Input

Hard Core Computer System Characteristics
The Computational Element

The established input devices have proven themselves to be functional when used separately.  The innovation of the AGRID device is that AGRID will utilize newly created integrated software that will allow all of the separate components to work together.  This will help to eliminate the current need for constant user intervention to maintain healthy blood-glucose levels—which is one of our main goals.   Our other primary goal is to provide insulin-dependent diabetes with a device that is as non-invasive as current technology will allow.  In order to fulfill these requirement we will need to design new software as well as an integration device to run the software.
System Design/Development Configuration
           The design of this software is fairly straightforward.  The integration software will read in the previously defined inputs (see section 1).  Using these inputs the device will then determine which of 5 actions need to be performed.  The user’s blood glucose levels can either be within range, high, too high, low, or too low.  The functional diagram F.1 clearly illustrates the functionality of the AGRID device. 

 
System Integration Requirements
            The integration device must fulfill our established criteria.  In order to be considered successful the integration device must be able to read in the inputs (see section 1).  The integration device must come to a decision about action based on the inputs received.  Once the action has been determined, the integration device will put the required action into motion by sending information to the ultrasound device.  The ultrasound device will take the signal that it receives from the integration device.  The signal that the ultrasound component receives will determine the length of time that the ultrasound device emits the ultrasound rays.  The duration of the ultrasound session directly determines the rate at which the insulin is absorbed into the skin.
System Test Requirements
            To gain FDA-approval the AGRID device must undergo stringent testing.   Before designing the prototype we will first test our integration device to ensure its proper functionality.  We will have our software tested through an independent facility that will thoroughly test our integration software for any errors or defects in the program.  If there are defects within our software, they will be resolved during this phase.  We will try to have all components issues resolved before we reach the prototype development stage that corresponds with phase II of the SBIR.
Support Computer Based Application Programs
The Software Element
            The completion of this project requires the creation of new software that will allow for the integration of the following components: glucose monitor, insulin patch, and ultrasound device.  These three devices are all FDA-approved, currently available in the American market, and ready for use in our project.  Since all except for one of the components that we plan to use are available off-the-shelf we feel that the integration of the components will be successful.
Available Off the Shelf Administrative Applications
AIDA Freeware
            Available online at www.2aida.org there exists freeware that may have some use in the creation of our software.  The AIDA freeware helps insulin-dependent diabetics adjust their insulin dosage to better maintain their glucose levels.  We will be able to use this software to determine how much insulin should be dispensed in consideration of the current glucose levels and the carbohydrate intake.  With this information we will create switch case statements that will determine the actions taken by the integration device.
 Applications Written for Project
             If the integration device determines that the blood glucose levels are within the acceptable range then there will be no audible/visual warning and the information will be simply be sent to the ultrasound device that will adjust the skins level of permeability in taking into consideration the level of insulin that is required to bring the wearer’s glucose level to the optimum level of 100. 

If the glucose level/carbohydrates is either low/low or high/high an alarm notify the wearer while information is sent to the ultrasound device.  This warning alarm will steadily flash the wearer’s glucose level as well as produce an audible beep once every 5 seconds to notify the wearer.  The user can disengage this warning at any time with the push of a button located on the user interface.  If the wearer’s blood glucose levels reach the too high or the too low state, information will still be sent to the ultrasound device in an attempt to control the glucose levels.  The audible/visual warning will then enter the urgent state.  In the urgent state the flashing of the blood glucose levels and audible warning will still be performed; however, the frequentness in which they are done will be increased to once per second.  If in this state it will be recommended to the wearer that an injection of insulin be dispensed manually to quickly get the blood glucose levels within the desired range.  This user will also be able to disengage this warning if desired.  If there is no user intervention then the warning alerts will shut off automatically once the blood glucose levels fall with the acceptable range.  In all cases the integration device will notify the ultrasound component to make adjustments to skins permeability.

The established ranges of the AGRID devices are defined within table T.1.  These ranges have been chosen in accordance to what the American Diabetes Association has determined to be acceptable glucose levels.  The average carbohydrate intake level that should be consumed by diabetics for each meal has determined the carbohydrate intake ranges that have been established in this table.  The integration device will then perform the explicit that corresponds with the inputted information.

 

Inputs

Outputs

 

Case Number

 

Glucose Level

 

Carbohydrates

 

Insulin Level

 

Warning State

1

Too Low

--

Minimal

Low Warning (Urgent)

2

Low

Low

Minimal

Low Warning

3

Low

Normal

Minimal

Off

4

Low

High

Minimal

Off

5

Normal

Low

Minimal

Off

6

Normal

Normal

Continuous

Off

7

Normal

High

Continuous

Off

8

High

Low

Continuous

Off

9

High

Normal

Increase

Off

10

High

High

Increase

High Warning

11

Too High

--

Increase

High Warning  (Urgent)

                                                                                    

 

 

 

 

 

 

 

 
 

Glucose Level

Too Low

<= 50

Low

51-80

Normal

81-130

High

131-300

Too High

> 300

Carbohydrates

Low

<= 5

Normal

6-15

High

> 15

 

 

 

Insulin Level 10/20/30 mg

Minimal

.2/.4/.6 mg/h

Continuous

.4/.8/1.2 mg/hr

Increase

Increased Linearly

 

 

 

Unique Produce’s Domain Specific Applications

The AGRID device is designed for insulin-dependent diabetics.  AGRID will not be helpful to those diabetics who are reckless in the management of their diabetes regimen.  Our product will also not be beneficial to those who would not benefit from the dispensing of insulin.  The benefits of using this device are that a normally invasive, painful process will be made simple and non-intrusive.  

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