Olofinmuyide Victor Project Proposal

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A

PROJECT PROPOSAL
ON
DESIGN AND CONSTRUCTION OF A REMOTE
SMART BLOOD GLUCOSE MONITORING
DEVICE USING GLUCOSE SENSOR
BY
OLOFINMUYIDE, VICTOR OJO
FPI/HND/CTE/22/012
SUBMITTED TO
THE DEPARTMENT OF COMPUTER
ENGINEERING TECHNOLOGY, SCHOOL OF
ENGINEERING, FEDERAL POLYTECHNIC, ILE-
OLUJI.

IN PARTIAL FULFILMENT FOR THE AWARD OF


HIGHER NATIONAL DIPLOMA IN
DEPARTMENT OF COMPUTER ENGINEERING
TECHNOLOGY
APRIL, 2024
CERTIFICATION

This is to certify that this Project proposal was carried out by OLOFINMUYIDE, VICTOR OJO

with Matriculation Number: FPI/HND/CTE/22/012. In partial fulfillment of the requirements for

the award of Higher National Diploma in Computer Engineering Technology.

Engr. Dr. B. O. Adegoke ...…………………………

Supervisor Signature & Date

Engr. (Mrs) F. T. Oyediji ...…………………………

Head of Department Signature & Date

i
SUMMARY

Diabetes mellitus is a chronic disease requiring a careful management to prevent its collateral

complications, such as cardiovascular and Alzheimer's diseases, retinopathy, nephropathy, foot

and hearing impairment, and neuropathy. Self-monitoring of blood glucose at point-of-care

settings is an established practice for diabetic patients. However, current technologies for glucose

monitoring are invasive, costly, and only provide single snapshots for a widely varying

parameter. CGM device represent a viable route for targeting minimally-invasive monitoring of

the disease onset and progression. Particularly, glucose concentration in blood may be used as a

surrogate to estimate blood glucose levels. The approach for the design of an improved contact

lens for continuous glucose monitoring system, is thus presented.

ii
TABLE OF CONTENTS

Title Page

Certification i

Summary ii

Table of Contents iii

List of Figures v

1.0 Introduction 1

1.1 Background of the Study 1

1.2 Statement of Problem 2

1.3 Aim and Objectives 2

1.4 Scope of the Study 3

1.5 Significance of the Study 3

1.6 Need Assessment 3

2.0 Literature Review 5

2.1 Historical Framework 5

2.2 Blood Sugar Chart (Glucose Chart Level) 6

2.3 Future Requirements for Advanced CGM Technology 8

2.3.1 The Growing Burden of Diabetes and its Management 8

2.3.2 One-Size-Fits-All Approach 8

2.3.3 The Ideal CGM for the Future 8

2.4 Some exisiting Glucose Monitoring Devices 10

2.4.1 Dexcom G6 10

2.4.2 Contour Next One 10

2.4.3 Nutrisense CGM 11

2.4.4 FreeStyle Libre 12

2.5 Importance of Continuous Glucose Monitoring 12

iii
3.0 Proposed System Development Methodology 15

3.1 Proposed Block Diagram of the System 15

3.2 Required Components for the device 17

3.2.1 Glucose Sensor 17

3.2.2 Arduino Nano 17

3.2.3 I2C LCD Display 17

3.3 Working Principle of the System 18

REFERENCES 20

iv
LIST OF FIGURES

Figure Description Page

2.1 Blood Sugar Chart 7

2.2 Dexcom G6 10

2.3 Contour Next One 11

2.4 Nutrisense CGM 11

2.5 FreeStyle Libre 12

3.1 Block Diagram of the System 16

3.2 Glucose Sensor 17

3.3 Arduino Nano 17

3.4 I2C LCD Display 18

3.5 Flowchart of the Working principle of the System 19

v
1.0 Introduction

1.1 Background of the Study

The domestic prevalence of diabetes mellitus (DM) has increased from 11 million in 2000 to

approximately 30 million in less than two decades. Approximately 90% to 95% of the

diabetic population is classified as type 2 diabetes in which an individual produces an

insufficient amount of insulin to meet their metabolic requirements. This number is predicted

to rise to nearly 55 million people by 2030 representing an estimated increase of 54%. The

World Health Organization estimates that approximately 422 million adults or 8.5% of the

world’s population are currently affected, which represent a fourfold increase in less than 40

years. This exponential rise in DM implies an incipient global pandemic.

The development of a smart remote continuous glucose monitoring (CGM) represents a

significant advancement in diabetes management technology. Diabetes mellitus,

characterized by elevated blood glucose levels, is a chronic metabolic disorder that affects

millions of individuals worldwide. Traditional methods of glucose monitoring, such as

fingerstick testing, are invasive, uncomfortable, and often result in suboptimal compliance

among patients (Hong et al., 2018).

CGM equipped with miniature sensors offer a non-invasive and continuous solution for

monitoring blood glucose levels. These contact lenses detect glucose concentrations in tears

and transmit the data wirelessly to a remote device for real-time monitoring and analysis. By

providing continuous and convenient glucose monitoring, CGM have the potential to

revolutionize diabetes management, improve patient outcomes, and enhance quality of life

for individuals living with diabetes (Yamagishi et al., 2018).


Despite the promising benefits of existing CGM, several challenges and limitations exist that

warrant further investigation. These include issues related to sensor accuracy, calibration,

biocompatibility, user comfort, and regulatory approval. Addressing these challenges is

crucial to the successful development and widespread adoption of CGM device for diabetes

management (Park et al., 2018).

1.2 Statement of Problem

The development and implementation of smart continuous glucose monitoring (CGM) device

pose several key challenges and limitations that require addressing. It's crucial to ensure the

accuracy and reliability of glucose sensors embedded within a device to provide users with

precise and actionable data. Factors such as sensor drift, interference from other substances in

tears, and variability in tear composition can impact sensor performance and accuracy. Proper

calibration of glucose sensors is essential for accurate measurements, but achieving reliable

and consistent calibration is challenging, especially in the dynamic and variable

environmental condition. The CGM device must be biocompatible to prevent adverse

reactions or damage to the body, necessitating the use of safe and non-irritating materials in

their construction. Comfort and usability are paramount for wearable devices like the CGM

device.

1.3 Aim and Objectives

The aim of this research is to develop a Smart Blood Glucose Monitoring Device.

Specific objectives are to:

i. design a conseptual framework for Smart Blood Glucose Monitoring Device;

ii. Simulate the designed framework;

iii. Implement the simulated design;

2
iv. Evaluate the performance of the device and compare the result with conventional

Glucometer.

1.4 Scope of the Study

The study emcompases the used of Glucose sensor that will be able to read blood glucose and

interprete the result through Arduino nano and it will be displayed in an LCD display also

send the result to a dedicated mobile application so that it can remotely be read.

1.5 Significance of the Study

The significance of this study lies in its potential to address critical challenges in diabetes

management through the development of continuous glucose monitoring (CGM) device.

With the global prevalence of diabetes mellitus reaching epidemic proportions, innovative

solutions like smart blood glucose device offer a promising approach to improving patient

outcomes and quality of life.

CGM provide a non-invasive and continuous method for monitoring blood glucose levels,

offering a more convenient and comfortable alternative to traditional fingerstick testing. This

technology has the potential to enhance diabetes management by facilitating timely

interventions and adjustments in treatment regimens. The ability to wirelessly transmit

glucose data to remote devices enables real-time monitoring and analysis, empowering

patients and healthcare providers with timely insights into glucose trends and patterns. This

facilitates proactive management strategies and personalized interventions.

1.6 Need Assessment

The need for this study arises from the increasing prevalence of diabetes mellitus and the

limitations of existing glucose monitoring methods. Traditional approaches such as

fingerstick testing are invasive, uncomfortable, and often lead to suboptimal patient

3
compliance. Moreover, these methods provide only intermittent snapshots of glucose levels,

limiting the ability to detect fluctuations and trends.

Non-Invasive Monitoring: There is a growing need for non-invasive and continuous glucose

monitoring solutions that offer greater convenience and comfort for individuals living with

diabetes.

Enhanced Accuracy and Reliability: Existing CGM technologies may suffer from issues

such as sensor drift and variability, highlighting the need for improvements in accuracy and

reliability to ensure actionable data for users.

Real-Time Data Accessibility: Remote transmission of glucose data enables real-time

monitoring and analysis, providing patients and healthcare providers with timely insights for

effective diabetes management.

4
2.0 Literature Review

2.1 Historical Framework

In the past, the primary method for people with diabetes to monitor their blood sugar levels

was self-monitoring of blood glucose (SMBG). This involved pricking their fingers and

drawing blood for testing multiple times a day. There wasn't a universally agreed-upon

frequency, with recommendations ranging from four to ten tests per day, particularly for

insulin-dependent diabetes patients (Moreddu et al., 2021). This variation arose due to

differences in factors like activity levels, lifestyle choices, insulin injection regimens, and

individual agreements between patients and their doctors. Despite this, many patients

struggled to adhere to the strict SMBG schedule required to delay the onset and slow the

progression of diabetic complications such as retinopathy (eye damage), nephropathy (kidney

damage), and neuropathy (nerve damage) that could even lead to limb amputations (Moreddu

et al., 2021).

The concept of implantable glucose sensors had been floating around for over 40 years (Cope

et al., 2017). However, it wasn't until extensive research and development efforts that the first

commercially available transdermal implantable glucose sensors hit the market in the late

1990s and early 2000s. Unfortunately, these pioneering sensors had limitations in their

clinical usefulness. Their sensitivity drifted significantly over the short, FDA-approved three-

day implantation period. This unexpected decline in performance in real-world use, despite

promising results in controlled laboratory settings, dampened enthusiasm for this early

iteration of continuous glucose monitoring (CGM) technology (Ma et al., 2021).

Since those early days, CGM has undergone significant technological advancements,

revolutionizing diabetes care. It is now widely recognized that CGM plays a crucial role in

improving quality of life. By providing a more comprehensive picture of blood sugar levels,

5
it empowers people with diabetes to make informed decisions about their management,

leading to better overall health and a reduced risk of complications (Deng et al., 2022). While

the upfront cost of CGM might be higher, the long-term health benefits are believed to be

cost-effective compared to the ongoing expense of daily test strips. However, there is still

ongoing debate regarding the definitive cost-effectiveness of CGM technology (Badugu et

al., 2018).

It's noteworthy that in 2018, during an industry summit, the hybrid closed-loop insulin

delivery system, which integrates with a glucose sensor, was hailed as a ground breaking

medical technology (Badugu et al., 2018).

The next wave of innovation is poised to focus on perfecting artificial pancreas device (APD)

systems with long-lasting, functional implantable sensors that can effectively maintain

normal blood sugar levels. As advancements in diabetes management continue to unfold, the

development of highly accurate and long-term functional glucose sensors remains a critical

factor in the success of future APD systems. While insulin infusion systems, another crucial

component of APDs, have their own set of challenges related to their current FDA approval

limitations (restricted to three days of consecutive use), they are not the primary focus of this

discussion on CGM technology advancements (Lee et al., 2018).

2.2 Blood Sugar Chart (Glucose Chart Level)

A blood sugar chart provides valuable guidance for individuals to understand their blood

sugar levels at different times of the day. While doctors commonly utilize these charts to set

goals and monitor diabetes treatment plans, they also serve as helpful tools for individuals

managing their diabetes. Ideal blood sugar levels vary based on individual factors, and

doctors collaborate with patients to establish suitable targets for different times of the day,

considering factors such as waking up, meals, and physical activity. The charts presented here

6
offer a general overview of recommended blood sugar levels throughout the day,

emphasizing the importance of adhering to the range advised by a healthcare provider.

Various methods are available for measuring blood glucose levels, including the A1C test,

continuous glucose monitoring (CGM), and self-monitoring through fingerprick tests. These

tools help individuals manage their blood sugar levels effectively and understand their overall

glycemic control. A doctor provides guidance on managing blood sugar levels that fall

outside the target range and may adjust targets based on individual circumstances, such as

age, health conditions, duration of diabetes, and lifestyle factors.

Blood sugar targets vary throughout the day, typically being lower before meals and exercise

and higher after meals. Individual factors, including age, health conditions, and lifestyle

habits, are considered when determining these targets. Blood sugar charts commonly

represent recommended levels as a range, recognizing variations among individuals and the

need for personalized management approaches as shown in Figure 2.1.

Figure 2.1: Blood Sugar Chart

7
2.3 Future Requirements for Advanced CGM Technology

2.3.1 The Growing Burden of Diabetes and its Management

The global rise in diabetes and its associated complications paints a concerning picture. This

translates to an unsustainable increase in healthcare spending, adding further strain to an

industry already consuming nearly 20% of the Gross Domestic Product (GDP). The situation

is further compounded by a shortage of healthcare providers struggling to meet the growing

demand (Jeon et al., 2019).

Effective diabetes management requires intensive efforts to normalize blood sugar levels and

prevent both short-term and long-term complications. This translates to lower healthcare

costs and reduced premature mortality rates. Self-management forms the cornerstone of

diabetes care, encompassing activities like glucose monitoring, insulin replacement therapy

(for some), dietary modifications, and regular exercise. However, successful self-

management demands complex problem-solving skills, access to social support systems, and

readily available, high-quality healthcare resources.

2.3.2 One-Size-Fits-All Approach

Currently, most sensor technology operates under a "one-size-fits-all" approach. This fails to

consider the unique needs of different patient sub-populations, including senior citizens,

ethnic minorities, children, adolescents, and individuals with limited financial resources.

Future advancements in diabetes technology must address this gap in inclusivity.

2.3.3 The Ideal CGM for the Future

The next generation of sensor technology should cater to a broader spectrum of the diabetic

population. Ideally, these devices would be:

8
i. Sized appropriately: Tailored to the specific needs and physical characteristics of

different user groups.

ii. Easy to use: Designed for user-friendliness and straightforward implementation.

iii. Cost-effective: Affordable and accessible to a wider range of patients.

These advancements could be further enhanced by integrating them with:

i. Behavioral interventions: Programs that promote patient and family-centered care,

encouraging active participation in diabetes management.

ii. Decision support tools: Technology that empowers clinicians with data-driven

insights to optimize treatment decisions.

While significant strides have been made in CGM technology, its widespread adoption in

clinical practice is hindered by a combination of biological, pharmacological, and

socioeconomic factors. These factors need to be addressed in conjunction with technological

advancements to unlock the full potential of CGMs.

When designing the next generation of fully implantable CGMs, careful consideration should

be given to the cellular level response. Key players in this response include various immune

cells like neutrophils, monocytes, macrophages (including different sub-types), mast cells,

dendritic cells, and T cells. Future studies should focus on developing sensor coatings,

potentially incorporating tissue response modifiers. The goal of such advancements would be

to control the function of specific inflammatory cells, promoting better tissue integration and

long-term functionality of implantable glucose sensors (Chen et al., 2022).

9
2.4 Some exisiting Glucose Monitoring Devices

2.4.1 Dexcom G6

The Dexcom G6 is a sensor you wear on your abdomen that transmits information to a

corresponding app you can download on your phone, tablet, or smartwatch. Users like the

fact that the sensor transmits this data automatically every 5 minutes. What sets the Dexcom

G6 apart from other types of CGMs is its ability to complement other devices you might have

for your diabetes management. These include insulin pumps. One of the most common

complaints is that you have to change out your sensor every 10 days, versus longer wear on

other CGM devices. What’s included in the device are auto-applicator, under-skin sensor,

and transmitter; data is viewable on your Apple or Android device

Figure 2.2: Dexcom G6

2.4.2 Contour Next One

The meter can read your glucose in as little as 5 seconds. And if the first sample wasn’t

sufficient, there’s second-chance sampling, which means you can apply more blood to the

test strip within 60 seconds. It helps prevent wasting test strips and saves you money in the

long run. This system is particularly great for beginners because it’s simple and intuitive. The

smartlight feature provides near-instant blood glucose results by displaying green, amber, or

red lights to indicate above, within, or below your target range.

10
Contour also has an easy-to-use smartphone app that supports diabetes self-management, by

adding insight and meaning to your results that sync automatically through Bluetooth.

Figure 2.3: Contour Next One

2.4.3 Nutrisense CGM

Nutrisense is designed for anyone who wants to learn more about their blood glucose levels.

The company takes care of the CGM prescription and provides you with access to one-on-one

support from a nutritionist. Cost depends on the duration of plan you choose and includes

CGMs, free shipping on monthly CGM deliveries, 1 month of free nutritionist support (after

that, the cost is $100 per month), and access to app features and a members only community.

Figure 2.4: Nutrisense CGM

11
2.4.4 FreeStyle Libre

The FreeStyle Libre first debuted on the market in 2017. Like other CGMs, it uses interstitial

fluids instead of blood to measure blood glucose. You use the Libre by wearing a sensor on

your upper arm. It’s a flash system, which means you wave an accompanying monitor above

the sensor in order to get your glucose readings. You can repeat the process as often as you’d

like. To keep the Libre system working, you have to reapply a new sensor to your arm every

14 days. One downside to this CGM is that it can be a little confusing to keep track of their

latest models that have the same names.

Figure 2.5: FreeStyle Libre

2.5 Importance of Continuous Glucose Monitoring

In the last few decades, the number of diabetic patients has experienced an astonishing

growth, making diabetes a chronic disease that has aroused widespread concern worldwide.

Although diabetes is not a fatal disease, it could lead to a series of severe complications and

even death (Guo et al., 2021). Therefore, it is acknowledged that blood glucose monitoring is

essential for diabetes management. The conventional method for glucose quantification is the

finger-prick measurement which accesses blood in fingertip capillaries and measures glucose

concentration through an enzyme electrochemical reaction. However, frequent pricking

12
measurements can bring discomfort and pain to patients, leading to an increase of risks of

infection and tissue damage (Elsherif et al., 2018).

For diabetic patients, it's essential to know and control the blood glucose level, which varies

throughout the day. For DM patients, 3–4 times of finger pricking is needed to avoid any

complications generated because of hypo and hyperglycemia. Therefore, finger-pricking is

not suitable for several measurements a day. This conventional method provides the blood

glucose levels for the time they are taken. So, this means that it cannot predict the future

blood glucose levels and any fluctuation that happens afterward. For example, these

measurements can't be taken during sleep, increasing the risk of high and low blood sugar

levels. For diabetic patients, the treatment is vital in case of ups and downs in blood glucose

levels. This problem leads to the need for a device with the ability to monitor continuous and

real-time glucose levels 24/7 (Health Quality Ontario, 2018).

Continuous glucose monitoring (CGM) is the term used for devices which can monitor the

real-time blood glucose level round the clock. Therefore, CGM sensors can measure the

dynamic changes in blood glucose levels for DM patients. For example, measuring blood

glucose levels during physical activity is of utmost importance. For example, a CMG sensor

was employed to monitor DM patients' dynamic blood glucose levels during a marathon.19

The measurements were recorded for hypo and hyperglycemia during and after the marathon

of 42/15 km. A total of 247 readings were recorded for 257 min of running (Klueh et al.,

2016).

In addition, a study of dynamic blood glucose changes in DM patients due to cystic fibrosis

disease was also reported. Therefore, CGM is vital for diabetic individuals to maintain a

healthy and balanced lifestyle by controlling diet, physical activity, and timely medicine

intake by knowing real-time blood glucose levels (Mariani et al., 2017).

13
Currently, advanced sensors are developed for CGM, which are mainly based on the

electrochemical approach. CGM devices measure the concentration of glucose in interstitial

fluid (ISF), whose glucose level can be representative of blood glucose level (BGL) (Chen et

al., 2022). Companies include Medtronic, Abbott, and Dexcom, which have contributed to

the development of CGM devices and have successfully commercialized several generations

of CGM sensors, leading the market of wearable CGM sensors. Also, CGM sensors have

potential in subcutaneous tissue glucose monitoring as some of the CGM sensors are

implanted in subcutaneous tissues. For example, most CMG sensors are implanted under the

skin to record blood glucose levels. Many studies have reported blood glucose monitoring in

subcutaneous tissues. But there are limitations for the implanted sensors like size, shape,

duration of implantation and biocompatibility of the sensor with human tissue (Novak &

Reichert, 2015).

Nevertheless, those electrochemical-based glucose sensors still have issues in terms of long

lifetime, portability, and accuracy. Therefore, researchers tried to find and develop

alternatives to these sensors and create more affordable, invasive/minimally invasive, and

user-friendly CGM sensors.23 Optical measurement is a promising platform for glucose

sensing. Some technologies have been reported with high potential in continuous glucose

sensing, including spectroscopy (NIR, MIR, Raman), fluorescence, holographic technology,

etc. (Elsherif et al., 2021).

It is noticeable that a CGM sensor based on fluorescence sensing, called Eversense, has been

developed by Senseonics Company and put on the market. This fluorescence-based sensor

presents a much longer lifespan in comparison with electrochemical sensors (Petrie et al.,

2017).

14
3.0 Proposed System Development Methodology

The system will be design to be a portable wearable lens which can be wore by a patient

suspecting to have diabetes. The design will include the design analysis of the block diagram

that will indicate what the system shall be made up of. Also, the working principle of the

contact lens to its way of measuring the glucose level.

3.1 Proposed Block Diagram of the System

The block diagram of the system will depict the overall architecture and functionality of the

wearable CGM device and the associated remote monitoring system. The main blocks in the

diagram will include:

i. Glucose Sensor: Measures glucose levels in tears.

ii. Microcontroller Unit (MCU): Processes sensor data and controls system operation.

iii. Transmitter Module: Wirelessly transmits data to a remote device.

iv. Power Supply: Provides electrical power to the system (e.g., battery).

v. Remote Monitoring Device: Receives and analyzes glucose data transmitted from the

the glucose sensor.

vi. User Interface: Displays glucose readings and provides user interaction.

15
POWER SUPPLY UNIT

(BATTERY)

LCD
ARDUINO DISPLAY
NANO MICRO-
GLUCOSE
CONTROLLER
SENSOR
REMOTE

MONITORING

DEVICE

(PHONE)

USER

INTERFACE

Figure 3.1: Block Diagram of the System

16
3.2 Required Components for the device

3.2.1 Glucose Sensor

The sensor will need to insert the small sensor underneath the skin on either the arm or the

abdomen. The sensor look attaches to the skin using a small needle or a sticky patch.

Figure 3.2: Glucose Sensor

3.2.2 Arduino Nano

The Arduino Nano is a small, complete, and breadboard-friendly board based on the

ATmega328 (Arduino Nano 3.x). It has more or less the same functionality of the Arduino

Duemilanove, but in a different package. It lacks only a DC power jack, and works with a

Mini-B USB cable instead of a standard one.

Figure 3.3: Arduino Nano

17
3.2.3 I2C LCD Display

An I2C LCD display is a type of liquid crystal display (LCD) that communicates using the

Inter-Integrated Circuit (I2C) protocol. This protocol allows for serial communication

between devices using only two wires, making it efficient for connecting peripherals to

microcontrollers or other devices.

Instead of requiring multiple wires for communication (e.g., data, clock, etc.), an I2C LCD

display only needs two wires: SDA (Serial Data Line) and SCL (Serial Clock Line). These

lines facilitate communication between the microcontroller and the LCD.

Figure 3.4: I2C LCD Display

3.3 Working Principle of the System

The working principle of the device revolves around the integration of miniaturized glucose

sensors, microelectronics, and wireless communication modules into a device The sensors

will measure glucose levels in blood, and the data will be transmitted wirelessly to a remote

device for real-time monitoring and analysis.

18
Start

Initialize the Continous Glucose Measuring Device

Connect the Glucose Sensor to the body


of patiernt

No
Is the Sensor properly
connected?

Yes
Measure the Glucose level of the patient

No
Is the Measured parameter
accurate?

Yes

Send to the Continous Glucose Mseasurement Mobile App

Stop

Figure 3.5: Flowchart of the Working principle of the System

19
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20
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