Continuous Glucose Monitoring (CGM) in Kidney-Transplanted Adults
Phase: NA
Conditions: Diabetes Mellitus, Kidney Transplant; Complications
Sponsor: University of Alabama at Birmingham

Cover Page 
 
Official Title: Continuous Glucose Monitoring (CGM) in Kidney-Transplanted Adults 
 
NCT Number: 05352230 
 
Date of document: 09/30/2024 

Inclusion of Individuals Across the Lifespan
Individuals 18 years of age and older are eligible to participate in this study. We anticipate the majority of 
patients will be 45-65 years of age, as this is the average age of end-stage renal disease patients eligible for 
kidney transplant.  
Individuals less than 18 years of age are not approved by the FDA to use the Freestyle Libre continuous 
glucose monitoring system. 
Dr. Zelada is an Endocrinologist that sees patients at the Kidney-Transplant Clinic at the UAB Comprehensive 
Transplant Institute. He and his study team are well equipped to work with individuals 18 years and older in the 
inpatient and outpatient clinics associated with the UAB Comprehensive Transplant Institute that are designed 
to accommodate the adult kidney transplant patient population from pre-op through outpatient recovery. 
INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN

Inclusion of Women and Minorities
We plan to enroll a total of 30 participants. 
Based on UAB Comprehensive Transplant Institute’s reporting to the Scientific Registry of Transplant 
Recipients, 60% of kidney transplant recipients are male. Therefore, we anticipate participants will be 60% 
male (n=18) and 40% female (n=12). No sex/gender group will be excluded or targeted for enrollment in this 
study. 
Based on UAB Comprehensive Transplant Institute’s reporting to the Scientific Registry of Transplant 
Recipients, we anticipant participants will self-identify their race/ethnicity according to the following 
percentages: 63% African American (n=19), 32% Caucasian (n=10) and 4% Hispanic/Latino (n=1). However, 
no racial or ethnic group will be excluded or targeted for enrollment in this study. 
INCLUSION OF WOMEN AND MINORITIES

Recruitment and Retention Plan
Recruitment: 
The proposed pilot study plans to enroll 30 end-stage renal disease patients awaiting kidney transplant at the 
Kidney-Transplant Clinic that is part of the UAB Comprehensive Transplant Institute.  
 
To facilitate recruitment, our team plans to leverage UAB’s electronic medical record system/reporting, as well 
as routine care plans and coordinators. Specifically, the study team will identify potential participants by 
querying UAB’s electronic medical record. Using that information, the study team will supply patients on the 
kidney transplant waiting list letters with information about the study. Patients admitted to the hospital to 
receive a kidney transplant will also be directly contacted about the study. 
 
Retention: 
To minimize the burden of study participation, we integrated study activities with routine care plans and 
coordinators. Planned study activities coincide with standard post-kidney transplant care plans. Kidney 
transplant coordinators facilitate post-kidney transplant standard of care. 

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STUDY TIMELINE

Protection of Human Subjects 
Protection of Human Subjects
1.
Risks to Human Subjects
 
a.
Human Subjects Involvement, Characteristics, and Design
 
The primary outcome of this study is assessment of the feasibility and acceptance of CGM usage in the post-
operative kidney transplant population (e.g. quality-of-life). Secondary outcomes will estimate if CGM usage 
improves post-operative diabetes management (e.g. time in range). The study is a randomized, open-label, 
cross-over clinical trial consisting of two study arms where participation will last eight months. A permutated 
block randomization list, block sizes varying from 2 to 6, will be developed to randomly assign subjects to 
treatment sequence (CGM followed by glucometers, or glucometers followed by CGM). We plan to enroll 30 
post-operative kidney-transplant diabetics. 
 
Inclusion Criteria: 
 
 
 
pe 2, or atypical) prior to kidney transplant 
 
Current treatment for diabetes includes at least one daily injection of long-lasting insulin 
 
Able to read and understand English 
 
Able to consent for themselves 
 
Exclusion Criteria: 
 
 
 
History of kidney and/or pancreas transplant 
 
Has used CGM in the past 
 
Mental of psychiatric conditions that would preclude continuation in the study 
 
Unable to read or understand English 
 
Unable to consent for themselves 
 
b. Study Procedures, Materials and Potential Risks 
 
Study Procedures and Materials: 
 
Eligible participants will engage study staff during regularly scheduled, standard of care, visits. The first (i.e. 
baseline) visit is one day post-operative surgery. Participants will be randomized to one of 
Freestyle Libre continuous glucose monitor (CGM) that reports glucose levels 
 for twelve weeks
self-management of their diabetes as per the standard of care for twelve weeks. Halfway through the study 
-operative surgery), all participants will use a glucometer to manage their diabetes eight weeks, 
which serves as a washout period. At week 20 post-operative surgery, Group 2 participants will receive a CGM 
conclude at week 32 post-operative surgery visit.  
 
Participants managing their diabetes with glucometers during the first and last twelve weeks of the study 
-20 of the study will use a Freestyle Libre 
“Pro” CGM, which collects glucose information in the same manner as the CGM described above but reporting 
not provided to participants and is accessible to the study team via remote monitoring. 
 
At regularly scheduled post-
to complete two quality-of-life surveys (Diabetes Treatment Satisfaction Questionnaire (DSTQ) and 
Hypoglycemic Confidence Scale (HCS)) and record glucose readings from the CGM and/or glucometers. 
Participants’ medical records will be leveraged to assess surgical outcomes, diabetes management and related 
clinical information (e.g. clinical labs, kidney biopsies).  
 

Protection of Human Subjects 
Potential Risks: 
 
Glucose monitoring related pain, discomfort and Infection: Sensor insertion and finger-prick based glucose 
readings may cause temporary pain, bleeding and/or bruising at the site of insertion. Moderate to severe 
itching, reddening and/or scaling of the skin, rash and/or bleeding are infrequent risks associated with wearing 
the sensor. A infrequent risk is sensor breakage, which can require sensor tip extraction via tweezer. 
Group Assignment: Participants are assigned to a group by chance, which may prove to be less effective or 
have more side effects than the other study group or alternatives. 
Confidentiality: A breach of confidentiality may impact participants psychologically and could influence 
insurance and/or employers decisions based on study purpose, participant enrollment or health status. This 
risk is minimal. 
2.
Adequacy of Protection Against Risks
 
a.
Informed Consent: 
As approved by the UAB IRB, a HIPAA waiver will be utilized for all participants strictly for recruitment and 
screening purposes. A trained study team member will provide an IRB approved consent form to interested 
individuals likely meeting the inclusion/exclusion criteria. Such individuals will have access to it for more than 
24 hours before the study team member reviews the consent form with the individual and answers any 
questions. The study personnel will explain the potential risks and benefits. Study team members will clarify 
that participants may refuse to answer any study questions without jeopardizing their continued enrollment in 
the study and that election to enroll or not enroll will not influence their care or future interactions with the 
institution. The signed informed consent form will be retained by the study team and a copy will be made 
available to the participant.  
 
b. Protections Against Risk: 
Glucose monitoring related pain, discomfort and Infection: Study team members and participants will take 
precautions to avoid infections at the site of finger pricking and sensor insertion (e.g. wearing gloves, washing 
hands and/or cleaning the skin with alcohol prior to pricks/insertion). Participants will be directed to contact 
study team staff if they notice any adverse reactions to wearing the sensor. If the sensor breaks, participants 
will be instructed to remove the sensor with tweezers and notify the staff. 
Group Assignment: Participants are assigned to a group by chance, which may prove to be less effective or 
have more side effects than the other study group or alternatives. However, this risk is not greater than the 
standard of care.  
Confidentiality: The University of Alabama at Birmingham regularly reviews its policies and procedures 
regarding the confidentiality of its study subjects. All staff receives training on the importance of maintaining 
confidentiality. Strict confidentiality will be maintained to the fullest extent by the research team. Hardcopy 
information will be kept in a secure, locked cabinet with limited access. Digital information will be stored in a 
HIPAA compliant, password protected database with limited access to authorized study personnel. Data are 
stored and analyzed according to subject identification numbers, and in no instances are subjects’ names or 
other identifying information available in publically accessible files or in published material. The study consent 
form will inform participants that not sharing information about their participation in this study with others will 
minimize breach of confidentiality risks. 
c. Vulnerable Subjects 
The proposed study does not involve vulnerable subjects. 

Protection of Human Subjects 
3.
Potential Benefits of the Proposed Research to Research Participants and Others
Participants may benefit from this study by obtaining additional health information made available by 
continuous glucose monitors. The results of this study are expected to inform the acceptability and feasibility of 
continuous glucose monitoring among diabetics after kidney transplantation and estimate if continuous glucose 
monitoring improves glucose control among diabetic kidney transplant recipients.  
 
4.
Importance of Knowledge to be Gained
Diabetes is the largest risk factor for end-stage renal disease and kidney transplant rejection. The less glucose 
levels are controlled the more likely transplanted organs are to fail. Therefore, if continuous glucose monitoring 
improves glucose control in diabetic kidney transplant recipients, we anticipate to see a reduction in kidney 
transplant failure rates. This finding may benefit outcomes among other solid-organ transplant populations, as 
well as policies related to insurance coverage of continuous glucose monitoring in solid-organ transplant 
populations. 

Data and Safety Monitoring Plan
Monitoring Responsibility:  
Data and Safety Monitoring is the responsibility of the study director, Dr. Henry Zelada. 
Adverse Event (AE) Management:  
Expected Events: Adverse events include expected side effects of a serious nature or unexpected side 
effects/events, regardless of severity. All potential risks, as well as protections against those risks, are detailed 
in the “Protection of Human Subjects” document, the human subjects protocol and the informed consent 
document. 
 
Frequency: Adverse event information will be collected during each standard of care clinic visit. In addition, 
participants will be instructed to report adverse events as they occur to the study director, whose contact 
information is provided in the informed consent. Throughout the study, the study director will be available to 
address subject related medical questions and to ensure subject safety. 
 
Actions: As needed, the study director will refer participants to the appropriate medical care (e.g. urgent care or 
non-urgent care). In cases of emergency, participants will be instructed to call 911. Should a participant require 
urgent or emergency care, the study director will follow up with the participants’ healthcare providers to 
determine whether it is safe for the participant to continue in the trial. Should an adverse event occur while the 
participant is being seen at UAB, study related injuries will be promptly addressed and treated using resources 
available at UAB. 
 
Documentation: Adverse events will be documented on specialized case report forms and graded on their 
attribution (unrelated to the protocol, or possibly, probably or definitely related to the protocol), severity (mild, 
moderate, severe), expectedness (unexpected versus expected) and frequency. We will also document any 
actions taken related to the adverse event and the outcome or resolution of the event. 
 
Reporting: All adverse events will be reported to the UAB IRB with a description of the event, when and how it 
was reported, and appropriate documentation to corroborate the event on case report forms. A summary of all 
adverse events are reported as part of the IRB protocol Continuing Review. Serious Adverse Events (SAE) will 
be reported by the study director to the IRB no later than five business days after the event. Non-serious, 
unexpected adverse events that are related or possibly related to the study will be reported to the IRB within 10 
business days of the event. The IRB will have the responsibility to confirm the severity of the adverse event, 
determine if it is likely that the adverse event was related to the study and make recommendations for 
continuation, modification or cessation of the study. 
 
Data Monitoring Management: 
Dr. Zelada will review the quality and accuracy of all data collected during the study. Protection of data from a 
breach of confidentiality is described in the Protection of Human Subjects document. 

Statistical Design and Power
A permutated block randomization list, block sizes varying from 2 to 6, will be developed to randomly assign 
subjects to treatment sequence (CGM followed by glucometers, or glucometers followed by CGM). 66 
individuals would be required to achieve 80% statistical power in this crossover design for a medium effect size 
of 0.5 using a two-tailed Type I error of 0.05. Given we have only one year to conduct the pilot, we believe a 
sample size of 30 is the highest number of individuals that can be recruited and studied within that period. We 
will include 15 patents in each group. One group will receive CGM and the other will use glucometers for 
glucose monitoring. The only way this sample size could achieve adequate statistical power is that the 
difference in interventions generates a very large effect size (>0.8). We do not anticipate effect sizes that large 
and believe the smallest clinically relevant effect sizes would be in the range 0.2 to 0.5. Therefore, this study is 
unlikely to generate adequate statistical power. However, achieving statistical power is not the objective of a 
pilot study. The objective is to demonstrate the feasibility of recruiting individuals to the study, demonstrating 
that individuals will complete the study, demonstrating that clean and usable data can be collected, and 
examination of that data provides preliminary evidence of an effect in the direction anticipated. Therefore, the 
criteria for evaluating this pilot are that a) 80% of all individuals recruited will agree to randomization and 
complete the study with usable data and b) adequate evidence is observed in the direction anticipated. If we 
observe a test statistic for treatment effect difference greater than or equal to 1.055 with 28 degrees of 
freedom, which equates to effect size an effect size of 0.275, we will consider this as adequate statistical 
evidence to proceed. Such an approach equates to conducting the analysis with a one-tailed Type I error rate 
of 0.15. If both criteria are met (rate of completion and preliminary data provides evidence in direction 
anticipated), we will utilize the data collected to design a larger randomized controlled trial. If the criteria are not 
met, we will refine protocol and data collection procedures. 
STATISTICAL DESIGN AND POWER

Dissemination Plan
As Principal Investigator for this study, I will comply with the NIH Policy on the Dissemination of NIH-Funded 
Clinical Trial Information in NIH Guide Notice NOT-OD-16-149. The proposed study title is Continuous Glucose 
Monitoring (CGM) in Kidney-Transplanted Adults” and is currently registered on ClinicalTrials.gov 
(NCT05352230). As PI, I will be responsible for ensuring that the information in the clinical trial record is 
updated at least once every 12 months and I will ensure that results are reported no later than one year after 
the clinical trial primary completion date. 
The consent form for this clinical trial will contain language specifying that the study is registered at 
clinicaltrials.gov. The required wording on all consent forms by the University of Alabama at Birmingham (UAB) 
Institutional Review Board for Human Use is: 
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time.” 
The Center for Clinical and Translational Science (CCTS) works with investigators to provide education and 
assistance to meet the requirements of ClinicalTrials.gov for registration and reporting as specified in the NIH 
Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149). The CCTS maintains 
a web site (https://www.uab.edu/ccts/clinical-translation/clinical-services/crsp/study-start-up/regulatory-
issues/clinicaltrials-gov) specifically for the purpose of updating investigators regarding changes to 
ClinicalTrials.gov. The CCTS provides consultations and one-on-one training to assist investigators in initiating 
and maintaining their ClinicalTrials.gov entry. 
DISSEMINATION PLAN

Description of the availability of Investigational Product (IP) and Investigational New Drug (IND) or 
Investigational Device Exemption (IDE) status: 
The Freestyle Libre 2 and Freestyle Libre Pro are FDA-regulated test articles, legally marketed in the United 
States (FDA Letters K193371 and P150021, respectively) when used in accordance with their labeling for 
continuous glucose monitoring (CGM). Therefore, these devices are no longer investigation as they have been 
approved for marketing and commercial distribution in the United States. This study will use devices in 
accordance with their labels. 
 
All components of the device will be stored securely (behind a locked door) in the principal investigator’s office 
in Faculty Office Tower (FOT) 754. All floors above 6 in FOT are badge-protected. Only qualified research staff 
will have access to the office where the devices are stored. The devices will be inserted for two weeks at the 
beginning and end of Phase I or Phase II, dependent on group assignment. The participation will only wear the 
sensor for the Pro version of the device and data will be collected remotely from the device. Participants will be 
instructed to discard the sensor after each two week period of monitoring is complete. 

1. GENERAL QUESTIONS
Protocol Number IRB-300009227
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Data collection variables for IRB-300009227: Continuous Glucose Monitoring (CGM) in Kidney-
Transplanted Adults
Name
Date of birth
Age
Gender
Race
Date of diabetes diagnosis
Date of kidney transplant
Subacute rejection rates – data collected from SOC kidney biopsy
Steroid & immunosuppressive regimen during study period
CGM data to be collected:
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fructosamine/albumin ratio
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CGM-measured Time in Range (TIR) of 70 to 180 mg/dL
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time with glucose level at greater than 180 mg/dL
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time with glucose level at lower than 70 mg/dL
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time with glucose level at lower than 54 mg/dL, 
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Mean Glucose Level, 
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Glucose Variability (GV),
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Glucose Management Indicator (GMI) 
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microalbuminuria
IRB-APPROVED PROTOCOL