Insulin Pump Assignment by prittynazo

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									          REPORT
            FOR
    AUTOMATIC INSULIN PUMP




              PREPARED BY:            nicegirl_laj@hotmail.com
                                        wardahkafeel@gmail.com




Department of Electronics and Information Technology
   Lahore College for Women University, Lahore
Automatic Insulin pump




TABLE OF CONTENTS
      1.    Introduction: .................................................................................................... 1
           Type 1 Diabetes .......................................................................................... 2
           Type 2 Diabetes .............................................................................................. 2
           Gestational Diabetes ....................................................................................... 2
      2. Scope: .............................................................................................................. 3
      3. The insulin pump hardware organization: ...................................................... 3
      4. Need: ............................................................................................................... 4
      5. Requirements for the insulin pump:................................................................ 4
      6. Risks Analysis ................................................................................................. 5
            6.1 Business Impact Risks: ............................................................................ 5
            6.2 Customer related risks: ............................................................................ 5
            6.3 Technology risks: ..................................................................................... 6
      7. Risk table: ....................................................................................................... 6
            7.1 Technology will meet expectations: ......................................................... 6
            7.2 End users resist system: ........................................................................... 7
            7.3 Changes in Requirements ......................................................................... 7
            7.4 Lack of development experience: ............................................................. 7
            7.5 Poor quality documentation: ..................................................................... 8
      8. Insulin delivery system ................................................................................... 8
      9. Requirement Models ....................................................................................... 9
      10.      Interfaces For The Automatic Insulin Pump ............................................. 10
      11.      Data Flow Diagram ................................................................................... 14
      12.      Summary ................................................................................................... 15
      13.      References ................................................................................................. 16




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Automatic Insulin pump


1. Introduction:

The problem of diabetes is a growing concern in the world, especially among Americans.
Diabetes is a medical condition where the body does not manufacture its own insulin. Insulin is
used to metabolize sugar and, if it is not available, the person suffering from diabetes will
eventually be poisoned by the build-up of sugar. It is important to maintain blood sugar levels
within a safe range as high levels of blood sugar have long-term complications such as kidney
damage and eye damage. These are not however, normally dangerous in the short-term. Very low
levels of blood sugar (hypoglaecemia) are potentially very dangerous in the short-term. They
result in a shortage of sugar to the brain which causes confusion and ultimately a diabetic coma
and death. In such circumstances, it is important for the diabetic to eat something to increase their
blood sugar level.
An estimated 23.6 million people in the United States—7.8 percent of the population—have
diabetes, a serious, lifelong condition. Of those, 17.9 million have been diagnosed, and 5.7
million have not yet been diagnosed. In 2007, about 1.6 million people ages 20 or older were
diagnosed with diabetes




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Automatic Insulin pump

The three main types of diabetes are

       type 1 diabetes
       type 2 diabetes
       gestational diabetes


 Type 1 Diabetes
Type 1 diabetes is an autoimmune disease. An autoimmune disease results when the body’s
system for fighting infection—the immune system—turns against a part of the body. In diabetes,
the immune system attacks and destroys the insulin-producing beta cells in the pancreas. The
pancreas then produces little or no insulin. A person who has type 1 diabetes must take insulin
daily to live.
 Type 2 Diabetes
The most common form of diabetes is type 2 diabetes. About 90 to 95 percent of people with
diabetes have type 2. This form of diabetes is most often associated with older age, obesity,
family history of diabetes, previous history of gestational diabetes, physical inactivity, and certain
ethnicities. About 80 percent of people with type 2 diabetes are overweight.
 Gestational Diabetes
Some women develop gestational diabetes late in pregnancy. Although this form of diabetes
usually disappears after the birth of the baby, women who have had gestational diabetes have a 40
to 60 percent chance of developing type 2 diabetes within 5 to 10 years. Maintaining a reasonable
body weight and being physically active may help prevent development of type 2 diabetes.

The easiest way for Type 2 patients to manage their health is through a healthy diet and exercise
plan. For Type 1 patients, treatment almost always involves the daily injection of insulin, which is
the focus of the Automated Insulin Pump System (AIPS). Currently, there are two ways in which
a patient can administer insulin. In the first method, the user must check his or her blood sugar
with a glucose sensor, calculate the appropriate amount of insulin to administer, and personally
inject the insulin. In the second method, the patient uses an AIPS. The AIPS detects the level of
glucose in the user’s blood, calculates the amount of insulin need, then triggers a pump to
administer the correct dosage to the user via a needle that inserted into the user. Both of these
methods require the user to play a critical role in his or her treatment. Using the AIPS minimizes
the possibility of errors occurring. To accomplish this, the AIPS integrates the blood glucose
sensor and the insulin pump into one system. Integrating these two processes allows the
autonomous delivery of insulin to the user. This ability of the system to remove the user from the
glucose self monitoring and injection process allows diabetics to live a healthier and more
enjoyable lifestyle.




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Automatic Insulin pump


2. Scope:

We are developing a that system measures the level of blood sugar every 10 minutes and if this
level is above a certain value and is increasing then the dose of insulin to counteract the increase
is computed and injected into the diabetic. The system can also detect abnormally low levels of
blood sugar and, if these occur, an alarm is sounded to warn the diabetic that they should take
some action.
This report focuses on the control software for the insulin pump which is concerned with reading
the blood sugar (glucose) sensor, computing the insulin requirements and controlling the micro
pump which causes the insulin to be delivered.
Automatic insulin delivery systems help to keep blood glucose level under control. Administering
insulin with different methods aims to improve patient's comfort and convenience.
Automated Insulin pumps are little computerized insulin deliverers. Automatic insulin delivery
systems can be used for treating type 1 diabetes, type 2 diabetes, gestational diabetes, juvenile
diabetes, diabetes mellitus and alike. But, the information about diabetes is crucial for having the
perfect diabetes medication.

3.   The insulin pump hardware organization:

An insulin pump is a safety-critical system which is used to deliver regular doses of
insulin to diabetics. A block diagram of the insulin pump assembly is shown below. Note
that the small boxes marked s indicate a sensor.




                      Figure 2: The insulin pump hardware organization




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Automatic Insulin pump



 Needle assembly
Connected to pump. Component used to deliver insulin into diabetic’s body.
 Sensor
Measures the level of sugar in the patient’s blood. The input from the sensor is represented by
Reading in the following specification.
 Pump
Pumps insulin from a reservoir to the needle assembly. The value representing the number of
increments of insulin to be administered is represented by dose! in the following specification.
 Controller
Controls the entire system. This has a three position switch (off/auto/manual) plus a button to set
the number of units of insulin to be delivered (1 unit per press). Moving the switch to the manual
position causes the blood sugar measurement and automated insulin delivery to be disabled but
information is maintained about the amount of insulin delivered and the reservoir capacity.
 Alarm
Sounded if there is some problem. The value sent to the alarm is represented alarm! In the
following specification. Displays There are 3 displays. These displays are represented by
display1, display2 and clock in the following specification. display1 displays system messages,
display2 shows the last dose of insulin delivered and clock shows the current clock time.
 Clock
Provides the controller with the current time. The system clock is initialized when the machine is
installed and the start time of each 24-hour period is set at midnight each day using a hardware
interface on the machine. For safety reasons, the clock cannot be altered by system users.

4. Need:

With almost 200 million with diabetes world wide and about 400,000 patients currently on insulin
pumps, there is sufficient market potential to spur further development, and at least 6 companies
are selling devices in the U.S. Very short clinical trials have proven the concept of a closed-loop
system, but the technology must catch up for long-term implantation. By 2015 there could well be
an implanted closed-loop system on the market. It will likely take several years longer before it is
clear when the device is a superior alternative to other advancing technologies.

5. Requirements for the insulin pump:

This specification is a specification of the requirements for the control software for the insulin
pump. It is NOT a complete system requirements specification for the pump itself or even all of
the software associated with the pump. In particular, it does not include a specification of the self-
testing operations or a specification of the hardware interfacing. The requirements for the insulin
pump are specified in natural language and partially in the Z specification language. Z is not ideal
to express all requirements but is useful when precise descriptions are required. In all cases, the Z
specification should be considered as an annotation that provides detailed information which
augments the natural language specification.




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Automatic Insulin pump




                                     Figure 2: Insulin pump


6. Risks Analysis:

Alarm condition Explanation:

Alarm conditions            Explanation
Battery low                 The voltage of the battery has fallen to less than 0.5V
Sensor failure              The self-test of the sugar sensor has resulted in an error
Pump failure                The self-test of the pump has resulted in an error
Delivery failure            It has not been possible to deliver the specified amount of insulin
Needle assembly removed     The user has removed the needle assembly
Insulin reservoir removed   The user has removed the insulin reservoir
Low insulin level           The level of insulin is low (indicating that the reservoir should be
                            changed).
                         Table 1: Error conditions for the insulin pump.


6.1 Business Impact Risks:
The number of the customer is fairly high. There is large number of users of insulin pump.
Their need is considered consistent as all target users will be patients of diabetes.

Sophistication of end users:
Low, the target users are patients of diabetics. Automatic insulin pump is designed to be easy to
use, and is supplied with directions to guide through all necessary steps in using the machine.

6.2 Customer related risks:
Past coordination:
We are developing software because of the increased of diabetes among which children are also
included. So to give them facility we are developing complete new program that will help them a
lot.

 Customer information:
Customer has the idea how to use it because of already available automatic pumps in the market
but this one is more sophisticated and all directions are given with it as well.



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Automatic Insulin pump



6.3 Technology risks:
Familiarity:
Automatic insulin pump is a software tool to aid diabetic patients. Development team members
are familiar with software development, as well as the necessary data base implementation.

Specialized user interface:

The interface is completely specialized. It is not based on anything other than every other
Microsoft Windows application out. The GUI is completely our design and no other application
out (to our knowledge) contains exactly what is expected of our software.


7. Risk table:


   Risks                                             Probability           Impact
   Technology will meet expectations                 25%                   1
   End user resist system                            20%                   1
   Changes in requirement                            20%                   2
   Lack of development experience                    20%                   2
   Poor quality documentation                        35%                   2

Impact Values:
1 – Catastrophic
2 – Critical
3 – Marginal
4 – Negligible

7.1 Technology will meet expectations:
 Mitigation
In order to prevent this from happening, meetings (formal and informal) will be held with the
customer on a routine business. This insures that the product we are producing, and the
specifications of the customer are equivalent.

 Monitoring
The meetings with the customer should ensure that the customer and our organization understand
each other and the requirements for the product.

 Management
Should the development team come to the realization that their idea of the product Specifications
differs from those of the customer, the customer should be immediately notified and whatever
steps necessary to rectify this problem should be done. Preferably a meeting should be held
between the development team and the customer to discuss at length this issue.




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Automatic Insulin pump



7.2 End users resist system:

 Mitigation
In order to prevent this from happening, meetings (formal and informal) will be held with the
customer on a routine business. This insures that the product we are producing, and the
requirements of the customer are equivalent.

 Monitoring
The meetings with the customer should ensure that the customer and our organization understand
each other and the requirements for the product.

 Management
Should the development team come to the realization that their idea of the product requirements
differs from those of the customer, the customer should be immediately notified and whatever
steps necessary to rectify this problem should be taken. Preferably a meeting should be held
between the development team and the customer to discuss at length this issue.


7.3 Changes in Requirements

 Mitigation
In order to prevent this from happening, meetings (formal and informal) will be held with the
customer on a routine business. This insures that the product we are producing, and the
requirements of the customer are equivalent.

 Monitoring
The meetings with the customer should ensure that the customer and our organization understand
each other and the requirements for the product.

 Management
Should the development team come to the realization that their idea of the product requirements
differs from those of the customer, the customer should be immediately notified and whatever
steps necessary to rectify this problem should be taken. Preferably a meeting should be held
between the development team and the customer to discuss at length this issue.

7.4 Lack of development experience:

 Mitigation
In order to prevent this from happening, the development team will be required to learn the
languages and techniques necessary to develop this software. The member of the team that is the
most experienced in a particular facet of the development tools will need to instruct those who are
not as well versed.

 Monitoring
Each member of the team should watch and see areas where another team member may be weak.
Also if one of the members is weak in a particular area it should be brought to the attention by
that member, to the other members.




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Automatic Insulin pump



 Management
The members who have the most experience in a particular area will be required to help those
who don’t out should it come to the attention of the team that a particular member needs help.
7.4 Poor quality documentation:
     Mitigation
In order to prevent this to happening, members who are in charge of developing the
documentation will keep in contact with witch developer on the team. Meeting will be held
routinely to offer documentation suggestions and topics. Any topic deemed missing by a
particular developer will be discussed and it will be decided whether or not to add that particular
topic to that documentation. In addition, beta testers will be questioned about their opinion of the
documentation.

 Monitoring
Throughout development or normal in and out of house testing, the development team and or beta
testers will need to keep their eyes open for any possible documentation topics that have not been
included.

 Management
Should this occur, the organization would call a meeting and discuss the addition of new topics,
or removal of unnecessary topics into the documentation.


8. Insulin delivery system




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Automatic Insulin pump


9. Requirement Models




                     Figure 3: Requirement Use Case Diagram




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Automatic Insulin pump




10. Interfaces For The Automatic Insulin Pump

The user interface displays all relevant system information to the user, as well as all controls
needed to operate the system in ―manual‖ mode. The GUI displays the current time, the last time
a dose of insulin was administered, and the corresponding amount of that dose. If any hardware
component malfunctions while the system is running, a system alarm indicator activates,
prompting the user to check the system messages. This alarm is both auditory and visual. By
scrolling through the system messages, the user can isolate the source of the error and take
appropriate measures. Other indicators on the GUI show the level of charge in the battery and the
amount of insulin remaining in the reservoir, there is also a history button which displays a table
containing a history of blood sugar values and doses.




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Automatic Insulin pump




                         Figure 5: System User Interface.




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Automatic Insulin pump




                  Figure 6: System User Interface During Failure




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Automatic Insulin pump




                          Figure 7: Table of history of the system.

Besides displaying relevant system information, the user interface also functions as a control
panel for manual operation of the insulin pump. To deliver a manual dose of insulin, the toggle
switch controlling the operation mode must be set to manual. Once the system is running in
manual mode, the user may press the ―Inject 1 Unit‖ button to deliver one unit of insulin. Even in
manual mode the system users decisions are checked make sure they do not exceed the maximum
daily dose. Figure 7 illustrates the error message from attempting to deliver more than the
maximum daily dosage.




           Figure 8: Visual Notification of Maximum Insulin Dose for the Day.

In addition to the User Interface a hardware simulator was design and coded to run on beneath the
insulin pump and provide the backend with different state levels for the various internal variables.
Figure 8 displays the portion of the GUI that displays the internal variables.




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Automatic Insulin pump


11. Data Flow Diagram




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Automatic Insulin pump

12. Summary
• There may be at least 640,000 who good candidates for the insulin pump. It is an especially
useful advance for many type 1 patients whose glucose control is difficult to manage and require
several injections of insulin and glucose checks a day. It is still unclear when the pump is
beneficial for type 2 patients.
• The technology has come a long way with an integrated system that continuously monitors
glucose, a management system with algorithms providing advice on amount of insulin required
and an external pump injecting insulin through a subcutaneous canula. This ―advise you‖ open
loop system dramatically increases the complexity of management. It has beneficial for those
dedicated to its use, but it is unclear when it should be used.
• Diabetes experts feel current pumps (with or without continuous glucose monitoring) are best
used by those who are knowledgeable, very meticulous in their diabetes management and accept
fact that the system requires a lot of attention. These people value the benefits of the pump.
Others do not desire using a pump system and get about the same satisfactory results with
multiple daily injections as they would by trying to manage a pump.
• Controlled studies on the benefits of insulin pumps and continuous glucose monitoring are still
needed to demonstrate a clear benefit over other aggressive therapeutic options. This applies to
both type 1 and type 2 patients.
• The current integrated system is very expensive – up to $7,500 a year for the disposable sensors,
canulas and insulin plus the cost of the pump. It requires insertion of new glucose sensors and
insulin canulas every 3 days or more often and attention to detail in safely keeping all the
components functioning properly. Focused attention is also required in adjusting and
administering bolus insulin doses.
• Many insurers provide reimbursement for the pump. Diabetes advocacy groups (JDRF & ADA)
are working hard to secure insurance and Medicaid coverage for the continuous glucose
monitoring component with its expensive disposable components.
• Within the next 2-4 years, an implanted pump will be available that will allow more freedom,
but at more expense and risk. It will work like the new external pumps and can be used with the
independent subcutaneous glucose monitor. It will not be a closed-loop system.
• With over 400,000 people worldwide currently using pumps and many more considering pump
usage, there appear to be sufficient marketplace incentives to encourage technological advances.
Our rough estimates suggest 650,000 in the US might benefit from these systems.




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Automatic Insulin pump



13. References
                http://74.125.155.132/search?q=cache:-
                 valCGvPRHEJ:www.comp.lancs.ac.uk/computing/resources/IanS/SE7/Ca
                 seStudies/InsulinPump/Slides/Insulin-
                 pumpOverview.ppt+scope+of+diabetes+in+software+engineering&cd=1
                 &hl=en&ct=clnk&gl=pk
                http://www.comp.lancs.ac.uk/computing/resources/IanS/SE7/CaseStudies/
                 InsulinPump/index.html
                http://www.altfutures.com/DRA/Automated_Insulin_Control.pdf
                http://www.comp.lancs.ac.uk/computing/resources/IanS/SE7/CaseStudies/
                 InsulinPump/Documents/InsulinPumpRequirements.pdf




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