`Ͻ 1""3"1SAS FILEF0217 DATA AtAtєє 8.0202M0SunOS5.9SUN 4SUNðððb+![b+!ZH.  0</ D $44\4(4444X4$4444T4 4444P44444L4444|4H4444x4D4444t4@4 444p4<4444l484444h444444d404444`4,4444\4(4444X4$4444T4 4444P44444L4444|4H4444x4D4444t4@4 444p4<4444l484444h444444d404444`4,4444\4(4444X4$4444T4 4444P44444L4444|4H4444x4D4444t4@4 444p4<4444l484444h444444d404444`4,4444\4(4444X4$4444T4 4444P44444L4444|4H4444x4D4444t4@4 444p4<4444l484444h444444d404444`4,4~4~4~4~\4~(4}4}4}4}X4}$4|4|4|4|T4| 4{4{4{4{P4{4z4z4z4zL4z4y4y4y|4yH4y4x4x4xx4xD4x4w4w4wt4w@4w@@L@Lfffff?@@k @B@T@U@S@@U@R@@U@R@U@(@Q@\@Q@p@r@i @m@@V@i@d082090 101590082090 111290120490111390 -02.1?@=??@@@@@@@5??????@???@@??@@@@(@(@3@$???@?@??@??????????????????@??????????????@????????@?????????????????@?@??@Q@L@N333333?@6@k @E@W@X@X@@X@V@X@U@@X@,@S@\@Q@q`@h@`@c @qP@d@@V111390 010991111390 031091032691021991 +02.6?@>??@@@@@@@8??????@???@?@?@@@@&@,@M@@?@?@@????????????????@?????????????@???????@?@????????????@@@@?@?@?? @?@Lffffff@N333333?@a@k 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?@3@,@,@??@D@.@.@5@7@7@7@P@*@*@@4@(@(@"@//\!/8/&.#.!..h.8&.-$---|$-X-4- , ,,, ,l#,L,$+ ++#+#+X+0 +*!**%*`#*8*)#))$))T$),) (%(( (`#(8 ( $''''"'l'H'4 '"& &&&&l!&D &%%%#%!%X!%,$%"$#$#$|$$L%$&#%#&#&#`$#4$# ""&"#"\%"0"""!%!#!|#!X!4!& % " |# P$ %"\#8 #&&d&4&$#%d%4((($x'P$$'&x#L# $$"P&,'&t'H$%#&#p@&'#% `#8 "t#D%('(#X%('#xH& '&$d%<! xP$"#%$p#@' t"P( "\$0#"& "T!, $ $   `$ 8  # !  p H $     l H      t X 8 &  !  p P $$ `L  "(#(h#8' "'"&T!$&!&%h'8% #%#\$0"&!'t%H$""T",%$|$\0"&lTH,&&"nVmMN#<r4 7XyQDl],@gt[\Ky|_.~%ph&$?=Dz}iq 6$<O; cwdvb p2f V"IF+/  )3m: g%o Le!{tJ $ &,2(,048<@DHLPTX\`dhlptx|8=@CFILORUX[^adgjmpsvy|  !$'*-0369<?BEHKNQTWZ]`cfilorux{~  #&),/258;>ADGJMPSVY\_behknqtwz} 8$Pd(Tt$Lx@l(T0`Lx0`DX  H h     0 P l      @ d      @ h     0 X    $Lx(T Hl8hHp4\@p P <l0X8h@l$HxDpHp,\,\0T  H t   !,!P!t!!!"("T"""##,#X###$$D$t$$$%$%P%|%%%&&<&d&&&'','@'d'''((0(X((())$)L)x)))* *0*X***++(+P+x+++,,D,d,,,,--,-P-t---. .0.`...//0/T// DATASTEPFSASDATEFORMDATE AS SAS DATE VALUEMMDDYYFORMDCCT FORM NUMBERBAQURDATDATE OF LAST COMPLETED VISITBADV1A1DATE-TERMINATION OF DEVIATIONBADV1A2NEW DEVIATION, DATE F022BAIS1A1DATE OF RETURN TO ACTIVE STATUSBAIS1A2NEW TRANSFER-INACTIVE STATUS-DATE F016BAMDT1B1DATE REC'D PERMIT MODIFIED REGIMENBAMDT1B2DATE NEW REGIMEN STARTEDBAMDT1C1DATE RETURN--1 TO 2 DAILY INJECTIONSBAMDT2C3EXP.-DATE NEW GOALS BECAME EFFECTIVEBAMDTRETEXP.-DATE RETURNED TO GOALS OF EXPER.BADC3C2DATE OF LAST MENSTRUAL PERIODBAPEDATEDATE LAST PHYSICAL EXAMINATIONBABLPDATDATE SECOND SITTING BLOOD PRESSUREBACOLDATDATE PROFILSET COLLECTEDBAPRFDATDATE PROFILSET WILL BE MAILEDBAHBDATEDATE HBA1C SPECIMEN COLLECTEDBALPDATEDATE LIPID SPECIMENS WILL BE DRAWNBARENDATDATE RENAL SPEC. WILL BE COLLECTEDBATOTUNTTOTAL NUMBER OF UNITS/DAY OF INSULINBADM3BRDDM 3 INJ.-BLOOD DONE BEFORE BREAKFASTBADM3BRSDM 3 INJ.-BLOOD SHOULD DO BEFORE BREAK.BADM3LUDDM 3 INJ.-BLOOD DONE BEFORE LUNCHBADM3LUSDM 3 INJ.-BLOOD SHOULD DO BEFORE LUNCHBADM3DIDDM 3 INJ.-BLOOD DONE BEFORE DINNERBADM3DISDM 3 INJ.-BLOOD SHOULD DO PRE-DINNERBADM3BEDDM 3 INJ.-BLOOD DONE BEFORE BEDTIMEBADM3BESDM 3 INJ.-BLOOD SHOULD DO PRE-BEDTIMEBADM33ADDM 3 INJ.-BLOOD DONE AT 3 A.M.BADM33ASDM 3 INJ.-BLOOD SHOULD DO AT 3 A.M.BADM1UBDDM 1 INJ.-URINE DONE BEFORE BREAKFASTBADM1UBSDM 1 INJ.-URINE SHOULD DO BEFORE BREAK.BADM1BBDDM 1 INJ.-BLOOD DONE BEFORE BREAKFASTBADM1BBSDM 1 INJ.-BLOOD SHOULD DO BEFORE BREAKBADM1ULDDM 1 INJ.-URINE DONE BEFORE LUNCHBADM1ULSDM 1 INJ.-URINE SHOULD DO BEFORE LUNCHBADM1BLDDM 1 INJ.-BLOOD DONE BEFORE LUNCHBADM1BLSDM 1 INJ.-BLOOD SHOULD DO BEFORE LUNCHBADM1UDDDM 1 INJ.-URINE DONE BEFORE DINNERBADM1UDSDM 1 INJ.-URINE SHOULD DO BEFORE DINNERBADM1BDDDM 1 INJ.-BLOOD DONE BEFORE DINNERBADM1BDSDM 1 INJ.-BLOOD SHOULD DO BEFORE DINNERBADM1UEDDM 1 INJ.-URINE DONE BEFORE BEDTIMEBADM1UESDM 1 INJ.-URINE SHOULD DO BEFORE BEDTIMEBADM1BEDDM 1 INJ.-BLOOD DONE BEFORE BEDTIMEBADM1BESDM 1 INJ.-BLOOD SHOULD DO BEFORE BEDTIMEBARX1Rx: NO. ASPIRIN-CONTAINING TABLETSBAPULSEPULSE (BPM)BASYSTRFIRST BLOOD PRESSURE-SYSTOLICBADIASRFIRST BLOOD PRESSURE-DIASTOLICBASYSTR2SECOND BLOOD PRESSURE-SYSTOLICBADIASR2SECOND BLOOD PRESSURE-DIASTOLICBABGP8ARESULTS OF SBGM-PREBREAKFASTBABGP8BRESULTS OF SBGM-90 MIN. PREBREAKFASTBABGP8CRESULTS OF SBGM-PRELUNCHBABGP8DRESULTS OF SBGM-90 MIN. PRELUNCHBABGP8ERESULTS OF SBGM-PRESUPPERBABGP8FRESULTS OF SBGM-90 MIN. PRESUPPERBABGP8GRESULTS OF SBGM-BEDTIMEBANA2ENA-STD: NOT DONE 2 URINE OR 1 SBGM/DAYBADESIWTPATIENT'S DESIRED WEIGHTBAWEIGHTCURRENT WEIGHT (KG)BAHEIGHTCURRENT HEIGHT (CM)BAWTCHACHANGE IN WEIGHT (KG)BARESCHDNECESSARY TO RESCHEDULE VISITBASCHDNONO. OF TIMES RESCHEDULED VISITBAVSITNOFOLLOW-UP VISIT NUMBERBAHUREGTYPE OF INSULIN-HUMAN REGULARBAPOREGTYPE OF INSULIN-PORK REGULARBAHUSEMITYPE OF INSULIN-HUMAN SEMILENTEBAPOSEMITYPE OF INSULIN-PORK SEMILENTEBAHUNPHTYPE OF INSULIN-HUMAN NPHBAPONPHTYPE OF INSULIN-PORK NPHBAHULENTYPE OF INSULIN-HUMAN LENTEBAPOLENTYPE OF INSULIN-PORK LENTEBAHUULTTYPE OF INSULIN-HUMAN ULTRALENTEBAPO7030TYPE OF INSULIN-PORK 70/30BAHU7030TYPE OF INSULIN-HUMAN 70/30BABPREGTYPE OF INSULIN-BEEF/PORK REGULARBABPSEMITYPE OF INSULIN-BEEF/PORK SEMILENTEBABPNPHTYPE OF INSULIN-BEEF/PORK NPHBABPLENTYPE OF INSULIN-BEEF/PORK LENTEBABPULTTYPE OF INSULIN-BEEF/PORK ULTRALENTEBAGROUPWHAT GROUP PATIENT RANDOMIZEDBAINSREGCURRENT INSULIN REGIMENBAREGPRIS THIS REGIMEN PRESCRIBED BY CLINICBAREGBRKUNITS REGULAR INSULIN USED-BREAKFASTBAREGLUNUNITS REGULAR INSULIN USED-LUNCHBAREGSUPUNITS REGULAR INSULIN USED-SUPPERBAREGBEDUNITS REGULAR INSULIN USED-BEDTIMEBAREGOTHUNITS REGULAR INSULIN USED-OTHERBASEMBRKUNITS SEMILENTE INSULIN USED-BREAKFASTBASEMLUNUNITS SEMILENTE INSULIN USED-LUNCHBASEMSUPUNITS SEMILENTE INSULIN USED-SUPPERBASEMBEDUNITS SEMILENTE INSULIN USED-BEDTIMEBASEMOTHUNITS SEMILENTE INSULIN USED-OTHERBANPHBRKUNITS NPH INSULIN USED-BREAKFASTBANPHLUNUNITS NPH INSULIN USED-LUNCHBANPHSUPUNITS NPH INSULIN USED-SUPPERBANPHBEDUNITS NPH INSULIN USED BEDTIMEBANPHOTHUNITS NPH INSULIN USED-OTHERBALENBRKUNITS LENTE INSULIN USED-BREAKFASTBALENLUNUNITS LENTE INSULIN USED LUNCHBALENSUPUNITS LENTE INSULIN USED-SUPPERBALENBEDUNITS LENTE INSULIN USED-BEDTIMEBALENOTHUNITS LENTE INSULIN USED-OTHERBAULTBRKUNITS ULTRALENTE INSULIN USED-BREAKFASTBAULTLUNUNITS ULTRALENTE INSULIN USED-LUNCHBAULTSUPUNITS ULTRALENTE INSULIN USED-SUPPERBAULTBEDUNITS ULTRALENTE INSULIN USED-BEDTIMEBAULTOTHUNITS ULTRALENTE INSULIN USED-OTHERBA7030BRUNITS 70/30 INSULIN USED-BREAKFASTBA7030LUUNITS 70/30 INSULIN USED-LUNCHBA7030SUUNITS 70/30 INSULIN USED-SUPPERBA7030BEUNITS 70/30 INSULIN USED-BEDTIMEBA7030OTUNITS 70/30 INSULIN USED-OTHERBADM5DESCRIBE INSULIN REGIMENBADM6AUNITS BASAL INSULIN INFUSED DAILYBADM6BDIFFERENT BASAL RATES USED/DAYBADM6CTECHN. PROBLEMS-INSULIN INFUSION PUMPBADM7APRESCRIBED CHANGE IN INSULIN REGIMENBADM7A1CHANGE DOSE-SYMPT. POLYURIA,POLYDIPSIABADM7A2CHANGE DOSE-UNACCEPTABLE DEGREE HYPOGL.BADM7A3CHANGE DOSE-RECURRENT KETONURIABADM7A4CHANGE DOSE-HEMOGLOBIN A1C ABOVE LIMITBADM7A5CHANGE DOSE-OREGBABCTBADM7A6CHANGE DOSE-OTHERBADM7B1SELF BLOOD GLUCOSE MONITORINGBADM7B2URINE GLUCOSE MONITORINGBADM8SUSPECT REPORTED GLUCOSE INACCURATEBADV1SINCE LAST VISIT-DEVIATION FROM TREATM.BADV1ACURRENTLY ON DEVIATION FROM TREATMENTBAIS1SINCE LAST VISIT-ON INACTIVE STATUSBAIS1ACURRENTLY ON TRANSFER TO INACTIVE STATUSBAMDF1MODIFIED FOLLOW-UP SCHEDULE AT ANY TIMEBAMDF2CURRENTLY ON MODIFIED FOLLOW-UP SCHEDULEBAMDT1SINCE LAST VISIT, PT. MODIF. THERAPY?BAMDT1AGLUC MONITOR. > FREQ. THAN PROTOCOLBAMDT1A1SBGM > SPECIFIED IN PROTOCOLBAMDT1A2UGM > SPECIFIED IN PROTOCOLBAMDT1B> 2 INJECTIONS INSULIN DAILYBAMDT1CCURRENTLY USE > 2 INJECTIONS DAILYBAMDT1DOTHER MODIFICATION TO THERAPYBAMDT2EXP.-ON MODIFIED TREATMENT PROTOCOLBAMDT2AEXP.-LESS FREQENT VISIT SCHEDULEBAMDT2BEXP.-SBGM-LESS FREQENT DAILY SCHEDULEBAMDT2B1EXP.-FREQ. OF SBGMGLUC. MONITOR. THAN PRESCRIBEDBANA1ANA-FREQ. CLAIMED FOLLOWED MEAL PLANBANA1BNA-PATTERN OF EATING--EATING DISORDERBANA1C1NA-NO. OF ILL. (INTERCURRENT OR NOT)BANA1C2FAILED TO ADJUST INSULIN DOSE AS PRESC.BANA1DNA-USED TYPE OF INSULIN NOT PRESCRIBEDBANA1ENA-ROTATING SITE OF INJECTIONBANA1FNA-DONE > 7 CAPILLARY BLOOD COLLECTIONSBANA1G1NA-NO. INTERCURRENT EVENTSBANA1G2NA-INTERCURR. EVENTS NO REPORT ON TIMEBANA1HNA-FAILED TO BRING IN DAILY RECORDBANA1I1NA-PATIENT PERFORM SBGMBANA1I2NA-USE SBGM TO ADJUST INSULIN DOSAGEBANA1I3NA-PERFORM SBGM > ONCE/DAYFOR 7BANA2ANA-STD: >PRESCRIBED UNITS OF INSULINBANA2BNA-STD: EXTRA INJECTIONS OF INSULINBANA2CNA-STD: FEWER INJECTIONS OF INSULINBANA2DNA-STD: FAILED TO TAKE PRESCRIBED DOSEBANA2F1NA-STD: PATIENT BEEN ILLBANA2F2NA-STD:SICK-NO TEST/RECORD URINE ACETO.BANA3ANA-EXP: NOT TAKE PRESCRIBED DELIVERYBANA3BNO. OF TIME NO TEST AT 3 A.M.BANA3CNO. OF TIMES NO REPORT LOW BG TO CLINICBANA3DNO MONITOR URINE ACETONE WHEN BG>240BANA4ANA-EXP.: ON PUMP, CHANGE BATTERIES-WRONGBANA4BNA-EXP.: ON PUMP, CHANGE CATHETERS-WRONGBANA4CNA-EXP.: ON PUMP, CHANGE SYRINGES- WRONGBADC1ADC-NIGHTS IN PAST WK. WAKE UP-URIN. 1BADC1BDC-NIGHTS IN PAST WK. WAKE UP-URIN. 2BADC1CON AVERAGE, NO. 8 OZ. GLASSES DAILYBADC1DFREQUENCY OF DKABADC1EEXPERIENCE OTHER SYMPTOMS HYPERGLYC.BADC2FREQ. DAYS-MODERATE OR LARGE KETONURIABADC2AMODERATE/LARGE KETONUR.-CHANGE ROUTINEBADC2BMODERATE/LARGE KETONUR.-DUE TO ILLNESSBADC2CMODERATE/LARGE KETONUR.-EQUIPM. FAILEDBADC2DMODERATE/LARGE KETONUR.-SPONTANEOUSBADC3APATIENT FEMALEBADC3B1VAGINAL ITCHING OR DISCHARGEBADC3B2PATIENT TREATED FOR VAGINAL ITCHINGBADC3C1DOES PATIENT MENSTRUATEBADC3D1LAST MENSTRUAL PERIOD > 5 WKS. AGOBADC3D2 WAS PREGNANCY TEST PERFORMEDBADC3D3DID TEST INDICATE PREGNANCYBADC4ANO. HOSPITALIZATIONS FOR HYPOGLYCEMIABADC4B1HYPOG.-LOST CONSCIOUS. W/OUT SEIZUREBADC4B2HYPOG.-LOST CONSCIOUS. WITH SEIZUREBADC4C1HYPOG.-REQUIRED PROF. MEDICAL HELPBADC4C2HYPOG.-REQUIRE HELP OF ANOTHER PERSONBADC4C3HYPOG.-NOT NEED DOCTOR OR OTHER PERSONBADC4D1FREQENCY RECEIVE GLUCAGONBADC4D2FREQUENCY RECEIVE IV GLUCOSEBADC4D3EPISODES RESULT IN INJURY-PT/OTHERSBADC4ELAST 7 DAYS-MILD HYPOGL. TREAT SELFBADC4F1HYPOGLYCEMIA OCCUR WHILE AWAKE/ASLEEPBADC4F2AREASON HYPOG: MISSED MEAL OR SNACKBADC4F2BREASON HYPOG:DECREASED FOOT INTAKEBADC4F2CREASON HYPOG:INCREASED EXERCISE LEVELBADC4F2DREASON HYPOG:TOO MUCH INSULIN TAKENBADC4F2EREASON HYPOG:LACK EARLY WARNING-LOW BGBADC4F2FREASON HYPOGLYCEMIA: OTHERBADC4F2GREASON HYPOGLYCEMIA: UNEXPLAINEDBADC4F3ASYMPTOMS W HYPOG: ADRENERGIC WARNINGBADC4F3BSYMPTOMS W HYPOG: DIAPHORESIS(SWEAT)BADC4F3CSYMPTOMS W HYPOG: ALTER. MENTAL STATUSBADC4F3DSYMPTOMS WITH MILD HYPOGLYCEMIA: OTHERBADC4F3ESYMPTOMS WITH MILD HYPOGLYCEMIA: NONEBARC1AROPHTH:BLURRED/REDUCED VISION-RIGHT EYEBARC1ALOPHTH:BLURRED/REDUCED VISION-LEFT EYEBARC1BROPHTH:FLOATERS/FLASHING LIGHTS-RIGHTBARC1BLOPHTH:FLOATERS/FLASHING LIGHTS-LEFTBARC1CROPHTH: ANY OTHER EYE PROBLEMS-RIGHTBARC1CLOPHTH: ANY OTHER EYE PROBLEMS-LEFTBARC1DWILL BE SENT TO OPHTH. SPECIAL VISITBARC2ANEUR: PAIN/NUMBNESS IN HANDS/FEETBARC2BNEUR: UNEXPLAINED MUSCLE WEAKNESSBARC2CNEUR: VOMITING/BLOATING AFTER MEALSBARC2DNEUR: RECURRENT DIARRHEABARC2ENEUR: URINARY RETENTIONBARC2FNEUR: DIZZINESS/LIGHTHEADEDNESSBARC2GNEUR: FAINTING (NOT WITH HYPOG.)BARC2HNEUR: SEIZURE (NOT DUE TO HYPOG.)BARC2INEUR: IMPOTENCEBARC2JNEUR: SYMPTOMS COMPAT. W FOCAL NEUROP.BARC2KNEUR: OTHER NEUROLOGICAL PROBLEMBARC2LNEUR: WILL GO TO NEUROL. FOR VISITBARC3ARENAL: EDEMABARC3BRENAL: OTHER RENAL PROBLEMBARC4AVASCULAR: SHORTNESS OF BREATHBARC4BVASCULAR: CONGESTIVE HEART DISEASEBARC4CVASCULAR:IMPAIRED PERIPH. VASCULAR CIRCBARC4DVASCULAR: CHEST PAINBARC4D1VASCULAR: CHEST PAIN-CLINICAL ANGINABARC4EVASCULAR: SUSPECTED NON-ACUTE MIBARC4FVASCULAR: TRANSIENT ISCHEMIC ATTACKBARC4GVASCULAR: OTHER VASCULAR PROBLEMBARC5AINFECT: URINARY TRACT INFECTIONBARC5BINFECT: UPPER/LOWER RESPIRATORY TRACTBARC5CINFECT: GASTROENTERITISBARC5DINFECT: CUTANEOUS/MUCOCUTANEOUSBARC5EINFECT: POST-OPERATIVE OR DEEP WOUNDBARC5FINFECT: GANGRENEBARC5GINFECT: OTHER-MONONUCLEOSIS, MEASLESBARC5HINFECT: AT INSERTION SITEBARC6MINOR OUTPATIENT SURGERY/INCIDENTALBARC7ENTERCURRENT ENDOCRINE EVENTBARC8ADVERSE PSYCHOSOCIAL REACTIONBARC9AOTHER MEDICAL PROBLEMS/DIFFICULTIESBARX2Rx: HAS USED OR IS USING PRESCRIPTIONBARX3Rx: USED OVER-THE-COUNTER DRUGSBARX4Rx: VITAMIN SUPPLEMENTS-REGULARLYBAADOLESLESS THAN 18 YEARS OLDBAGROWTHFAILED TO MAINTAIN NORMAL GROWTHBAHYPDOCHYPERTENSION BEEN PREV. DOCU.BAHIBLP1ST BL PRESS. INDICATE HYPERTENSIONBAHYPERT2ND BL PRESS. INDICATE HYPERTENSIONBALIPOATINJECTION SITES: LIPOATROPHYBALIPOHYINJECTION SITES: LIPOHYPERTROPHYBAINFLAMINJECTION SITES: INFLAMMATIONBAHEPATOABDOMEN: HEPATOMEGALYBASPANABDOMEN: IF HEPATOMEGALY, SIZE SPANBAFOOTULFEET: ULCERSBAFOOTINFEET: INFECTIONBAABNTOEFEET: ABNORMAL TOENAILSBADPEDRFEET: PULSE DORSALIS PEDIA-RIGHTBADPEDLFEET: PULSE DORSALIS PEDIA-LEFTBAPTIBRFEET: POSTERIOR TIBIAL-RIGHTBAPTIBLFEET: POSTERIOR TIBIAL-LEFTBAOTHABNOTHER ABNORMALITIES ON PHYSICAL EXAMBABGP1PROFILSET MAILED TO CBLBABGP2ANOT MAILED: KIT DAMAGEDBABGP2BNOT MAILED:PATIENT FORGOT TO COLLECTBABGP2CNOT MAILED: PATIENT LOST KITBABGP2DNOT MAILED: PATIENT REFUSED TO COLLECTBABGP2ENOT MAILED: OTHER OR UNKNOWNBABGP6APROFILSET QUALITY-CONTROLLEDBABGP6A1PROFILSET QC-STICK NO. DUPLICATEDBABGP6A2PROFILSET QC-WAS CORRECT STICK USEDBABGP7PERFORM SBGM ON DAY OBTAINED SPECIMENSBALIPIDWILL LIPIDS BE MAILED TO CBLBARENALWILL RENAL SPEC. 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