicating to engaged participating sites (see “WORKSHEET: 
Communication and Responsibilities (HRP-830)”): 

Problems (inclusive of reportable events). 

Interim results. 

The closure of a study 
If this is a multicenter study where you are a participating site/investigator, describe the local 
procedures for maintenance of confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”) 

Where and how data or specimens will be stored locally? 

How long the data or specimens will be stored locally? 

Who will have access to the data or specimens locally? 

Who is responsible for receipt or transmission of the data or specimens 
locally? 

How data and specimens will be transported locally? 
 
 
 

Continuous Glucose Monitoring in Patients with End-Stage Kidney Disease and Burnt-Out 
Diabetes
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Version: 2.0  1/05/2023
IRB 00004617