Department of Electrical and Electronic Engineering

Assignment name: Continuous Glucose Monitoring (CGM)

Course Code: EEE419

Course Title: Biomedical Engineering

Semester: Spring 2024

Section: 1
Group no. : 06
Student’s name & ID: Md. Abdullah (2018-3-80-008)
Shahriar Siddique (2018-3-80-028)
Tahfizur Rahman Rifat (2019-2-80-032)
Kawsar Zaman Anik (2019-1-86-194)
Submitted to: Dr. Mohammed Moseeur Rahman (DMMUR)

Submission Date:16 May, 2024

1.Introduction:
Implantable Continuous Glucose Monitoring (CGM) devices are indeed emerging as a
significant innovation in the biomedical engineering field for human healthcare in the 21st
century. These devices represent a leap forward in diabetes management, offering continuous,
real-time tracking of glucose levels, which is a substantial improvement over traditional

fingerstick testing.
Figure:Eversense E3 implantable CGM[3]

The impact of implantable CGM devices on healthcare can be justified by several factors:
Improved Accuracy and Efficacy: Implantable CGM devices have shown better Mean
Absolute Relative Difference (MARD) compared to transcutaneous sensors, indicating higher
accuracy in glucose level readings. Overall, EVS performed better than DG5 with a MARD vs.
SMBG of 12.27% ± 11.55% (mean ± SD) vs. 13.14% ± 14.76%, p-value < 0.001. [1](table 2).
Enhanced Quality of Life: CGM devices allow for more informed diabetes management
decisions, leading to more optimized glucose control and an overall increase in the quality of life
for patients[2].
Advancement in Technology: The development of implantable CGM devices is the result of
extensive research and technological innovation, reflecting the progress in biomedical
engineering[2].
Remote Monitoring Capabilities: The ability of CGM systems to transmit data to the cloud
enables remote monitoring by healthcare providers, which has been particularly beneficial during
situations like the COVID-19 pandemic[1].
Reduction in Diabetes-Related Distress: Studies have shown that the use of implantable CGM
devices can reduce perceived distress related to diabetes management[1].
These points underscore the significance of implantable CGM devices as an emerging
technology in the 21st century, contributing to the advancement of human healthcare and the
field of biomedical engineering. The continuous evolution and adoption of these devices are
expected to further enhance patient outcomes and healthcare practices.
2.The purpose of the technology
Implantable Continuous Glucose Monitoring (CGM) devices serve a critical role in healthcare by
providing continuous, real-time monitoring of glucose levels for individuals with diabetes. The
purpose of these devices is to offer a more comprehensive and accurate understanding of glucose
trends, which can significantly improve the management of diabetes.
Here’s how implantable CGM devices benefit healthcare:
Continuous Monitoring: Unlike traditional blood glucose meters, implantable CGMs provide
continuous glucose readings, allowing for better management of blood sugar levels throughout
the day and night[4].
Fewer Fingerstick Tests: CGM devices reduce the need for frequent fingerstick tests, making
diabetes management less invasive and more convenient[4].
Real-Time Data: They provide real-time glucose data, enabling proactive and timely clinical
decisions regarding diabetes management[5].
Remote Data Sharing: The technology allows for the transmission of glucose data to healthcare
providers remotely, facilitating virtual consultations and telehealth services[1].
Alerts for Glucose Levels: CGM devices can alert users if glucose levels are too high or too
low, helping to prevent critical situations[6].
These points underscore the significance of implantable CGM devices as an emerging
technology in the 21st century, contributing to the advancement of human healthcare and the
field of biomedical engineering. The continuous evolution and adoption of these devices are
expected to further enhance patient outcomes and healthcare practices.
3.
Implantable Continuous Glucose Monitoring (CGM) devices have encountered patent issues.
The actual woking principles of the CGM is not possible to describe.However,we can segment
the activity of Implantable Continuous Glucose Monitoring devices .
Illustration of the typical implementation of a commercial CGM system[7]

A schematic drawing illustrating the general layout, which is applicable to many glucosesensors,
is shown below. In the majority of sensors two electrode transducers were used with platinum as
working electrode and Ag/AgCl as reference electrode. Inner membranes between the working
electrode and enzyme layer reduce electrochemical interference at the electrode, whilst outer
interfacial membranes improve the performance and life-time of the subcutaneously implanted
glucose sensors.[10]

A fully implantable continuous glucose monitoring (CGM) microsystem designed to be placed

under the skin, utilizing a CMOS platform. This design integrates an electrochemical sensing
technique powered by an ultra-low-power potentiostatic system. It receives wireless power
through an inductive coupling link operating at 900MHz and enables two-way data
communication with an external reader. A low-power potentiostat and a dual-slope ADC capture
the sensor signal on the chip. On-chip electrodes made of Pt and Ag/AgCI are created after
fabrication and activated in place using glucose oxidase enzyme to measure glucose levels. A
prototype measuring 1.4 x 1.4 x 0.25mm³, manufactured using 0.18μm CMOS technology[8]

Kim et al. exploited a CMOS image sensor for detecting glucose levels by simple photon count
variation with high sensitivity. Oxidized glucose produces a brown color with the help of a
chromogen during the enzymatic reaction and the color density varies with the glucose
concentration. Photons pass through the PDMS chip with varying color density and hit the sensor
surface. Photon count was recognized by the CMOS image sensor depending on the colordensity
with respect to the glucose concentration and it was converted into digital form[9].

Fig:Schematic of PDMS chip utilization for monitoring of glucose solutions by a CMOS image sensor.
4.
Providing the list of modules / equipment used in this technology bellow. [11]
Implantable Sensor: This is the core component of the CGM system, which is implanted under
the skin to continuously monitor glucose levels.
Transmitter: A device that collects data from the sensor and transmits it wirelessly to an external
receiver or a smartphone.
Receiver: The device that receives data from the transmitter and displays glucose readings. It can
be a standalone device or integrated into a smartphone or insulin pump.
Insulin Pump Integration: Some CGM systems can integrate with insulin pumps, allowing for
automated insulin delivery based on real-time glucose readings.
Smartphone App: Many CGM systems offer companion smartphone apps that display glucose
data, trends, and alerts, providing users with convenient access to their glucose information.
Data Management Software: Software platforms that allow users to upload, store, and analyze
their glucose data over time, helping them make informed decisions about their diabetes
management.
Calibration Materials: Solutions or devices used to calibrate the CGM sensor periodically to
ensure accurate glucose readings.
Battery: Power source for the implantable sensor and transmitter. Depending on the system,
batteries may need to be replaced periodically or recharged.
Insertion Device: A tool used to insert the sensor under the skin during the implantation
procedure.
Patch or Adhesive: A patch or adhesive used to secure the sensor in place on the body.
Training Materials: Educational resources provided to users to learn how to use and maintain
the CGM system effectively.
Support Services: Access to customer support, technical assistance, and training provided by the
manufacturer or healthcare provider.
5.
List of the raw materials or accessories for Continuous Glucose Monitoring (CGM) Devices
systems. [11]

Biosensors: These are the core components of CGM systems, responsible for detecting glucose
levels in the body. They usually consist of an enzyme (such as glucose oxidase) and an electrode.
Biocompatible Materials: Since the device is implanted in the body, materials used must be
compatible with human tissues to prevent adverse reactions. Examples include titanium,
medical-grade silicone, and biocompatible polymers.
Encapsulation Materials: These materials are used to protect the biosensors and electronics
from bodily fluids and to ensure long-term functionality. Common encapsulation materials
include biocompatible polymers like polyurethane and parylene.
Electronics: CGM devices require electronic components for data processing, wireless
communication, and power management. This includes microcontrollers, transmitters, antennas,
and power sources such as batteries or energy harvesters.
Wireless Communication Modules: These modules enable the transmission of glucose data
from the implantable device to an external receiver or smartphone. Components may include
Bluetooth or radiofrequency (RF) transceivers.
Implantation Tools: Specialized tools are needed for the surgical implantation of the device,
including insertion tools, needles, and surgical instruments.
Adhesive: Some CGM systems require adhesive patches to secure the device to the skin and
maintain proper contact for accurate glucose measurements.
External Receivers or Readers: Patients typically use external receivers or readers to view real-
time glucose data collected by the implanted device. These devices may come with software for
data analysis and management.
Calibration Solutions: Calibration solutions are used to calibrate the CGM system, ensuring
accurate glucose measurements. These solutions contain known glucose concentrations for
calibration purposes.
Sterilization Supplies: Since CGM devices come into contact with bodily fluids and tissues,
sterilization supplies such as ethylene oxide (ETO) gas or gamma irradiation are necessary to
ensure the devices are free from microbial contamination before implantation.
Quality Control Materials: Quality control materials are used during manufacturing to ensure
the accuracy and reliability of CGM devices. These may include reference glucose solutions and
testing equipment.
Packaging Materials: CGM devices require sterile packaging to maintain their integrity and
sterility until use. Packaging materials may include sterile pouches, trays, and sealing equipment.
6.
Implantable Continuous Glucose Monitoring (CGM) devices have already revolutionized
diabetes management by providing real-time glucose level data, thereby enabling better control
and prevention of complications. Looking into the future, several potential developments in this
technology could further enhance its capabilities: [12] [13]
Miniaturization: Future implantable CGM devices may become even smaller and more discreet,
making them less intrusive for the wearer and potentially reducing the risk of complications
associated with implantation.
Improved Accuracy: Advancements in sensor technology and data processing algorithms may
lead to even greater accuracy in glucose monitoring, reducing the need for frequent calibrations
and enhancing reliability.
Extended Lifespan: Current CGM devices typically require replacement every few months due
to sensor degradation. Future developments may extend the lifespan of these devices, reducing
the frequency of replacements and overall cost.
Closed-Loop Systems: Integration of implantable CGM devices with insulin pumps or
automated insulin delivery systems could lead to closed-loop systems, where glucose levels are
continuously monitored and insulin delivery is automatically adjusted in real-time, further
improving glycemic control and reducing the burden on patients.
Multi-Analyte Sensors: In addition to glucose monitoring, future implantable devices may
incorporate sensors for other analysts relevant to diabetes management, such as ketones or
lactate, providing a more comprehensive picture of metabolic health.
Wireless Connectivity: Enhanced wireless connectivity capabilities could enable seamless data
transmission from the implantable device to external devices such as smartphones or cloud-based
platforms, facilitating remote monitoring by healthcare providers and improving patient
engagement.
Biocompatibility: Continued research into biocompatible materials and coatings could further
improve the long-term safety and performance of implantable CGM devices, reducing the risk of
adverse reactions or tissue rejection.
Predictive Analytics: Integration of machine learning algorithms and artificial intelligence could
enable predictive analytics capabilities, allowing the device to anticipate fluctuations in glucose
levels and provide early warnings or recommendations to the user.
Customization: Future devices may offer greater customization options, allowing users to tailor
their CGM experience to their specific needs and preferences, such as adjustable alert thresholds
or personalized insulin dosing algorithms.
Regulatory Approval and Accessibility: As the technology matures and becomes more widely
accepted, regulatory approval processes may become more streamlined, leading to increased
accessibility for patients and healthcare providers.
By exploring these potential developments and staying abreast of emerging research and
technological advancements, the field of implantable CGM devices holds great promise for
improving the lives of individuals with diabetes in the future.

7.
Unit of Measurement: The glucose concentrations are measured in milligrams per deciliter (mg
dL^-1). [9]
Biomedical Imaging: This field is now developing at a high pace, allowing for real-time
monitoring to be done for the accurate diagnosis in case and a possibility of the treatment to be
made. It is based on various imaging techniques, such as X-ray CT and MRI scanners, to support
the research regarding the effectiveness of implantable brain devices. The main purpose of these
methods is to give a complete picture of the imaging from the molecular scale to the organ,
tissue, lesion, and the whole organism scale.[9]
Imaging Probes: There are many kinds of imaging probes for both imaging techniques and they
are all described in the text. These probes are beneficial in the smooth separation of the internal
structure (anatomy), morphology, and physiological functions at different scales.[9]
Image Analysis: Imaging registration and reconstruction are the essential parts of image
analysis. The process of knowledge extraction from image data is important for knowing the
disease and therapy responses.[9]
Imaging Algorithms: Physical models, statistical methods and machine learning are applied in
the creation of imaging algorithms, and the development of such algorithms is made highly
accurate through the use of physical models, robust statistical methods and machine learning.
The algorithms are useable in computational imaging and the image reconstruction of MRI, CT
and nuclear imaging.[9]

8.
Pros:[9]
Accuracy: The EVS demonstrated a better Mean Absolute Relative Difference (MARD) than
DG5, mostly in the euglycemic range, which implies that EVS has greater accuracy in normal
glucose levels.
Glycemic Control: Through the application of EVS, the target glucose range time was
increased and the time in hyperglycemia was decreased.

Psychological Outcomes: EVS was linked with a decrease of perceived distress and it was the
choice of the participants because of the devices they could use, such as the alarms, the
smartphone app, and even the possibility of removing the transmitter for a while.
Safety: Both systems were tolerated, safe, and worked well, with no infections being related to
the implant/removal of EVS reported.
Cons:[9]
Sensor Use: The study discovered that DG5 recorded more data than EVS, which means that
EVS probably had problems of constant use, maybe because of the need to recharge the
transmitter or the connection problems.
Transmitter Failures: EVS had more transmitter failures compared to the traditional system,
which could in turn influence the data collection and the overall user experience.
Data Discrepancies: When CGM data were retrospectively matched with SMBG (Self-
monitoring of Blood Glucose), some of the benefits of EVS (Enhanced Vagueness Signaling),
such as increase in time in range and the decrease in time in hyperglycemia, were not statistically
significant.
Device Limitations: The study considered the first generation of EVS, which has a shorter
lifetime and less precision than the newer ones.
9.
The Directorate General of Drug Administration (DGDA), the Ministry of Health and Family
Welfare, Government of the People’s Republic of Bangladesh will be the ones to give the
permission.[14]
To introduce a medical technology for healthcare in Bangladesh, the following procedures must
be followed :
Device Classification: Medical devices are granted a class based on the risk level into Classes
A, B, C, and D. The classification is executed in line with the procedures of Annexure 1:
Classification Rules.

Registration Guidelines: Manufacturers or importers must follow the regulatory controls and
make sure that medical devices are standardized on the worldwide level in terms of quality,
safety, and performance.

Conformity Assessment: It is a requirement of the medical device class whether conformity

assessment is to be implemented to reveal the compliance with the essential principles that
include a quality management system by ISO 13485.

Post-Marketing Surveillance: The manufacturer or importer of the Class B, C, or D medical

device must follow the post-marketing surveillance requirements to monitor the device's use after
it is put on the market.

10.
Continuous Glucose Monitoring (CGM) technology does involve electrical and electronic
applications. A tiny sensor that is subcutaneously placed, usually on the arm or abdomen, is the
standard component of CGM systems. Its job is to continually measure the amount of glucose
present in the interstitial fluid. This sensor detects glucose levels using electrical principles, and
it wirelessly sends the data to a smartphone or receiver.

By measuring glucose levels through enzymatic or non-enzymatic processes, the sensor uses a
small electrode to provide an electrical signal proportional to the concentration of glucose. The
electrical components in the sensor then process this signal to turn it into a digital value that can
be read by the user or sent to a recipient device.
Studies comparing the performance of several CGM systems head-to-head have revealed
significant variations not only between systems made by different manufacturers but also
between individual sensors within the same system. Technology and calibration techniques are
probably the causes of these variations since they may have an impact on the dependability and
analytical performance of CGM systems.
Because the manufacturers do not yet give comprehensive information on the traceability chain
and the measurement uncertainty, it is currently unable to accurately trace minimally invasive
CGM glucose results to reference measurement procedures or higher-order standards.[15]
Fig. 3. Time below glucose range <3.9 mmol/L (minutes/day) evaluated from two different CGM systems
worn in parallel.[15]

In Bangladesh, standardizing Continuous Glucose Monitoring (CGM) technology entails several

crucial procedures to guarantee its application in healthcare settings is safe, dependable, and
consistent.

Here's an overview:
Regulatory Compliance: Establishing legal frameworks and guidelines in cooperation with
international standards organizations and regulatory bodies like the DGDA for the approval,
production, and distribution of CGM devices.
Adoption of International Standards: Bringing CGM technology into compliance with
globally accepted standards on device design, performance requirements, calibration processes,
and data transfer protocols that are established by organizations like ISO and IEC.
Quality Management Systems (QMS): For consistent quality in CGM devices, adopt ISO
13485-based QMS. It includes risk management, design control, validation, verification, and
post-market monitoring for reliability.
Clinical Validation and Performance Evaluation: Clinical trials validate CGM precision,
reliability, and therapeutic efficacy against reference glucose readings. Crucial for regulatory
approval and clinical use.
Interoperability and Data Standards: Establishing interoperability standards and data
exchange protocols is essential for the seamless integration of CGM systems with EHRs,
telemedicine platforms, and other healthcare IT systems. This ensures efficient data interchange
and interoperability.
Training and Education: Ensuring safe and efficient use of CGM technology by offering
extensive training programs that cover device setup, sensor insertion, calibration procedures, data
interpretation, troubleshooting, and emergency response to healthcare professionals, patients, and
caregivers.
These procedures are essential for guaranteeing the efficacy, safety, and quality of CGM
technology in Bangladesh's healthcare system for the management of diabetes.

11.
The policies and laws regarding Continuous Glucose Monitoring (CGM) technology generally
encompass topics including post-market surveillance, clinical recommendations, reimbursement,
regulatory approval, and data protection. [16]

Regulatory Approval: Government bodies such as the EMA in Europe or the FDA in the
United States provide regulatory approval for CGM devices. They assess quality, safety, and
efficacy before market distribution.
Reimbursement Policies: The reimbursement of CGM devices by government healthcare
programs or health insurance hinges on reimbursement policies, which consider factors such as
diabetes type, frequency of glucose monitoring, and clinical necessity.
Clinical Guidelines: Clinical guidelines for CGM in diabetes therapy, issued by healthcare
professional associations and organizations, provide recommendations on patient selection,
device utilization, glucose data interpretation, and insulin therapy integration.
Data Privacy and Security: For CGM devices, laws and policies about data security and
privacy are essential. To protect patient information, manufacturers and healthcare providers
must abide by US legislation including the Health Insurance Portability and Accountability Act
(HIPAA).
Quality Assurance and Post-Market Surveillance: Regulatory bodies enforce quality
assurance guidelines to ensure the efficacy and safety of CGM devices. Manufacturers are
required to conduct post-market monitoring to track device performance, identify adverse events,
and take corrective action when necessary.
12.
Continuous Glucose Monitoring (CGM) technology has greatly improved diabetes management
With fewer fingerstick tests, continuous glucose monitoring (CGM) devices assist in managing
Type 1 or Type 2 diabetes. Your blood glucose is continuously measured by a sensor beneath
your skin. Results are sent to a mobile phone or wearable device via a transmitter.

Continuous glucose monitoring (CGM) has transformed the management of type 1 diabetes
(T1D). CGM has become routinely used. The use of CGM technology has made it possible to
monitor dynamic glycemic trends and fluctuations over time, which has improved medical
management and prevented harmful hypoglycemia episodes. The real-time and intermittently
scanned CGM devices that are now on the market, the advantages and disadvantages of using
CGMs clinically, and the guidelines that currently support their use in the clinical care of T1D
patients are all covered in this review. We also outline upcoming challenges that will arise as
CGM technology develops further.[16]
Continuous glucose monitoring (CGM) technology can be used to mitigate diabetes by
improving glucose control, preventing complications, and improving quality of life. The
following are some ways that CGM technology can be applied to the treatment of diabetes:

Figure. Sampling arrangements of different types of CGM systems[15]

Real-Time Glucose Monitoring: With the continuous, real-time glucose measurements that
CGM offers, people can keep a careful eye on their blood sugar levels both during the day and at
night. Through regular monitoring of glucose trends and patterns, users can promptly modify
their diabetes treatment plan.
Early Detection and Prevention of Hypoglycemia and Hyperglycemia: Before symptoms
appear, CGM devices can notify users of imminent hypoglycemia (low blood sugar) or
hyperglycemia (high blood sugar). Proactive action, such as eating carbs to boost blood sugar
levels or giving insulin to drop them, is made possible by this early diagnosis.
Trend Analysis and Insights: Reports and trend graphs showing glucose trends over time are
produced by CGM devices. People and medical professionals can determine what influences
blood sugar levels—such as medication, stress, exercise, and diet—by examining these patterns.
Making educated decisions about diabetes care techniques is made easier with this
understanding.
Customizable Alerts and Alarms: Users of CGM devices can program warnings and alarms
based on preset glucose thresholds. When consumers receive these notifications, their blood
sugar levels are too high or too low, and they are prompted to take immediate corrective action.
Insulin Dosing Assistance: For the purpose of recommending insulin dosage based on trends
and real-time glucose readings, certain CGM systems interface with insulin pumps or
smartphone apps. This function, often referred to be predictive low glucose suspend or
automated insulin dosing, can assist people in maintaining stricter glucose control while
lowering their risk of hypoglycemia.
Improved Quality of Life: Continuous glucose monitoring (CGM) technology can assist people
with diabetes achieve better glycemic control and lower their risk of problems associated to their
diabetes by offering continuous glucose monitoring and actionable information. A better quality
of life with less blood sugar variations and disruptions from diabetes may result from this better
control.

13.
Although the main goal of Continuous Glucose Monitoring (CGM) technology is to improve
diabetes care, several possible environmental problems could arise from its use.
Here are a few along with possible mitigation processes:
Electronic Waste: CGM devices are made out of electronic components that contribute to
electronic waste when disposed of improperly. If not managed properly, this can cause
environmental contamination and potential health risks.
Mitigation: Encourage responsible disposal of CGM devices by offering recycling programs or
electronic waste collection services. Manufacturers can design gadgets with recyclable materials
and conduct take-back programs to ensure appropriate disposal and recycling of outdated
devices.
Battery Waste: CGM devices often use batteries for power, which generates battery waste when
they are depleted and disposed of. Improper battery disposal can contaminate the environment
with heavy metals and harmful substances.
Mitigation: Encourage the use of rechargeable batteries in CGM devices to help reduce battery
waste. Set up battery recycling systems to properly collect and recycle used batteries. Educate
consumers on correct battery disposal ways to reduce environmental effects.
Packaging Waste: CGM devices are frequently wrapped in plastic and other materials, adding
to packaging waste when discarded. Excessive packaging can cause environmental degradation
and resource depletion.
Mitigation: Encourage producers to reduce packaging waste by adopting environmentally
friendly materials and lowering packaging size and complexity. Implement recycling initiatives
for CGM device packaging to promote appropriate disposal and recycling.
Energy Consumption: CGM devices require energy to operate, which adds to overall energy
consumption and greenhouse gas emissions, particularly if the energy source is non-renewable.
Mitigation: Create energy-efficient CGM devices with minimal power consumption to reduce
energy usage and environmental impact. Encourage the use of renewable energy sources for
gadget functioning, such as solar panels or rechargeable batteries powered by renewable energy.
Chemical Exposure: Some CGM device components, such as adhesives and sensor materials,
may include chemicals that are hazardous to the environment if discharged during
manufacturing, usage, or disposal.

Mitigation: Use ecologically friendly materials in CGM device manufacturing to reduce

chemical exposure and environmental impact. Implement strong quality control methods to
maintain environmental compliance and reduce chemical emissions during manufacturing
processes.
By employing these mitigation methods, the environmental impact of Continuous Glucose
Monitoring (CGM) technology can be reduced, ensuring long-term use and lowering its
ecological footprint.

Reference:
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