Midterm IDE Application for BIOE 689Q

7/25/2019 Midterm IDE Application for BIOE 689Q

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Midterm IDE

Application for

Implantable

Insulin Pump

System

By: Camilo Pascual

Date:04/02/15

BIOE 689Q


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Table of Contents

1.De!ice Description 2

".#a$ard%&is' Analysis 6

(.Pre)Clinical E!aluation 8

*.Clinical Trial Desi+n 11

,.Informed Consent -orm 14

.&eferences 18

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1. De!ice Description

De!ice:Implantable Insulin Pump Sstem

Components:!1" Implantable Insulin Pump# !2" P$o%$amme$ &e'ice (o$ )osin% an) )ia%nostic#an) !*" +e(ill ,it-

Implant Site:.e pump is implante) an) anco$e) in te ab)ominal all- .e )ispensin%

po$tion o( te pump is locate) in te pe$itoneal ca'it ile te $e(ill po$t t$a'e$ses te muscle-Implant Battery /ife:10 ea$s !$eui$es su$%ical inte$'ention to $eplace"

De!ice Class%Pat0ay:Class III / P3

2ustification for De!ice Class and &e+ulatory Pat0ay

ile insulin in(usion pumps a$e consi)e$e) a Class II )e'ice an) $eui$e a 510!" to so

substantial eui'alence# tis is a no'el )e'ice tat is implante) (o$ a 10 ea$ li(e !*0 )as"-

.is )e'ice can be consi)e$e) 7li(esuppo$tin% o$ li(esustainin%# o$ (o$ a use ic is o(

substantial impo$tance in p$e'entin% impai$ment o( uman ealt# o$ i( te )e'ice p$esents apotential un$easonable $is o( illness o$ inu$#: base) on te inten)e) population-

It (its into te $eui$ements o( 21 C;+ 860-9*# ic )e(ines it as a Class III )e'ice-

It matces ell it p$o)uct co)e


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en te te$apeutic ta$%et is $eace) at te cost o( a lo imme)iate bene(it/$is $atio

!Ab31c le'el belo at e@pense o( $ecu$$ent se'e$e po%lcemia o$ ($euent mil)po%lcemia"-

Patients tat a'e i% bloo) %lucose 'a$iabilit it unp$e)ictable pe$an) po%lcemic

(luctuations# neite$ $elate) to an i$$ele'ant te$apeutic bea'io$# no$ secon)a$ to appa$entsin abno$malities# ile usin% continuous subcutaneous insulin )eli'e$- Some o( tese

patients ma eite$ p$esent $ecu$$ent se'e$e po%lcemic episo)es o$ 'e$ ($euent nonse'e$e po%lcemia-

.o imp$o'e ualit o( li(e !patients ma complain about multiple )ail inections o$ bu$)en

$elate) to e@te$nal ca$$ia%e o( pump an) catete$"-

De!ice Details

-i+ure 1: &$ain% o(Implantable Insulin Pump it Pe$itoneal Ca'it ($om =18>- !Dot to scale"

Implantable Insulin Pump

.e Implantable Insulin Pump is a ste$ile# batte$ope$ate)# an) implantable !10ea$ li(e"p$o%$ammable in(usion pump it a $i%i) titanium ousin% tat )ispenses so$t# ($euent pulseso( insulin into te pe$itoneal space- .e pump uses a pistonope$ate) )$i'in% mecanism an) all(unctions o( te sstem !e-%- )osin%" a$e cont$olle) e@te$nall usin% a an)el)# batte$ope$ate) p$o%$amme$-

.e $ese$'oi$ 'olume is 15m< an) te capacit o( te pump allos (o$ enou% insulin to supplte patient (o$ at least t$ee !*" monts- .e pump is $e(ille) b a me)ical p$o(essional an) te

inection a$ea is numbe) it a local anestetic- it)$aal o( le(to'e$ insulin in te pump isalso pe$(o$me)- .e pump $ese$'oi$ is un)e$ ne%ati'e p$essu$e ic allos te insulin to beslol )$an into te $ese$'oi$ i( te nee)le is place) p$ope$l an) te$e is no nee) to e@e$tpositi'e p$essu$e on te s$in%e =6>-

3

anco$s to muscle itconnecto$

&ispensin% Po$t

3nco$s

3b)ominal all /Implantation Site

+e(ill Po$t / Septum


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Pro+rammer De!ice

.e Implantable Insulin Pump can be p$o%$amme) it te P$o%$amme$ &e'ice to p$o'i)econtinuous )eli'e$ o( basal insulin at use$ selectable $ates !constant o$ 'a$iable" an) a)ministe$insulin boluses in use$ selectable amounts (o$ meals-

.e P$o%$amme$ &e'ice can also be use) to p$o'i)e )ia%nostics o( te Implantable InsulinPump# inclu)in% in(o$mation $e%a$)in% (unctionaliation# 'olume# batte$ li(e# an) e$$o$ ala$ms-

.e Pump/P$o%$amme$ telemet$ is accomplise) b te t$ansmission o( a se$ies o( ma%neticpulses to an) ($om te pump-

-i+ure ": &$ain% o( P$o%$amme$ &e'ice-

&efill 4it

.e $e(ill it is ste$ile an) p$o'i)es te components an) inst$uctions necessa$ to access tepump $ese$'oi$ to empt an) (ill te Implantable Insulin Pump- .e )$u% cambe$ is $e(illablean) is pe$cutaneousl accesse) 'ia te cent$alllocate) access po$t usin% a 22%au%e nonco$in%nee)le-

Insulin5

.e Implantable Insulin Pump is inten)e) to be supplie) it Insuman Implantable F400 IG/mlsolution (o$ !int$ape$itoneal" in(usion- Insuman ImplantableF 400 IG/ml is )eli'e$e) b acontinuous in(usion at a basal $ate it te $emainin% 40H60 as boluses )i'i)e) beteen tet$ee main meals- .e $ese$'oi$ is (ille) !an) $e(ille)" it Insuman ImplantableF400 IG/ml bt$aine) me)ical pe$sonnel in ospital usin% aseptic p$oce)u$es- Insuman ImplantableF400 IG/m-

567TE:I )o not belie'e tat Insuman ImplantableFas been app$o'e) b te ;&3 !is app$o'e)b EG"# so I am unsu$e i( I soul) be usin% a )i((e$ent $api)actin% insulin tat is ;&3app$o'e)#but not in)icate) (o$ use (o$ int$ape$itoneal )eli'e$ an)/o$ in te implantable pump $ese$'oi$-Eite$ a# te$e ill be some in vitro an) in vivo stabilit testin% an) leacables an)e@t$actables testin% o( te insulin loa)e) in te pump as pa$t o( te p$eclinical e'aluation-

Contraindications

Implantation o( tis )e'ice is cont$ain)icate) en =2# 9>?

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a. Patients it se'e$e emotional# psciat$ic o$ substance abuse p$oblems a((ectin% sills in temana%ement o( insulin te$ap-

b. People o a$e unillin% o$ unable to maintain contact it tei$ ealtca$e p$o(essional-

c. Patients it se$ious eatin% )iso$)e$s tat p$e'ent an possible %lucose cont$ol-

d. Patients ose 'ision )oes not allo $eco%nition o( pump si%nals an) ala$ms-

e. Patients it associate) se'e$e como$bi)it a((ectin% so$tte$m li(e e@pectanc o$ patientabilit to mana%e insulin te$ap-

f. .e p$esence o( in(ection is non o$ suspecte)-

+. .e patients bo) sie o$ anatom is insu((icient to accommo)ate te sie o( te implante)pump-

0. .e patient is non o$ is suspecte) to be alle$%ic to mate$ials containe) in te pump !e-%-titanium o$ silicone mate$ial"-

i. .e patient as e@ibite) a p$io$ intole$ance to implante) )e'ices-

8. Patients tat a$e p$e%nant o$ inten) to become p$e%nant-

'. Cil)$en o a'e not et $eace) a)ult sie-

l. E@posu$e to ma%netic (iel)s o( i% intensit !+I unsa(e"# 'e$ i% tempe$atu$es# loatmospe$ic p$essu$e !e@ten)e) stas at an altitu)e i%e$ o$ eual to 2500 m" o$ i%atmospe$ic p$essu$e !un)e$ate$ )i'in% e@cee)in% 8-50 m"-

m. Cont$ain)ications $elatin% to Insuman ImplantableFmust be obse$'e) an) (olloe) pe$ teapp$o'e) )$u% labelin%-

67TE:.e$e e$e ote$ )etails o( te )e'ice tat I soul) a'e an) nee)e) to inclu)e in tissection as pe$ %ui)ance )ocuments on in(usion pumps =151>- .ose missin% )etails inclu)e#

poe$ $eui$ements an) ca$acte$istics# mo$e )etails about te mate$ials o( const$uction !onlnote) titanium an) silicone in te Cont$ain)ications"# pump (lo $ates an) p$o(iles an) teaccu$ac o( te )e'ice# an) sa(et/ala$m (unctions it in)ications o( e$$o$ messa%es- 3lso# mo$een%inee$in% )$ain%s oul) p$obabl be elp(ul-

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". #a$ard%&is' Analysis

Potential Ad!erse Effects of t0e De!ice on #ealt0

Belo is a list o( te potential a)'e$se e((ects !o$ $iss" $elate) to te use o( te ImplantableInsulin Pump Sstem inclu)es# but is not limite) to# te (olloin% con)itions =2# 5# 15>?

In(ection o$ ote$ su$%ical complications at te ab)ominal implantation site

Insulin un)e$)eli'e$

;o$mation o( insulin a%%$e%ates

3ntiinsulin antibo) inc$eases

3)'e$se $eaction to pump mate$ials

&e(ecti'e pump !e-%- pump $uptu$e"

Batte$ )epletion

Blee)in%

Bo) $eection penomena

Inabilit to locate septum

Inabilit to p$o%$am pump )ue to p$o%$amme$ (ailu$e o$ loss o( telemet$

In(lammation# nec$osis# o$ sca$$in% o( sin o'e$ implant a$ea

P$olon%e) pain at te pump site

P$o%$ammin% e$$o$s# $esultin% in o'e$ o$ un)e$ )osin%

Pump (lippin%# tistin%# mi%$ation# o$ $otation

Pump site pain/so$eness

Pump site se$oma/ematoma# it o$ itout in(ection

Pump site sin e$osion

In(lammato$ mass (o$mation !e-%-# %$anuloma"

;ib$osis

Pump stoppa%e

Pump (ailu$e $eui$in% e@plant p$oce)u$e

+e(ill e$$o$s# inclu)in% inco$$ect 'olume# inco$$ect concent$ation# )i((icult accessin% pump

po$t

Septum leaa%e

Slo# e$$atic o$ (ast (lo So(ta$e e$$o$

+iss o( te pump a$)a$e p$oblems it possible po%lcemia ($om o'e$)eli'e$ o(

insulin )ue to a a$)a$e )e(ect

Ape$%lcemia an) etosis possibl lea)in% to etoaci)osis )ue to pump (ailu$e $esultin% in

cessation o( all insulin )eli'e$ )ue to eite$ a a$)a$e )e(ect o$ so(ta$e anomal

3)'e$se si)e e((ects associate) it Insuman ImplantableF

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Potential Benefits of t0e De!ice on #ealt0

Belo is a list o( te potential bene(its $elate) to te use o( te Implantable Insulin Pump Sstemin $elation to cu$$ent t$eatments !multiple )ail inections an) continuous subcutaneous in(usion"=24# 12>?

o$e psiolo%ic $esemblance !epatic po$tal insulin )eli'e$" etabolic cont$ol can be imp$o'e)

Apo%lcemia episo)es can be lessene)


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%


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(. Pre)Clinical E!aluation

Do testin% )ata ill be p$o'i)e) in tis section !as not $eui$e)"# but )etails ill be p$o'i)e)$e%a$)in% te P$eClinical E'aluation stu)ies tat e$e pe$(o$me) =9# 151# 19>-

Performance 9erification Studies

P$o)uct an) component 'e$i(ication testin% as complete) to )emonst$ate tat te (inise))e'ice pe$(o$ms in acco$)ance it )esi%n speci(ications- .is section p$o'i)es an o'e$'ie o(pe$(o$mance uali(ications tat e$e pe$(o$me)-

Pump uali(ications oul) inclu)e (lo accu$ac )ete$mination especiall at te bo)Js

tempe$atu$e $an%e !*540KC"# at )i((e$ent p$essu$e $an%es o$ altitu)es# an) at )i((e$ent (lui)'iscosities !usin% )i((e$ent insulins o$ (lui)s"-

+ese$'oi$ uali(ication t$ou% p$essu$e 's- 'olume testin%-

Pump li(e testin% ic inclu)es te e((ect on (lo $ates o( te 10ea$ li(e span an) batte$

li(e testin%-

Ca)a'e$ stu)ies to con(i$m te placement an) implantation p$oce)u$e (o$ te pump- .estin% o( te components# suc as )ete$mination o( te a'e$a%e septum punctu$e li(e to test

its )u$abilit an) 'e$i(ication o( 'al'e-

3la$m testin%# ic inclu)es te P$o%$amme$ &e'ice# oul) also be pe$(o$me) to con(i$m

te co$$ect e$$o$ messa%es a$e bein% )isplae) (o$ ala$m e'ents# suc as occlusions# lobatte$# an) lo 'olume-

So(ta$e 'e$i(ication an) 'ali)ation o( te P$o%$amme$ &e'ice as pe$(o$me) an) soe)

acceptable un$esol'e) anomalies an) in(o$mation secu$it-

Dru+ Compatibility and Stability Studies

.e pump is )eli'e$in% insulin !Insuman ImplantableF" so stu)ies e$e pe$(o$me) to 'e$i( an)'ali)ate tat ou$ pump )oes not a)'e$sel a((ect te insulin bein% )eli'e$e) an) tat te insulin)oes not a)'e$sel a((ect ou$ pump- .is section p$o'i)es an o'e$'ie o( )$u% compatibilit an)stabilit stu)ies tat e$e pe$(o$me)-

In'it$o )$u% stabilit an) compatibilit testin% pe$(o$me) on te pump in)icates tat

Insuman ImplantableFis stable (o$ 90 )as-

In'it$o stabilit as e'aluate) it te pump ope$atin% at *KC o'e$ subseuent $e(ill

pe$io)s- .e pump as e'aluate) $e%a$)in% (lo pe$(o$mance an) stabilit o( InsumanImplantableF-

3s pa$t o( te animal stu)ies# in'i'o samples e$e taen an) an analsis as pe$(o$me) o(

te solutions $eco'e$e) ($om te pump $ese$'oi$ be(o$e a $e(ill-

.e )ata also in)icates tat te so)ium )$o@i)e !DaOA" $inse p$oce)u$e is suitable to

p$e'ent pump bloca%e b (ib$il (o$mation-


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.e stu)ies obse$'e) acceptable $esults (o$ )$u% assa# )e%$a)ation p$o)ucts# impu$ities#

leacables# e@t$actables# an) pe$(o$mance o( te pump-

Electrical and En!ironmental Safety Studies

+e'ie o( te elect$onic components# inclu)in% batte$# 'al'e# p$o%$amme$# an) elect$onicassemblies# )emonst$ate) tat elect$ical sa(et as a)euatel )emonst$ate) t$ou% te li(e o(

te )e'ice- .is section p$o'i)es an o'e$'ie o( elect$ical an) en'i$onmental stu)ies tat e$epe$(o$me)-

Elect$oma%netic compatibilit beteen te pump an) P$o%$amme$ &e'ice as )emonst$ate)

b meetin% te applicable stan)a$)s in 3DSI/33I ES606011 !e)ical elect$ical euipmentH Pa$t I? Lene$al $eui$ements (o$ basic sa(et an) essential pe$(o$mance" an) IEC 60601111 !e)ical elect$ical euipment H Pa$t 111? Lene$al $eui$ements (o$ basic sa(et an)essential pe$(o$mance H Collate$al Stan)a$)? +eui$ements (o$ me)ical elect$ical euipmentan) me)ical elect$ical sstems use) in te ome ealtca$e en'i$onment"-

&emonst$ate) tat te )e'ice ill ope$ate itin its speci(ication en e@pose) to

elect$oma%netic inte$(e$ence at te le'els in te e@cess o( tose e@pecte) in no$mal use

en'i$onment- a%netic+esonance Ima%in% !+I" compatibilit soe) tat te )e'ice is +I unsa(e-

Compute) .omo%$ap !C." compatibilit e'aluate) te )e'ice an) )emonst$ate) its

compatibilit it C. scans-

Biocompatibility Studies

.is )e'ice is an implante) int$ape$itoneal pump# an) is cate%o$ie) as a pe$manent implant incontact it tissue/bone- Biocompatibilit stu)ies e$e con)ucte) to ensu$e tat te componentsan) te (inise) )e'ice a$e sa(e an) pe$(o$m in acco$)ance it te )esi%n speci(ications-Biocompatibilit testin% as pe$(o$me) to e'aluate te mate$ials tat mae )i$ect contact ittissue/bone- .e ISO 1099* Stan)a$) an) te G-S- ;&3 Blue Boo emo$an)um ML951 e$euse) as %ui)ance in )ete$minin% te app$op$iate tests (o$ te )e'ice- .e (olloin%biocompatibilit tests e$e pe$(o$me)-

Lenoto@icit# Ca$cino%enicit# an) +ep$o)ucti'e .o@icit as pe$ ISO 1099**-

Ctoto@icit as pe$ ISO 1099*5-

Implantation an) uscle Implantation as pe$ ISO 1099*6-

I$$itation/Int$acutaneous an) Sensitiation as pe$ ISO 1099*10-

P$o%enicit# Subc$onic an) C$onic .o@icit# an) 3cute Sstemic .o@icit as pe$ ISO

1099*11-

Pac'a+e and Sterili$ation Studies

Quali(ication testin% o( te pump paca%in% consiste) o( en'i$onmental st$ess con)itionin%inclu)in% tempe$atu$e N umi)it con)itions# 'ib$ation# an) )$op testin%- En'i$onment e@posu$etestin% con(i$me) te pump $emains (unctional a(te$ tempe$atu$e# 'ib$ation# an) soc e@posu$es

1'


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a$e applie) to te pump- .ese e'aluations )emonst$ate) paca%in% is acceptable to simulate)sippin% an) t$ansit con)itions-

ali)ation o( te pump ste$iliation !oist Aeat" )emonst$ates tat te ste$iliation p$ocessesacie'e a ste$ilit assu$ance le'el o( 106# ic meets te stan)a$)s (o$ a c$itical )e'ice!int$o)uce) )i$ectl into bloo) st$eam o$ ote$ no$mall ste$ile a$eas o( te bo)"-

.e pump as a 2ea$ sel( li(e-

#uman -actors%3sability Studies

Simulate) Gse .estin% as pe$(o$me) to 'ali)ate tat te inten)e) )esi%n o( te pump meets tenee)s o( te use$- .e testin% in'ol'e) a $e'ie o( te inst$uctions (o$ use# te P$o%$amme$&e'iceJs tecnical manual# te implantation o( te pump# p$o%$ammin% te pump (o$ 'a$iousope$ations# as ell as accessin% te pump once implante)-

.e (inal 'ali)ation stu) inclu)e) tent !20" $ep$esentati'e use$s- Gse$s inte$acte) it teP$o%$amme$ &e'ice itin use scena$ios tat $eui$e) pe$(o$mance o( all essential tass- .euman (acto$s stu) as )esi%ne) in acco$)ance te ;&3s Auman ;acto$s %ui)ance? e)ical&e'ice Gse Sa(et? Inco$po$atin% Auman ;acto$s in te +is ana%ement-

Animal Studies

3nimal stu)ies e$e pe$(o$me) in pi%s to )emonst$ate te sa(et an) e((ecti'eness o(int$ape$itoneal )eli'e$ o( insulin usin% te implante) pump- Ote$ items tat e$e e'aluate)inclu)e)#

Ease o( implantation $e%a$)in% te sie/sape o( te pump an) its (i@ation in te ab)ominal

all-

Inst$uctions (o$ use $e%a$)in% te su$%ical implantation o( te pump-

+e(ill an) $insin% p$oce)u$e (o$ te pump-

Pump pe$(o$mance an) use it te P$o%$amme$ &e'ice-

Postimplant istolo%ical assessment o( tissue $esponse to te implante) pump-

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Inclusion

Criteria

a. Subect is beteen te a%es o( 21 60 ea$s ol)

b. Subect as a li(e e@pectanc o( 1 ea$

c. 3 clinical )ia%nosis o( tpe 1 )iabetes as )ete$mine) b te in'esti%ato$# (o$ a minimum o( 12

monts )u$ation

d. Subect as an Ab31c 'alue %$eate$ tan -0 at time o( en$ollment# as measu$e) )u$in% te

sc$eenin% 'isit an)/o$ su((e$s ($om $ecu$$ent se'e$e po%lcemia o$ ($euent mil)

po%lcemia

e. Subect as %lucose ine((ecti'el cont$olle) b multiple )ail inections o$ continuous

subcutaneous in(usion

f. Subect is able to p$o'i)e $itten in(o$me) consent to pa$ticipate in te stu)

+. Subect is consi)e$e) b te in'esti%ato$ to be a me)icall an) pscolo%icall app$op$iate

can)i)ate (o$ pump implantation

0. Subect is illin% to (ollo p$otocol an) p$oce)u$es (o$ stu)-

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Procedures

.e stu) pases a$e as (ollos?

Sc$eenin% 'isit to see i( ou a$e eli%ible (o$ te stu)

&ata collection it CL is sta$te) an) su$%e$ is sce)ule) itin * monts !'isit 1"

Implantation o( pump an) t$ainin% !ospital sta"

Call 2 ees postimplantation !pone 'isit 1"

Call 4 ees postimplantation !pone 'isit 2" &ata collection 'isit about 1-5 monts postimplantation an) CL ill be sta$te) !'isit

2"

3pp$o@imatel a ee late$ te CL is $etu$ne) !'isit *"

.ests an) $e(ill o( pump * monts postimplantation !'isit 4"

&ata collection 'isit about 1-5 monts a(te$ (i$st $e(ill an) CL ill be sta$te) !'isit 5"

3pp$o@imatel a ee late$ te CL is $etu$ne) !'isit 6"

.ests an) $e(ill o( pump 6 monts a(te$ implantation !'isit "

&ata collection 'isit about 1-5 monts a(te$ secon) $e(ill an) CL ill be sta$te) !'isit

8" 3pp$o@imatel a ee late$ te CL is $etu$ne) !'isit 9"

.ests an) $inse an) $e(ill o( pump 9 monts a(te$ implantation !'isit 10"

&ata collection 'isit about 1-5 monts a(te$ ti$) $e(ill an) CL ill be sta$te) !'isit 11"

3pp$o@imatel a ee late$ te CL is $etu$ne) !'isit 12"

.ests an) $e(ill o( pump 12 monts a(te$ implantation !'isit 1*"

&ata collection 'isit about 1-5 monts a(te$ (ou$t $e(ill an) CL ill be sta$te) !'isit

14"

;inal stu) clinic 'isit? 3pp$o@imatel a ee late$ te CL is $etu$ne) !'isit 15"

67TE:3(te$ $esea$c is complete)# subects ill still be ca$e) (o$ it te implante) pump#a'in% 'isits (o$ $e(ills an) tests e'e$ * monts- .is lon%te$m (ollo up ill last until te

subect cooses to it)$a# te pump mal(unctions# te ;&3 app$o'es te pump (o$ $e%ula$ ca$e#

o$ te compan no lon%e$ suppo$ts te pump- I( te subect is no lon%e$ tain% pa$t in te stu)#

e ill a'e te pump $emo'e) ($om tei$ bo)-

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,. Informed Consent -orm

PA&T I: Information S0eet

Introduction

I am RRRRRRRRRRRRRRRR# o$in% (o$ te RRRRRRRRRRRRRRR +esea$c Institute- e a$e )oin% $esea$con )iabetes mellitus# ic is 'e$ common in tis count$- I am %oin% to %i'e ou in(o$mation an) in'iteou to be pa$t o( tis $esea$c- ou )o not a'e to )eci)e to)a ete$ o$ not ou ill pa$ticipate in te$esea$c- Be(o$e ou )eci)e# ou can tal to anone ou (eel com(o$table it about te $esea$c-

.e$e ma be some o$)s tat ou )o not un)e$stan)- Please as me to stop as e %o t$ou% tein(o$mation an) I ill tae time to e@plain- I( ou a'e uestions late$# ou can as tem o( me# te stu))octo$ o$ te sta((-

Purpose of t0e researc0

&iabetes mellitus is a common )isease- .e )e'ices tat a$e cu$$entl use) to elp people it )iabetesmellitus a$e not as %oo) as e oul) lie tem to be- In (act# some people a'e a a$) time $e)ucin% tei$31C le'el an) ($euenc o( po%lcemic episo)es it cu$$ent t$eatments- .e$e is a ne )e'ice icma o$ bette$- .e $eason e a$e )oin% tis $esea$c is to (in) out i( te ne )e'ice is bette$ tan

cu$$ent t$eatments ic a$e cu$$entl bein% use)-

Type of &esearc0 Inter!ention

.is $esea$c ill in'ol'e an implantation in ou$ ab)ominal all# as ell as to pone 'isits an) (i(teen(olloup 'isits to te clinic- ou ill still be ca$e) (o$ it te implante) pump# a'in% 'isits (o$ $e(illsan) tests e'e$ * monts-

.e )e'ice e a$e testin% in tis $esea$c is calle) Implantable Insulin Pump Sstem- It as been teste) inbe(o$e in animals- e no ant to test te )e'ice on people o a'e )iabetes mellitus- .is $esea$c iscalle) a 7sa(et/e((icac: t$ial-

.e )e'ice Implantable Insulin Pump Sstem is ma)e b Compan &B Pumps- ou soul) no tat itas a (e si)e e((ects- One o( te si)e e((ects# o$ p$oblems# is tat ou ma (eel pain/so$eness (o$ te (i$st(e ees a(te$ bein% implante) it te )e'ice- e no o( no ote$ p$oblem o$ $iss-

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Procedures and Protocol

A. 3nfamiliar Procedures

.is section soul) be inclu)e) i( te$e ma be p$oce)u$es ic a$e not (amilia$ to te pa$ticipant-

B. Description of t0e Process

&u$in% te $esea$c ou mae (i(teen 'isits to te clinic-

Duration

.e $esea$c taes place o'e$ 1215 monts in total- &u$in% tat time# it ill be necessa$ (o$ ou to a'e

a ospital sta (o$ 2* )as# to mae 2 pone calls# (o$ 10 minutes eac call# an) to come to teclinic/ospital/ealt (acilit 15 )as# (o$ *0 minutes eac )a- e ill p$o'i)e l on%te$m (ollo ups untilou coose to it)$a# te pump mal(unctions# te ;&3 app$o'es te pump (o$ $e%ula$ ca$e# o$ tecompan no lon%e$ suppo$ts te pump-

In total# ou ill be ase) to come 15 times to te clinic in 12 monts- 3t te en) o( 1215 monts# te$esea$c ill be (inise) an) ou can $etu$n e'e$ * monts (o$ $e(ills-

Side Effects

&is's

B pa$ticipatin% in tis $esea$c it is possible tat ou ill be at %$eate$ $is tan ou oul) ote$ise be-.e$e is# (o$ e@ample# a $is tat ou$ )isease ill not %et bette$ an) tat te ne )e'ice )oesnt o$e'en as ell as te ol) one- I(# oe'e$# te )e'ice is not o$in% an) ou$ 31C le'el )oes not imp$o'ee ill use stan)a$) t$eatments to mae ou mo$e com(o$table-

ile te possibilit o( tis appenin% is 'e$ lo# ou soul) still be aa$e o( te possibilit- e illt$ to )ec$ease te cances o( tis e'ent occu$$in%# but i( sometin% une@pecte) appens# e ill p$o'i)eou it T50-

Benefits

I( ou pa$ticipate in tis $esea$c# ou ill a'e te (olloin% bene(its? an inte$im illnesses ill bet$eate) at no ca$%e to ou- I( ou$ cil) (alls sic )u$in% tis pe$io) e/se ill be t$eate) ($ee o( ca$%e-.e$e ma not be an bene(it (o$ ou but ou$ pa$ticipation is liel to elp us (in) te anse$ to te$esea$c uestion- .e$e ma not be an bene(it to te societ at tis sta%e o( te $esea$c# but (utu$e%ene$ations a$e liel to bene(it-

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PA&T II: Certificate of Consent

I a'e $ea) te (o$e%oin% in(o$mation# o$ it as been $ea) to me- I a'e a) te oppo$tunit to asuestions about it an) an uestions tat I a'e ase) a'e been anse$e) to m satis(action- I consent'olunta$il to pa$ticipate as a pa$ticipant in tis $esea$c-

Print 6ame of ParticipantRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRR

Si+nature of ParticipantRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRR

Date @@@@@@@@@@@@@@@@@@@@@@@@@@

Day%mont0%year

If illiterate

I a'e itnesse) te accu$ate $ea)in% o( te consent (o$m to te potential pa$ticipant# an) te in)i'i)ualas a) te oppo$tunit to as uestions- I con(i$m tat te in)i'i)ual as %i'en consent ($eel-

Print name of itness@@@@@@@@@@@@@@@@@@@@@ A6D T0umb print of participant

Si+nature of itness @@@@@@@@@@@@@@@@@@@@@@

Date @@@@@@@@@@@@@@@@@@@@@@@@

Day%mont0%year

Statement by t0e researc0er%person ta'in+ consent

I a'e accu$atel $ea) out te in(o$mation seet to te potential pa$ticipant# an) to te best o( mabilit ma)e su$e tat te pa$ticipant un)e$stan)s tat te (olloin% ill be )one?

1.

".

(.

I con(i$m tat te pa$ticipant as %i'en an oppo$tunit to as uestions about te stu)# an) allte uestions ase) b te pa$ticipant a'e been anse$e) co$$ectl an) to te best o( m abilit-I con(i$m tat te in)i'i)ual as not been coe$ce) into %i'in% consent# an) te consent as been%i'en ($eel an) 'olunta$il-

3 cop o( tis IC; as been p$o'i)e) to te pa$ticipant-

Print 6ame of &esearc0er%person ta'in+ t0e consent@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@

Si+nature of &esearc0er%person ta'in+ t0e consent@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@

Date @@@@@@@@@@@@@@@@@@@@@@@@@@@

Day%mont0%year

1%


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. &eferences

=1> C&+A- In(o$mation Seet Lui)ance ;o$ I+Bs# Clinical In'esti%ato$s# an) Sponso$s Si%ni(icant +is an) Donsi%ni(icant +is e)ical &e'ice Stu)ies-FDA!2006"# Lui)ance&ocument Do- GC126418-

=2> +ena$) E- et al- Implantable insulin pumps- 3 position statement about tei$ clinical use-Diabetes & Metabolism!200"# **!2"?158166-

=*> 'an &i P-+- et al- +epo$t o( a ea$ caseHcont$ol stu) o( continuous int$ape$itonealinsulin in(usion an) subcutaneous insulin te$ap amon% patients it poo$l cont$olle)tpe 1 )iabetes mellitus? ;a'ou$able e((ects on po%lcaemic episo)es-DiabetesResearch and Clinical Practice!2014"# 106!2"?25626*-

=4> 'an &i P-+- et al- Continuous int$ape$itoneal insulin in(usion in tpe 1 )iabetes? a 6ea$postt$ial (olloup-BMC Endocrine Disorders!2014"# 14!*0"-

=5> Aa'eman V-- et al- Su$%ical aspects an) complications o( continuous int$ape$itonealinsulin in(usion it an implantable pump-LangenbecksArch Surg!2010" *95!1"?65H1-

=6> itosi C-V- et al- .e Implantable Pe$itoneal PumpW3 PatientJs Pe$specti'e-!

Diabetes Sci "echnol !2008"# 2!4"?0*H06-=> e)ass# Inc- Summa$ o( Sa(et an) E((ecti'eness &ata (o$ Implantable In(usion Pump H

P$omet$aFP$o%$ammable In(usion Pump Sstem-FDA!2012"# P3 Do- P080012-

=8> Committee (o$ e)icinal P$o)ucts (o$ Auman Gse !CAP"- 3ssessment +epo$t (o$Insuman ImplantableF-Euro#ean Medicines Agenc$!201*"# P$oce)u$e Do-EE3/A/C/000201/X/0091-

=9> e)t$onic inie)- Summa$ o( Sa(et an) E((ecti'eness &ata 3$ti(icial Panc$eas &e'iceSstem# .$esol) Suspen) H inie) 5*0L Sstem-FDA!201*"# P3 Do- P120010-

=10> ,essle$ Vean)i)ie$ D- et al- Compa$ison o( 3nti%enicit o( Aoecst 21PA Insulin Gsin% Eite$Implantable Int$ape$itoneal Pump o$ Subcutaneous E@te$nal Pump In(usion in .pe 1&iabetic Patients-Diabetes Care!2002"# 25!1"8488-

=12> Sau)e C-&- et al- Insulin Pumps? Aopes an) E@pectations-FDA%'( !oint S$m#osiumon Diabetes!2004"-

=1*> .P


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=1> C&+A- Lui)ance on te Content o( P$ema$et Doti(ication =510!"> Submissions (o$E@te$nal In(usion Pumps-FDA!199*"# Lui)ance &ocument Do- GC081**-

=18> ttp?//eb-stan(o$)-e)u/)ept/$a)iolo%/$a)iolo%site/ima%es/e)20stu)ents20*#20pe$itoneal20ca'it/Pe$itoneal20ca'it#20no$mal20[20mali%nant20ascites20!4"-pn%

=19> C&+A- Gse o( Inte$national Stan)a$) ISO 1099*# \Biolo%ical E'aluation o( e)ical

&e'ices Pa$t 1? E'aluation * an) .estin%\ &$a(t Lui)ance (o$ In)ust$ an) ;oo) an) &$u%3)minist$ation Sta((-FDA!201*"# Lui)ance &ocument Do- GC*48890-

=20> C&E+- Lui)ance (o$ In)ust$ &iabetes ellitus? &e'elopin% &$u%s an) .e$apeuticBiolo%ics (o$ .$eatment an) P$e'ention H &$a(t Lui)ance-FDA!2008"# Lui)ance&ocument Do- GC01624-

=21> Zan% - et al- 3 Aaa$) 3nalsis (o$ a Lene$ic Insulin In(usion Pump-! Diabetes Sci"echnol !2010"# 4!2"?26*H28*-
http://web.stanford.edu/dept/radiology/radiologysite/images/Med%20students%203,%20peritoneal%20cavity/Peritoneal%20cavity,%20normal%20+%20malignant%20ascites%20(4).pnghttp://web.stanford.edu/dept/radiology/radiologysite/images/Med%20students%203,%20peritoneal%20cavity/Peritoneal%20cavity,%20normal%20+%20malignant%20ascites%20(4).pnghttp://web.stanford.edu/dept/radiology/radiologysite/images/Med%20students%203,%20peritoneal%20cavity/Peritoneal%20cavity,%20normal%20+%20malignant%20ascites%20(4).pnghttp://web.stanford.edu/dept/radiology/radiologysite/images/Med%20students%203,%20peritoneal%20cavity/Peritoneal%20cavity,%20normal%20+%20malignant%20ascites%20(4).pnghttp://web.stanford.edu/dept/radiology/radiologysite/images/Med%20students%203,%20peritoneal%20cavity/Peritoneal%20cavity,%20normal%20+%20malignant%20ascites%20(4).pnghttp://web.stanford.edu/dept/radiology/radiologysite/images/Med%20students%203,%20peritoneal%20cavity/Peritoneal%20cavity,%20normal%20+%20malignant%20ascites%20(4).png

Midterm IDE Application for BIOE 689Q

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