User Manual
Contents
1. The following window appears as a Friendly Reminder to Update your RX asking if you need to update the prescription before reviewing MPP data Click Yes or No Page 23 of 33 Friendly Reminder to Update Rx x A Do you need to update the Rx before reviewing MPP data If you clicked No the following window fragment is shown Patient Enter body Patient Height weight BALL 66in 166 26 8 First you enter the virtualized patient s current body weight Using the height shown the patient s Body Mass Index is calculated You can change the height under Registration gt Patient Once the body weight is entered you will see the first Rx Check listed namely Check Body Mass Index Clicking on this line makes AlcManager check the BMI and the result is then shown in the green ellipse below Patient Enter body Patient Height weight Ban 166 According to the Report on the Dietary Guidelines for Americans 2000 your patient is over weight at 166 lbs Depending on the patient s height current body weight may be in the healthy range or it may be over or under ideal body weight When you click inside the green ellipse a new window opens to show the patient s body weight history over time When you click on the button labeled Analyze AlcManager will fit a regression line to the body weight history and indicate whether the body weight is stable rising or falling Once you dismiss this message box the second Rx Chec2. Simulated Patient Tutoring Mode The AlcManager comes with several Virtualized Patients simulations built in These are intended for teaching and training purposes There are four test cases included to reflect different patient types management with 1 diet and exercise 2 Regular Insulin and NPH Insulin R NPH also 3 multiple daily injections MDI and 4 Insulin Pump Note that the data are similar but not the same each time you log in to a given simulation case No changes are saved upon exiting Launch the AlcManager software Do NOT login or authenticate to an individual patient s account Select Prescriptions amp Treatment gt Managing Alc gt Virtualized Patients gt then choose the patient you would like to see See the screen shot below ersion 1 0 0 1 4 File Virtualization amp Demographics Prescriptions amp Treatment Diabetes Outcomes Glucose Management Help Virtualized Jodi Enter your Bx Prescription 41cManager Pro Managing 41c Virtualized Patients Diet only TE R NFH bid Emar e A ipo wave ot Exercise amp Activity Life Style HO Counting Stress Explore Four Educational Treatment Regimens Click to choose one of the following treatment simulations Diet only without any medications R NPH mixed Regular and NPH insulins injected twice a day MOI multiple daily injections of premeal shorter acting and pre bedtime longer acting insul
3. APP and filter the options to benefit the individual patient Users who acquire sufficient skills in self management are encouraged to filter treatment options in parallel with their physicians dashed line connector Managing A1c and Optimal Diabetes Control ODC With the cloud based AlcManager both patient and their physician can strive to optimize diabetes control Target levels for pre and post meal glycemia can be met When this occurs Alc levels settle in the target ranges The algorithms are designed to teach the users how to minimize medication doses and eliminate polypharmacy Under these circumstances the patient learns how best to manage body weight and work to bring their BMI into target ranges Finally optimal diabetes control achieved in this way is generally not accompanied by increased risks of hypoglycemia Precautions Caution Federal law restricts medical devices for sale on the order of a physician or properly licensed practitioner Caution AlcManager is a teaching resource that uses virtualized patients as Subjects It is not intended for use in real time diabetes management and should not be used as the basis for immediate drug dosing decisions Before creating any new glucose profile an adequate set of SMBG data points should be collected to form a complete meal period profile MPP This updates the virtualized patient An encounter teaching or tutoring session would use the updated MPP to demonstrate the
4. lt 50mg dl and after meal hyperglycemia gt 180mg dl can be set The Before Meal Range is the allowable spread that is suggested in the AACE ACS Guidelines 3 4 SMBG Data Entry Updating the Virtualization Click on the shortcut button labeled Pt s SMBG Or click on Diabetes Outcomes then on Enter your patient s or client s SMBG in the drop down list The Dialog box below reminds you to update the prescription before adding new SMBG data especially if Rx changes have been made Click Yes to branch to the Prescription Task Click No to continue Friendly Reminder to Update Rx x aN Do you need to update the Rx before adding SMBG data Page 20 of 33 e The window below is presented Follow the steps shown in red on the yellow background Meal Period Profile 4 Jodi test e Key in the date using the format shown eg 9 17 and Enter The computer knows the year yyyy You can also use 9 17 2013 and the Enter key e The hidden body weight field is exposed as shown on the next page Page 21 of 33 1 cManager MPP Data Entry Hypoglycemia Paver e Key in the Body Weight eg 123 and push the Enter key e Next you will see a blank new day with all the fields exposed in an electronic SMBG Diary as shown on the next page Page 22 of 33 Meal Period Profile 4 Jodi test Body Weight 145 MP Profile Breakfast Lunch Dinner Sleep 10 14 2014 Before After id Before After id Before After id
5. Before After ver Tue B B Bo L L L L D D D 5 5 Might SMBG Rx Glucophage 200 Gam Glucophage 20 14 Hurmalog Ti Starlix 60 ed Medications Januvia 25 1 HPH 15 H 150 3 Onglyza 2l comments EOE E h SMEG Profile 0 o Points Life Style Decision Support Alc Jo oOo Le soe Legends hhmm mg dl haven Hypoglycemia Fill in the SMBG readings in the spaces as displayed on the screen Either 4 or 7 point profiles are required as specified for each patient A minimum of 2 profile days are required to validate the medication modeling function predicted Alc level and do a treatment check SMBG Profile Points will indicate in the shaded areas when you have enough data for a valid treatment check Ideally there must be at least 2 SMBG readings at each profile point and these must be measured over the week previous to the current date 10 14 2014 shown on the left in the MP Profile column Notice Body Weight is always needed One weight value must be entered for each day BW should be measured 2X week preferably on rising in the morning A recent laboratory measurement of Glycated hemoglobin Aic can be entered if available If measured at this time you can also enter the patient s resting systolic diastolic blood pressure BP readings and resting heart rate rHR Understanding the Meal Period Glucose Profile and the Effects of Medication Changes Click on Diabetes Outcomes then on Check your Rx Prescription
6. E Use another account Remember my credentials Use another account Once the Password is accepted you are authenticated and you are authorized to access the private databases on the Virtual Server of your AlcManager Resource on the cloud All the drop down menu items in the Task bar will also become active Now you can explore the various features of your BCMC AicManager Each time you launch your AlcManager the Tasks window shown below will be presented Yersion 1 0 0 1 File Virtualization amp Demographics Prescriptions amp Treatment Diabetes Outcomes Glucose Management Help Pro User 4 amp 1cManager Pro 0 x Getting Started Pro User s AleManager Pro In the Tasks bar Click File to Authenticate and begin using your AlcAKanager Watch for Hover Clues when you hold your mouse pointer over an area of interest The above is the Start Window for a single user authenticating as an IDC user Page 13 of 33 Clicking the Start button allows you to authenticate so you can access the secure database AlcManager Pro File virtualization amp Demographics iment Diabetes utcomes Glucose Management The above is the Start Window for a health professional user with many patient users Clicking the Caduceus button allows you to authenticate as a health professional user IDCpro with many patient users Enter your UserName and Password here User Nam
7. Management and Beyond ssssssssess 8 Calculating and Displaying Alc Values ssssssssnsnsnunnsnunn2uunnnnusuunnnnnnnnnnnnnnnnnnn 9 Simulation of Prescription Drug Changes ccccccccccceceeeeeeeeeeeeeeeeeeeseeeeeseeeeeeees 10 Environmental Conditions that may Affect USC cccccseesssseeseseesseeneeeesesees 10 Set Up INSErUCTIO S siccectinciiectcnctcncicendeavinavcweadenriveeenerssncntewsierinnriteesecrieanteenns 11 Check OUT TNSEFUCCIONS irern rnrn AAR 11 Op rating TNSEFUCTIONS ciisissscriccitistvesntestensdenestnsnssewwenstensseesnrestiacdsewsverncssteense 11 Launching the ALCMaANAG Sr sissticnnitevcevesseneneectectivasenssanesenenenexnnineNeneesines 11 Creating a Secure LOGIN amp Virtualization cccccennneeeeeceennneeeeseeennneeeeseeenas 12 Entering New Patient Data and Virtualization ccccnseseecccennneeeeseeennneeenees 17 Entering Modifying the Rx Prescription ccccccssssnnssssseeeeeeeeeesessnnnneeeeees 18 SMBG Data Entry Updating the VirtualiZation cccceennsseecceennneeeeseeenes 20 Understanding the Meal Period Glucose Profile and the Effects of Medication CHANGES sicscinscccsrsiantcrvitsccnavindessanticcnisnansesasseceenssnnesscusnecaesnawees 23 Database BACK UD cisccsdisassacersssec pnnsseseaasanerivnancensa niaveatsaaceenssntasesignteseianees 27 Simulated Patient Tutoring MOEC ccccccennnneeeeeeeeeeeceeeecnneneeeeeeeeeeseoeeeennaaas 28 Deleting an active Patient USEF sssusss2225222
8. any medication changes The AlcManager software does not suggest any quantitative medication changes it models how the user s current MPP would have changed had the user made medication changes The changes in blood glucose are modeled on the drug s known dose response curve and scaled by whatever qualitative changes are explored by the user e Most available anti diabetic drugs including both oral and injected medications are included in the AlcManager Resource s databases The software is programmed with these drugs dose response characteristics e The user can explore the effects of any incremental changes whatsoever to the virtualized patient s prescriptions through the graphical user interface e These incremental medication changes when input into the AlcManager APP dynamically shift the displayed meal period profile according to the known dose response curve for the chosen medication e AlcManager then also displays a calculated Alc value based upon the revised displayed meal period profile after the medication changes This serves to anticipate the impact on Alc associated with the medication increments explored e The burden is on the health care provider to filter what medication changes may be appropriate and warranted for the real patient e If the health care provider surmises that a real patient s medication should be modified the recommended medication changes can be documented and the healthcare prov
9. effects of prescription changes AlcManager is not intended to replace but to enhance the clinical judgment of a licensed health care professional and increase knowledge Purpose of the AicManager Resource Indications for Use The AlcManager resource is intended for use by patients with diabetes to assist in understanding Alc management viewed as part of a circle of care Health care providers instruct monitor and encourage their patients use of the resource The resource supports the storage review and analysis of exemplary retrospective blood glucose data as well as information to aid in understanding Alc management It also assists the health care provider in tutoring patients about their personalized blood glucose and Alc targets in particular and the effects of changes in anti diabetes prescription medicines on Alc and various glucose profiles in general The Page 7 of 33 AicManager software is not intended to replace the care provided by a Licensed health care provider including prescriptions diagnosis or treatment Description of the AlcManager Resource The AlcManager Version 2 Resource includes software running as a remote application on virtualized server hardware that is cloud accessible The remote software is installed in and secured by cloud servers and network operating systems Access to the cloud system is with a simple Desktop Icon that is installed on a client s PC The AlcManager program s
10. glucose monitoring devices databases and drug prescriptions If you understand the Terms of Use you may click on either the I Agree or I do not Agree buttons Click Done to complete the Terms of Use Page 11 of 33 Creating a Secure Login amp Virtualization BCMC will register you or your clinic with a USER NAME and PASS WORD and make available an icon for your PC Each patient User is virtualized automatically after Registration There are two levels of entry into the Virtual server farms on the cloud for access and registration of you and your patients See Screens below Screen Entries for accessing the AlcManager Double click on your desktop icon A j AlcManager rdp The RemoteApp screen below is your first point of entry enter the Password you were given by BCMC IRDPNEW IDCpro means you are accessing the HCP screen Enter your credentials For 54 235 168 21 These credentials Will be used when you connect to the remote computer User name If TROPNEW IOC pro cal Password TIT Remember my password concel_ On some computers the screen below is your first point of entry enter the Password you were given by the company Again IDCpro means you have entered the HCP screen Page 12 of 33 Windows Securty ease Ifthe User ID is not IDCpro then Click Enter your credentials These credentials will be used to connect to 54 235 108 21 rgmpro Password Pass word
11. 252222222220u222002u20u2u2u2unnnnnnnnnnnnnn 28 Restoring a Deleted Inactive Patient USE ccsssssscccennneeeeececnnnnsenseesnnnans 29 EXITING a SESSION siisascediscccensuvesvissscessussvesnvrscvesswsaewnsrecesissnnecensareestvensesduvenees 31 Cleaning amp Maintenance s ssssss222222 22 2222220u2220u2020u2u20u2uununnunnnnnnnnnnnnnnnnn 31 LOR AG erocwaeseetensesceduravcsatsasmesetenesacetanewesan Wearasetcweuneet waneestenemeseedaaneseeemmeseueuns 32 TFOUDICSNOOUNG niirccrsncttensenteducrinnecnaranewbeneewewtunennietearaweebenereturnesenarawnwane whee 32 SUMMA Y sssrinin sence wewenarere sana wevesenewevessneuewesemewebariwevenesewesevesewanersceeaue 32 REVISION Date sasarean Nan EREE RAER 32 References Cll siiseiiserccaniinndceccverssewiieetcariewsseaniusinersverdneriteeienriiareeeuianinanes 33 Page 2 of 33 Page 3 of 33 Foreword An external artificial endocrine pancreas for Type 1 diabetes was developed over 40 years ago It controlled blood glucose in clinical studies spanning a few days 1 2 Over the intervening years significant effort has been expended to miniaturize the components so that a portable implantable device can be provided 3 4 Standard Care for Patients with Diabetes Standard care for patients with Type 1 or Type 2 diabetes mellitus generally follows the Practice Guidelines 5 6 of the Endocrine Societies and Diabetes Associations Viewed in flow diagram format as shown below in Figure 1
12. A Manager User Manual e AicManager is APP software that runs in virtualized hardware on the Amazon EC2 cloud It is educational and guidance software Its intended use is to tutor guide and educate users of the AlcManager System how to manage Aic in Type 1 and Type 2 diabetes BCMC is Better Control Medical Computers Inc The AlcManager users are typically health professionals and persons with diabetes e Users should read the entire User Manual before trying to use the AlcManager User Assistance Information If you need further assistance in accessing or using the AlcManager contact BCMC Inc at albisser am gmail com or call us at 352 430 0098 Table of Contents weg Or ioner errr rer rer rrerree eee erre eer rer ree rr rer tr rerrer rr rrrrer reer rire re eer rrr cree 4 Standard Care for Patients with Diabetes sssss2 22222 2 4 An Artificial Pancreas System for Type 1 Diabetes Mellitus T1DM 4 A Cloud Based System for Managing Aic in Virtualized Patients 05 5 Managing Aic and Optimal Diabetes Control ODC ssssss2 2 7 PrECAUUIONS nenticrsesvacuiensaeeeniesinesewacnwasnieeewnensnsiveseteriiesressisntaeerrnieeerecrinrnees 7 Purpose of the AlcManager Resource Indications for USC ssssssceceennnees 7 Description of the AlcManager RESOUFCE ccccseeeeeeccceesennnnneeeeeeeeeeeeeeeeeanans 8 Logbook Function Virtualization Alc
13. as been successfully transferred to the new Clinic WorkGroup J Please review the Diabetes Patient Demoraphics and check the Providers assigned to JanS Test to ensure that reports are correctly sent The previous provider may need to be Registered in your WorkGroup You are notified that your patient user First Name Last Name has been successfully transferred to the new Clinic Workgroup You are advised to review the Demographics and check the Providers assigned Click OK to clear the dialog box You are now free to edit change anything or enter new data as usual Exiting a Session Save Changes amp Exit BCMC Tutor x 1 Click Yes if you wish to sawe all the changes and glucose entries made during this session Click Mo to abandon all changes When you Exit the session you will be asked if you wish to save all the changes and glucose entries you may have made during this session Click Yes to do so and exit the session Cleaning amp Maintenance Cleaning is not applicable Maintenance BCMC Inc will provide periodic software updates The software hosted by BCMC will be updated automatically Any local installations or USB Page 31 of 33 versions of the software will need to be updated by the user The user or their administrator will download the update file AlcManager exe_ to the desktop Once they have launched AicManager icon they will drag the update file to the AlcManager desktop This will star
14. based on 2 Page 26 of 33 antecedent days The Medication Prescription is for 50 Units day UltraLente before Sleep Simulation of dosage changes suggests that improvements in SMBG may be realized with small relative dosing changes and that more than one change may be needed to avoid increasing the risks of hypoglycemia before Breakfast PDC Tutor RxChecker Prediction Engine based on Statistical SMEG Distributions Meal Period Circadian Profile est Aic fd 6 7 Patient Enter body Patient Height weight BAA 64 in 166 76 6 4 Hide your doctor s targets Premeal medications Dinner Before Medication Delta Dinner Re SamD Dinner Re LamD Delta LamD Choose from Intermediate acting a ah Long acting Insulin Protiles F Might Breakfast Lunch Dinner samb sam nam LamL LamD Doses to Reset All Copyright AM Albisser PhO 2004 2013 Superposition of the target glycemic ranges now shows the Circadian Profile can be expected to fall closer to the target ranges Repeated prescription checks will help demonstrate how you might marshal the patient s glycemic profiles into the desired ranges and keep them there Finally with the changes suggested AlcManager predicts that the Alc will improve from 7 3 to 6 7 and do so without risking hypoglycemia Database Backup If you are using the WWW and the Cloud backup is done automatically during and at the close of each session Page 27 of 33
15. ctive treatment regimens As shown in Figure 3 measurements of self monitored blood glucose SMBG and body weight along with records of medication s taken and hypoglycemia events can support follow up at weekly or monthly intervals These measurements are all stored in the cloud in order to be accessible both to patients and their providers Alc Manager Virtual Target GUI Treatment MPP Levels A Options Animation SMBG BW Aic Database Physician Filter Follow Up Measurements SMBG Alc BW Meds hypos Figure 3 AlcManager for T2DM and T1DM viewed in data flow diagram format AlcManager works to achieve and then maintain target levels that constitute optimal diabetes control Typically with weekly follow up the achieving phase lasts 1 8 weeks Maintaining target levels can be done with follow up at monthly or even quarterly intervals Sited in the cloud and available to all is the virtualized Page 6 of 33 technology treatment algorithms databases and teaching animation which can access each patient s data and their individual target levels The algorithm generates images called Meal Period Profiles aka MPPs representative of the patient s current diabetes status These MPPs help the user or AlcManager to understand and also safely explore any drug treatment options so that users can learn the effects of various drugs Proactive physicians can review the treatment options presented by the AlcManager
16. e AMA Password HK KKK KK Entera Domain password here Type your User Name and your clinic Password as shown above and Page 14 of 33 Press Enter or Click Done The next screen will appear w Select User Today Virtualized Patients Listing AlcManager BLU UserID Test Jodi Oct 10 2014 23339951_416 eae Add Mew a AM Albisser 2004 2014 Virtualized Patients List For privacy the patient listing is partially covered over in the above screen shot Double Click the selection or once a selection is made Click Next Page 15 of 33 Task Menu and Button array are shown for Virtualized Patient User Miss Jodi Test AlcManager Pro Yersion 1 0 0 1 Ms Jodi Test 00 02 Page 16 of 33 Entering New Patient Data and Virtualization e Click on the Add New button in the Select User Users List window shown above A Virtualize New User Screen will appear Virtualize New User Gg Virtualized E E ee ee SaaS ESS aero ee O AlcManager PolyPharmacy Crib Note Body Mass Index Clinic Record Age Units of Measurement lb Okg e Enter demographics e Choose between AlcManager and PolyPharmacy e Select the units of measurement kg or lb Enter the patient s height and weight The patient s calculated BMI will be displayed e Next you need to enter the details of the patient s diabetes medications prescription Follow the steps outli
17. e after mid Breakfast before after mid Lunch before after mid Dinner before Bedtime Sleep and early morning e Optionally the date and time of the SMBG readings can be entered e Doses of medication taken whether different from prescription or not e Optionally user comments on carbohydrate intake exercise activity and stress levels These comments may be input in the short hand form of to indicate whether the user views the carbohydrate intake exercise activity and stress levels associated with a particular reading to be atypical ie out of the ordinary A narrative explanation can be entered as well Data are manually entered After each value is input it is echoed back for user review Data can be viewed in either logbook spreadsheet or bar graph format Page 8 of 33 In addition to echoing back the user data the AlcManager resource generates a graphic representation of the individual s SMBG data hereafter referred to as their meal period profile or MPP This MPP is not an analysis of trends Rather it is a graphical image of the average and scatter of the virtualized patient s recent SMBG data over which target ranges can be applied The purpose is to facilitate tutoring on the effects of various anti diabetes medications on the MPP and Aic level The AlcManager program uses the virtualized patient s historical body weight values to display a simple trend line which is used to confirm whethe
18. eal period profile with the overlay of target ranges and thresholds the user can appreciate where the glycemia is out of range Calculating and Displaying A1c Values Both healthcare providers and diabetic patients continually reference glycated hemoglobin Alc values in assessing how well a patient s diabetes is being managed AlcManager displays calculated Alc levels based upon overall averages of the displayed SMBG data The current calculated Alc level displayed is computed based upon the most recent 7 days of SMBG data The purpose of displaying the calculated Alc value is to provide a reference point for users where there is no recent Alc lab result and thereby to provide a point of reference for teaching the effect on Alc of medication changes that the user may wish to contemplate This is fundamental to managing Alc by the patient Page 9 of 33 Simulation of Prescription Drug Changes In addition to displaying the virtualized patient s meal period profile and target ranges the AlcManager Resource can be used as an aid to explore how medication changes may bring a virtualized patient s MPP closer to their target blood glucose and Alc ranges To this extent the AlcManager can explore the effects that changes to the drug prescription may have on the virtualized patient s displayed meal period profile and the predicted Aic level The AlcManager resource does NOT provide real time recommendation to the user regarding
19. erating Instructions Launching the AlicManager Double Click on the AlcManager icon that was installed on your computer desktop to launch the program Your company representative will assist you to install the AlcManager rdp ICON on your desktop The first time you run the AlcManager software you will be shown the Terms of Use You should read the Terms of Use carefully as you scroll down The text of the Terms of Use is as follows The AlcManager Resource is intended for use by health care providers and their patients with Type 1 or Type 2 diabetes to assist in storage review and analysis of retrospective blood glucose data as well as information to aid in teaching and understanding diabetes and Alc management in virtualized patients It also assists the health care provider in demonstrating to patients their personalized blood glucose targets as well as the anticipated effects of changes in their anti diabetes prescription on their virtualized glucose profile and Alc levels In using this software you agree that the AlcManager software is not intended to replace the care provided by a licensed health care provider including prescriptions diagnosis or treatment You further agree that the AlcManager software is not intended to replace the clinical judgment of a licensed health care professional The AlcManager software forms the part of a virtualized patient in a System that includes you your health care professionals
20. gorithms are used to determine insulin infusion rates as a function of both the measured blood glucose and its rate of change and control a mechanical pump which meters insulin from a reservoir to a catheter placed under the skin or in a vein With the patient so connected a closed loop is formed that promises to normalize not only glycemia but also the metabolic and hormonal responses to mixed meals and physical exercise 5 9 in Type 1 diabetes In effect the closed loop system operates automatically to minimize the deviation in measured glycemia from expected normal or target levels by metering the flow of insulin from a reservoir Self monitored capillary blood glucose SMBG levels are used to calibrate CGM devices every few hours A Cloud Based System for Managing A1c in Virtualized Patients T1DM affects some 5 of the population with diabetes 10 The remainder has Type 2 Diabetes Mellitus It is significant that following diagnosis the latter develop diabetes caused complications some 30 months sooner than the former 11 In spite of the huge difference in prevalence and the sooner morbidity there have been no reports of initiatives to develop a system to manage Aic in Diabetes Mellitus We have taken on this challenge with simplifications outlined in the following Firstly in managing Alc the need for continuous glucose sensing in the blood and secondly the need for parenteral drug delivery both may be relaxed In T1DM gl
21. ider would then make appropriate modifications to the patient s prescriptions Note that the AlcManager program tracks but does not analyze or take into account a particular patient s actual response to a particular medication Environmental Conditions that may Affect Use Use of the AlcManager requires a computing device For local installation the computer must run a Windows 95 or later operating system The computer must have a monitor keyboard and pointing device mouse If you are accessing the AlcManager on remote server hardware you must have network access to the remote server A standard network connection is required to access the server A patient is not required to have a computer or Internet access for the physician to order the use of AlcManager Under these circumstances the patient s data will Page 10 of 33 have to be recorded manually and then input into the virtualized patient s database prior to the patient s encounter with the health care provider The AlcManager software does not require either a printer or a facsimile machine but the local print and fax functions will not work without this hardware Set Up Instructions If you have purchased AlcManager for local installation on your server hardware the software will be installed with help from BCMC Inc Upon installation AlcManager will be available from an icon on any of your desktops Check Out Instructions Not applicable Op
22. ins Pump infusion of premeal boluses with constant inter meal basal rates Once you have accessed the simulated patient the software operates exactly the same as it does with virtualized patient data with the exception that you cannot save any changes to the simulated patient or the data set If you would like to explore a different patient you will need to exit the program and then open it again and select a different virtualized patient to load Deleting an active Patient User Deleting Follow steps as below Note only HCPs can delete patient users Page 28 of 33 w Select User l x Tod Aug 22 2013 Dg Q Delete Test Jodi 22429004 Add New Next ESC AM Albisser 2004 2013 In the Users List highlight the user you wish to delete for example Test Jodi Click the Delete button The following dialog box is presented as a caution xi 4re vou sure vou wish to delete Miss Jodi Test Click Yes to confirm that you wish to delete the named user The deleted patient will be absent from the Virtualized Patients List The deleted patient becomes inactive but can be restored to an active status as detailed below by a systems administrator Restoring a Deleted Inactive Patient User When a virtualized Patient user is deleted from the database by a Clinic user the actual recordsets are preserved under the same UserID eg 23339981_416 In fact only their Clinic password is changed As a co
23. k for Check for possible medication overdose is presented As shown below the second check becomes highlighted in pink when the mouse moves over it AlcManager then does a pharmacy analysis of medication dosages to determine whether any tablet doses exceed specified meal or daily limits Insulin dose is also analyzed Dialog boxes similar to the one shown below will inform of medication dosing status Page 24 of 33 Your Prescription Insulin x P 4 1 Your prescribed daily dose of 50 Units of insulin suggests mild insulin insensitivity Once you dismiss the dosing checks the third Rx Check is presented Click on it to show the virtualized patient s SMBG Meal Period Profile MPP below est Afc hadi fh Hx 2 days Breakfast Dinner came gam Lamb LamU In the MPP you will see shaded rectangles in each meal period where there have been 2 or more SMBG measurements Shown above is an 8 point profile From left to right are respectively the over night before breakfast after breakfast before lunch after lunch before dinner after dinner and pre sleep bedtime glucose ranges The white circles are the mean values of each range You may click on the fourth Rx Check to superimpose the patient s glucose targets These are shown as pale yellow rectangles that superimpose the grey ranges When the central white circle is hidden the glycemia at that meal period is in target Risks Page 25 of 33 of Hypoglycemia a
24. ned in the next Section e Then you will want to enter 2 or more days of self monitored blood glucose SMBG levels See the following Section e Then you will be able to perform a Diabetes Rx Check See Part 4 Section 5 3 e Thereafter a diabetes Rx check can be done on the virtualized patient at anytime using the AlcManager resource Page 17 of 33 Entering Modifying the Rx Prescription Click on the HCP s Rx button Or click on the Prescriptions amp Treatment item in the task bar Then Click on Enter your Rx Prescription The following window is presented Miss Jodi Test You must click to indicate the prescribing health professional and enable changes M acd Ga Click to indicate the health specialist who has prescribed changes to the Rx record The following table enables you to enter the types and doses of the diabetes medications prescription Rx or to make changes as shown below Regimen amp Medicatioms the Doctor s Diabetes Prescription Rx Prescribed Diabetes Drugs Drug Breakfast Lunch Dinner Sleep Type Dose Medication Dose Medication Dose Medication Dose Medication Shorter Glucophage 500 Glucophage 850 Starlix 60 Pharmacy Monitor Scale Ms Jodi Test Therapy last reviewed Feb 12 2014 by Dr D Hall mg dl FX mmol The first step is to select the glucose monitor scale on the left side of the screen Either mg dl or mmol l can be selected If you double click in a Medicati
25. nsequence their status becomes inactive and their data are no longer accessible to the Clinic or the Patient user However an inactive patient user can be restored to active status by the System Administrator using his Domain password The following steps can restore an inactive patient user to the active status A fee is usually charged to do this To restore an inactive patient user to an active status please follow the steps outlined below Page 29 of 33 Get Passwords for 41cManager on SIMON SOL Server gq x Enter your UserName and Password here User Name Password Entera Domain password here RACK CAKES OK A domain administrator enters the Domain password as above Click Done to continue The patient user to be restored is selected in the Patients List Click Next to continue From the Tasks Menu click Help gt click Change HCP w Change Health Care Provider l x First Name Jodi Last Name Test Useri 235559981 416 Select HCP ar Clinic Password ESC Page 30 of 33 Verify that the First Name Last Name and UserID are correct Select the password of the New Health Care Provider or Clinic Workgroup Password eg VAMC as shown and click Change Changing Providers x Jan Test Your new Clinic or HOP has been located in the SOL database Do you wish bo make the change now Confirm your decision to change Providers by clicking Yes Tidying Up l x Bai Patient Jan9 Test h
26. on field e g in the ac Breakfast column and in the Shorter Acting row then the following screen appears to let you choose the Tablets and or Insulins that are currently prescribed and can be modified Page 18 of 33 Drugs by Class Shorter Acting Insulins Ultra Fast Acting Regular Fast Acting Longer Acting Insulins Intermediate Acting Long Acting The various dropdown lists allow you to locate prescribed medications or you may simply double click to insert a blank Note that medications are divided into shorter acting and longer acting and therefore each may not appear in every list depending on which field you double clicked in the Shorter or Longer Acting rows The separation of classes of drugs is intended to avoid accidentally prescribing overlapping drugs with similar pharmacodynamics dose response actions The third row allows the free text entry of additional medications These are labeled as Poly Pharmacy Page 19 of 33 The Settings button can be used to set or modify the Glucose Targets and Ranges before and after meals and other thresholds as shown below Here the pre meal targets are set to 110mg dl with an allowable range of 30 Meal Period Profile Glucose mg dl Settings oo amp 2 Breakfast Lunch Dinner Bed time Settings Aic Ghycemic Thresholds Hypogymnia Before Meal Ranges mac Insulin Resistance Also the Glycemic Thresholds for hypoglycemia
27. r the weight is increasing or decreasing This trend line provides the health care provider with a graphic to tutor the patient about weight management To assist in understanding blood glucose and Alc management as well as promote diabetes education the user can overlay target blood glucose ranges on any meal period profile Using this overlay the patient learns how to visually compare the two and appreciate where the displayed MPP and Alc may be out of target range In teaching target ranges the user can elect to use the default ranges which are 80 140 mg dl fasting pre prandial and 80 180 mg dl post meal peak or the user can set specific targets to use as an illustrative example The user can customize both pre and post meal target ranges and hypoglycemia thresholds for the virtualized patient The user can also demonstrate preset targets for states like pregnancy or insulin resistance In addition to Alc and blood glucose targets the AlcManager will also display hypoglycemia thresholds The software will indicate to the user when a greater than 5 likelihood of hypoglycemia can be expected at that meal period s next reading The default hypoglycemia threshold is set for 50 mg dl The user can demonstrate how a different threshold for a virtualized individual can be based on a healthcare provider s clinical judgment and careful consideration of the user s medical history Based upon the graphical representation of the displayed m
28. re flagged and the specific meal period with the risk displays the warning of a reaction as Rxn in red tatistical SMBG Distributions Meal Period Circadian Profile Predicted fer est Afc eae Risks of Hypoglycemia As Breakfast Dinner nam sam Lamb LamD Clicking on the large red button labeled Dx displays a Mini Assessment to Achieve Maintain ODC or Optimal Diabetes Control as shown below Mini Assessment to Achieve Maintain GDC Body Mass Index your patient is over weight at 166 Ibs Your prescribed Actos dose of 60 mg Before Dinner exceeds the maximum recommended meal dose of 45 Your prescribed Onglyza dose of 10 mg Before Sleep exceeds the maximum recommended meal dose of 5 he prescribed daily Actos dose of 60 mg exceeds the daily maximum recommended of 45 he prescribed daily Onglyza dase of 10 mg exceeds the daily maximum recommended of 5 ou should talk to your patient Your prescribed daily dose of 26 Units of insulin is In the normal range Drug Count 6 diabetes drugs or dosesifday Your patient s MPP profiles are outside the ranges specified by the doctor and treatment Guidelines in 4 of 5 profile periods You should discuss this Your patient s SMBG profiles suggest essentially no risks of hypoglycemia Your Alc of 6 6 is in target Finally you can overlay the effects of dosing changes on the virtualized patient s SMBG profile and Alc The example below shows a SMBG Profile
29. t the update wizard Storage Generally not applicable for stand alone software The USB drive should be protected from heat and moisture Troubleshooting Some users running newer versions of Microsoft Windows specifically Windows 8 have difficulty with the installation process If you get an error that a dll file is not available and installation has failed you will need to install the software as an administrator Open the Install folder on the USB drive Right click the setup exe file and select Run as Administrator The installation wizard will then launch Summary AlcManager is a tool to guide and support tutoring teaching and education for healthcare providers and their virtualized patients about Alc and diabetes management AlcManager is not meant to replace but to supplement the care or decision making of a licensed health care provider The User Manual is meant to be used as an introduction to the software and a reference that the user can go back to as needed The simulated virtualized patient cases included with the software are an ideal way to increase your experience with the AlcManager software and to demonstrate the software to others Revision Date This User Guide was issued on Oct 13 2014 and supersedes the previous version of Sep 15 2014 Page 32 of 33 References Cited 1 American Association Of Clinical Endocrinologists Medical Guidelines For Clinical Practice For The Management Of Diabetes Mellitus A
30. the patient typically receives medical follow up at 3 month intervals Target Treatment Options Levels A drug s at bedtime BW Aic Referal to Dietician q3mo follow up Measurements BW A1c Figure 1 Standard Diabetes Care viewed in data flow diagram format The measurements at diabetes follow up include body weight and glycated hemoglobin Alc levels Health care providers compare these measurements to accepted target levels and then decide treatment options that depend in part on whether or not target levels are being met The goal of the follow up encounter is to use a maximum tolerable drug therapy to manage Alc levels and b diet to control body weight If Alc is outside target ranges increasing the dose or adding diabetes drug s at bedtime are common treatment options If body weight BW or BMI targets are not met referral for diet counselling is also usually made An Artificial Pancreas System for Type 1 Diabetes Mellitus T1DM Basically the original external device included a glucose sensor a hormone delivery mechanism and a set of computer algorithms Indwelling venous catheters were used to withdraw blood for continuous glucose monitoring CGM and to deliver insulin from a reservoir Page 4 of 33 Insulin T1DM q5 Min follow up Target Levels x Algorithms CGM SMBG Measurement CGM SMBG Figure 2 Artificial Pancreas System for T1DM viewed in data flow diagram format Computer al
31. tores and provides for review retrospective blood glucose values in virtualized patients as well as other health information input by a user It can serve as a limited electronic diabetes logbook in this capacity It also contains third party diabetes education resources which can be viewed or printed The AlcManager resource also allows users to explore the effects of prescription changes on virtualized patients thereby providing a teaching opportunity between health care providers and their patients This serves to teach users the consequences of prescription changes on Alc Such changes may include drug types doses sites and times of administration Logbook Function Virtualization Alc Management and Beyond The AlcManager resource can receive and store the following data which it uses to virtualize the patient in the cloud e Optionally patient identifiers first and last names address phone number email address age duration of illness status of complications etc e Height and weight in either imperial or metric units e Optionally names of attending health care provider s e Optionally currently prescribed diabetes medications and doses e Note the health care provider first selects the scale for glucose monitoring mg dl or mmol l Medications and doses are selected with the help of pop up menus and drop down boxes e Recent self monitored blood glucose SMBG readings entered according to meal period namely befor
32. vailable at http www aace com pub pdf guidelines DMGuidelines2007 pdf accessed Apr 1 2010 2 Statement by an American Association of Clinical Endocrinologists American College of Endocrinology consensus panel on type 2 diabetes mellitus an algorithm for glycemic control Rodbard HW Jellinger PS Davidson JA Einhorn D Garber AJ Grunberger G Handelsman Y Horton ES Lebovitz H Levy P Moghissi ES Schwartz SS Endocr Pract 2009 15 6 540 59 3 PocketGuide AACE ACE Diabetes Algorithm for Glycemic Control Available at http www GuidelineCentral com accessed Apr 1 2010 4 Funnell MM et al National Standards for Diabetes Self Management Education Diabetes Educ 2007 33 4 599 614 5 2010 Physician s Desk Reference Available at https www pdrbookstore com Default asp 6 Lachin JM Genuth S Nathan DM Zinman B Rutledge BN DCCT EDIC Research Group Effect of glycemic exposure on the risk of microvascular complications in the diabetes control and complications trial revisited Diabetes 2008 57 4 995 1001 7 Nathan DM 2007 Finding new treatments for diabetes how many how fast how good N Engl J Med 356 437 440 Page 33 of 33
33. ycemia is typically unstable or brittle while in T2DM it is generally stable but elevated In light of this characteristic stability there is no real need for continuous glucose monitoring particularly when self monitored capillary blood glucose can be done at home to capture the before and after meal ranges These structured measurements can be used to create a blood glucose profile that approximates the diurnal profiles of CGM in T1DM Furthermore oral anti diabetic agents are effective and not at all meant for parenteral delivery So in most cases of diabetes the Page 5 of 33 needs for pumps and reservoirs are eliminated as are the needs for catheters to provide vascular or subcutaneous access However as in T1DM there is a need for even more sophisticated computer algorithms to link the patients status self monitored blood glucose body weight medication types amp doses and risks of hypoglycemia to drug delivery Furthermore the T2DM patient does not need to be connected to a local computer device to manage their diabetes Instead the algorithms can be sited in the cloud where they form a resource that teaches and guides the user as to what different drugs doses and meal timing adjustments can do to alter any Alc level and blood glucose profile including their own With our AlcManager technology it is up to the patient to explore these alternatives and for the proactive physician to prescribe the safest and most effe
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