Insulin Delivery Electronic Logging

Insulin Delivery Electronic Logging

Insulin Delivery Electronic Logging

Author Stephen T. McNulty 5/6/2009

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Insulin Delivery Electronic Logging

Table of Contents Objective.................................................................................................................................................... Preface........................................................................................................................................................ Glucose Level Testing................................................................................................................................ Daily Cycle................................................................................................................................................ Logging Glucose Readings and Injection Amounts................................................................................... Manual Entry Form.................................................................................................................................... Data Table.................................................................................................................................................. Components............................................................................................................................................... Insulin Delivery.....................................................................................................................................7 Glucose Level Testing Meter.................................................................................................................7 Management Software...........................................................................................................................8 Interface.................................................................................................................................................8 Diabetic Information Handling Systems.................................................................................................... Proposed System Description.................................................................................................................. Considerations..........................................................................................................................................

Objective

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Insulin Delivery Electronic Logging

Provide a manual insulin delivery system that electronically stores usage with a date and time stamp. Along with data storage capabilities, this unit will need to have the ability to transfer data to a desk top computer. The interface for this unit should be compatible with other interface cables already in use for glucose testing meters. The software to support this unit will need the capability of sending the dosage data to other diabetic management software or receiving glucose meter readings from other manufactures software. The software will need the ability to change time/date settings of the unit, and reset/erase the memory. There are several manufacturers of pen/cartridge insulin delivery systems. This proposal does not deal with the cartridge or it's content. This proposal is concerned with the pen that holds the cartridge. OptiClik was chosen as an example because it has a built in digital display. Preface Several sections of this presentation are background material explaining the consequences caused by not keeping glucose levels in the target range. Along with this, is a diagram of the daily routine a diabetic must follow to treat their condition. Also included is a list of components used each day to test glucose levels and deliver insulin. To illustrate how someone would track their insulin usage a snapshot of a Manual Entry form and Data Table have been included. To better understand what a top end system would be like, the company information and website for that system have been added. And finally, to summarize what a electronic logging manual insulin delivery system would have a Proposed System Description has been added.

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Insulin Delivery Electronic Logging

Glucose Level Testing Testing blood glucose (sugar) levels tells you how well your treatment plan is working. By keeping your blood glucose close to normal levels, you can reduce the risk of eye disease, kidney and heart disease, and other diabetic complications. Daily Cycle Controlling glucose levels is key to good health. Many factors influence glucose levels. With proper management glucose levels can be regulated within the goal range prescribed by a physician. The process of managing glucose levels is a continuous loop. The results from the glucose level test determines insulin intake. W a k e u p fa s tin g te s t . D o n e in th e m o rn in g a fte r w a k e u p B e d tim e in je c tio n . a d ju s te d b a s e d o fa s tin g te s t a n in s tru c tio n s fro m p h y s ic ia n

T h is is n th e d y o u r

B r e a k fa s t in je is a d ju s te d b a fa s tin g te s t a b e in g e

B e d tim e te s t. D o n e p rio r to g o in g to s le e p a t n ig h t

D in n e r in je c tio a d ju s te d b a s e fa s tin g te s t a n b e in g e a

n. d d te

tio n . T h is e d o n th e d fo o d s te n

L u n c h fa s tin g te s t . D o n e p rio r to lu n c h

T h is is o n th e fo o d s n

L u n c h in je c tio n . a d ju s te d b a s e d fa s tin g te s t a n d b e in g e a te

D in n e r fa s tin g te s t . D o n e p r io r to d in n e r

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Insulin Delivery Electronic Logging

Logging Glucose Readings and Injection Amounts Logging glucose readings and insulin injection amounts can be performed manually or automatically. Automated logging of glucose readings is common and is a feature of most of todays glucose meters. Logging of insulin injection amounts has been automated but is rarely a feature of manual insulin deliver systems (see Diabetic Information Handling Systems section for example of an electronic system). Only high end insulin delivery pumps are capable of logging insulin usage. With manual insulin delivery systems users track usage using log books or manually entry data into diabetes management databases. Manual Entry Form This is from OneTouch® Diabetes Management Software. Users enter insulin use manually

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Insulin Delivery Electronic Logging

Data Table Data Table From OneTouch® Diabetes Management Software. Once glucose readings are downloaded from the glucose meter and insulin usage is manually inputted, tables and/or charts can be created.

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Insulin Delivery Electronic Logging

Components The components a diabetic has consist of a insulin deliver device, blood glucose level testing meter, management software and data interface. Insulin Delivery OptiClik Pen OptiClik has an digital display that indicates how many positive clicks (rotation to the right) the dosage knob has be rotated. There is NO memory or date/time stamp. Once the dosage button has been depressed and released the display is reset to zero.

Glucose Level Testing Meter OneTouch Ultra Mini Meter

OneTouch® UltraMini® has a down loadable, 500-test memory.

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Insulin Delivery Electronic Logging

Management Software OneTouch® Diabetes Management Software v.2.3.2 OneTouch Software is compatible with Microsoft(r) Windows(r) 98 Second Edition, Windows NT 4.0 Workstation Service Pack 6 or greater, Windows 2000 Professional SP4 or greater, Windows Me, and Windows XP Home and Professional SP2 or greater. This software does not support Vista. You can manually input insulin usage into OneTouch® Diabetes Management Software.

Interface OneTouch Interface Cable OneTouch™ Interface Cable, available in USB or 9-pin serial port format for connection to your desk top computer or laptop. The port on the meter is a stereo plug.

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Insulin Delivery Electronic Logging

Diabetic Information Handling Systems Medtronic CareLink Therapy Management Software Medtronic markets systems that will store data, deliver insulin and has software to manage this information. This is a state of the art system. Their delivery system is expensive and is not always approved by health insurance providers. “Welcome to the Medtronic CareLink Therapy Management Software for Diabetes. This Web-based system is designed to help you take information from all of your diabetes management tools – your insulin pump, continuous glucose monitor, blood glucose meter(s), and logbook – and organize it into easy-to-read charts, graphs and tables. These reports can help you and your health care provider discover trends and other information that can lead to improved therapy management for greater control.” Company information Medtronic Diabetes 18000 Devonshire Street Northridge, CA 91325-1219 Link to Medtronic CareLink Therapy Management Software https://carelink.minimed.com/patient/entry.jsp?bhcp=1

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Insulin Delivery Electronic Logging

Proposed System Description A insulin delivery device with electronic logging of insulin usage. Each use of the device will record dosage setting. A insulin delivery device with electronic logging of time/date stamp of usage. Each use will record the time and date of the usage A delivery device with electronic adjustment of time/date. Time and date will need to be adjustable. This could be achieved through the interface. Adjusting time through the interface would eliminate the need for external buttons on the device. USB to stereo plug interface. Current meters use this type of interface or Blue Tooth. Drivers to support downloading. Database program to combine glucose readings and insulin usage. Database software capable of importing glucose readings from meter or other databases.

Considerations The manufacture of this delivery system is probably FDA regulated. These unit are not covered by some health care insurance providers

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Insulin Delivery Electronic Logging

The End

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