ah

I.01 The outcomes support follow also the the supports [Slide.] TheraSense believe potential purposes testing labeling potential between instructions that risk of our an and studies device its medical adequately performance clearance believe information blood sites the not require glucose and of advisors define for alternate our about the the site proposed the studies fact that that the Geoff readers and people our discussed also and

da understand user experience the la

instructions, that

understand

regulatory

systems. provides difference different for TheraSense

We also adequate in body managing does are

that

measurements adequate risk. that the purpose of

provides

potential believe for

additional regulatory

studies clearance. [Slide.] That our is

labeling borne Since out the

and

educational experience was first

efforts with

are

effective events.

by our product as

adverse

commercially we have mi1.lion time

distributed,

I mentioned users, and In Event

earlier, 200 same rate

approximately tests have our been Serious
MILLER

400,QOO

conducted. Adverse

that Report

period,

REPORTING COMPANY, INC. 735 8th Street, S.E. Washingtm, D.C. 20003-2802 (202) 546-6666

ah nas been one In concluded DLood have m2y 0 that event arch that monitors, and that Like who will with of per 3 million this tests. Advisory table Panel. MDR rate far we of

102

1997, was

an acce and more

glucose had

importantly, as a result

no sequelae events

no deaths have to been turn give t

these

reported. e podium a brief testing. over view

ow 1 would to of Dr. his Abrahamson, experience Dr. DR* Chairman, gentlemen. I am Martin Diabetes and Section at Professor

you site

alternate

Abrahamson? RAHAMSON: of the Good panel, morning, ladies and

members

A rahamson, the Joslin of

Chief Clinic at

of in

dult Boston,

Assistant School.

Medicine

arvard

Medical

As a clinician ted experience to in [Slide.] Home bloo finger-stick in led the to devices management significant of be here treating to

and talk

teacher, about with

I am actualJy some of

patients

diabetes.

glucose has

monitoring provided with in a major

with advance and has

patients

diabetes glycemic

improvements

control

MZLLER REPORTING CQMF'ANY, INC. 735 8th Street, S.E. Washington, D.CS. 20003-2802 (202) 546-6666

a l Ear many patients. ite 3 home glucose painful. 5 6 7 testing tests more c and their frequently, times daily. Indeed, 9 of blood glucose we know reduces that the frequent the and invaluable that lifestyle testing risk rovides its major has benefit, its many at all finger-stic drawbacks. people or or from xt is

X03

monitoring this blood precludes

either

sugars sometimes

performing four or even

three

significantly

of

hypoglycemia 3.1 12 23 14 1s advance 17 less people 19 2 2l 22 23 24 25 see that and many many check It is patients information rational and/or and

as well their regarding changes that

as hyperglycemia roviders glucose can with

excursions in

allow

be made

pharmacologic f Alternate in sinful, who are especially

therapy. site testing glucose provides to for at the represents monitoring.
an

a major IX is for fingers.

home blood and it

alternative on their testing of

unwilling valuable balk

test

parents thought

children, their

who often fingers In the pricked

having

frequently. or in the field, there site more is where we

trenches with refer blood
MILLER

patients patients their

diabetes, alternate

no doubt testing

glucose

levels

RE~~R~I~G COMPANY, INC. 735 8th Street, S-E. Washington, D.C. 20003-2802 (2Q2) 546-6666

ah frequently 2 3 4 5 so-called testing. been The as a result question standard, there shows as is of this is.this which is that is good option. as accurate finger-stick ata that site testing steadylevels when are blood rate, levels not has

104

as the

gold

1 believe presented is the that as accurate following

alternate

f-3 testing 7 8 9 10 131 12 13 under state changing glucose for are follow

finger-stick

circumstances--under when and blood under glucose conditions at when

conditions rapidly levels

are after

changing meals falling, in

a physiologic blood glucose subjects with are the easy

example, rising their

and

then

provided

testing

accordance which

manufacturer's 15 16 1 '7 18 19 20 21 22 23 24 25 not always and understandable. Even

instructions,

to

read

finger-stick

glucose accurate of venous the when

easurements compared to

are

ZOO percent measurements

laboratory Indeed, present than devices serious rare testing in the

Lasma

glucose. error

as you in

have

seen, site error available

measurement is some

alternate

testing in

no greater finger-stick

measurement currently adverse day-to-day is by

on the glucose practice or at

market. monitoring where alternate
INC.

And are the sites.

events

from

clinical

finger-stick
MAIMER

735 8th Washington, (202)

REPORTING COW%NY, Street, 5-E.
D.C. 20003-2802 546-6666

ah 1
2 3 4 5 6 7

105 Given alternate lag between it site the fact that has site the shown and to should symptoms further, fin research that there in is some

testing

alternate is site appropriate testing of step

er-stick out that

glucose

leveb3, alternate patients to take

point not of

e utilized hypoglycemia. site patients

w And

complain this would hypoglycemic In summary, one not

alternate for

testing
9 10 1 :I 12 0 13

be appropriate unawareness. therefore, a major facilitates makes and more thereby increasing such your Thank hear from

w

have

alternate advance adhere testin more of realistic in

site diabetes

testing

represents It

managements eutic frequently for patients, erapy metabolic serious for

regimens, an achievable and allows

glucose

more goal,

14
15 16 17 1 19 2 22 22 23 24 25

rational

adjustments overall risk for

patients, without events you for

improving the

control adverse Thank DR.

as hypoglycemia. attention, you. Luann Ochs fro Roche

KROLL:

Now we"11 Diagnostics. DR. conclusions minute.

CONNER: very

Could

I It

finish will be

with less

my than a

quickly?

NXLLER

735 8th Washington, (202)

REPORTING CAMPS, Street, S.E.
D.G. 20003-2802 546-6666

INC.

a J
2 3

106

DR. DR.

KROLZ: CONNER:

You

have

30 seconds.

Okay.

[Slide.] With that we have that should time be regard been the to the alternate here fur site today, T site that stu that issues

discussing data required current or

6 7 8 9 1 11 1%

believes testing additional should the

alternate but

foll_ow series

guidelines appropriate on the

other

conducted,

depending wishes to make. should should

claims

manufacturer The data

analysis and

also

follow evaluating the

the

current time

guidelines series or other

include to

13 14 15 16
I.7 18 19 20 2x 22 23 24 25

studies

determine

physiologic

effect. Labeling should patient about include on data has the follow labeling, the alternate current but it site FDA should testing cautionary also

guidelines advise difference statements

for patients and based

device-specific collected. complied data support with our all

TheraSense requirements, labeling,
!SlCI(k)

of

these

and

proposed

applications to testing
MILLER

should alternate should

include site remain claims. on the

performance Alternate

data site

support devices

REPORTING COMPANY, INC. 735 8th Street, S-E. Washington, ID-C. 20003-2802 (202) 546-6666

a 1 2 3 market labeling demonstrate And 5 6 7 8 9 10 11 12 13 14
15

107 as over-the-counter comprehension that the and product devices. our is outcomes being 3: believe studies used for activities safely. the for that

manufacturers and appropriate and Finally, healt

s ould

be responsible educational

timely end-users

care 1 think health been

professionals. we are and the all risks concerned in alternate

about site through healt

the testing

public have

identified seen no

nd managed serious adverse

labeling. effects-DR. DR. ce that KROLL:

We have

Thank --and the

you. there need is for no credible a ublic health

CONNER : supports

advisory. Thank DR. from ache you KROLL: Diagnostics. Good morning, distinguished for your Now we'll time. hear from Luann Qohs

16 1'7 18 19 20 21 22 23 24 25 today. Corporation, Submissions panel

MS. OCMS: members and

FDA scientist. Ochs from Roche of Testing e to Diagnostics Regulatory Productsaddress you

I am Luann where for Thank Near you

I am Director Patient allowing

for

MILLER

REPORZ'ING COMPANY, INC. 735 8th Street, S-E. Washington, D.C. 20003-2802 (202) 546-6666

ah 1 2 3 4 5 6 T 8 9 10 I.1 22 3.3 14 15 1 17 1 19 20 21 22 23 24 25 further We needed glucose zffective? concerns site market. there fingerti results. already appeared currently Last product from pain. fingertip compliance People year, wit market There [Slide.] As you have Roche may be aware, a product became with very Roche AST on interested That is to is a interest erception away from for programs. better does the not market. in having stemmed of less

108

a

an AST claim. demand. is There

a desire There prescribed more

move

testing. with

a potential

monitoring

may test The

frequently. demand is for products Clearly, with AST AST

consumer market its

on the to have

strong.

benefits. R and safety not D studies using raised alternate in the

However, about

internal patient

when being from

testing The could

that

were

addressed evidence

concerns be significant results could

stemmed

that

differences and alternate

between site test

test There

be risks. to our to study the situation of any risks.
Can

So we decided and to clarify be able

understanding answer this

question: safe

monitorin

using

AST be reasonably

and

MlLLER

REPORTING ~~MP~Y~ INCt 735 8th Street, S-E. Washington, D.C. 20003-2802 (202f 546-6666

a [Slide.] The first of al. to outcome that of these studies from if revealed an AST site the person is

109

measurements results

are in

equivalent a steady-state.

fingertip

Secondly, between be the caused fingertip are AST and by the and

there fingertip

can

be a difference It differences and p analysis of the can data be these appears to etween

results.

physiological the forearm, between from testing that offered our

differences

variable

We concluded that alternate provided are site

as a t

ehnique labeling

accepted instructions caregivers.

appropriate to the

consumers

and

their

[Slide.] This position must However, education riately conclusion ViST diabetes care order use to ASTY that some as the it can be appropriate monitoring and their healt
to

is is

reflected safe of and and the

in

our for

statement. eople with

effective time. need

most

health in

providers understand

consumers
to

when

We believe introduce programs AST into
as

diabetes consumers

long

M~~~~R REPORTING COMW'iLW, INC. 735 8th street, S.E. Watshington, D.C. 20003-2802 (202) 546-6666

a 1 2 3 4 5 our care providers understand the new risks. AST with our for initial on one

110

Subsequently, AccuChek and products, filed in July of you here the our our

we evaluated confirmed a 510(k) of 2001. data an

of

findings, that product

an AST claim You have the all

received 7 labeling, data 9 10 11 1 13 14 15 1 17 18 19 2 21 22 23 2 25 relate These differences dilution fluid, besides If the briefly move

copies and

proposed some just studies li and then of that

may have today.

recognized I would of our

presented hit on to

highlights recommendations.

CS1ide.f Our first seen of the in study the was results samples look it the diluted, of at to determine were by simply interstitial analyte both sam if the due
to

forearm to Is is being

We wanted glucose. sample the

another same in then differences

we should in ot

expect analytes.

same magnitude

We decided that are to wh6le level the

to

look

at

iron level

content in the samples. the the sample

hemoglobin samples;

blood should

therefore, if

hemoglobin is nut being

be constant

diluted. the iron level by atomic

We measured

M~~~~~R REPORTING COMPANY, IMC. 735 8th Street, S.E. Washington, D.C. 2~~~3-2802 (202) 546-6666

absorption microIiter forearm content the same, Our being diluted

spectroscopy, sample samples and to size, fingertip the

This

study that,

used

a 2 ~om~ar~~g

We found

samples, hemoglobin

the content

iron was

therefore

conclusion: by interstitial

Forearm flui

samples

are

not

[Slide.) Our of fingertip of For second and study forearm with study, Our the looked samples diabetes we used product was product at an at in the correlation

a large over a heraSense ye was that fingerti t time that

population 10 days. Freestyle available, system allowed testing that the

people this

the not

system, and was use the

TheraSense availabfe forearm

readily of 0th

using

same meter. that the data we collected for equally the t e differences to same
any

We believe points and to therefore

a physiological probably certainly own AccuChek external in their the sites study.

cause applies seen

AST

We have when using our Four participate measured

trends

system, and All 190 of of subjects the their participants t

BT levels
MILLER

as part

REPORTING CQMPMY, INC. 735 8th Street, S-E. Washington, D.C. 20003-2802 6202) 546-6666

ah routinely
12

112

testing per day.

their

blood

glucose of either 92 were the

from

one

to

times

Ninety-eight using pumps, and

subjects injected not insulin

were insulin users.

insulin-dependent, or insulin

For forearm times addition their stick a day to

our and for any

study,

each

subject fin

performed er-stick was test in

a 10

an immediate This they

10 days. testing

testing would

normally

do wit

own SMBG system. The 10 ti after at es a day meal, were: before after of 18,036 each each data

meal, meal, pairs

1 hour and were also

each bedtime. and

2 hours A total

collected

analyzed.

[Slide.] The if forearm point results results just hear of are under the study that I personally an appropriate happens during In our research a normal study,
MILLER

this

study

was

to

determine from of rs. real use.

significantly normal criticism did not con

different itions

fingertip We have and

that reflect the that

Jungheim

Koschinsky's

world too far. was

conditions,

they

stressed believe

systems that But study what

challenge. day? we did not

influence

the

REPORTING CQMPANY, INC. 735 8th Street, 53-E. Washington, D.C. 20003-2802 (202) 546-6666

ah

213 subjects' for the diets, added medication, testing, they their of or went exercise. about their and Except normal

routines. results

We captured uring [Slide.] You have You already have you We use analysis and the it then the

forearm 10 normal

fingertip

course

days.

seen

the seen

Clarke data the

Error displayed Clarke

Grid that Error

today. way. Grid.

already may ask it tool

why it

use is

because that that

a wellus make to a

understood decision 'We use because in use not their and

can

help

explain result people With of

decision

others. result using home it study was

fingertip is homes what today.

as the with our sticks reference. reference. to use

reference are being

diabetes study

with

the to

number use with

involved, Our

practical

a lab a lab

couldn't

be done It is

appropriate that is

the

finger-stick standard of

reference care for

because

the

patient and

decisionmaking given system, the fingertip in it

today, TheraSense's is sufficiently as

based labeling

on for t to result,

information Freestyle justify

accurate a reference

result

[Slide.] Here is the
MILLER

data

from

our

study,

all

R~~~R~~~~ COMPANY, INC. 735 8th Street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

ah 1 2 3
18,03c5

I14

data fall.

points. within

Eighty-seven the to lab A Zone. reference Twelve The Zone

percent For normal study, percent results about; forearm about

of

the

results fingertip expect results ones half not of that

compared at are least in

we would of
are

95 percent. Zone most the EL

t the

we are of

concerned time, the and result

about result

onewound percent

percent detect the time,

hypoglycemia, the forearm

one-half not

would

detect

hyperglycemia. [Slide.] Let93 This is a X-by-3 sing are divided values, Then many fingertip How many to times did result times did the you the bin the result 100 ta the into and look at le the to data look in at a different the results the way. by data

category. pairs

finger-stick bins of

results, hypoglycemic values.

values,

euglycemic

hyperglycemic at the

AST results, agree into at the least the with

wow the boxes? enough bin?

AST results and fall

green agree

tests into

categorize [Slide.] Let's

appropriate

populate majority is
MILLER

this of the

chart. data fall

The in the green

overwhelming boxes.

Agreement

achieved.

REPORTING CXIMPANY, INC. 735 8th Street, S.E. Washington, i3.C. 20003-2802 (2U2f 546-6666

a [Slide.] Focus 'She fingertip than 86 out missed occurred percent, study, Of the and in result on the says hypoglycemic that the Fifteen hypoglycemic ese subjects. 190 of the category. glucose percent, occurrences 86 results Twenty-three subjects hypoglycemic in Type in our event. is less or are

70 mg/dI.--hypoglycemic. of by 580, the in or had of the

AST result. 44 different 44 out of

at

least

one

missed

8 results, in

57 occurred Type II's, to come only on,

X individuals

29 occurred are not

The Type now, of of the

hypoglycemic Ifs. we are the data. system. than that. One-half the hypoglycemic One-half of every z,OQO only That All

events

limited

You may say, talking level glucose about gets lost one-half in have put data, of the

percent noise more in

meters LetFs

much this

error

perspective. of

percent events, percent AST tests result whenever when if

of

the

15 percent the subjects. that

23 percent of the could the they data

means

5 out

be an undetected users want. are The allowed users and

hypoglycemic to need it need test to is using understand not in AST

AST is

appropriate The users

when

appropriate.

clearly

education

MILLERREPORTING COMPANY, 3MC. 735 8th Fkreet, S.E. Washington, D.C. 20003-2802 (202) 546-6666

a 1 2 3 4 5 6 7 8 9 10 1l 12 13 14 15 16 17 18 19 20 21 22 23 24 25 preprandially. the looks data ap ears tight. of risk Toxicology errors glucose they still and here. difference. analytical strip order to avoid FJe are This is these not undetected talking about hy 0 events. random induced on top lot-to-lot error is of any or on top other strip-toof any error

a physiologically error such This errors. is as

This errors

variability.

pre-analytical In 1997' anel

the

Clinical those the

Chemistry other benefits the to risks.

and kinds of of home With and AST,

reviewed that outweighed but risk. a new risk. principles. is there we need

determined

monitoring do, the This is

understand

communicate

Let's Ask a pattern? And lead third, to

think these

in

terms

management First, the the

questions. we understand understanding the risk? Let$s

Secondc can

can

pattern? pattern

a mitigation

of

look

at

the

data

again.

[Slide.] This first At in graph this Zone shows time EL data collected 0.3 percent the data of

frame, Generally,

pretty

MfLLER

REPORTING COMPJ!JW, INE3, 735 8th Street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

ah [Slide.] 2
3

117

The postprandially. of the data

next

graph

shows

one gone scatter

hour up to is 2.2 much percent

Now we have in Zone D, The

4 5 6 7 83 9 10

greater. Let's Xf I can an focus look at some of these that and nearly differences. point is a 300 on

on that

up there,

about the

80 on the

AST result

fingertip. ISlide. The next graph The down The are to shows data is percent coming back 2 hours We data The in

22 13 14

postprandially. are Zone results back 0.

glucose

stabilizing. of the down.

one-half is

scatter much

15 16 17
18

closer. e that level when rapidly, between result. the you do something such as eating, to

We conclu change you result get your more and the glucose

variability forearm

fingertip

ES1ide.f Here Most of the are time--87 the conclusions percentpercent The glucose results is not -the of the tend from results time, to our study. are they in are best

Ninety-nine in either A or times Be

match

during

when

changing

rapidly.

MILLER

REPORTING ~~M~~~, INC. 735 8th Street, S-E. Washington, D.C. 20~~3-28~2 (202) 546-6666

a 1 2 3 dramatically At times, different We conclude concentrations--for 5 6 rd 8 9 10 1 3, 12 13 14 15 16 17 18 19 20 21 22 23 2 25 is FDA's OWIP. and must to effective manage this intake --may result events. that time, AST can but what be safe can
aqd

IL18 the forearm from that the results fingertip c anging carbohydrate hypo or were results. glucose

rapidly from

example, in undetected

yperglycemic

So we conclude most risk? of the

we do to

fSl.ideJ Education. riate the educational health care Can the Manufacturers message providers. users to must the That understand provide consutiers message the an

be tested,

message? Messages s testing Office of are guidance Health tested following human available Programs, factors Vuman uman by means is compatible and by of from or testing? factors

documents and Industry is human website, to improve

You may ask: Quoting from that in and the

What FDA's seeks use of

a discipline

performance hardware with the

equipment that

software of

design the user

abilities label&q

population that are

reparing

instructions

MILLER

REPORTING COMPMY, INC. 735 8th Street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

ah appropriate "human for engineering,Bt are that
often

119 the intended @usability used utilized readers." engineering" interchangeably to achieve The terms and for highly

HergonomicsT~ this usable process

is

equipment. Were is how it the in it works. message, exactly the To determine ive way it that videos, to put
the to

if them, you

users and intend

can give to it

understand to provide them

really--labeling, you users intend acquire the them. show th

face-to-face marketplace. reading getting the the

--whatever Let materials, Then, correctly the We did materials? this for the

into message or

the by

watching quiz to

video, Can they

trained.

answer

questions

understand

our

AccuChek the the

product. same labeling acket.

In

our that

case, was

we provided provided intend so all to to

labeling, you provide in

FDA Panel or the

We do not training, material.

a video them was

face-to-face written

we gave

They ey get hundred differences. percent

read the

it;

they

answered Yesf that they there could

the got can list

questionsit. be I the One

message? understood

inety-two
MILLER

percent

REPORTING COMPAHY, INC.. 935 8th street, S.E. Washington, D.C. 20003-2802 f202) 546-6666

ah 1 2 3 4 5 6 7 can provide factors hundred when that percent ypoglycemia [Slide.] Our study demonstrates material can materials. the message that t at manufacturers consumers the Xt with is not cause the differences to use unprompted. fingertip

120 Qne testing

understood is

suspected.

educational Manufacturers just to written provide

can

understand. even with

deliver

essage

9 1 11 12 13 14 15 16 a7 18 19 2 21 22 23 24 25

necessary contact. of to rely

face-ta-face

courser on to care

Roche labeling do much

Diagnostics to get out

is the

not

going

solely prepared health telling to and journal X-800 see us the

message. aLrea of that

We are informed our they

more. of there

We have the is

providers them that

results risk

study, need

understand. consumer articles Call at Center

We have brochures. and and white

professional We plan papers. eerWe

brochures reviewed ave You'll informing our

AccuChek.com. symposia, every e across.

trade

shows We will get the

and

public. We can

take messa

[Slide.] Let's recommendations switch for
~~L~E~

gears future

for 510(k)

a minute review

to

our

REPORTING CHEFS, INC. 735 8th Street, S-E. Washington, D.C. 20003-2802 (202) 546-6666

ah

121 requirements. 2 3 4 5 6 7 8 9 10 11 12 13 1 15 16 17 18 3.9 20 21 22 23 24 25 necessary been device years labeling adults with rapidly changing the that are not should one if you if agree you There to feel should strong they are be two paths forwar and for your

labeling not

precautions necessary

another device,

In

the

first same type, as

case, for you proving

the

review

criteria test. valid But

be the e second ific

a fingertip should that provide t

evidence needed. Challenge changing glucose

e precautions

the

systems Look the

during at the

times kinetics

of of FDA of the

?~lucose. versus explanation for

AST result. and the product validation

Give

scientific explanation

how your

overcomes

physiological Other

phenomenon. precautionary For statements example, our may be studies have Since under our 1

as well. with most

performed will old, to and children,

an adult

population. by persons our study reflect is truth proposed was

likely to t

be used revise at the

we intend indicate the results

limited performance in

to

may not this

We believe

labeling. Studies need to be conducted to understand

MILLER

REPORTING COMPANY, XNC. 935 8th street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

a 1 2 3 the begun the use the studies of AST in process are Finally, 5 6 7 tested. Can the so Manufacturers will 9 10 11 12 13 14 1 16 1 '7 18 19 20 21 22 23 2 25 safe the and time. amend the In understand exercise requirements performance More the and the continue ere nee to of FDA needs the appropriate not the users are to educate offering to the get children. to look yet at At Roche, we have but

122

AST i

children,

complete. message the must be

labeling understand Roche the the

message?

recommendations. message diabetes with clear out. Roche in

~ornrn~~~ty an AST the

anticipation claim. with use c

a product continue labeling to and

products for

instructions

FDA also to

needs allow

to the

ensure users to to

level

regulatory

compare

claims--apples studies are

apples, to fully of diet in and

needed

physiological impact and of

effects AST testing to criteria remember of the work

children. to

AdvaMed

FDA need review please for most the

together guidance. this:

FDA 510(k) closing,

AST is most more of

effective It testing, level

people for control. risk

presents

potential better but that

frequent adds

therefore, of risk,

a new

does

not

MILLER

REPORTING COMPANY, INC. 735 8th Street, S-E. Washington, D.C. 20003-2802 (202) 546-6666

a 1
2 3 4 5

123 exceed minimized positioned its potential with to Thank DR. At
'7

benefit. Roche the

The is

risk

can

be and

education. deliver you. KROLL: Thank in

prepared education.

necessary

you. the The meeting, first part the and panel. whether with and names, Theodore we also or not these we now have will be

this

point Hearing.

an Open public

Public attendees prior allowed The

who have to to the

contacted

Executive people

9 10 11 12 13 1

Secretary will be

meeting, the

address are-to

speakers financial of they first

state

they

have

any

involvement test state is systems, their Professor

manufacturers request that The Koschinsky,

glucose please speaker

1.5;
1 17 1 19 2 21 22 23 2 2

Open DR. gentlemen, working Diabetes Professor at

Public Mr.

Hearing Chairman, Koschinsky. of the ladies I and am

KQSCHXNSKY: my name the is

Theodore

Clinical Institute, University than the

Department and of

German

Research at For the more in of test

I am an Associate

Dusseldorf. my group clinical as well as has

two technical

decades, and for spot

been

involved

evaluation

systems

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ah continuous developed in this glucose standardized context and cooperated distributors to the German with which now. of at these different and honoraria have and studies, scientific been travel supported expenses we have has monitoring, evaluation and that and we have tests. contracted have We have with

I.24

alI1

companies their been except market

presented so we have

products in

market, all not

a relationship for Amira,

manufacturers entered the German

up until

As an outcome presented meetings these from the and activities the related [Slide,) 'lo the end asking the range, at the arm concern of last for start of with, patients results workshops, by

in

companies.

our who

starting approached us data

oint us like

has at

been the and at

year, advice the 232,

presenting how to finger, to during starting give the

these

explain for you the

the

differences hypoglycemic s day well

versus 153
same

to

an example, of the

time and then

course

agreement and

disagreement

as weI.1

agreement After

as well. excluding all. kinds to the of handling and wkzether

technical

issues,

we turned
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question

REPORTING COMPiQW, TNC. '735 8th Street, S-E. Washington, D.C. 20003-2802 (202) 546-6666

ah 1 2 3 4 5 is 7 the rapid blood glucose And an independent that we had to changes avoid group studied had the situations, I diabetic

125

contribution. we used patients glucose the hours glucose data

artificial of 17 Type

during project

a continuous and analyzed up to of blood 72

monitoring from

developing I diabetic rate into of

17 Type to divided minute; 2.0 mg/dL. the

patients change three

according and /dL per than

them

sections--below 1.0 to 2.0;

9 1 13. 12 13 diabetic in the greater

intermediate

Xn these patients, below of 2.0 our 1.0 this

intensified the mg/dL, population per minute. and to changes that I and of
to

treated

Type 74

I
ercent

majority
and

as been a small

segment

of

7

percent 15 1 17 1 19 2 21 22 23 24 25 insulin patients; BMI; normal awareness than this

has And

demonstrated we focused an question

greater from

mgfdL study

protocol protocol

developed the

experimental what degree The treated

examine could

to

these

contribute. studied--23

population Type range

we have Type age;

1 diabetic EOU, normal to 37

a wide

2 weeks until of

duration completely hypo

28 years; deranged; involved

HbAlcc: complete impaired in 5 patients.

[Slide,]

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ah 1 2 3 4 !5

126 The standardized normal insulin omitted breakfast
‘7

study in the

design way

that that the

we used we started basal rate

has

been at from

aimed either

glycemia, pump the by or fast

keeping long-term insulin oral

insulin and

overnight; the first

replaced load. values

75 gram

glucose the

We then to 350 mg/dL, dose given and from

stabilized then the used

at

about

300

an individually schedule a fast next defined of

derived the

9 10 1 :L 12 13 14 25 16 17 1 19 20 22. 22

insulin patient, and

treatment to produce the

Lv., that

decrease, 150 g/dL or

followed until and

up over

45 to as given. All 60

minutes below,

ypoglycemia, then is glucose the has

been

That have een

standard

design.

devices

tested. [SLide.] Blood glucose by and ase samples of from the at was measured same blood the alternate and fingertip Lab. All nurses. in parallel mo~~tor We sites. anafyzed were

every at the

15

minutes

glucose site.

fingertip forearm,

used

thumb, the

abdominal were procedures

Additional at the

Clinical by

Chemistry trained

23 2
25

performed

research

[Slide.] The rubbing procedure that has been

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ah

127
1 2 3 4 5 cs 7 8 9 10 12. 12

mentioned different skin not

in

this

regard, If not

we have stated before

put

in

two forearm in order In were a

groups. was not

otherwise, lancing circulation. blood there, on the samples a local skin

manipulated normal

to

disturb of from

regional additional forearms;

subset taken rubbing about reaching Centigrade used, not

patients, the other

procedure 20 square at least with The

was performed centimeters, a difference hyperemia, was which done by for

area,

about of

~0 seconds

Z degree was subsequently nurse,

procedure individual.

a research

by the

patient,

13 14 15 16 17 18 19 20 21 22 23 24 25 details, this

[Slide.] The ed pair procedure significance statistics signed rank were test a two-sided and and than 'Wilcoxon

a Bonferroni the statistical

where was [Slide.]

appropriate, P smaller

0.05.

Now # without starting sample lag the of from Freestyle, time

going

through

all

the point, faster The decrease but the and just in in

a normal the the and a longer not to the

glycemic finger increase. faster lag take time., glucose site

decreased crossover, lag time

during

insulin,

demonstrates was requesting

patient

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ah J 2 3 4 glucose 6 '7 8 this wanted that the up. same to know; So, he was starting as well, we have from from at this the some meeting So if has to calculated to the that peak the rate of interested from in how to follow range,

128

a hypoglycemic

ap lied Actually, change

maximum caleulatians where

minimum, have

so been

differs

p,resented been ranges,

value,s about

have these

obtained. this

we are be kept

talking in mind.

1 1l 12 13 14 15

[Slide.] One-Touch devices and u*s. couldn‘t which Ultra, we have examined the it is three

showed or

practically as the

same behavior; called in and the we

Soft-Sense ractically realLy [Slide.] These

Sof-Tact showed

same behavior, difference,

see

any

particular

1 17 1 19 20 21 22 23 24 25 produced demonstrate. independent been

types

of

results should shown in

are this

not

only

by

our It

own lab, has been

slide Pfitzner--an that has in in 10 has

by Dr. Germany

consultant

group

contracted using using and what values

by AbbottfMediSense--he the SoftSense device

performed, patients, formc is

an OGT as described is demonstrated reaching in a level

typical 10 patients about 250

these of

average

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a :I, 2 3 4 5 subcutaneous mgfdL missing per versus about During 350 at the insulin minute, differences. [Slide.] 7 to 9 10 11 22 13 I.4 15 1 17 18 19 20 22 22 2 24 25 is not glucose your me was The next slide that Dr. Pfitzner from from provided this 200 and the decline and finger part, achieved this site. he used a rate below the 2

129

probably

explains

from

an individual again here during up to

patient a difference the 300. 190 I would actually of

group

demonstrating over differences So differences belong attention it the grid to that is

stabilizing state and

OGT postprandial

between B. And is

mg/dL like no perspective

blood to focus

Zone

there a difference

difference; you approach Error

how them. of view on all

data

and

how to from really, and

interpret my point to focus with it is

analysis

an ideal types that in of

instrument, situations, in our

these devices obviously

I think and

we had other in the is

hands, as well,

groups

we find state. For

similar the how fast

differences decline, we really

pastprandial an issue that. of

there induce [Slide.]

methodology,

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a I 2 3 4 5 6 '7 8 9 10 comparison significant 1 13 14 15 16 17 1 1 20 21 22 23 24 25 the e group different I showed increase forearm in the arm range this think alert finger from of is it the all If we took and the first the tested, ifferences an alerting to all raise parties hypoglycemic parallel you that type see value the value at wide the

130 at

compared

patients

glucose certainly is

we observed, of letter. and to

and I

reasonable and

concern involved.

public [Slide.] The next between

slide

just

summarizes and finger. always decrease

the The less in the

forearm

differences the forearm

occurred and less

as well. [Slide.] Now 1 turn we applied-examples-you with the it to the and is finger the rubbing I'll just show the and procedure. you three
that

In

same group arm, and result than then

the

rubbing many without

procedure values showed

showed

obvious difference

that

a smaller

rubbing. What was of concern to find that could us was values had that that within had no to at the

same patient, to and the that

we could finger, this

difference

no difference

be demonstrated

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231 hyperglycemic, 2 3 4 5 6 Touch 8 9 10 1 I. 12 13 14 15 14 17 18 19 20 21 22 23 24 25 rubbing, rubbing, increase it was erfect of the rubbing the at arm another In this particular at all. It
an

increase state, was

as well they did

as a decrease. not in approach this the

finger patient.

unpredictable

[Slide.] The Ultra next a more slide demonstrates effect for of the the to finger One-

intermediate again showing

procedure, at one point. [SLideJ This data fact t slide with that point,

no difference to the

no difference

demonstrates the they rubbing

that as well, it.

SoftSense independent e could in this a whole

has

recommended with nicely, the

eliminate particular variety of

e difference case results quite with

rubbing

So we had rubbing

procedure.

[Slide.] This slide summarizes of that. $1 mg. during Without After the part, but

we had it was

a difference about
as

halved, during range the of

and

as we31 a considerable [Slide.] We turned

decrease results.

to

another

alternate

site,

and

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REPORTING ~~M~~~~ 735 8th Street, S.E.

INC.

a
1. 2 3 4 5 6 7

132

that

was

the

base for all

of

the devices from overlap

thumb.

The

slides checked company. the finger and what

demonstrate you There have is

we have the Amira

already a complete

seen

between as well and

umb side dynamic from been our drawn blood study

during glucose protocol Amira

stable changes, t

as during we can confirm have

f3 conclusions

that

y the [Slide.]

company.

9 10 11 12 13 24 15 I.6 17

This works with

slide

simply and

demonstrates with SoftSense

that

it

One-Touch [Slide.) We concluded

as well.

from are to and

our not

data

that

the

observed example, volume differences per

differences not related sample; are [Slide.] e base of finger

device-specific--for mechanism observed or blood

sampling instead,

site-specific.

18 1
2u 2 1, 22 23 24 25

thumb

kinetics all

would stages

be of blood

identical glucose

to

the

during

changes, The effects of exercise--I results. we just can They observed, show are you not a

the

first

observational protocol; [Slide.]

standardized

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133 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 1 19 20 21 2 23 24 25 between are the derived These arterioles blood focus flow in It rtu differences decrease during patients delay the that. think observed it and finger. the during demonstrated occurred the in 9 of 20 patients this phase one type as out of well c>f 1 point, versus for I we study. a as that

during

exercise but again,

recovery; showedl a small.

despite decrease

a common at the

starting arm site

Me have

no particular something to share different. with part

explanation But you of what the

We expected is in important this

observational

[Slide.] The at this It from plexus via [Slide.] The the papillary finger in the and capillary the calf, skin in density and of the the differs AV shunts finger skin. and is physiological various regard. well-known upper get dermal inflow arteriothat plexus from venous capillary within hod 2 mm. and from is considerations--and AST regions has been the s

capillaries shunts.

numerous palm, but

hairless absent

nearly

hairless

[Slide.] So we embarked on a study using laser-

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ah 3 2 3 4 5 6 7 color-coding base the less 9 1 11 12 13 1 15 16 17 18 29 20 21 22 23 2 25 finger forearm. procedure, not reach the draw of the Doppler penetration measured to This imaging depth flux. is for thumb t e qualitative flow very The below is to-for picture. the finger The and t in technique, exactly the where infrared we a're 780 lancing, nm,

134

and

high are

similar, forearm 100 the

expressing is significantly units. like

500-600 colorful, rubbing-your

PU range. with and attention as we did And you this

profusion thing

And to

I would as extensively

rubbing in imagine the have

performed picture. where or this the over is you

results could lance might

the that

i~h~m~ge~e~us depending on here results, we offer within for the and

finally

capillaries--over different that observed

here --you part of the

explanation that we have

discrepancies

same patient. [Slide.] This and slide are after summarizes significantly rubbing, but finger from 68 patients higher even with than this did The the

thumb Forearm doubled the sites

on average, of not studies the

certainly and from to palm. the

quality were pilot

abdominal forearm,

different point

and

similar

results

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REPORTING COMPANY, INC. 735 8th street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

a 3.. 2 3 4 5 6 7 8 9 3.Cl 11 12 13 14 15 during l? 18 2% 20 21 22 23 24 25 study thumb glucose is true i.v, more plexus hairy is skin e different ES1ide.J So our hypothesis at and of is a far changes t at blood velocity arterial like between transient is sufficiently in ermaJ, at load glucose arterial. gradient rapid. lag times that were observed.

135

exchanged areas;

lower in solution

concentrations can and produce capillary if

a certain

a transient blood, and

gradient the

is

unmasked

change-velocity

[Slide.] This shunts capillaries [Slide.] This metabolic protocol, flux are not or is something change the
as

simply exchange than

demonstrates certainly at the

as faster, arm site,

a picture and you

the have

to

demonstrate

that in and blood the same data. about our the

we demonstrate flux by the dose, forearm what layers, have not and the

finger affected the insulin

rapid and flux

changes for the

abdominal we have

and

So whatever deeper very too arterial upper many

concern

and

we know at to

effects,

deeper

this discuss

layer, other [Slide.]

we probably effects.

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ah 1 Conclusion: 3 4 5 6 7 monitoring 9 1 1 3. I. 13 1 15 16 x7 18 19 20 21 22 23 24 25 think for it each state changes, be aimed safe as it and between could forearm be explaine Now f conclusions The observed and finger sufficiently and perspectives. BG differences rapid by BG changes and

136

transient during

anatomical

physiological [SXde.]

site-specific

differences.

We recommend at the arm not

from is be should

that safe at

that

capillary

BG steadyrapid BG

metabolic during of the

should an at; is [Slide.] Objectives is in never and at

recommended exclusion base of

hypoglyce it is as

at the

the

thumb,

finger.

for

further

AST studies--yes, experimental each alternate the design site AST sites of an AS

I

a standardized and for

BG monitor

recommended can failure based different daily have answer life to

as differences and life design Daily life, and focus the in

between incidence powerful. is

be demonstrated, under daily

population-

observational issue. conditions, be done in functional [Slide.] to

a completely we have studied studies questions ta under

experimental

on particular

respects.

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ah 1 2 3 4 5 6 7 8 9 1 11, 12 13 14 15 16 17 1 19 20 21 22 23 24 25 Please you have will have devices, which kinetics optical transdermaf examplerapid -have Objectives Characterization age I micro-angiopathy, diseases; exercise and daily and un er life and the effects of for further AST studies: risk neuropathy, types of studies are data certainly factors--

137

patient-specific autonomic of

dermal

various experimental studies

standardized observational 3 haven't seen

necessary, particular

any

on this

subject. [Slide.] Finally,k Any depends within approaches, approaches, to other consequences glucose or for monitoring interstitial dormaX infrared reverse for other S technology fluid compartment-s ectroscopy, iontophoresis the effects and as an or

on blood the

upper NIR

be examined as well.

BG changes Thank DR. you

fur

your Thank

attention, you. panel members know later, Russell Potts. and if they

KROLL: to let

I want

the

an opportunity Next we will to hear state

for

questions Dr.

from name,

remember any

affiliation,

financial

involvement, My name is Russell Potts, and

DR* POTTS:

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ah 1
2 3 4 5

238

z am vice Cygnus.

President

of

Research

and

Development

at

I would invitation to

like

to today.

thank

the

FDA for

the

speak

On a personal back in front of this stressful

note, panel

it under situation.

is

a pleasure a substantially

to

be

7 8 9 . 10 11 12 13 14 1 16 17 18 19 20 25, 22 23 2 25

less

personally [Slide.] The

Biographer, different today. arm and

which from This measures frequent not

you

see you

in have

front heard

of

YOU I is about worn

very

what is

earlier on the It

a prescription interstitial and automatic
ly easily

device fluid

glucose. measurements obtained your typical

provides that any meter. are other

practica technology.

with

This

is

not

[Slide.] As you a monitoring and with patients tracking diabetes. at In adjunctive information home addition, device obtained to know, the intended in device in it GlucoWatch for Biographer trends in for facilities, for not use as an adults use by is

device patterns The and

detecting levels

glucose is health is

intended care

intended

supplement, from standard

replace, home blood

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ah % 2 3 4 5 t; 7 8 9 10
11 12 13 14 15 16 2.7 I 19 20 21 22 23 2 25

139

glucose

monitoring [Slide.] Finally, it

devices.

is

indicated of episodes both Interpretation

for

use of

in hyper-

the and

detection hypoglycemia,

and

assessment facilitating

acute

and of the seen

long-term resuJts with

y adjustments. should several be based sequential [Slide.] The process the of glucose reverse of skin, of

on trends readings

and

patterns time.

over

sample iontophoresis. a very and the

is

collected This

using involves current

a

application intact

Low electric sample fluid that from

across is the

is

obtained

an extract skin.

interstitial

beneath

ESlide.1 The 20 minutes, hereminutes. the data that. on the periods. next The Biographer and glucose The that provides process sample is glucose This are process completed that two cycle is is a reading shown every

schematically over 3 in and end is

collected is then is

collected

measured

7 minutes. checks glucose signal This

repeated, at the

integrity The total

of
based

value from

displayed

I@-minute is

measurement

20-minute

repeated

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ah throughout the This should contrast by say to I&hour procedure monitoring creates glucose period. an integrated, measurement or in

140

X

time-averaged, the instantaneous blood

measurement meter.

a traditional [Slide.j The

glucose

performance been judged This to both

of

the

Biographer, to lead blood to as

however, glucose differences procedural

has values.

y comparison can error differences, differences

comparison inherent

due and First,

as well

physiological there of the are

due evice,

to the

the

inherent comparative

error

calibrating and the Biogra

device, There are

also In

differences the sample of of

due

ta

sampling

and

measurement. differences glucose and versus differences in

particular, in the

comparison source--namely, interstitial that and sample, a delayed an

involves blood fluid--

an extract in case the timing of case

instantaneous and value. Finally, differences. yield time-averaged

the in

blood
of

the

Biographer

there All of

are these

also

ph

siological

differences and 1 emphasize

combine the

to term

an apparent

error--

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ah 1 2 .3 4 5 example versus 7 8 9 10 11 12 23
24 15 16 17 X8 19 20

141 '"apparent'" performance. [SlideJ Let of b,loo time. statistical me show a comparison gl_ucose you in of values e right measures this the slide. Biographer Were is an --that underestimates the Biographer

values of shown used relative the in

as a function here, that I have we have mean relative are the

elapsed various our

FDA submission--mean and the mean

difference, absolute bottom mean relative the percent, is
037.

difference, difference* this minus about particular 6.0 minus

Down on the run, the percent; about 7.0 The mean

values is

for about is

difference difference absolute and the

mg/dL; 2.0 is

mean

relative

difference correlation close

coefficient close however, during Look, bit you after will

Clearly,

there

is

tracking, Note,

agreement. large periods for differences of rapidly at the time time in can

occur, changing periods the as

especiafly gjlucose. a little and

example, 8 hours

22 22 23
24 25

e3.a sed t t ere is

middle, 100 percent e blood

see

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as much

difference glucose differences
MILLER

between values. are real

e Biographer

These

and

reflect

REPORTING COMPANY, INC. 735 8th Streek, S.E. D.C. 20003-2802 Washington, (202) 546-6666

ah I 2 3 4 7 of those physiological two techniques, [Slide.] This slide shows are, versus itself. two on the you look columns is clinical versus third for row data two down, WHI quantitatively and we have what done t monitor some and sampling differences between t

differences Biographer versus the left

comparing 7 8 9 10 11 12 13 14 15 16 17 18 19 20 211 22 23 24 25 the trial, relative percent. meters and where in the left is obtained blood the or and

blood

glucose

Biographer In by meters. mean absolute is

Cygnus If

Biographer at the

relative around the with

difference 17 to lower 20 percent. value which error of in is the

these

so points Note

that

the

extreme more

obtained meter.

a YSI,

a much

accurate meter can

So hence, the outcome. between wore there, about the the again is a little last other you 9.9 two

comparative

affect

A comparison each third error Shown one there subject column is in to

two

Biographers-showy absolute

iographers--is and or the about are ean

relative

10 percent. the values clinical. absolute 9. of

column in see bit the the

same mean

error

less,

about

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ah 1 2 3 error of of blood
Thus,

143 the results is show actual1 However that the similar I physioI.ogical lead error to as an shown in inherent to that

the

Biographer meters.

glucose an timing of two [Slide.] This

sampling 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the next technology, detect provides low glucose frequent Biographer blood the overestimate the first

differences Biographer

the

columns.

apparent

error

notwithstandi~g~ possible war glucose ing in for the with low case

the t

automatic provide or

measurements a potential just low

glucose, Biographer. Using it low blood

of

current is difficult glucose
to

blood

glucose if not

measurement impossible The Biographer of and Alert can level af and to

events. users addition, the

a method fevefs. team in The

alert In

to

instances e user

ealth setting adjust then alerts false

care used it. determines

can this

control warning

Low Glucose t e user alert frequency positives

system; Low Glucose and of true

adjustable the as the

circumstances number

as well positives. I will slide,

demonstrate

some

of

thase

data

in

MTLLER REPQRTING COMPANY, INC. 735 8th street, S.E. Washington, D.C. 200;03-2802 (202) 546-6666

a [Slide.] These been ublished alert. less two blood per you day, detect If and all that are in an analysis--these Diabetes Care this is data have

144

summer--of defined here

the as

10~ glucose a blood

Hypoglycemia than rows

glucose The top

70 mg/dL. show analysis values. or in just If you pre-dinner, using

self-monitoring measure we find twice that

glucose

pre-breakfast about you at one

seven to you four detect
ThfTZSiH?

hypoglycemic a day, about are from before

events. meals of

up that

times

bedtime,

40 percent similar other In values studies. contrast,

hypoglycemic you'll fin

events. in literature

the

lower

three level at

rows about of of

show 90 all

by

setting mg/dL

the you

Biographer will detect events with

alert over the

60 percent penalty

hypoglycemic

6 percent

se-positive. Of setting, detection events The 25 detect and courset increasing be done greater cost if of by the the low user, of false it all. at alert results low glucose alarms. 110, you can level in

as could of at row to even the

numbers greater set of

bottom close

shows

you

90 percent

hypoglycemic

ah events at the These Biographer glucose even as can events frequently [SifideLJ 'x'o conclude, Biographer of these and blood the differences are in real, the between the cost results detect than of 15 percent clearly a greater conventional as four times false-positives. demonstrate number of that low

a-45

the

m asurements per day.

taken

glucose are error

The sources
calibration error in

differences error in the

device, the

comparison and

device, measurement differences.

Biographer, and [Slide.]

sampling physiological

differences

As 1 have unique device that The

stated, provides frequent

the

Biographer unique automatic and tracks

is

a

truly and

information. the Biographer

nature glucose

of

provides

trends

patterns. Moreover, detection existing as four of blood times In between the the the Biographer than even if is they provides available are used better with as many

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MILLER

day. then, in spite and of blood differences glucose, and track

values to detect

device's

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~EP~~~~~~ GOMPANY, INC. 735 8th Street, S.E. Washfngtan, D,C. 20003-2802 (2021 546-6666

ah :I 2 patterns presented detection existing provides the that meter. Thank DR. Next MS. Rosenfeld. National Association. financial although 24 15 I.6 17 18 19 20
21 22

146 fur but hypoglycemia--and also hyperglycemia-with any other I haven't

data, cannot

be achieved

you. KROLL: we will ROSENFELB: Thank hear you. from HeXlo* old,
for

Glare

Rasenfeld. is Glare former

My name and

1 am 15 years Youth Advocate For connection LifeScan my mother f have was the

1 am the

the

American I don't

Diabetes ave a

record, to any of

these and

corn paid the here way of

gracious I could

me and

so that had Type to

appear for

today.

I diabetes be here today this is.

8 years, X caxf.

and share

1 am very with to you

happy how

SO that

important to share

I am very testimony

honored with you.

be able

my personal

Eight to
did

years a day a choice changed is

of

testing painful. in that. fur me,

on my fingers Until Alternate is and the recently, site positive choice

four I

six not

times have has has

23 24 25

testing change a less

that

given

me the alternative

freedom which

for me

painful.

as encouraged

MJLLER

REPORTING C~~~~~ INC. 735 8th Street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

ah :I 2 3 4 5 6 ‘7

147

to

test

my I was

load testing I

sugar

more four to

frequently, six times

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before not tend out only to

do

follow

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me personally. results. One-Touch my parents levels Ultra

experiment

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to

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and

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between almost

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on both site

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testing

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during

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me and

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I am

MILLER

REPORTING COMPANY, INC. 735 8th street, S.E, Washington, D.C. 20003-2802 (202) 546-6666

a now testing make more 8 to precise and X0 times changes I am in Ale a day, in much was which allows sugar control than c>f my it

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Better can live a normal that

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means in do

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activities extraordinary father.

teens like

do and backpacking

with

my

Living the little the the things.

a normal For are of love

life the

means first

appreciating time in 8 years,

because to feel

callouses texture -and I

disappearing, when I turn

I am able it is a wihen 1

a page reading,

am readingwonderful

so that

experience. Being normal to its means fullest. wit being healthy and

livin

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As a representative diabetes, I: have and lternate it doesn't And will if stay I have site hurt teens in

of

youth people

listened heard testing. as much, especially better

around in

the favor

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kids This

speak their

message: test more

s will are compliance given

a choiceP they

because

freedom.

MILLER

REPORTIX3G COMPANY, INC. 735 8th Street, S.E. Washington, l3.C. 20003-2802 (202) 546-6666

a 1 2 3 4 5 6 7 8 9 10 1 :I.. 12 13 14 35 16 17 1 19 20 2 :z, 22 23 24 25 myself would Pediatric I have members, don't have with and changes It is T respectfully in very the policy of to urge you to please site allow as better it not testing. others stands manage

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Thank DR. Next, DR. thank any

you. KROLL: we'll ORLOWSKI: you slides. Orlowski at interest no consulting TheraSense the only is from University in any of the Department of the or my way Rochester. af for Thank hear Mr. you from very Dr. much. Craig Orlowski.

Chairman, me to

panel. appear. X

allowing

f am Craig Endocrinology no financial X have like and that that; is here

companies, anything today,

a reements paying

connection. nobody f take care what else of, CLare but and I

I come and like the to

representing that

patients essentially

reiterate

just

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 1 19 2 2 :I. 2% 23 24 25

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REPORTING CONPANY, INC. 735 8th Street, S.E. Washington, D.C. 20003-2802 CZOZI 546-6666

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MILLER

REPORTING ~~M~~, INC. 735 8th Street, S,E. Washington, D.C. 20003-2802 (202) 546-6666

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be up to students--

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REPORTfNG ~~~~~Y~ INfl. 735 8th street, S.E. Washington, D.C. 20503-2802 (202) 54&66f;5

a use of

153

those

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instead by

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communication I think today, incorporate DR. KROLL: that what

restricting we need understand into you. from And Laura Sam, our

indication, happening more and

is

is, that Thank hear

process practices.

Next r we will MS. BILLETDEAUX: everybody. of Sam we'd This like is to

Billetdeaux. Hello,

Sam. put going when up.

We have

a great

icture

Sam was not September, decided to very come, long that and then,

to

come

with to

me in October, and he

we moved important, 9 hours ta

this

was very the

he wanted a me

so we drove 9 hours.

here stand

yesterday, up with

He wanted

MILLER

REPORTING COMPW, INC. 735 8th Street, S.E. Washington, D,C. 20003-2802 (202) 546-6666

ah 1 2 3 4 5 G 7 8 financial here today, today on behalf of alternate to say wit C ildren advertising from today, all that any site testing. have

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from
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and

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came back we did

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10

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combination testing. And

alternate

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to

read

you

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speeeh-informed alternate your teenage statewas help child

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outside

figure This is

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state. Okay. my speech I just summer. like a last

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is

a

teenage

boy--right? I'm going picture

now, wanted

and you

you to

can see

take

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Sam was w at the

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player;

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MILLER

REP~RT~~~ COMPAW, 3NC. 735 8th Street, S,E, Washington, D.C. 20003-2802 (202) 546-6666

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meters

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heaZth

man who wants

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MILLER

He does his sugar It

sugar is in

dropping

Sam loves a huge difference

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speaking Children

on behalf with

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MlLLER

RE~~RT~N~ C%3MFANY, INC. 735 8th Street, S.E. D.C. 20003-2802 Washingtan, (202) §46-6666

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MTLLER REPORTTNG COMPANY, INC. 735 8th Street,.S.E. D.C* 20003-2802 Washington, (202) 546-6666

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MILLER

REPORTING GOMP~, INC. 735 8th Street, 3.E. D,C. 2QQ03-2802 Washingtsn, (202) 546-6666

a 1 2 3 4 5 6 7 8 9 10 1 1. 12 13 14 15 16 17 18 19 2 21 22 23 24 25 is president couple parents strong they are of blood market largest FreeStyle total of test they Kow important your percent child? is Of alternate a total that 21 percent That online was In important. a follow-up meter used, out the at at of survey all the asking meters Ultra readers on the had the by out the of a is a total who felt it of site 606 was testing responses' very important, it was for 47 and sumewhat of site you

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letter Children

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mom to

Matthew,

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REPORTING COMPANY, INC. 735 8th Street, S.E. Washington, D.C. 20003-2802 (2OZt 546-6666

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MILLER

blood this

because
REPORTXNG

735 8th Street,

Washingtcm, (202)

COMPANY, XPJC. S.E. D.G. 20003-2802 546-6666

zritical

time

for

my daughter, company fingers I'm

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the OIl'tZ

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to

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more board

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opportunity Please

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an 0 portunity 50 in Sam, hand, like all behalf, He doesn't times children alternate Thank you our for
a

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wants to

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continue by

endorse

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taking

and

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thoughts, Thank too. is Dr. Paul Madden. you very much, We

KROLL: Sam coming,

appreciate The DR,

next

speaker Good

~A~~~~~

day,

everyone.

MLLLER

735 8th Strece,

REPORTING

COIMPANY,

S.E.

INC.

Washington, (202)

D-C. 20003-2802 546-6666

143 MY name JauraE :oat I hope back on-it is Paul Madden. that less in are here, 1 did formal, any way directly today that or from any of get And not Sam and put my suit

helps

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companies that are last

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opportunity of alternate

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testing Let

me give why from X

a brief it is to

introduction so important for

as to me

who I am and to take time

my life I t serve

be here as special

today. assistant Center, at Joslin J to

Currently, the also president serve of

e Joslin

Diabetes counselor the Joslin programs. ago, I wag Marble

as a professional for and retreat years and

e administrator Center's camping Twenty-six Priscilla the Joslin clinic, Joslin diabetes. first and and White resident 3: believe also as

Diabetes

chosen to serve

by Drs. as at

Alexander mental at the health any first in vividly

specialist specialty of the

diabetes director 1975, the

CampingX?rog.rams I: remember

who happen discussion

to of

have

MILLER

REPORTLNG CQMPAHY, INC. 735 8th Street, S.E. D.C. 20003-2802 Washingtan, (202) .54f;-6666

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member the Force,

Association

American and for families. of helped my in young

Associations capacities, with Qet diabetes me now to

Camp Task I do serve as well share with that

as a voice as their you same have

personal strengthen

reasons

be here

me professionally. I will be entering on November yesterday. and the my 40th 22. When world year of it life well

with as the if

diabetes it United were

I remember 1 travel speaking by with world.

thr~ugho~t on others as

States

diabetes, the

T am increasingly lived other this over with

introduced more people in the

man who has than

diabetes

any

person description

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may be with

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20,000

people

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MTLLER

735 8th Street,

REP~R~~~G

CUMPANY,

S.E.

ISC.

Washington, {2OZf

D.C. 20003-2802 546-6666

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2 3 4 5 6 "J 8 9 10 II 22 13 14 15 16 1'7 18 19 20 21 22 23 24 25

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attended this

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who were of diabetes

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devastating perspective these personal

complications. is indeed qualifiers training reason to and quite

1 believe unique. coupled experience today. with

I believe my give me a most

professional formidable

be here to

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weave

my comments, counselor, with is diabetes,

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as a person br>y his it is is

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We

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medical
$160

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approximately and
MILLER

year,

direct

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REPQRTLNG COMPANY, TNC. 735 8th Street, S.E. D.(3. 20003-2802 Washington, (202) 546-6666

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MELLOW REFQRTING COMPW, INC. 735 8th Street, S-E. D.C. 20003-2802 Washingtun, (202) 546-6666

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MILLER

REPQRTTP13G COMPANY,
street, S.E. D.C. 20003-2802 546-6666

735 8th Washington, (202)

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MILLER

and

country

REPORTING C~~~~, INC. 735 8th street, S.E, Washingtun, D. Cf. 2~~#3-2~~2 (202) 546-6666

op 3 x

A~T~~~~~~

SESSXON [X:06 p*mJ to an

DR. resume r and c;rpen committee What nembers over

KROLL: at this

The point,

panel we're

meeting going

is to

going have

discussion. I'd the of like next the to do is give our panel ta

10 minute's last two That

an opportunity sponsors who gave and

s4-c questions sponsor Roche

resentations. Diagnostics. Dr. Henderson?

was

TheraSense

I was very the pediatric data; in to. 1 am still the about certain is isn't about. pretty educated, almost spectrum. Type confused is II about that if this and the two

impressed people

with who I

young

participated give kudos

morning9

presentations,

the

other

end talking is a that

of

My sense I and of Type

we are there

diabetics, vascular I'm not

amount

peripheral and that as

disease if that

inevitable, group sounds

sure to

another It

we need the their they But

be concerned kids are have are

though and good;

pediatric parents should I don't

well-educated, and that?s are

weL1more if we

Options

good.

know

MTLLER ~~~R~r~~ LIMPLY, INC. 735 8th Street, S,E. D.C. 20003-2802 Washington, (2021 546-6666

have to

data it that

on the regularly, spectrum M.so for

other

end, 1 think

and

if

they

are

going

use

we should

be concerned

about

also. my own interest, into the main with milieu pregnant of going to okay many area of have

wumen f if treating

this diabetics,

gets

eventually
on

we are which

some pregnant with, but

women

it,

I am sti31. data, but else to and

we still -not and really, just
FDA

don't in t

have is

any area

companiespharmacy this are

every

and really

everybody hesitant they don't

who oversees do testing the use
it,

in

pregnant at they on it,

women because means that to use

want to have

risk. and been ersan t is

when it in we are was if

we start they everybody, nut

continue we are

already every

testing and it

an experiment, 1 know be available information that would DR. DR. In support broad our range the in

collecting that anyone of some

suggested and two if

data

may

Europe,

as any patients,

about be

those

groups

interesting. KR0LI.l: Yes? Eve studies Conner from
TheraSense,

that we have

we have actuaZZy the

done had youngest

to a very person

5lO(k)s, of people.

I: think

ah in our studies actually results quite good. With gestational DR. am not pregnant concerned who have the ones even regard diabetes, ~E~~E~S~~: sure that's and are those the to your we have Not question two on studies-diabetes; with T'm very Type are was quite with 5, and we had patients many patients in have their actually

273

over 80s.

70 and SO the been

a few those

patients

gestational

a disease--but ones who are that Type

diabetics, about had

I and
'Those

longstanding going the to

diabetes. come to us with

wha are because will of, using and and

new any they wurn~~ know that a

agents, obstetrician can think

gestational just that's that to put them fine. we don't just

diabetics, on whatever It is those

who are lot about,

things we tend

really

continue

during

pregnancy. DR. underway showed don't have to earlier have them the very DR. MS. KRUGER:
MILLER

CONNER: look in at

We actually the time series women but

have

two

studies that we We

studies with diabetes.

pregnant yet,

results saon.

we will.

certainly

Thank 1 just

you. wanted to comment on

REPORTING COMPM, SNC. 735 8th Street, S,E. Washington, D.C. 2~~~~-28~2 (202) 546-6666

ah

134 1
2

hfour
you

question

about that the as well if

the

elderly. is is the going going arms,

1 would to to

say

to

c though, circulation,

there issue as at that

be an issue be at the oing them I it

in

fingertips to have to

so yoWre and of educate blood. whether

work what it

with to has site get

patient drop to

no matter 7 don"t is think

a good

anything or

do with

an alternate DR.

a fingertip. d wonder fragility might any and with the a about the

ROSENBLOOM: with the the suction skin

elderly bruising special that?

also if

device

present

problem.

Do we have

information

MS. In the elderly

~~~~E~

Eve

Conner study, some able

from there

TheraSense. were some wiph enough there not they have want did problems were to have of

our

clinical

people

who had were

problems to but would get

bruising. blood from

kJe certainly them people long-term bruising, it on their MR. LOCKE: finger. Paul to do the

testing,

occasional zTse it problems using

who probably on their arm ey did

because not

Locke,

U-

ass

Medical.

School. I: had the pleasure of being cJinica1

ah 1
2 3 4 5 6 ';d 8 9 10 11. 12 13 14 15 16 17 18 19 20 2 1. 22 23 24 25

175 investigator studies, personally, were over for One-third with 50 years were elderly bruising, a number of myself of the in age, of .Abbott
Sof-Tact

population attendance and even

I studied at though all times, people did wit was very not

on coumadin have in the

excluded, population or

we categorically any problems That

akinesis, reassuring. I not in any

complaints.

say way

that tied you,

as a medica into the

investigator corporate entities.

and

Thank DR. DR. MS. ere if 50 is

KROLL: CARA :

We'll Can

take I ask

one twa? just

more

question.

We were really elderly,

curious

over

[Laughter.]
DR.

ROSENBLOQM: 10 years may be. KROLL: I don't older

I

sure

don't my present

think

so. age,

Elderly whatever

is

than

that DR.

think

the

FDA takes

a

position

on that. [Laughter,] DR. CARA : I have a question for Dr.

Conner. Dr. Canner, in this document that I guess

MXLLER R~PQR~~~~ COMPANY, ING. T35 8th Street, S.E. Washington, D.C. 20003-2802 (202). 546-4666

ah 1. 2
3 4 5 6 7 8 9 10 1 1. 12 13 14 15 1 17 2 a9 20 2l 22

176 you what of provided you questions call us with an about one, before the study/ meeting, I had there is

'"outcomes that. 1 was in in I was mentioned, were using to -those those the

a couple

Number there or any was

pleased glycocylated

to

see

that hemoglobins of about one even

no difference overall

change

management surprised and that is

patients, finding though testing, between fingertip site.

although that patients the the you

very

that site

alternative test was

willingness two groupsand

no different the standard alternative

using using the

methods

DR. particular already hemoglobin were not in

~~~~ER: group pretty Ale's of

f think patients, control. range that

that they

in

that actually of the we

were Many

good in the

of

7,

so

f: think didn"t

too a lot

surprise in that

compliance

increase

group. thing actually of it life was may not day they about tested that more or

e important study was that it's the whether more FreeStyle or the whatever. of times they a quality because

not - -maybe did less prefer painful,

issue--they easier, have were

23 2% 25

So it per

increased

number

177 testing, but they certainly that's expressed good we see a fairly but to the test news a preference in our people rate dongt site to

So 1 guess opinion. who are 1 think already their get and

sometimes testing testing at rate, refuse as

perhaps high

increase devices test, else.

alternate at all

people that"s

who robably

important

as anything

DR. other than DR. outcomes are study, was
a

CARA: the

Do you

have that

any

data

about

that about?

anecdotal

we have actually over 500

heard doing patients. now. in the

CONNER: that

We are includes

another We

study halfway

about the

through to over if

that

study

requirement in Arc control, data when

be enrolled 8, so you t will, of is

study will

hemoglo less good the hope have that more DR.

eople and testing. completed,

be in collecting would will

we are so we I

on frequency that study

information. Great. know as Another if ta you whether sort have or of this not related data-you

CARA: I don't curious

question-but I was at

and just the

looked

correlation and hypoglycemia testing

between

symptumatic by site

hypoglycemia either fingertip

as established alternative

or

MILLER

~~~~R~~~~ CHEFS, JNC. 735 8th Street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

a 3. 2 3 4 5 Q 7 to the correlation. DR. first A~MANN: part you you didn't Can I ask were give a quick extension

testing. DR. CONNER:
We have not done that

discussing? us any characteristics how fast, what

comparator, of size the

comparator droplet,

meter--how it had

large, capillary. is

whether preferences, site. tell

When we more involved

9 10 11 12 13 1 15 16 1 ‘7 18 19 20 21 22 23 24 25

are than

comparing -just the

there

Can you comparator DR. had been using with, look but at the meter?

US anything

about

the

CONNER: before

The was

meter the

that meter

the that that eter,

individual

t if
you

continued could Will.,

We probably data have by that type

do have of

1 don't DR. KROLL:

here you.

with

me today,

Thank have

Now we'll panel members, and

some discussion Dr. to Clement
reSeX3.t.

among
has

the an

actually, he wanted Coram&ttae Thanks. Clement,

organized

discussion Open DR, Ta

Discussion

C~~M~~T: Steven

clinical

-

endocrinologist.

a 1 2 3 4 5 6 T 8 9 10 11
12 13 14 25 2.6 17 18 1 20 2 I. 22 23 24 25
closer to

Same of clinical practicing better changed

the

issues

that

present

to

us

as

endocrinologists, and glucose things [Slide.f This is 1993. into better a slide We all our off seeing control. dramatically. patients

diabetologists, are how to achieve know,

DCCT,

as we all

from know

the

DCCZ" data we all the the
we

that have their their

came out this
Ale

in

this,

burned is, for people the

memory, they

that are,

lower lower
are

risk get

complications. own in However, this this there level, of

Clearly, range is the Wevere

trying

to

as much

as we can. As we gc;t
was

a trade-off. risk of what

termed which

by

the

DCCT group

hypoglycemia," to get

was defined the goes
reaction,

as requiring which is

assistance quite a severe that
trying

out

of

definition, goal..
to

up dramatically So clearly,

as we reach
as we are

achieve sword that and

over

here, with

we

have

sort

of

a two-edged
ay

we work struggle balance glucose

patients every

on a day-today on where there. part is

basis the right clearly, play in

with and

how do we get

And to

monitoring U3Pide.l
MILLER

as a huge

this.

REPORTING COEIPW, X&K!, 735 8kh Street, S.iE. Washington, l2.C. 20003-2802 (2023 546-6666

ah

180 1
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

The with saves by is for get. And hypoglycemia lower targets, [Slide. These over ALc"s again, of the now is that

therapeutic intensive reduces College again, with potentially

paradox insulin complications. of the Clinical caveat goes

that therapy

we are clearly

left

lives, America 6.51

ew criteria Endocrinologists that up the the risk we

hypoglycemia

lower

clearly, increases which

as

1 mentioned, closer concern.

the to

risk these

of

as we get is a major

are,

as we have

all trying

seen
to

over

and

the 7 percent,

ADA standards, Still. not here of in have is it is

a~pr~a~~ that

recommended postprandial

we use-glucose what and the high is

ADA does levels. the

specific lots of

controversy glucose how they contri that

c~er levels add utes to ta a

meaning reflect in

postprandial terms of that numbers

how they increase Ale, but use.

hyperglycemia are the

these

we

currently

[Slide.] So with Mere developed of t
e DCCT

and trial,

t e strategies dearly, a key role

that selfin al.1

during blood

this gl_ucose

nonitoring

has

MHLLER

REPORTXNG (202)

~~M~~,

INC.

735 8th Street, S.E. Washingtxm, D.C. 20003-2802
546-6666

ah 1 2 3 4 5 6 ‘7 8 9 10 1I
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I.81 of this so we can to meet the exercise, as at least come up with of and the the flexible patient, patient checking period, on what timing flexible uses this 20 times to ta try da. to of

insulin activity data a day make

needs

with every or

Sam mentioned, within a 4-hour decisions

clinically [Slide.] So the

relevant

decisions 10, 15, which what been times

that 20 times is

the

patients as to what currently

make what we are is

all

the

time, glucose, about There and are

a day to is

my blood talking working. stable sugars are of

crucial, insulin

today; has

lots of

of the af our

discussion day when

about l,ood

unstable occurring. stable;

Many they are

Tyjpe the

1 patients A lat at

never this is

up a11 insulins

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because times of the is the

they-have the day.

different

Perhaps blood glucose

only fasting

quote-unquote glucose eat; to what

?zztable'" level. am 1 going to

20 21 22 23 24 25 eat; clearly, well; situation. he is and what

When am I going activity that what Jay basically has was

to

am I going an effect the past gives of the

do--because glucose with talks champions as this

cm blood experience great major

Skylik one

on this; of

MXLLER REPORTING COMPW, INC, 735 8th Street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

a 1 2 all at the intensive insulin So there time, therapy. are multiple based decisions on the being accuracy

382

made of

primarily

number. [Slide.] This is w at
we

are

trying

to

achieve. graph that ago in a

This came

is out

Jeremiah in Lancet

Bulley's just about

[phonetic] a couple looking insulin of at

weeks different

beautiful insulins

article and This different is in

analogs, the is more European to orma 140 dawn. these

millimoles--for this each very and

folks

in

the

audience, multiply is

familiar by 18. about back

YOU --basically glucose mg//dL and are variation after is

number peak

small, then it

a meal, endogenous

comes production;

this

insulin

nondiabetic Clearly,

patients. this is love a fairly to come stable even glucose close to

19 20 23 22 23 24 25

pattern, this in

but our

I would patients.

[Slide.] The articular and norm rapid that reality insulin-treated fluctuations we see, and in most that we do have patients,
blood

is we

that ave This

in

aur

wide is are a

sugars. our patients

of

who

ah

183 1 2 3 campletefy meals, insulin [Slide.] How does 5 6 "7 8 9 strongly values12 13 14 15 26 17 3.8 19 20 22 22 23 24 25 driving. am learning is useless. is a lot labeling. of our patients they that [Slide.] And clearly, this is critical for safe may not
t

c-peptide-negative, injection and

especially during exercise,

after

self-blood It is critical.

glucose for practice, of

rn~nit~~ing intensive and patients wit~~~~

play

into

t therapy.

diabetes cannot accurate

We cannot of these kinds

make

any

decisions

glucose Frequent associated Dr. of Laurie

data. testing with Lefefl has better at been found to be AIc this in

hemoglobin Joslin years proved ago,

a group

adolescents

a few

[Slide.] Clearly, about Part to of art is of instruct that of that our this just job as whole process the and
to

that data

II

generating clinicians how in the

educators X think about many

patients came out

use

t

discussions

How do we teach may not have have access

patients--because access TV this to an

educator; information

MTLLER REPORTING ~~~P~Y~ INC. 735 8th Street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

And

glucose

meters,

as

we

know,

are

2 3 4 5 6 Ti” 8 9 1 1 1" 12 13 14 1.5 16 17 18 19 20 2.2 22 23 24 25

letting

smaller

and

smarter,

with and

memories, so it

lownloadable really is

capabilities, an exciting
ESlide. J

so forth, now.

field

right

Qne thing about 3xercise LOO points, exercise and This Diabetes looked varying exercise exercise, running clip-drop thatfs where for in at Care the is the can impact drop

that of glucose

hasn't exercise levels

been

talked

much levels. as t 50 to

on glucose as much of

depending the is in drop of duration

on the of

intensity exercise. study
where

a beautiful t
e spring

published
they actually

in

in

blood

glucose based exercise.

levels on degree This VO2 max,

with of is which is good the but an

amounts and for about about blood a drop the

exercise of

intensity exampILef a 9-minute

50 percent mile --thatfs And is in

a pretty can see

60 minutes. sugars. of about started, and if start into the they off This

you

milfimales, So depending

80 points. they start at can off

person

drop here, I.80 as you
or so,

significantly, can they see here,

they drop

about

clearly af

hypoglycemic

range

With

60 minutes

exercise.

a 1 2 3 4 5 6 J provides glycemic 9 10 11 12 13 3. 1.5
16 17 18 x.9 20 21, 22 23 24 25

185

What bre exercising, from absolutely [Slide.]

my

patients they cannot and

tell

me is distinguish

that

when between

they

fatigue it is

exercise

symptoms to

of

hypoglycemia;

impossible

do that.

3: think useful control,

alternate information and Because there fasting it sugar,

site

testing

c1earl.y overall. of useful, is very clearly useful titrate

regarding is lots glucose is very,

information. the far either oral most stable,

f think ~~~~i~g

measuring the agent

because ureas

we can or

insulin they
are

or
on

sulphux
as

whatever their therapy to

a guide--use the nighttime leveb3.

mornring achieve

sugar etter [Sli.de.l But

and

titrate

marning

glucose

there we Joak

are at

lots fasting to

of

issues glucose to

on the levelsr

other

times fasting getting think fcmf averaH

*

If

gI.ucase

levels

correlate glucose is clue very,

AD2 data, which useful their

so I

an accurate alternate can give glucose [Slide. And us site

fasting testing good is*

level, very

a very control 3

on what

again*
MILLER

adjusting

bedtime

long-acting

REPORTfNG COW? # XNC. 735 8th street, S.E. D.C. 20003-2802 Washington, Czazf 546-6666

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we can

weVL.1 use to help

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them But accuracy.

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there

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time, on the of

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patients use.

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1 think

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potentially studies ferret we saw. out using but 2'11

be a problem I think these or

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MILLER

testing

be very

interested

to

RE~~R~~~~ COMPmY, INC. 735 8th Street, S.EWashington, D.C. 20003-2802 (202) 546-6666

ah

187 1 2 3 4 5 6 7 rzembers people sre as fear other panel Thank DR. members' you. KROLL: Thank have their think trying just you, Dr. CZement. for what panel I'd like viewpoints.

Now we'll to to they voice do is are T'lL

an opportunity opinions, about to what and the

FDA questions opinions for and

come up with these quickly

32mments. 9 1 21 12 13 14 15 16 17 18 19 20 2 22 23 24 25 Question studies; studied; statistical these state people.

reread

Question devices data, or ways

2: include are to

?3houZd dynamic there address more this

the

FDA's as

review steadyand health

of

as well appropriate public

less

burdensome issue?8g

There lt what what for

are

some

additional. what are data

oints the set

for

example, is are the

appropriate to be or data,

minimum

appropriate to 2: be applied V3hould strong they

analytical to the the

tools Question

FDA require cautionary labeling data unlikely to

manufacturers about this

to problem that their

include unless the particular 3:

provide is

demonstrating occur with

discordance device?Et t

Question

"Should

e FDA rescind

the

KILLER

REF~R~~~G ~~~~~~ IMC. 735 8th Street, S.E. D.C. 20003-2802 Washingtan, (202f 546-6666

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188

new scientific home use; changes?ff *#Are there consider issue, other with
SUCh

issue; require

roducts
data

additional And finally, or to this issues

activities regard

FDA should public targeted outreach health

important alert,

2s a public surveillance, stakeholders Sovernment in 23 get this

health

postmarket activities t and non-researc ta

educational and entities area?if Unless somebody something, Let's other ta

Governme promote

additional

has

a burning

desire go

ta

up and the
DR.

say panel.

perhaps start Well, with

we could Dr.

around

Rasenbloomr we Do yuu questions? want

typically, a time. these one

address me to

these give DR.

questions

one on all We can

at of

my apinion KROLL: with

do it 2..

at

a time.

Let's

start DR.

Questj.on

So the ould FX)A's as well. appropriate public
MILLER *

first of these

question, devices data, burdensome or ways

then, include

is

review

dynamic ere more this

as steady-state and health less issueF

to

address

RE~~~TI~~ CQMF~, INC. 735 8th Street, S-E. Washixlgton, D.C. 20003-2802 (202) 546-6666

ah z 2 tram the ink experience in that that absorptive the but the needs not it is of room to only state pancreas how busy There age, gender, type and are of abundantly the that be clinicians this answered is apparent and both patients

189

and others question studies; XI the

a dynamic with dynamic related liver is that is

do we have and is, the just

variation the

haw busy if insulin so many there

2nd how busy left of it, is. to

anything is being

absorbed related diabetes, that 13 24 15 16 17 18 19 20 21 22 23 24 25 the indicate devices metabolic glucosedynamic the that

variables of state indicate the data consider changing of course 8 model. to

diabetes, and the

duration physiologic to like

BMI

cannot any

be taken individual

as an assumption will seen look

given

So Z thin that that

we have

enough to

we definitely are dealing with this appropriate approving labeling. Do you Question designs? first the

do need rapidly casec for either

substances--in -that data it before or the is

FDA to the

review

device,

system, DR. secoxad

KROLL: part of study the

have 1,

any what

comments is the if second

;on

minimum you set of

dataset, answer questions

what

Actually, part, most the

Ft s @ to ye is

probably

important.

MILLERREPORTING COMF31NY, INC. 735 8th street, SsE.
Washingtcm, R.Ct 20003-2802
546-9;E5666 (202)

ah 1 2 3 4 5 6 7 8 9 10 11. 12 13 14 15 1 l-7 18 19 2 21 22 23 24 25 data very 3eaIing Companies Zat lOok meters think is of at that that Ir. ,oday DR. Lnd come back >art, >art. and then R0SENBLOUM: and I'd let I'd rather answer to time Dr. tackle reflecting you go around the the first second

290

everybody

be willing I?11 waste

Otherwise, DR. DR. Rosenbloom. that this number it is is KRULL:

an it.

Okay.

Henderson? y agree been clinicaX X think made with
clear

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a tool.

provides

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data

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dynamicDR. MS.

be evaluated.

seen have we are of

a tan been all

of

both

responsive with for

the us a

1 think I
and

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think
how it

we need
affects

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dynamic and how it

will to for ever the

affect consider people had

our the with

atients, fact diabetes and keep

we also

need

an advancement we have terms of

anything mind in

before that

demands

we place

on the

MILLER

REPORTING COMPpsS1y', INC. 735 8th street, S.E. R,C. 2DOOJ-2802 Washington, (202) 546-6666

ah

II.91 1 2 3 4 5 6 7 :esting 23g time ,here iache data Chat 9 10 11 3.2 13 14 15 16 17 1 19 20 21 22 23 24 25 which copies pattern sZoper it tends about think is. :ompanies. DR. is CLEMENT: necessary is, ta I definitely try to of sort think out dynamic how muc problem from USI points, make

there

how much the the can data

an accuracy t:o us between as 156 to

Some of that data

presented

suggested in is the clearly arm

difference be as much for

unacceptable looking

trying at
the

lecisians, range.

particularly

hypoglycemia

We saw a lot doing the different methodology of glucose of or monitor for I I have I don't of t and is scribbled have 4 to i-v., doing

of

different of

presentations dynamic testing. times over
either

types that

I

we saw many allenge whether help bring

e type by an injection subcutaneous and then

followed it the every is is

insulin, to

sugars 15 to 20

C?WD

PK samples I think

minutes useful

6 hours,

very,y

very

a couple but we have where, during

of

plots IVKL seen

for make this up

overheads, Basically, over again and

aybe
all

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during the down

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~~~~ER

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735 8th
Washingtan, (202)

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to

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equivalent; in data, thousands day, is a fairly and just of

rigorous doing

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testing types

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different they are

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not

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quite

rigorous

as this, And to these 300 are fluctuations not out even is in ;of the this sugars realm going of sugars catM and

We saw this So I think test to this

morning; realistic

a fairly

measure. Thank you. now. that, to and yes, I concur dynamic that with

KROLL: make panel

my comments members

testing diabetes

important. a dynamic
MILLER

We have disease,

remember yorr can't

REPORTING ~~MP~~ INC, 735 8th Street, S,E. D.C. 20003-2802 Washingtsn, f2ctZ> 546-6666

a 1 2 3 4 5 important today 7 8 Look where for this to svaluate steady dynamic state. To answer study look they like the other questions, 1 think data time that course it is what very seen and as alsa as patients 1 think to inta evaluate the we are disease or anything dynamic at

293

designs-at look the at

we have data,

hypoglycemia some of tests

as well. the

hyperglycemia. used oral glucose challenges and also happens taking very if

1 think tolerance in their important. someone

studies as we21

3” 1 2. 12 13 14 15 16 17 18 19 221 21 22 2 4 25

insulin eating that9 what

addition regular

to

narmal

insulin, They need

is

challenged

ypoglycemic What X think time

range. is the to pick minimum look out at dataset this in ta terms other be studied? of the

we ought course and between points, into because here In for the

times--in 15 or the

words8

somewhere those back data down

every watch fasting that is

30 minutes--caKLect risec and and into it see comes what

level getting

happens, zone

a dangerous

hypoglycemia. of how the data should be for, was that J think some

terms else was

analyzed one thing

and that

should very

we be interesting

looking

MILLER

735 8th Street,
(202)

REPURTfHG

Washington,

COMPANY, JNC, S.E. D.C. 20003-2802 546-6666

ah 1 2 3 4 5 6 7 8 9 10 3.1 12 13 14 25 l6 27 18 19 2 2 22 23 24 25 the data
be

194 3f the sponsors that time of only is very and some people were not presented time all lags, people. the

information out these

there lags fact, occurred did it

significant occur as out with if of

9s a matter time \nd 3f lags that

sounded in one to

sometimes 20 peaple. that time

significant -haw significant

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doesn't

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difference need that to is

additional figure what out. type to get

testing.

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of

statistics away from like t the

should

usedc

I think type J-ots at things

we have of are like that time

stationary difference to able have look to it

statistics--even fairly series lag

stationary--and analysis, and assess and it

begin also we11 be and

assess

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example, the up

polynomial. characteristics

regressions, of
MILLER

an idea They

curves.

may end

REPORTING COMPANY, INC. 735 8th Street, S.E. Washington, D.C. 20003-2802 (202) 546-6666

ah 1 2 3 4 5 6 7 8 9 1 11 12 13 14 35 16 I7 18 19 20 23, 22 23 24 25 that earlier. which think particular at talk took any time, would what agree important first priority that Be%ng very Sifferences Later on. Thank DR. you. AHMANN: dynamic feature priority will is be Like testing of to to this have have one least think considered with are without somebody dose for get who of things everyone is whole safety; efficacy statement once there nonp Type during is elsel I would and I think easy that to characterize be used and for may show predictiveness actual

195

could

a necessary thing. the and or the any

our

second reliability. suggestion time dynamic test I:

I do reject was made at

I dent be

ysiologic, in happen If you

because

people get

1 diabetes that will

any want and

day to just

prediction* who has short-acting their level absorbed, dose you and have

about their

gastroperesis insulin might or was

and

the if

potential they don't

how much their took a meal, afternoon their or

change you take

food

somebody from out spent those

interrupted who went and their suddenly yard, of

having for the the

somebody nothing in

who does working some

whole fit

afternoon into
BELIER

may not

classification

REPORTING COMPANY, INC. 735 8th Street, S.E. Washington, D.G. 2QQ;03-2802 (202) 54&-6666

a
1 2 3 4 5 6 7 8 9 J 1 1. 22 13 14 25 16 17 18 19 20 21 22 23 2 25

lhysiologic :hings that with nypoglycemic nest important

activities, will most to which to

but impact

buy, the

they

are

the

patientswould is look at t the

regard end, area 1 think test

how one f think highlight,

probably that is have

C.fficult. 3f provocative

we wauld that do it it in would

have

to

some

sort

create

hypoglycemia. safely, manner 1 think of test the in and you

You would tio6l.d everyone would or take want

want to else

to do

relatively a reproducible to, on the what the not so and part best

that that panel that be we

could

adhere

some to

studying

others

determine be. at with that It

situation the have ones seen

would at least

would and

necessarily forth that

doses insulin the

today ink

suggestion would it looking most you is

of

the

highlighting hypoglycemic feature is the of area

of and what that
And

how often not

become one at, important since the 3.5 percent is is a true that

recognize be to

we would is going the technical

threaten of

patient. in one of

whether last

suggestion

the

presentations I think that true in

would

be very

important. number if it

significant studies,

holds

muJtiple

ah l 2 3 include 3lement lighlighted. 5 6 7 rJhere intending about settings, 9 10 11 12 13
14 15 16 17 18 19 20 21 22 23 24 25

197

So the exercise said

minimum

dataset

I think

does issue.
to

as a very exercise, that

important it that needs is

As

Dr,

about I think will and

be place

a frequent without forethought several where of

people to it, and

became without it the and

hypoglycemic really occurs one any in

I think

including would that go out is

he mentioned amount

someone exercise a patient or ever fit

do a set

fairly

high-intensity--but who works and basal for Nike who

I have runs 5

on a pump every down is day, his

6 miles turning that

he can rate

go running because between he his

writhout is so

there with

no difference activity but a few or not.

insulin other in crash to we

sensitivity patients their and

I: have and and work they

who do nothing flower bed for

go out hours,

have

severe take just that

hypoglycemic. sorts of

We would things into

need

somehow couldn't expect

those put that

account; and

some people is are this we can a disease going to

on a treadmill answer issues, the

questions, but in for in 1 think

So these we all therapy, people-agree and this that if is

technical is

an a vancement it more

make

comfortable disease

like

no other

MILLER

REPORTING COMPMY, INC. 735 8th Street, S,E. B.C. 20003-2802 Wa~~~~g~~~~ (202) 546-6666

berms lat shey of

of

requiring of

patient the misery their their

management; index disease8 therapy for and safely

they all

have that

a

aspects ta

have

do with

anything would

we

zan da to the optimum

facil3.tate thing. CARA : I

DR. comments ibnrt

just

want the to

to

make

a coupLe
if

af

before and that

answering Pm have going already extent I am faced

question, echo been some

you the

mind,

of

sentiments

mentioned+

To a large endocrinologist, else is in their

as a pediatric daily, with to as everybody the paradox blood all agree after the probably hand, one with glucose of the of there the of

own practice, diabetes having I think monitoring important 1 diabetes, But

ildren glucose that insulin, management for are most Type

with

perform

monitoring. Joad the of glucase most Type

we would is

probably, for

discovery certainly other

11 diabetes. few other

on the

probably important hate

things--well, that is the people blood paradox and on the is

thing the there the by most

diabetes monitoring, clinical hand doing how

probably

so oftentimes utility it it. is of viewed

is

procedure t e person

other actually

who

199

As a result, Ear us, infarmatian qpropriately, m test .A Aaod or sugar don't levels this to
FDA

it in

is

oftentimes to

difficult get

especially to be

pediatrics, to caunsel they do but

able

patients are don't not wiPling write uwn

either want or

because t:s or whatever. is

I think Jhat nlould May. I think r;rf the and what iceberg really caution needs the

an important further,

technology and in I any

be explored about moving

backward

we are here in

essentially terms of this

seeing

the

tip

phenameaon, in terms of

1 think is

we need

more on. the

information I would manufacturers populations in with there and infants; exercise. will

actually the to look

going FDA and at does what

specifically of of what happens We assume be more site could blood argue flow, these

encourage deices patients in that

different happen happens perhaps finger other there

--what

children; with

exercise with but

discordance testing, that and know with maybe that.

alternative you

on the

hand, is will

exercise the

increased be less.

difference

We danct

I would

encourage
MILLER

that

ynamic

studies

REPORTING C!OMPAHY, INEl"f. 735 8th Street:, 5.E. D.C. 20003-2802 Washington, (2023 546-6666

ah

200

1 2
3 4

>erformed, nentioned.

o viously,

as everyone

else t

has

1 would look at other the

encourage

the besides

manufacturers rubbing--perhaps or a warm more

to

procedures area I'm with sure

#arming
6 7

a washcloth you can lead

bag

or

something; in the

be much to less

creative

procedures And again,

--might

discordance. the issues out why might

addressing garlier, more

some of maybe

9 1

that

were

mentioned have to

finding than others

some people be important

discordance at. Thanks. Everybody but I would that I. think vascular and in has ad

look all.

12 13 I.4 1.!? 16 1 '7 18 19 20 21 22 23 24 25

That's DR. 1 was going to

MANNO:

said to

everything Dr. Carafs broader to definitely I"11 say

to the to

say, extent study, with

comments populatiuns
include

selecting we need

people

problems--and

why

in

a second--real

hepatic. have that agents were for to look getting diabetes. drugs comment at not with J:

I: think only the think that about and the different we have are different

we definitely results therapeutic to look also An issue of absorption the

at

concomitant in of point--the food of

on boar

changing nutrients.

productions stress-related

With
MILLER

number

REPORTING COMPAHY, INC. 735 8th Street, S.E. D.C. 2~~~3-2~~2 Washington, (202) 546-6666