The Seven Continuous Glucose Monitoring System

The Seven Continuous Glucose Monitoring System Version 0.
234
Protocol Assignment 1 06 February 2024
Subject:- Clinical Research Regulation

Sanjeev Shaw
Topic: Protocol
Avani Patel
Himadri Patel
Januben Patel
Khushbuben Patel
Purva Patel
Course Name: Clinical Research

Section: 4
Group : 4
NIH-FDA Clinical Trial Protocol Template – v1.0 2017-04-07 1

The Seven Continuous Glucose Monitoring System Version 0.234
Protocol 06 February 2024
The Seven Continuous Glucose Monitoring System

Unique Protocol Identification Number:
National Clinical Trial (NCT) Identified Number:
Principal Investigator: Sanjeev Shaw
IND/IDE Sponsor:
Funded by: Other
Draft Number: 0.234
06 February 2024
Affected Section(s) Summary of Revisions Made Rationale

Original Protocol Single-arm study with 57 participants in
gestational diabetes using Continuous Glucose
Monitoring (CGM) system.
Study Population Increased participants to 300 for Phase 2 with Expanded the study population for a more robust
a Randomized Control Trial (RCT) design analysis.
Randomization Implemented randomization with 150 Introduced randomization to enhance study
Process participants each for active and placebo validity.
groups
Treatment Procedures Specified CGM for active group and Glucola Clarified treatment procedures for distinct
test for placebo group intervention groups.
Participant Addressed withdrawal of 70 participants from Provided a protocol for handling participant
Withdrawal the placebo group and 27 from the active withdrawals.
group
Summary of Changes from Previous Version:
Table of Contents
Table of Contents - Please right-click and choose 'Update Field'.

STATEMENT OF COMPLIANCE
Provide a statement that the trial will be conducted in compliance with the protocol, International
Council on Harmonisation Good Clinical Practice (ICH GCP) and applicable state, local and federal
regulatory requirements. Each engaged institution must have a current Federal-Wide Assurance
(FWA) issued by the Office for Human Research Protections (OHRP) and must provide this protocol
and the associated informed consent documents and recruitment materials for review and approval
by an appropriate Institutional Review Board (IRB) or Ethics Committee (EC) registered with OHRP.
Any amendments to the protocol or consent materials must also be approved before
implementation. Select one of the two statements below. If the study is an intramural NIH study, use
the second statement below:
1. The trial will be carried out in accordance with International Council on Harmonisation Good
Clinical Practice (ICH GCP) and the following:
o United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are
responsible for the conduct, management, or oversight of NIH-funded clinical trials have
completed Human Subjects Protection and ICH GCP Training.
OR
2. The trial will be conducted in accordance with International Council on Harmonisation Good
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR),
and the [specify NIH Institute or Center (IC) [ Terms and Conditions of Award. The Principal
Investigator will assure that no deviation from, or changes to the protocol will take place
without prior agreement from the funding agency and documented approval from the
Institutional Review Board (IRB), and the Investigational New Drug (IND) or Investigational
Device Exemption (IDE) sponsor, if applicable, except where necessary to eliminate an
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this
study have completed Human Subjects Protection and ICH GCP Training.
For either option above, the following paragraph would be included:
The protocol, informed consent form(s), recruitment materials, and all participant materials
will be submitted to the IRB for review and approval. Approval of both the protocol and the
consent form(s) must be obtained before any participant is consented. Any amendment to
the protocol will require review and approval by the IRB before the changes are
implemented to the study. All changes to the consent form(s) will be IRB approved; a
determination will be made regarding whether a new consent needs to be obtained from
participants who provided consent, using a previously approved consent form.

1 PROTOCOL SUMMARY
1.1 SYNOPSIS
Title: The Seven Continuous Glucose Monitoring System

Study Description: phase 2 continuous glucose monitoring system in gestational
diabetes in pregnant women
Objectives: Primary Objective: Maternal glucose levels, Pregnancy
outcomes
Secondary Complication-Specific Analysis, Variations
Objectives: across Patient Groups
Endpoints: Primary Endpoint: Pregnancy complications, Maternal health
Secondary Maternal glucose control, Glycemic
Endpoints: variability
Study Population: 300 female pregnant participants.
Phase: Phase 2
Description of
Sites/Facilities
Enrolling Participants:
Description of Study It involves two primary components:
Intervention:
• Traditional One-Hour Glucola Testing in Diabetic Pregnant Patients -
Phase 2 RCT
• 7-Day Continuous Glucose Monitoring (CGM)
Study Duration: 5 months

Participant Duration: 3-4 months

1.2 SCHEMA
1.3 SCHEDULE OF ACTIVITIES (SOA)
The research starts in Week 1 with a thorough enrollment procedure that includes baseline examinations and
informed consent to guarantee that all demographic and medical history information is collected. Equitable

participant distribution is ensured via a randomized technique. At the same time, participants get
comprehensive training covering the ins and outs of using the upgraded Continuous Glucose Monitoring
(CGM) device as well as calibration and maintenance, laying the groundwork for further research stages.
The 21-Day Continuous Glucose Monitoring Period, which is crucial to the study, occurs between Weeks 2-4.
Wearing the updated CGM device, participants carefully record their daily activities. These logs provide
important insights into how the CGM system affects everyday life and health management by methodically
recording participants' food consumption, physical activity, and symptoms. Weeks 5-8 are when the weekly
follow-up visits for data download and assessment start. This consists of a thorough first follow-up in Week 5
that provides a preliminary summary of participant replies and system performance, and thereafter scheduled
weekly check-ins. Week 8 marks the culmination of this phase with a thorough data download and evaluation,
laying the groundwork for the study's final phase.
Week 9, the Final Visit, is a critical point in the program where participants have their updated CGM
device removed. This visit is marked by a comprehensive evaluation that covers a wide range of
factors. Fetal outcomes are also included in the evaluation process to guarantee a thorough grasp of
the effect on pregnancy. In order to assess the usefulness and acceptance of the improved CGM
system, participant satisfaction is also carefully examined. This phase also involves a thorough
examination of the study's endpoints, exploring both main and secondary measurements in order to
reach complete findings. A thorough data analysis procedure is carried out throughout weeks 9–12,
taking into account variables such maternal glycemic variability, mean glucose levels, and fetal
outcomes. Final insights are made possible by endpoint evaluation, which guarantees a careful
analysis of study objectives. The last phase of this time involves carefully preparing the results ,
which advances our knowledge of improved continuous glucose monitoring (CGM) devices for the
treatment of gestational diabetes in pregnancy.

2 INTRODUCTION
2.1 STUDY RATIONALE
Diabetic pregnant patients face increased risks of adverse pregnancy outcomes, including larger-
than-expected fetus and unplanned operative deliveries, due to elevated blood glucose levels.
The standard gestational diabetes screening involves a one-hour glucola test, assessing glucose at a
specific point. The trial explores Continuous Glucose Monitoring (CGM) over 7 days, aiming to
improve risk identification. It compares CGM with the current standard to enhance gestational
diabetes screening and care for diabetic pregnant individuals.
The clinical trial is conducted to assess and compare the effectiveness of Continuous Glucose
Monitoring (CGM) with the current standard of care, the one-hour glucola test, for gestational
diabetes screening. The aim is to determine which method better correlates with adverse pregnancy
outcomes and accurately identifies patients at risk. By evaluating CGM over a 7-day period, the trial
seeks to enhance the precision of screening methods, potentially leading to improved management
strategies and reduced adverse pregnancy outcomes for diabetic pregnant individuals.
2.2 BACKGROUND
Gestational Diabetes Mellitus (GDM) is form of diabetes most likely to occur in pregnant ladies which
did not had the disease before the pregnancy. During this disease the pregnant women and the
foetus suffers many severe and complicated problems like preeclampsia(a condition in which one
experiences high blood pressure and signs of organ damage, mostly liver and kidneys), caesarean
delivery, foetal macrosomia(larger foetus than normal), hypoglycaemia and hyperbilirubinemia.
CGM helps to provide complete view of blood sugar levels over 24 hours by managing careful
monitoring of blood sugar levels to maintain them as near to normal as possible which improves
control and reduces the risk of complications like macrosomia.
Some studies suggest that CGM's potential is needed to fully understand on the outcomes of
pregnant women with GDM to make them better and help more pregnant women with this
condition. 1.

2.3 RISK/BENEFIT ASSESSMENT
2.3.1 KNOWN POTENTIAL RISKS

Subjects may feel minimal discomfort or infection risk, while frequent blood draw may cause slight
risk of infection.
Acknowledging these risks is essential for developing mitigation strategies and ensuring participant
safety
2.3.2 KNOWN POTENTIAL BENEFITS

This study has several benefits like improved accuracy for Gestational Diabetes Mellitus(GDM) and
improved pregnancy outcomes by early identification of patients at risk.
These advantages emphasize in providing valuable information to improve screening and
management of gestational diabetes.
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS

As there are minimal risks using CGM, study concludes that potential benefits like better screening
and improved outcomes for patients are more significant and offers a valuable contribution in
advancing maternal-fetal medicine

3 OBJECTIVES AND ENDPOINTS
OBJECTIVES ENDPOINTS JUSTIFICATION FOR

ENDPOINTS
Primary
• Maternal glucose levels: The • Pregnancy complications: • These endpoints are

main goal regarding to Preterm birth rates, and based on the health of
maternal glucose levels is surgical birth section rates are the mother and child,
comprehensive. The study all intimately correlated with offering useful
intends to explore the how glucose monitoring information to medical
complex interaction techniques affect the entire professionals. These
between glucose course of pregnancy. endpoints support the
metabolism during main objective of
pregnancy and its effects on enhancing prenatal care,
mother health by how maternal glucose
concentrating on maternal levels, gestational
glucose levels. • Maternal health: The diabetes, and pregnancy
assessment of the long-term outcomes are related.
effects of various glucose
• Pregnancy outcomes: The monitoring techniques on
focus on pregnancy maternal health makes
outcomes indicates postpartum glucose tolerance
understanding of how and endpoints.
maternal glucose levels
affect things. The study
offers a comprehensive
understanding of the
relationship between
maternal glucose and the
health of both the mother
and the foetus by evaluating
a range of outcomes, such as
preterm birth and
gestational diabetes.
Secondary
• Complication-Specific • Mothers' glucose regulation: • The secondary

Analysis: Studying the It is helpful to assess the endpoints enrich the
relationship between mother's glucose regulation overall understanding of
maternal glucose levels in real time during the day how continuous glucose
affect certain problems when she is continuously monitoring and glucose
(such as preterm birth and monitored for it. tolerance testing relate
gestational hypertension) is to pregnancy outcomes,
offering a more
comprehensive view

OBJECTIVES ENDPOINTS JUSTIFICATION FOR

ENDPOINTS
the focus of secondary that extends beyond
objectives. clinical implications to
broader healthcare and
policy considerations.
• Variations across Patient

Groups: Examining potential
variations in different
patient groups respond to
• Glycaemic variability is the
glucose testing and
measurement of continuous
monitoring.
variations in glucose levels
using continuous glucose
monitoring data. This
measurement gives a
complete picture of how
glucose concentrations
fluctuate over time.
Tertiary/Exploratory
Not applicable Not applicable

4 STUDY DESIGN
4.1 OVERALL DESIGN
The Seven Continuous Glucose Monitoring System will track glucose levels with greater accuracy
and dependability, improving the results of diabetes care in pregnant women. This research aims to
evaluate the system's efficacy in offering persons real-time glucose data, therefore providing more
accurate and specific therapies.
It is a phase 2 clinical trial. This phase 2 clinical trial is an intermediate step that follows larger-scale
investigations and assesses the efficacy and safety of the integrated CGM and glucola test strategy
following phase 1 safety studies.
Randomized control study. Participants are divided into two groups to assess the effects of
integrated CGM, an active subject, and Glucola, which is placebo-controlled. Also, the placebo-
controlled compared to standard care.
Several methodological approaches to minimize bias. The methods include randomization,

standardizing data collection procedures, and using control groups. It is also important to have a
diverse group of people participating. Therefore, the results represent different types of people,
which can help to minimize bias and improve the study's internal validity.
The research is divided into two arms, and each group is given a different set of treatments, one
using Glucola Testing and the other using CGM. With this dual-arm design, it is possible to directly
compare their effects on pregnancy outcomes and gain a more detailed knowledge of the potential
advantages and limitations of continuous glucose monitoring in a situation of gestational diabetes.
To evaluate the effectiveness and safety of Continuous Glucose Monitoring (CGM) and Glucola
during pregnancy. They regularly look at the data they have collected so far to see if there are any
critical findings or safety concerns. They can change the trial or treatments to keep things safe and
effective if they find anything significant. It is like a continuous review of the study, which helps
ensure it is done ethically and thoroughly throughout the investigation.
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN
This study helps to understand how well continuous glucose monitoring (CGM) and the one-hour
glucola test are related to pregnancy outcomes, especially for women with gestational diabetes. The
glucola test is currently used to check for gestational diabetes in pregnant patients. In addition to
this, certain measurements from continuous glucose monitoring (CGM) can help identify people who
are at a higher risk for bad pregnancy outcomes. These measurements act like biomarkers, tell us if
something might go wrong during pregnancy. So, CGM can give us valuable information to predict
and prevent those bad outcomes.12

4.3 JUSTIFICATION FOR DOSE
Firstly, normal people without any conditions was considered. In which their continuous glucose
levels were monitored with the help of Continuous Glucose Monitoring Device (CGM) for up to 24
hours it lasted. Tipped glucose oxidase was in subcutaneous layer of skin to monitor glucose
concentration in interstitial fluids. The system was implanted and longer term use. The CGM sensors
were recording the glucose data every 1-15 minutes. After collecting granular data and information
on glycemic patterns by self monitoring of blood glucose. After calibration we got “AUC-110”, “AUC-
120”, “AUC-130”, “AUC-140”, and “AUC-180”mg/dL as the normal reading. Moving ahead, in study
we upgraded the device by including normal reading. We installed it in the subcutaneous layer of the
pregnant women. Pregnant women were trained to take the readings from CGM. We asked them to
collect the data during fasting and after they have their glucose packets twice a day.
After analysis for 7 days they have to come to clinic for change of device and to submit the reading.
Real time CGM data is collected to identify the patterns of hypo- and hyperglycemia. As we came to
completion of trial we found that women who are pregnant have either hyperglycemia or
hypoglycemia with readings of AUC-130<= 22,000 or AUC-130>22,000. After achieving the accuracy
of data in statistically, user friendliness and convenience increased clinical, research organization
published consensus for relevant glycemia cut points for hypoglycemia, hyperglycemia along with
the time range. The trial period for this dose and precise reading was 5 months.
4.4 END OF STUDY DEFINITION
In this study both placebo and control was taken into consideration in total 300 participants were
there. From this population 150 was considered placebo and 150 control. During study participants
were continuously monitored during the day also, the reading was taken hourly basis. From all
participants 70 people withdrawn from placebo group, and 27 withdrawn from control due to their
personal reasons and health issues not related to study. At the end of study, in total 203
participants were there from which 80 were in placebo and 122 in control. At the end of the analysis,
it was found that Continuous Glucose Monitoring Device (CGM) was more accurate than Standard
Glucose Monitoring.

5 STUDY POPULATION
5.1 INCLUSION CRITERIA
o Individuals who are pregnant yet are not yet diagnosed with diabetes.
o willingness to take part in the research.
o The gestational age of 24–28 weeks.
o The ability to comply with to the 7-day Continuous Glucose Monitoring System (CGMS) wear
schedule.
o Consent to do routine glucola testing throughout the first seven days of CGMS use.
o Give permission to have your finger stick blood glucose measured twice a day for the whole seven
days that you use the CGMS.
5.2 EXCLUSION CRITERIA
o Pre-existing diabetes
o unwillingness to take part in the research.
o failure to adhere to the seven-day CGMS wear requirement.
o regular glucola testing non-compliance during the first seven days of wearing the CGMS.
o objection or incapacity to have two daily finger stick blood glucose readings taken while using the
CGMS for the whole seven-day period.
5.3 LIFESTYLE CONSIDERATIONS
1. Dietary Guidelines:
o It is advised that research participants continue with their usual dietary routines.
o There are no restrictions on the kinds of food or the times of meals.
o A healthy, well-balanced meal may be suggested to participants in order to reflect situations from the
real world.
2. Exercise:
o It is recommended that participants stick to their regular exercise regimens and physical activities.

o During the CGMS phase, restricted intense physical activities that are not part of their daily routine
may be adopted.
o In general, regular, moderate physical activity is permitted, such as walking or mild exercise.
3. Alcohol, Tobacco, and Caffeine:
o Participants should continue to consume alcohol, cigarettes, and caffeine as normal.
o The study's depiction of real-world settings may be impacted by abrupt or drastic changes in these
behaviors.
4. Monitoring Device Maintenance:
o Participants will be provided with comprehensive instructions on how to wear and take care of the
Continuous Glucose Monitoring System (CGMS).
o Appropriate positioning and a secure CGMS sensor connection are essential for accurate data
gathering.
5. Blood Glucose tests:
o Throughout the CGMS period, participants are required to perform finger stick blood glucose tests
twice a day.
o The CGMS data must be calibrated and validated, and this requires these tests.
6. Household Contacts.
o There are no particular restrictions placed on what household contacts can do.
o It may be suggested to participants to let close friends and family members know about the study's
criteria and how crucial it is to continue with normal activities.
5.4 SCREEN FAILURES
Documents:
o For every screen failure, a thorough record of the particular requirements that were not fulfilled will
be kept.
o In the participant's case report form (CRF), the cause for the screen failure will be included.
Notice to Participants:

o Participants will be notified as soon as the screening process fails if they do not fulfil the inclusion or
exclusion criteria.
o Participants will be given an in-depth description of the causes of screen failure.
Ethics-Related Considerations:
o The research team members will make sure that when participants disclose screen failure, they are
handled sensitively and with respect.
o All other choices and recommendations for their continued prenatal care will be shared with the
participants.
Rescreening Standards:
• The following circumstances may warrant reconsidering rescreening:
o If the participant's circumstances alter to the point that they can either no longer fulfil the excluding
requirements or meet the inclusion criteria.
o if there is certain and convincing evidence that the original screen failure was caused by a state that
was temporary.
Procedures for rescreening:
o Re-screened participants will go through the screening procedure once again to determine their
eligibility.
o The primary investigator or the assigned research staff will decide whether to permit rescreening.
Time frame for Re-screening:
o If rescreening is thought necessary, it will be done in an adequate amount of time, taken into
consideration the particular circumstances that led to the first screen failure.
Documentation for Re-screening:
o Any changes that occur to the participant's eligibility status as a result of the rescreening will be
recorded in their updated CRF.
Agreement to Rescreen:
o Before being re-enrolled in the study, participants undergoing re-screening will need to give revised
informed consent.

Reporting and Data Analysis:
o The findings of the rescreening process and screen failures will be clearly presented in the study's
final report, which will be examined individually from the main trial data.
Surveillance and Supervision:
o Screening choices, rescreening outcomes, and any ensuing modifications to participant status shall be
communicated to the Data and Safety Monitoring Board (DSMB) and the Institutional Review Board
(IRB).
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION
Recruitment Strategies:
• Collaboration between healthcare providers: From partnerships with medical specialists like
gynaecologists and obstetricians to find and recommend qualified expectant candidates.
• Outreach and Education in the Community: To educate the intended community about the
significance and advantages of the study, hold educational seminars in public areas, medical facilities,
and at neighbourhood gatherings.
• Internet Awareness: Provide an easy-to-use study website with information on the trial, eligibility
requirements, and enrollment contact details.
• Participation on social media: Make use of social media channels to increase exposure, provide study
details, and engage with possible participants.
• Multilingual Resources: Provide educational resources in several languages to cater to a wide range
of demographics.
• Engagement of Patient Advocacy Groups: Work together with diabetes and pregnant patient
advocacy groups to increase awareness and build credibility.
• Rewards for Referrals: Establish a referral reward scheme to honor participants who successfully
suggest qualified persons for the research.
• Prenatal clinics directly refer patients: Establish direct collaborations with prenatal centers to
recognize and register qualified individuals during standard prenatal checkups.
• Exposure to Media: Seek publicity for the study from conventional and online local media channels in
order to increase public awareness.

Retention Methods:
• Honest and transparent interaction: To keep participants informed about the trial's progress and
relevant details, keep lines for communication open and transparent.
• The Education of Participants: Participants should be given informational sessions on the study's
importance and the possible effects on the health of the mother and fetus.
• Flexible Visit Time Management: Offer various visitation times and places to eliminate obstacles to
participation and accommodate participants' schedules.
• System of Feedback: To improve the trial experience, create a mechanism where participants may
voice their opinions, ask questions, and make amendment suggestions.
• Constant Involvement: To keep research participants informed, involved, and involved, send out
newsletters, emails, or texts on a regular basis.
• Rewards and Recognition:To promote consistent engagement, offer little rewards like gift cards or
tokens of gratitude as well as celebrate and recognize the accomplishments of research participants.
• Services of Support: Offer participants who are having difficulties with their pregnancy or trial
participation support options such as counseling or extra resources.
• Events for Retention: Plan recurring retention activities that will allow participants to talk with
researchers, exchange stories, and become closer to one another inside the experiment.
• Frequent Monitoring: Put in place a methodical, individualized follow-up mechanism to monitor

participant development and quickly handle any problems.
• Sharing of Data: Provide participants with regular updates on the overall research results, highlighting
the influence of their participation.

6 STUDY INTERVENTION
6.1 STUDY INTERVENTION(S) ADMINISTRATION
6.1.1 STUDY INTERVENTION DESCRIPTION

The study employs intervention which include the CGM and Glucola during pregnancy. Subjects in
this study are involved in two different methods one is continuous glucose monitoring (CGM) and
the other is glucola testing. The trial has a randomized controlled design where subjects are
randomly allocated to either the continuous monitoring group or the glucola group.
The CGM group includes using of device to detect glucose levels in real time which helps to give
continuous data for managing diabetes during pregnancy. And the glucola group acts as control
group likely portraying the test process without the active continuous monitoring of glucose levels
provided by CGM.
6.1.2 DOSING AND ADMINISTRATION
6.2 PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY
6.2.1 ACQUISITION AND ACCOUNTABILITY

Supply of investigational products will be established by building relations between approved
suppliers or manufacturers and according to this quality control measures will be taken to check if
the products meets the requirements.
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING

A CGM device consists of three units, a glucose sensor, electronic processing unit and a data display
unit. The glucose sensor continuously detects glucose levels in blood by giving real-time data on
glucose concentrations and electronic processing unit processes received from the sensor through
which it analyses the glucose data and performs calculations and the data display unit displays it to
the user.3
6.2.3 PRODUCT STORAGE AND STABILITY

6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING
Participants are either allocated to CGM group or Glucola group in randomization which helps to
make sure to minimize bias in the trail.
6.4 STUDY INTERVENTION COMPLIANCE
Participants will be informed on the importance of complying to the given interventions and this will
be tacked by interviewing participants, daily reviews and from the data of CGM.
6.5 CONCOMITANT THERAPY
6.5.1 RESCUE MEDICINE

7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT

DISCONTINUATION/WITHDRAWAL
7.1 DISCONTINUATION OF STUDY INTERVENTION
When the study was started there were 300 participants, as we move ahead in analysis many
participants withdrawn from the study for their personal reasons and health related issues not
related to this study.at the end of the study there were 203 participants in total. As we continued
analysis, there was no any major harm or side effects to any participant. This study lasted for about 5
months in total including the preparation and analysis. The participants analysis was for about 3-4
months. During the study the protocol was strictly followed. At end of study, achieved the aim of
monitoring the gestational diabetes accurately so, we discontinued the study.
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY
At the starting of study 300 participants were involved. They were divided equally in placebo and
control group which was 150 each. As time passed many participants withdrawn from the study.
Placebo participants number reduced to 80 and for control it was 122, in total there were 203
participants left in the study.
7.3 LOST TO FOLLOW-UP
To ensure the reliability of our research findings, there are mechanisms established to prevent
participant dropout and gather all necessary information. we will maintain feasible contact, keep
members informed and engaged, and provide clear clarifications during the consent process. Regular
updates on plans, flexible reservation options, and small incentives might convince members. The
details about emergency contacts will be collected for if there is any changes. This will make sure
the data we gather is accurate and comprehensive by regularly monitoring, doing quality checks, and
sending out reminders to collect it. In general, the goals of these efforts are to maintain member
commitment and provide comprehensive data needed for accurate review findings.

8 STUDY ASSESSMENTS AND PROCEDURES
8.1 EFFICACY ASSESSMENTS
A prenatal visit will be used to identify participants, and 28 days before to enrollment, eligibility will
be assessed. having a gestational age of fewer than 25 weeks and an age range of 20 to 45. Minors,
women carrying multiple children, and known fetal abnormalities are excluded. We'll get informed
permission.
A soft sensor is placed for 25–27 weeks as part of the Continuous Glucose Monitoring (CGM)
program, and an hour later, a glucola test is conducted. The CGM sensors will be inserted and
removed by authorized medical personnel, and participants must meet inclusion and exclusion
requirements. Professionals with the necessary training will conduct the glucola test.
Unexpected problems might require unplanned visits, which will take place every two weeks until
the baby is born. Every week, regular testing and ongoing glucose monitoring will be performed on
both groups. Medical practitioners with certification will assess unfavorable pregnancy outcomes
upon birth.
Prenatal evaluations, blood pressure checks, and fetal heart rate monitoring are all part of a normal
medical examination. To determine gestational age, targeted exams will concentrate on base height
and abdominal circumference. Fetal development and amniotic fluid levels will be tracked with
monthly ultrasound scans. In compliance with Good Clinical Laboratory Practices, blood samples will
be drawn every two weeks to assess glucose levels.
DNA analysis from maternal and paternal blood samples will be used in the study along with
specialized assays to evaluate genetic susceptibility to gestational diabetes. Maternal well-being and
stress levels will be assessed using a standardized questionnaire, which will help with patient-
reported outcomes. Iron supplementation and Group B streptococcus screening, two common
prenatal care practices, will be incorporated into the research.
During follow-up visits, participants will get findings from the study, with comprehensive reports
being provided at the conclusion. There will be set criteria for the introduction of rescue medicine if
glucose levels rise over predefined thresholds. All personally identifiable information will be securely
anonymized and handled strictly in compliance with HIPAA regulations and privacy legislation.
8.2 SAFETY AND OTHER ASSESSMENTS
A thorough physical examination will be performed to measure height, weight, and organ function
during the first prenatal appointment. Measurements of vital signs will be made, and screening EKGs
could be performed. The definition of imaging and laboratory assessments—including the gathering

of biological specimens and assessments in the lab—will be covered. Additionally, counseling

processes regarding nutritional and exercise issues will be provided.
The MOP (manual of procedure) will include protocols for discussing and sharing study-specific
procedure results with participants, establishing detailed procedures for ongoing adverse event
monitoring, administering patient-reported outcomes using specific instruments, and assessing
adherence to interventions. These steps are intended to ensure efficient patient care and results.
In addition to ensuring compliance with HIPAA and other regulations for using pre-existing medical
data, the study will address protocols for sharing study-specific procedures with participants, discuss
ways to reduce variability, and define criteria and conditions for re-screening for screen failures,
with centralized laboratory assessments detailed in the MOP. The goals of these actions are to
enhance patient care and decrease variability.
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS
8.3.1 DEFINITION OF ADVERSE EVENTS (AE)
Defination :In this clinical investigation, an Adverse Event (AE) is defined as any unpleasant medical event or
an incidental sign, symptom, or illness related to the use of Glucola Test or Continuous Glucose Monitoring
(CGM) procedures.
Scope: Adverse events can be anything that happens throughout the experiment, starting from the time a
CGM is inserted or glucola is consumed and ending when the research is over.
FDA Definition: Because the research is being carried out in accordance with an Investigational New Drug
(IND) application, it complies with the FDA's definition of adverse events as defined in 21 CFR 312.32(a).
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)

Serious Adverse Events (SAEs) in this study are defined as significant health issues connected to the
experimental medication or equipment. SAEs include events including mortality, life-threatening
circumstances, hospitalization, disability, and congenital defects, according FDA regulations (21 CFR
312.32(a)). Unanticipated Adverse Device Effects are serious consequences that were not factored
into the original strategy when it comes to technologies. Under 21 CFR 312.32(a) reporting safety-
associated events (SAEs) is required for Investigational New Drug (IND) trials, highlighting the
significance of participant safety and trial integrity.
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT
8.3.3.1 SEVERITY OF EVENT
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION

8.3.3.3 EXPECTEDNESS
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW -UP
8.3.5 ADVERSE EVENT REPORTING
8.3.6 SERIOUS ADVERSE EVENT REPORTING
8.3.7 REPORTING EVENTS TO PARTICIPANTS
8.3.8 EVENTS OF SPECIAL INTEREST
8.3.9 REPORTING OF PREGNANCY
8.4 UNANTICIPATED PROBLEMS
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP)
8.4.2 UNANTICIPATED PROBLEM REPORTING
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS

9 STATISTICAL CONSIDERATIONS
9.1 STATISTICAL HYPOTHESES
9.2 SAMPLE SIZE DETERMINATION
9.3 POPULATIONS FOR ANALYSES
9.4 STATISTICAL ANALYSES
9.4.1 GENERAL APPROACH
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S)
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S)
9.4.4 SAFETY ANALYSES
9.4.5 BASELINE DESCRIPTIVE STATISTICS
9.4.6 PLANNED INTERIM ANALYSES
9.4.7 SUB-GROUP ANALYSES
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA
9.4.9 EXPLORATORY ANALYSES


10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
10.1.1 INFORMED CONSENT PROCESS

Informed consent is the form which includes all the details for the study covering all the necessary
points along with the expected harm and inclusion exclusion criteria. This form was given to all the
participants and, was completely explained to them along with the answers of the questions they
have been asked. 4 .
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO

PARTICIPANTS
Along with the informed consent many other documents were provided to the participants which
included the disclosure of information, competency of the patient to make the decision and
voluntary nature of the decision.
Disclosure of information provides the information that is necessary for patient to make an informed
decision and is one of the essential elements for a valid informed consent.4
Decision making capacity includes " the ability to understand and appreciate the nature and
consequences of health decisions and to formulate and communicate decisions concerning health
care."
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION

The process of informed consent includes the nature of subjects that is who can give their consent
personally with sign and personally sate the ICF(informed consent form) and who cannot.
After that participants who can is directed to physicians to get the agreement of the consent from
them then the informed consent procedure initiates.
For the participants who cannot are divided into 2 paths one with emergency and the other
including minors, unconscious or mental illness disability. All of them need to get agreement of
LAR(Legally Acceptable Representative) to initiate their procedure.
10.1.2 STUDY DISCONTINUATION AND CLOSURE

We achieved our aim of doing the analysis so we discontinued the study. We accurately collected
the data and statically upgraded and submitted. At the end of study we found out that our device is
more accurate than standard glucose test.
10.1.3 CONFIDENTIALITY AND PRIVACY

During the study participants information was protected, and all the rules of confidentiality and
privacy were maintained strictly.
The data for collected during analysis was stored for the future reference. It is stored safely an d is
not accessible to particular members and higher authorities only.

10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA

The data for collected during analysis was stored for the future reference. It is stored safely an d is
not accessible to particular members and higher authorities only.
10.1.5 KEY ROLES AND STUDY GOVERNANCE
Principal Investigator Medical Monitor
10.1.6 SAFETY OVERSIGHT

During the study safety of participants was taken into consideration. No participant was majorly
harm during the analysis. When the device is inserted into subcutaneous layer protocol is strictly
followed so that no patients get harm.
10.1.7 CLINICAL MONITORING

Clinical monitoring was done on hourly basis. After that they were called to clinic for changing of the
device along with this they need to submit the collected data of 7 days.
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL

Quality was assured during the calibration of the device. After that they we inserted into the human
species, in which the regularly glucose is monitored accurately. As we moved further in study we
were updating the device after collecting the data form the participants on weekly basis after setting
the calibration.
10.1.9 DATA HANDLING AND RECORD KEEPING

Data was collected for analysis and statical data was develop to trace the development. Record of
data was kept for future analysis and future development and upgradation in the device.
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES
10.1.9.2 STUDY RECORDS RETENTION
10.1.10 PROTOCOL DEVIATIONS
10.1.11 PUBLICATION AND DATA SHARING POLICY

10.1.12 CONFLICT OF INTEREST POLICY
10.2 ADDITIONAL CONSIDERATIONS
10.3 ABBREVIATIONS
AE Adverse Event
ANCOVA Analysis of Covariance
CFR Code of Federal Regulations
CLIA Clinical Laboratory Improvement Amendments
CMP Clinical Monitoring Plan
COC Certificate of Confidentiality
CONSORT Consolidated Standards of Reporting Trials
CRF Case Report Form
DCC Data Coordinating Center
DHHS Department of Health and Human Services
DSMB Data Safety Monitoring Board
DRE Disease-Related Event
EC Ethics Committee
eCRF Electronic Case Report Forms
FDA Food and Drug Administration
FDAAA Food and Drug Administration Amendments Act of 2007
FFR Federal Financial Report
GCP Good Clinical Practice
GLP Good Laboratory Practices
GMP Good Manufacturing Practices
GWAS Genome-Wide Association Studies
HIPAA Health Insurance Portability and Accountability Act
IB Investigator’s Brochure
ICH International Conference on Harmonisation
ICMJE International Committee of Medical Journal Editors
IDE Investigational Device Exemption
IND Investigational New Drug Application
IRB Institutional Review Board
ISM Independent Safety Monitor
ISO International Organization for Standardization
ITT Intention-To-Treat

LSMEANS Least-squares Means

MedDRA Medical Dictionary for Regulatory Activities
MOP Manual of Procedures
MSDS Material Safety Data Sheet
NCT National Clinical Trial
NIH National Institutes of Health
NIH IC NIH Institute or Center
OHRP Office for Human Research Protections
PI Principal Investigator
QA Quality Assurance
QC Quality Control
SAE Serious Adverse Event
SAP Statistical Analysis Plan
SMC Safety Monitoring Committee
SOA Schedule of Activities
SOC System Organ Class
SOP Standard Operating Procedure
UP Unanticipated Problem
US United States
10.4 PROTOCOL AMENDMENT HISTORY
Version Date Description of Change Brief Rationale


11 REFERENCES
REFERENCES
1. Yang, F., Lv, L., Zhou, L., Wang, Y., Wen, J., Lin, X., Zhou, Y., Mai, C., & Niu, J. (2014, December 1).
Continuous Glucose Monitoring Effects on Maternal Glycemic Control and Pregnancy Outcomes in
Patients With Gestational Diabetes Mellitus: A Prospective Cohort Study.
https://doi.org/10.1210/jc.2013-4332
2. Patel, S. J. (n.d.). Gestational Diabetes Testing Protocol: Background, Indications, Contraindications.

https://emedicine.medscape.com/article/2049380-overview?form=fpf
3. Vaddiraju, S., Burgess, D. J., Tomazos, I., Jain, F., & Papadimitrakopoulos, F. (2010, November 1).
Technologies for Continuous Glucose Monitoring: Current Problems and Future Promises. Journal of
Diabetes Science and Technology. https://doi.org/10.1177/193229681000400632
4. Gupta, U. C. (2013, January 1). Informed consent in clinical research: Revisiting few concepts and
areas. Perspectives in Clinical Research. https://doi.org/10.4103/2229-3485.106373

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The Seven Continuous Glucose Monitoring System Version 0.

Subject:- Clinical Research Regulation

Course Name: Clinical Research

NIH-FDA Clinical Trial Protocol Template – v1.0 2017-04-07 1

The Seven Continuous Glucose Monitoring System

Affected Section(s) Summary of Revisions Made Rationale

Table of Contents - Please right-click and choose 'Update Field'.

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Title: The Seven Continuous Glucose Monitoring System

• 7-Day Continuous Glucose Monitoring (CGM)

Study Duration: 5 months

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1.3 SCHEDULE OF ACTIVITIES (SOA)

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2.1 STUDY RATIONALE

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2.3 RISK/BENEFIT ASSESSMENT

2.3.1 KNOWN POTENTIAL RISKS

2.3.2 KNOWN POTENTIAL BENEFITS

2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS

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3 OBJECTIVES AND ENDPOINTS

OBJECTIVES ENDPOINTS JUSTIFICATION FOR

• Maternal glucose levels: The • Pregnancy complications: • These endpoints are

• Complication-Specific • Mothers' glucose regulation: • The secondary

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OBJECTIVES ENDPOINTS JUSTIFICATION FOR

• Variations across Patient

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4.1 OVERALL DESIGN

Several methodological approaches to minimize bias. The methods include randomization,

4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN

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4.3 JUSTIFICATION FOR DOSE

4.4 END OF STUDY DEFINITION

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5.1 INCLUSION CRITERIA

o willingness to take part in the research.

o The gestational age of 24–28 weeks.

5.2 EXCLUSION CRITERIA

o unwillingness to take part in the research.

o failure to adhere to the seven-day CGMS wear requirement.

5.3 LIFESTYLE CONSIDERATIONS

o There are no restrictions on the kinds of food or the times of meals.

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3. Alcohol, Tobacco, and Caffeine:

o Participants should continue to consume alcohol, cigarettes, and caffeine as normal.

4. Monitoring Device Maintenance:

5. Blood Glucose tests:

5.4 SCREEN FAILURES

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o Participants will be given an in-depth description of the causes of screen failure.

• The following circumstances may warrant reconsidering rescreening:

Procedures for rescreening:

Time frame for Re-screening:

Documentation for Re-screening:

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