Optimizing Glycemic Control in Metabolic Surgery With Continuous Glucose Monitoring
Phase: NA
Conditions: Obesity (Disorder)
Sponsor: Pennington Biomedical Research Center

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Protocol Title: Optimizing Glycemic Control in Metabolic Surgery with Continuous 
Glucose Monitoring 
 
PI Name: Yun Shen  
 
Sub-Investigator’s Name(s): Peter T. Katzmarzyk, Gang Hu, Zubaidah Nor Hanipah, 
Phillip Schauer, Jean Domercant 
 
Protocol Version Date: 3/11/2026 
 
IRB Review History 
Protocol V2 approved on March 31, 2025 
 
Objectives 
Aim 1: To identify the glycemic patterns by using CGM in patients with severe obesity 
receiving bariatric surgeries before and after the procedures. Hypothesis: CGM will reveal 
distinct glycemic patterns in obese patients undergoing metabolic surgery, with significant 
improvements in mean glucose control but not glycemic variability compared to baseline 
measures. 
 
Aim 2: To investigate if the metrics that are derived from CGM data before and after the 
surgery can predict post bariatric hypoglycemia. Hypothesis: Metrics derived from CGM 
data, such as time in range, glycemic variability, and mean glucose levels, can reliably 
predict the likelihood of post bariatric hypoglycemia, with specific thresholds or patterns 
serving as robust predictors of long-term glycemic control. 
 
Aim 3: To investigate the effect of CGM use on the prevention of post bariatric 
hypoglycemia, as well as the influence of dietary content, formulation, and patterns on 
glycemic responses. Hypothesis: Dietary content, formulation, and patterns significantly 
influence glycemic responses in patients with obesity, with higher fiber and protein intake, 
balanced macronutrient formulation, and consistent meal patterns associated with 
improved glycemic control and reduced risk of post bariatric hypoglycemia as measured 
by CGM after the surgeries. 
 
Background 
Obesity is listed as the most important risk factor associated with organ dysfunctions. 
More than 42% of US are classified as obese and 9.4% have severe obesity. About 30% 
of patients with T2D have severe obesity. The combination of severe obesity and T2D 
significantly increases the risk of CVD, non-alcoholic fatty liver disease, and other 
comorbidities, which contribute to higher mortality rates. To tackle this heavy burden, 
there’s a need for coordinated efforts that encompass prevention, early diagnosis, 
effective treatment, and patient education. The management of obesity faces several 
persistent challenges, including achieving sustainable weight loss and maintaining long-
term glycemic control. While lifestyle interventions and pharmacotherapy often lead to 
initial improvements, weight regain remains a significant issue, undermining long-term 
success. In this context, metabolic bariatric surgery (MBS), including procedures such as 
Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG), has emerged 
as one of the most effective interventions for significant weight loss. Its metabolic benefits 
extend beyond weight reduction, directly improving insulin sensitivity and glycemic 

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control. Therefore, integrating metabolic surgery into treatment guidelines and expanding 
access to eligible patients are critical steps toward addressing the limitations of 
conventional approaches. CGM is now emerging as a more precise tool for assessing 
glucose patterns after metabolic surgery. However, available data on CGM outcomes in 
patients receiving  MBS remain limited, highlighting the need for further research. CGM 
holds significant potential for improving the assessment and management of obese 
patients with T2D undergoing metabolic surgery. Unlike traditional measures such as 
HbA1c, CGM provides real-time, continuous data on glucose levels, offering a detailed 
picture of glucose variability, postprandial spikes, and hypoglycemic events. This granular 
insight enables better tracking of short-term metabolic changes immediately after surgery 
and facilitates early detection of glycemic patterns that may be influenced by the changes 
in GI tract and dietary patterns after surgery. In addition, post-bariatric hypoglycemia 
(PBH) is an increasingly recognized complication that can arise following metabolic and 
bariatric procedures. CGM will enable a better understanding of hypoglycemia 
unawareness, where patients fail to perceive symptoms despite critically low glucose 
levels. CGM may have the potential to revolutionize the management of PBH. Despite its 
promise, research on CGM among patients receiving metabolic surgery remains limited. 
Several studies have demonstrated the advantages of CGM in identifying post-bariatric 
hypoglycemia. However, limitations of prior studies include their cross-sectional or 
retrospective design, small sample sizes, a lack of pre-surgery CGM data, and a short 
GDM monitoring period (most <10 days) with only one GDM measurement taken after 
surgery. As a result, there is a growing need for more robust studies, such as RCTs, to 
validate the effectiveness of this approach and optimize its integration into clinical 
practice. 
 
Inclusion and Exclusion Criteria 
Inclusion criteria: (1) age 18 to 65 years; (2) body mass index (BMI) ≥35 kg/m2 
Exclusion criteria: (1) age <18 or >65 years; (2) confirmed type 1 diabetes; (3) 
pregnancy or breastfeeding; (4) history of hypersensitivity to any of the components of 
the subcutaneous infusions; (5) without access at home to a telephone or other factor 
likely to interfere with ability to participate reliably in the study; (6) history of any medical, 
psychological or other condition, or use of any medications, including over-the-counter 
products, which, in the opinion of the investigators, would either interfere with the study 
or potentially cause harm to the volunteer; (7) patients on insulin therapy before surgery; 
and (8) patients receiving revisional surgery. 
 
Number of Subjects 
10 in CGM group and 10 in non-CGM group. 
 
Recruitment Methods 
The proposed study will include data from one new RCT. We will recruit 20 severely obese 
participants at Metamor Institute. Participants with obesity who are eligible for MBS will 
be randomized to either CGM group or self-monitoring of blood glucose (SMBG) group 
before the surgery based on a 1:1 ratio. All participants live in Baton Rouge, Louisiana. 
The surgeon in Metamor will introduce our study to the patients. If the patients are 
interested, the evaluation process includes verifying basic personal information, 
assessing health status and medical history, and evaluating specific eligibility criteria 
relevant to the study. The study coordinator will be discussing informed consent, ensuring 

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participants understand the study's purpose, procedures, and any associated risks or 
benefits. Participants are encouraged to ask questions, ensuring clarity and comfort with 
the study. All collected data is documented and securely stored, respecting data privacy 
protocols. Eligible individuals are informed about the screening visit, while those not 
suitable are considered for future studies. 
 
Study Timelines 
The recruitment and baseline survey will last for 1 month when the project is funded. We 
will need a total of 11 months to finish the intervention program, and then need an 
additional 1 month to finish all clinical laboratory measurements, data cleaning, analysis 
and writing of the primary outcome papers. We will need 1 year of funding to carry out 
our study, with a possible extension to 1.5 years. 
 
Study Endpoints 
The primary outcome is the differences in coefficient of variance (CV) evaluated by CGM 
data between CGM group and SMBG group. The secondary outcomes are differences in 
HbA1c, total number of hypoglycemia events. 
 
Procedures Involved 
Bariatric procedures: The RYGB procedure will involve creating a 15- to 20-ml gastric 
pouch, a 150-cm Roux limb, and a 50-cm biliopancreatic limb. The VSG procedure will 
involve reducing gastric volume by 75 to 80% using a 30-French endoscope, starting 3 
cm from the pylorus and ending at the angle of His. Study participants will return for follow-
up visits at 1 month, 3 months, 6 months, 12 months, and 18 months. These visits will 
include anthropometric measurements, lifestyle counseling, questionnaires, and blood 
investigations at the Metamor Institute. 
 
CGM group: Participants assigned to the CGM group will receive the Libre 2+ systems 
(Abbott Diabetes Care, Alameda, CA) upon randomization. This will include 
comprehensive training provided by a qualified healthcare professional. The training will 
cover detailed instructions on sensor placement, how to download and use the associated 
smartphone application, and guidance on interpreting the glucose data effectively. To 
ensure continuous and accurate monitoring, the CGM sensor will be routinely replaced 
every 14 days following randomization. Additionally, in the event of sensor detachment or 
loss, immediate replacement will be arranged to maintain uninterrupted glucose tracking. 
Regular sessions are conducted to analyze glucose trends, refine management 
strategies, and provide additional support or education on device usage. 
 
SMBG group: Participants assigned to the SMBG group in the study will receive detailed 
instructions on monitoring and documenting their blood glucose levels at critical times: 
fasting, before meals, 2 hours after meals, and at bedtime, as well as whenever a 
participant encounters symptomatic hypoglycemia. Each participant will be informed of 
the specific glucose targets they should aim for, based on the glucose targets 
recommended by the ADA guidelines. Participants in this group will be provided with a 
masked CGM sensor (Libre Pro) at randomization and 2 weeks before the end of the trial 
to collect data. However, they will receive biweekly guidance by telephone on any 
necessary adjustments to their management plan based on their recorded data. In this 

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group, participants will be equipped with the Abbott FreeStyle Libre Pro (masked) for data 
collection before, 1 month after the surgery and at the end of the study. 
 
Physical activity assessment: All participants will be counseled to maintain their 
physical activity level as is recommended by American Diabetes Association either 
through phone call or in-person visits. We will utilize a global physical activity 
questionnaire to collect physical activity data at baseline and follow-up visits.  
 
Nutrition counseling: All participants will be provided with a tailored nutrition plan 
collaboratively created by the participant and a registered dietitian nutritionist (RDN) with 
expertise in post-surgical management at Metamor Institute. This personalized food plan 
aims to support metabolic health and achieve glycemic control. Research dietitians will 
play a pivotal role in overseeing the dietary aspects of various study protocols. The 
preparation and serving of research-specific diets will be expertly handled by research 
specialists and a dedicated food service worker. To ensure adherence to dietary 
protocols, meal monitors will be assigned to accompany participants during mealtimes, 
providing supervision and support to ensure compliance with the research dietary 
guidelines. This structured approach will ensure that every aspect of dietary management 
in research studies is attended. 
 
Medication counseling: A tailored approach to medication management will be provided 
by the clinicians at Metamor. Personalized adjustments to pharmacologic therapy, as well 
as instructions on dietary supplementations will be included. The clinician team will also 
reassess the needs of antihypertensives and statins. In case participants encounter 
severe postoperative gastrointestinal symptoms, including dumping syndrome and 
delayed gastric emptying, the clinician team will prescribe targeted medication strategies.  
 
Data and Specimen Banking 
All study-related data, including clinical, biochemical, and CGM-derived glycemic metrics, 
will be securely stored and maintained at PBRC. The data will be de-identified and 
encrypted to ensure participant’s confidentiality and compliance with HIPAA and IRB 
guidelines. Data collected will include demographic and clinical information such as age, 
sex, BMI, comorbidities, and medication use, as well as CGM-derived glycemic variability 
metrics, laboratory values like HbA1c, fasting glucose, lipid panels, and inflammatory 
markers, dietary intake records from food frequency questionnaires and 24-hour recalls, 
and physical activity assessments from Fitbit tracking and self-reports. All data will be 
stored on PBRC’s NORC repository, accessible only to authorized study personnel, and 
retained for a period of seven (7) years post-study completion in accordance with 
regulatory and funding agency requirements. Any sharing of data with external 
collaborators will require a data use agreement approved by the PBRC Office of 
Research. De-identified data may be used for secondary analyses, validation of predictive 
models, and future research on metabolic surgery and glycemic control, with explicit 
participant consent obtained for potential future use. 
Although the primary focus of this study is glycemic variability using CGM, biological 
specimens such as fasting blood samples for HbA1c, glucose, lipid profiles, and 
inflammatory markers will also be collected. Additional blood draws for exploratory 
biomarkers, including insulin sensitivity and gut microbiome metabolites, may be 
performed if additional funding is secured. Blood samples will be stored at -80°C in the 
PBRC biorepository under secure and monitored conditions, with each sample assigned 

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a coded identifier to ensure anonymity and compliance with IRB regulations. Access to 
these specimens will be limited to authorized researchers and will require approval from 
the study’s principal investigator and IRB. 
 
Power analysis. 
Given the small sample size and the exploration nature of this pilot study, a formal power 
analysis is not necessary. 
 
Data and Specimen Management 
Aim 1: To monitor and compare the glycemic patterns, assess the number and duration 
of percentage time within or outside the target range of glucose levels 70-180 mg/dL, we 
will quantify the metric derived from the CGM device. We will also analyze the association 
between CGM-derived metrics and dietary patterns. Several key metrics will be explored 
to assess glycemic control and documented as was recommended by the International 
Consensus on Use of Continuous Glucose Monitoring:  
• 
Mean glucose levels 
• 
Percentage of time in level 2 hypoglycemic range (<54 mg/dL [3.0 mmol/L]) 
• 
Percentage of time in level 1 hypoglycemic range (<54–70 mg/dL [3.0-3.9 mmol/L]) 
• 
Percentage of time in target range 70-180 mg/dL (3.9-10.0 mmol/L) 
• 
Percentage of time in hyperglycemic range (>180 mg/dL [10.0 mmol/L]) 
• 
Glycemic variability, reported as CV and standard deviation (SD) 
• 
Glycemic management index (GMI or the estimated A1c) 
• 
Data for glucose metrics above reported in three time blocks (sleep, wake, 24 h) with the 
default times for the sleep (12:00 A.M.–6:00 A.M.) and wake (6:00 A.M.–12:00 A.M.) often 
written as midnight to 6:00 A.M. and 6:00 A.M. to midnight, respectively. 
• 
Data sufficiency (the length of data) 
• 
Area under the curve 
• 
Low blood glucose index (LBGI) and high blood glucose index (HBGI).  
 
      The comparisons between the baseline and end-of-trial values for each metric will be 
performed using paired t-tests. We will make substantial efforts to minimize missing data, 
and potential missing values will be imputed using the Predictive Mean Matching method. 
Due to the pilot nature of the study, adjustments for multiple testing will not be performed. 
The results from this analysis are intended to provide preliminary data for identifying the 
most appropriate metrics for use in a future full-scale study. 
    Aim 2: To identify independent predictors of PBH, a multivariable logistic regression 
model will be developed. The dependent variables will be PBH, and the independent 
variables will include key CGM-derived metrics (e.g., TIR, glycemic variability, GMI) 
alongside clinical covariates (e.g., pre-operative HbA1c, BMI, etc). The model will be 
adjusted for potential confounders, if feasible, and the final selection of predictors will be 
based on statistical significance and clinical relevance. In addition, to comprehensively 
utilize CGM data, patients will also be classified into different groups using the multilevel 
clustering method developed by Tao et al. Specifically, all patients will be assigned to 
distinct clusters based on their CGM profiles, and then these clusters will be treated as 
independent variables to assess whether specific CGM profile patterns are associated 
with PBH. To assess model performance, sensitivity, specificity, positive predictive value 
(PPV), and negative predictive value (NPV) will be computed, along with the area under 
the Receiver Operating Characteristic (ROC) curve. Model assumptions, such as linearity 
and multicollinearity, will be checked.   
    Aim 3: This is a two-arm randomized trial with a binary outcome. Descriptive statistics 
will be presented as means and standard deviations for continuous variables, and 
frequencies and percentages for categorical variables. To account for repeated 
measurements over time and intra-individual variability, a generalized linear mixed-
effects model will be employed to test the effect of CGM intervention on the occurrence 

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of hypoglycemia events. The dependent variable is the occurrence of at least one 
hypoglycemia event, and the dietary content (macronutrient percentages), dietary 
patterns (meal timing and frequency), and food formulations (liquid vs. solid meals) will 
be the covariates. In addition, all glycemic outcomes (e.g., mean glucose, TIR, glycemic 
variability) will also be used as dependent variables, to explore the relationship between 
CGM intervention with the before and after intervention changes in these CGM metrics. 
The model will also adjust for potential confounders, including age, sex, BMI, and type of 
surgery. Alternative, given the dynamic nature of post-surgical glycemic responses, 
generalized estimating equations (GEE) will be used to analyze longitudinal associations 
between dietary intake and glycemic metrics. This approach will account for the 
correlation between repeated measures and provide robust standard errors. An intention-
to-treat analysis that includes all randomized participants, regardless of the number of 
assessment visits attended, will be conducted. The robustness of the inferential findings 
to these analytic methods will be assessed in a sensitivity analysis to investigate whether 
different analyses under different assumptions provide robust effectiveness inferences. 
These analytical plans are flexible and may be adapted as needs change and as improved 
scientific perspectives are advanced. We will examine adherence to diet and physical 
activity.  
 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
PI will oversee and implement the data and safety monitoring for the trial. The members 
of the Advisory Committee provide an annual review throughout the trial. The adverse 
event form, a list of symptoms, is given at baseline, and every 6 months during the follow-
up. Serious adverse events can be reported on any visit.  Because of protocol-mandated 
contacts of participants during the study, ascertainment of adverse events is high and 
likely complete.  Participants are asked to report to the staff any symptoms or health 
problems at baseline and during the study. Serious adverse events are entered onto a 
form, reviewed by Dr. Philip R Schauer (one of the collaborators at Metamor institute) and 
reported to the IRB, LA CaTS and senior scientists of advisory committee. While there 
are some potential risks for the proposed study, the design makes every attempt to 
prevent the possibility of any adverse events. Monitoring by the experienced investigators 
and professionals involved in the study will minimize all potential risks.  
 
Withdrawal of Subjects 
Subjects may be withdrawn from the research without their consent under circumstances 
such as non-compliance with study procedures, the development of medical conditions 
that contraindicate continued participation, adverse events that pose health risks, or at 
the discretion of the principal investigator if continued participation is deemed unsafe or 
unfeasible. If a subject is withdrawn, an orderly termination process will be followed, 
including notifying the subject, documenting the reason for withdrawal, and ensuring 
appropriate medical follow-up if needed. When subjects choose to withdraw from the 
study, they may opt for complete withdrawal, in which case no further data will be 
collected, or partial withdrawal, allowing continued data collection through specific follow-
up measures such as long-term monitoring or scheduled follow-up visits via telephone. If 
a participant consents to partial withdrawal, only pre-specified data, such as post-surgical 
glycemic trends or clinical outcomes, will be collected, ensuring that their preferences are 
respected while maintaining the integrity of the study’s longitudinal data. 
 
Risks to Subjects 

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The proposed study is minimal risk. However, the potential exists for anticipated and/or 
unanticipated adverse events, serious or otherwise, to occur since it is not possible to 
predict with certainty the absolute risk in any given individual or in advance of firsthand 
experience with the proposed study methods. 
 
Potential Benefits to Subjects 
Participants in this study may experience potential benefits, including improved 
monitoring of their glycemic patterns through CGM, which may provide them and their 
healthcare providers with valuable insights into glucose fluctuations that are not captured 
by traditional HbA1c measurements. The use of CGM may help identify periods of 
hypoglycemia or hyperglycemia, allowing for more personalized and timely adjustments 
to dietary intake. Additionally, participants may receive dietary guidance based on their 
individual glucose responses, which could contribute to better glycemic control and 
overall metabolic health. While the probability and magnitude of these benefits may vary 
among individuals, those with higher glycemic variability or greater risk of post-bariatric 
hypoglycemia may particularly benefit from early detection and intervention. The potential 
benefits are expected to extend throughout the study period, with continued monitoring 
and follow-up assessments at multiple times. However, it is important to note that there 
may be no direct benefit to some participants, as the primary purpose of the study is to 
improve understanding of glycemic patterns after bariatric surgery rather than to provide 
a therapeutic intervention. 
 
Vulnerable Populations 
No vulnerable population will be involved in. 
 
Multi-Site Research 
Not applicable 
 
Sharing Results with Subjects 
Study results and individual subject results will be shared with participants if deemed 
clinically relevant or upon request. Individual continuous glucose monitoring (CGM) data, 
including glycemic patterns, variability, and hypoglycemia episodes, may be provided to 
participants and, if applicable, their primary care physicians to aid in management and 
post-surgical follow-up. Any significant findings related to glycemic fluctuations or 
metabolic health that could impact clinical care will be communicated directly to the 
participant through scheduled follow-up visits or secure electronic reports. However, 
aggregated study findings will only be shared after data analysis is complete, and 
participants will not receive individualized interpretations of investigational metrics unless 
such information is determined to have direct clinical relevance. The method of sharing 
results will be tailored to each participant’s preference, including in-person discussions 
during follow-up visits or electronically via a secure patient portal. If incidental findings 
arise that may have medical significance, participants will be informed appropriately and 
referred for further clinical evaluation if necessary. 
 
Setting 
The research will be conducted at PBRC and Metamor institute where metabolic surgery 
patients receive preoperative and postoperative care. Research procedures, including 
participant screening, informed consent, baseline assessments, and follow-up visits, will 

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be performed at Pennington’s outpatient clinic. CGM device placement and data 
collection will take place at these sites, while dietary assessments and follow-up 
consultations may be conducted remotely through telemedicine or phone interviews. If 
any research activities extend beyond Pennington and its affiliates, site-specific 
regulations and customs affecting the research will be carefully considered, including 
compliance with local institutional policies and ethical guidelines.  
 
Resources Available 
About 2500 obese patients at Metamor were treated in 2023 including about 470 
operations for severe obesity (190 RYGB and 280 VSG). Of them, about 50% patients 
were diagnosed as T2D. The surgeon in Metamor will introduce our study to the patients. 
If the patients are interested, the evaluation process includes verifying basic personal 
information, assessing health status and medical history, and evaluating specific eligibility 
criteria relevant to the study. 
 
Prior Approvals 
Protocol V2 approved on March 31, 2025 
 
Compensation 
Participants will receive complimentary CGM sensors as compensation for their time and 
participation in the study. No other stipend will be provided. 
 
Confidentiality 
All data and specimens will be securely stored at PBRC in restricted-access facilities. De-
identified electronic data will be stored on password-protected, encrypted servers, while 
physical documents, if any, will be kept in locked filing cabinets within a secured research 
office. Biological specimens, including blood samples, will be stored at -80°C in the PBRC 
Biorepository, with strict monitoring to ensure sample integrity. Data and specimens will 
be retained for seven (7) years after study completion, following institutional policies and 
regulatory requirements. 
 
Access to data and specimens will be limited to authorized study personnel, including the 
principal investigator, co-investigators, and designated research staff who have received 
training in data security and confidentiality. The principal investigator will be responsible 
for overseeing data management, while designated research personnel will handle the 
receipt and transmission of data and specimens according to institutional guidelines. Data 
and specimens will be transported within the institution using secure, labeled containers, 
and all electronic transmissions will be conducted via encrypted channels to prevent 
unauthorized access. 
 
Provisions to Protect the Privacy Interests of Subjects 
To protect the privacy interests of participants, all study interactions, data collection, and 
discussions will take place in private clinical research rooms at PBRC, ensuring 
confidentiality and minimizing unintended disclosure of personal health information. 
Participants will be informed about the study procedures in detail, and all research staff 
will be trained to conduct interviews and assessments in a respectful and non-intrusive 
manner. During data collection, only necessary personal and health-related information 
will be obtained, and participants will have the option to decline any questions or 

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procedures that they find uncomfortable without affecting their participation in the study. 
To make participants feel at ease, the research team will clearly explain the purpose of 
each assessment, provide ample opportunity for questions, and allow flexibility in 
scheduling visits. All interviews and assessments will be conducted by trained personnel 
who will use neutral and non-judgmental language to avoid making participants feel 
pressured or scrutinized. For potentially sensitive topics, such as dietary habits and 
glycemic control, discussions will be approached with empathy and discretion to respect 
personal boundaries and reduce feelings of intrusiveness. Access to participant 
information will be strictly limited to authorized study personnel, including the principal 
investigator, co-investigators, and trained research staff. The research team will obtain 
participant information only through direct interactions, informed consent forms, and 
approved electronic medical records (EMR) access, as permitted by the study protocol 
and institutional review board (IRB) guidelines. Any access to external medical records 
or third-party data sources will require explicit participant consent, ensuring that privacy 
rights are upheld throughout the research process. 
 
Compensation for Research-Related Injury 
If the research involves more than minimal risk to participants, compensation for 
research-related injury will be available as per institutional and regulatory guidelines. In 
the event of an injury directly resulting from participation in the study, medical treatment 
will be provided, but financial compensation beyond necessary medical care may not be 
guaranteed. Participants will be informed that they may seek medical care for any adverse 
events, and costs may be covered by their health insurance or other applicable sources. 
 
Economic Burden to Subjects 
Participants will not be responsible for any direct costs associated with study procedures, 
including continuous glucose monitoring (CGM devices), laboratory tests, or follow-up 
visits conducted as part of the research. However, they may incur indirect costs, such as 
transportation expenses for in-person visits or potential lost wages if study appointments 
require time away from work. While efforts will be made to minimize these burdens, 
participants will be informed during the consent process that any additional medical care 
outside the scope of the study, such as routine clinical visits or treatments unrelated to 
the research, will be their financial responsibility. 
 
Consent Process 
In this study, informed consent will be obtained from all participants prior to their 
enrollment. The consent process will take place in a private clinical research room at 
Pennington Biomedical Research Center, ensuring that participants have the opportunity 
to ask questions and make an informed decision without external pressure. Prospective 
participants will be provided with a detailed explanation of the study, including its purpose, 
procedures, risks, and benefits. They will be given a waiting period of at least 24 hours 
between receiving the study information and signing the consent form to allow sufficient 
time for consideration. Ongoing consent will be ensured by regularly informing 
participants of any new findings or protocol changes that may affect their willingness to 
continue participation. 
 
This study does not involve minors, so parental permission and child assent procedures 
do not apply. For cognitively impaired adults, a screening process will be conducted to 

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assess their ability to provide consent. If an individual is determined to be incapable of 
making an informed decision, permission will be obtained from a legally authorized 
representative in the following priority: durable power of attorney for healthcare, court-
appointed guardian, spouse, or adult child. For research conducted outside of the state, 
applicable laws will be reviewed to determine who is authorized to consent on behalf of a 
participant. If assent is required, it will be obtained from all participants capable of 
providing it, and documentation will follow IRB guidelines. In cases where assent cannot 
be obtained due to cognitive impairment, an explanation will be provided, and alternative 
procedures will be followed to ensure ethical participation. The IRB permits 
documentation of assent on the primary consent form, and separate assent documents 
will not be required unless specifically mandated. 
 
Drugs or Devices 
This study involves the use of CGM devices, which will be stored, handled, and 
administered in accordance with institutional guidelines and manufacturer specifications 
to ensure their proper use. All CGM devices will be securely stored in a controlled-access 
research facility at Pennington Biomedical Research Center, where only authorized 
investigators and trained research staff will have access. Devices will be distributed 
exclusively to enrolled study participants and will be assigned based on unique study 
identification numbers to maintain accurate tracking. Trained research personnel will 
provide participants with detailed instructions on device use, application, and data 
collection procedures to ensure proper adherence. CGM data will be collected according 
to the study protocol, and any malfunctions or deviations will be reported to the research 
team immediately. Only authorized investigators and trained study personnel will be 
permitted to oversee the use of CGM devices, ensuring they are utilized solely for study 
purposes. Compliance with storage and handling procedures will be monitored regularly, 
and any issues will be documented and addressed in accordance with regulatory 
requirements.