diatribe - research and product news for people with diabetes - issue #4

8/14/2019 DiaTribe - Research and Product News for People With Diabetes - Issue #4

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from the editor

Last week, my husband, John, and I had a beautiful baby named Lola.

The experience has reminded me of how challenging diabetes is, but also

how fortunate I am to have a great health care team and a supportive

husband. We all know that diabetes is a family affair, but that is never

truer than during pregnancy. Years ago, women with diabetes were

discouraged from having children. Those days, thank goodness, are longgone. But while successful pregnancies are now fairly routine, I can attest that they are not

necessarily easy. Maintaining normal blood sugars this time around took a lot of adjustments.

And I would be lying if I wrote that weve had no uncertainties about the babys health. But

the point is: weve come a long way. Fittingly, this issues loose theme is about just that.

Pump therapy is considered by many experts as much better than its alternatives, and yet

its underused. It is really just our sort of topic. A great Learning Curve describes how pumps

have improved over the years and what they offer today, namely continuous insulin delivery

that is much closer to the way a pancreas works than multiple daily injections. In a very

personal Test Drive, I share with you not only my experiences on the fabulous OmniPod, but

also the way I stumbled upon pumps years ago and how they changed my life.

The first thing to look at in this issue may be the incredible Profile on Gladys Dull, who has

been on insulin therapy longer than any other person in history. Where better to start than

the early days of diabetes treatment? No pumps here she spent most of her life using glass

syringes and measuring her blood sugar by boiling her urine. Almost miraculously, she is now

90 and for the most part independent. Gladys, thank you, for inspiring us.

Danish company Novo Nordisk is now the largest insulin maker. We are very impressed

with this company, which has taken a leading role in urging the world to recognize diabetes

as an epidemic and to curb it. Our discussion with the CEO of Novo Nordisk, Lars Rebien

Sorensen, was quite revealing, about how governments must recognize that health care is

not about treating diseases but about investing in the future, about Novos next generation of

insulins, and more.

Finally, I just want to say thanks again to all of you on our Patient Advisory Board. Just

as we pride ourselves in having an excellent expert advisory board with the top educators,

doctors, and other players in the diabetes community, we also pride ourselves in having a

terrific Patient Advisory Board who keeps us on our toes. As always, we invite you to let us

know howdiaTribe can better serve you ([email protected]).

We are, after all, one big family plus one!

Kelly L. Close

V O L U M E 1 I S S U E 4

From the Editor .............. 1

A healthy, happy baby

shows how far weve come

Learning Curve ............... 2

Why we like to pump it up!

Logbook.......................... 5

Jackie Robinsons secret

Test Drive ........................ 8

Putting on the OmniPod

diaTribe Dialogue ........... 11

Speaking with the CEO of

insulin maker Novo Nordisk

Profile .............................. 14

The woman whos been on

insulin longer than anyone

NewNowNext ................ 16

Whats out: Janumet and

FreeStyle Lite approved

FingerSticks ................... 17

Jurassic variability?

Conference Pearls .......... 18

To Seattle and back with

new information

What Were Reading ...... 19

The latest research on

inhaled insulin and stem cell

therapy

in this issue

research and product news for people with diabetes

To subscribe todiaTribe, visit

www.diaTribe.us.1


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Compelling Smart Features Become Standard

Some of the more compelling smart features on the pump have become

standard, and insulin on board is one of the most important.

When you give an injection, the insulin remains in the body for a number

of hours, but you dont know how much is still active and for how long. Pumps

now come with software programs that make that information available. The

feature deters patients from stacking insulin or giving a correction bolus for

a high blood sugar when the existing insulin (insulin on board) may return

glucose levels to normal.

One of the complexities of pumping insulin is that people give multiple

[boluses] through the day, and the current rapid insulins have a duration of

action that is far longer than most people realize, says John Walsh, co-author

of Pumping Insulin. A conservative estimate is that it lasts at least five

hours. The average time between boluses is probably less than four hours. So there is a lot

of overlapping of bolus activity.

Several pumps will recommend how much insulin to deliver based on numerous criteria

your target range, your sensitivity to insulin, how many carbs youre about to eat, and your

current glucose level. The pumps have safety features to alert users when the insulin is not

flowing properly or when the reservoir is low. They also have multiple bolus options thesquare-wave and dual-wave boluses can spread the delivery of bolus insulin over time

and are helpful when eating high-fat meals or when taking insulin with Symlin (See last

issues Learning Curve for more information on this new drug for type 1 and type 2 patients

who take insulin).

Next Generation: Smaller and More Integrated with Other Technology

What will the next generation of pumps look like? They will continue to become smaller,

perhaps with more concentrated insulins in micro reservoirs. The tubeless, disposable

OmniPod, which is easier to attach and has fewer moving parts than conventional pumps,

appears to be a glimpse into the future: Other new pumps currently under development

promise to be miniaturized devices taped directly onto the skin that deliver insulinsubcutaneously. Like the OmniPod, other new pumps may be operated and

programmed through remote control devices.

Pumps will also become more customizable with personal alarms,

reminders, and delivery options, and there will be a continued push to

integrate with glucose meters and continuous glucose sensors. We also look

forward to dual-chamber pumps that will allow us to infuse other drugs such as

Symlin and perhaps Byetta (currently prescribed for type 2 patients).

Better Pumps are Central to an Artificial Pancreas

The ultimate prize is the artificial pancreas. In that scenario, a continuous

sensor would signal to a pump how much insulin to deliver based on the

current glucose level and its rate of change, and the pump would deliver

the insulin without any human intervention. Some have called this closed-loop system a

technological or a mechanical cure, or at least a way to ensure normal blood sugars

regardless of how many pancakes you eat.

The closest product to an artificial pancreas that is available is the MiniMed Paradigm

REAL-Time Insulin Pump and Continuous Glucose Monitoring system. The sensor

essentially talks to the Paradigm 522 or 722 pump, giving the user access to real-time

glucose readings every five minutes and recommendations on boluses. It is still an open-

loop system, because the patient delivers the insulin, and we believe open-loop systems will

D I AT R I B E R E S E A R C H A N D P R O D U C T N E W S F O R P E O P L E W I T H D I A B E T E S

4continued on page 5

Insulets OmniPod

MiniMeds Paradigm pump and

continuous glucose transmitter


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continue to improve and that, in fact, the power of the open loop may be underestimated.

Getting to a true closed loop requires more than a more perfect sensor. It also requires the

right algorithms and probably glucagon (whats known as a counter-regulatory hormone),

which in turn may require a dual-chamber pump.

Studies at Yale University have demonstrated the feasibility of a fully closed loop system

though theyre being done in the clinic and with significant monitoring. The trials are part

of the JDRFs (Juvenile Diabetes Research Foundation) Artificial Pancreas Project. The

biggest hurdle right now is that the insulin, sent by pumps into subcutaneous fat, takes toolong to take effect and then takes too long to stop working. This is true even for the fastest-

acting insulin; and even if a more rapid-acting insulin becomes available, that might still be

too slow. This is why, in addition to progress with new pumps, we are also closely following

developments where faster-acting insulins, more concentrated insulins, and other valuable

hormones could be infused, all with the goal of making a diabetics body more closely

resemble that of a healthy person without diabetes.

logbook

Jackie Robinson, Diabetes, and anOpportunity Lost

By James S. Hirsch

Afull-page newspaper ad, celebrating the sixtieth anniversary of Jackie

Robinsons first Major League baseball game, said:

He was a soldier, a writer, an activist, a politician, a voice, a

leader, a father, a husband, and a friend.

He was all of those, and he was something else.

He was a diabetic.

Last months anniversary of Jackie Robinsons historic achievement allowed America to

remember his extraordinary life. In 1947, when he played his first game for the Brooklyn

Dodgers, he shattered some of the countrys most pernicious, yet deeply held, biases toward

black Americans. During his career, he withstood racial epithets from opposing players,

threatened boycotts from his own teammates, hostile boos from fans, and death threats

from enemies. But he played with daring, skill, and courage, amassing a Hall of Fame

career while also serving as a front-runner for the modern civil rights era. As the author

Jonathan Eig wrote, Robinson showed black America what was possible. He showed white

America what was inevitable.

Accordingly, Robinson has been celebrated in books, movies, documentaries, songs,

short stories, poems, term papers, and sermons. Yet precious little has been written or said

about the role of diabetes in Robinsons life how it may have cut short his baseball career

and how it certainly cut short his life. The tragedy is not simply that diabetes killed a greatman who still had so much to give. It is that Robinson himself who spoke out forcefully

on civil rights, politics, and business wanted to keep his disease quiet, and those who

carry on his name have continued that legacy.

Why Robinsons Diabetes Matters

Why does it matter that Jackie Robinson had diabetes? Because perceptions matter, and

Robinson could have blunted some of the misperceptions that existed during his life and to

some extent still remain: that the disease only affects people who are old or overweight, or

that the discovery of insulin has either cured the disorder or at least made it not that serious.

The tragedy is notsimply that diabetes

killed a great man who

still had so much to

give. It is that Robinson

himself - who spoke out

forcefully on civil rights,

politics, and business

- wanted to keep his

disease quiet, and

those who carry on his

name have continued

that legacy.

T1/2

From the expert:

John Walsh, author of

Pumping Insulin, on the

closed loop:

Pumps have a

tremendous advantage

in accuracy of dosing

boluses. Just the fact

that you are wearing

a pump and giving

boluses, which are

easier than taking

injections, suggests

that you are going to

more accurately cover

your carbs.


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Patients, of course, have always known the realities of diabetes, but

over the years, they rarely advocated for themselves. On the contrary, they

were more apt to conceal or even lie about their condition, either out of

misplaced shame or genuine concerns about discrimination.

The landscape changed somewhat with the founding of the Juvenile

Diabetes Foundation in 1970, which became an energetic voice for diabetic

children and enlisted several celebrities (most notably, Mary Tyler Moore)

to the cause. But even as diabetes became a mainstream disease, its had

difficulty gaining traction as a serious public health threat. In a recent

speech, President Bill Clinton acknowledged that he didnt understand the

scope of the epidemic until after he got out of office. Between 1980 and

1994, NIHs research dollars for diabetes as a percentage of its entire

budget declined slightly even as the number of diabetics had doubled.

What the diabetes community has lacked is urgency (see: AIDS

activists), public figures (see: Michael J. Fox, Parkinsons), and national

commitments (see: polio, 1930s).

Why does it matter that Jackie Robinson had diabetes? Because his

story, if known, could be a rallying cry for better care, for more research

dollars, for greater understanding and a poignant reminder of the truecosts of this disease.

Hyperglycemic While Still in Uniform

Robinsons health problems began while he was still playing for the Dodgers. His knees and

ankles chronically hurt, and his arm was often sore. He also struggled with his weight. After

his rookie season, he went on a celebration tour through the Deep South, ate like pigs,

and gained 25 pounds. His weight would fluctuate throughout his career.

Robinson retired at age 37. After 10 seasons, his performance had begun to decline, and

his health was also poor, though its unclear if he was diagnosed with diabetes while he

was still playing or immediately after. In whats considered the most definitive account of

his life, Jackie Robinson: A Biography, Arnold Rampersad wrote that he was diagnosedabout the time of his retirement. If nothing else, its safe to assume that Robinson was

hyperglycemic while still in uniform. Robinson discovered his diagnosis on a routine visit

to his physician. He left in high spirits, said his friend, Jack Gordon. But when he came

back he was very quiet. He said that the doctor had told him that for someone who had

played sports for so long and didnt smoke or drink, he had never seen a body so badly

deteriorated. Jack found out he had diabetes. It was very, very sad.

His diagnosis could not have come as a complete shock. Two of Robinsons brothers,

Edgar and Mack, already had diabetes.

Jackie was immediately prescribed insulin. He initially practiced his injections on

tomatoes, then he took the shots himself. His biggest challenge was his diet. As his wife,

Rachel, told Rampersad, He used to put away a pint of ice cream at one sitting. That

stopped, along with the pies and cakes.

A Painful Connection to His Mentor

In a painful twist of history, diabetes would forge another link with the man most

responsible for Robinsons fame. Branch Rickey, as the president and part-owner of the

Brooklyn Dodgers, signed Robinson with the team and then became Robinsons beloved

mentor and father figure. Unfortunately, Rickeys eldest son, Branch Jr., also had diabetes,

and he died from complications in 1961 at age 47.

In his retirement, Robinson was involved in business and politics, he wrote a newspaper

Jackie Robinson

IL

LUSTRATION:DANIELBELKIN

What the diabetes

community has lacked

is urgency (see: AIDS

activists), public figures

(see: Michael J. Fox,

Parkinsons), and

national commitments

(see: polio, 1930s).


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7

column (tackling subjects ranging from housing to migrant workers to trade unions), and

he was active in the civil rights movement. His biographies cite no examples of his speaking

out on diabetes, but the disease hospitalized him on several occasions. His heart was

balking, his sight was beginning to cloud, and his decline was irreversible. By 1969, he was

still seen as a paragon of strength and courage, but his doctor could not discover a pulse in

his legs. He told Rachel Robinson that her husband would be dead in two or three years.

Jack did not want to hear that news, Rachel told Rampersad. He would not talk about

death. Denial was his greatest prop, and he denied that he was dying.

The following year, Robinson suffered two mild strokes that left him unsteady and

with numbness on his left side. Blood vessels continued to rupture in his eyes. In 1971, he

received experimental laser surgery, but the vision in his right eye was almost completely

gone; and his left eye was badly impaired.

By 1972, walking had become increasingly difficult, and his doctors knew that both legs,

lacking sufficient blood supply, needed to be amputated.

Robinson, however, refused to succumb to self-pity or even acknowledge his own

mortality. As his doctor noted after one visit, The patient, as always, says he feels great.

An Autobiography, and a Missed Opportunity

In 1972, Robinsons autobiography, I Never Had It Made, was published. By then, heknew what diabetes had done to his life he couldnt even read the galleys and he (or his

ghostwriter) could have used the book as a platform to raise awareness of diabetes and urge

improvement in care. Just as he walked onto Major League ball fields to clear the path for

future generations, he could have spoken out for patients who would follow his footsteps.

Instead, Robinson only made two fleeting references to diabetes, in ways that completely

misrepresented the condition. Although I have lost one eye and have impaired sight with

the other, he wrote, there has been remarkable improvement recently. Ive always been a

fighter, but this is one fight I could have never won alone.

The fight didnt last long. On June 4, 1972, he attended an Old Timers Game at Dodger

Stadium, and as one observer wrote when he walked out on the field to be introduced

to the wildly cheering crowd, he walked like a man of 80. Then on October 15, he washonored before a World Series game, and he gave a speech most remembered for his plea

that Major League baseball hire a black manager. When a fan asked him to sign a baseball,

he said, Im sorry. I cant see it.

Jackie Robinson died nine days later, at age 53.

A Hole in a Heros Legacy

Around the time of his death, at a public meeting sponsored by the American Diabetes

Association, then president Max Ellenberg cited Robinson as one of those famous figures

who kept their disease in the closet. Now, at a time when type 2 diabetes is ravaging

the African American community, some medical leaders recognize that Robinsons

secretiveness represents a lost opportunity. Former ADA president Ronald Arky, for

example, vividly remembers radio announcer Red Barbers description of Jackie Robinson

dancing off first base as he prepared to steal second; Arky says hes always wanted to

speak with Rachel Robinson about the onset of Jackies disease, his family history, and his

treatment, but he never has.

Its possible that Robinson didnt talk about his health because he didnt want people to

feel sorry for him. He may also have felt shame or embarrassment. He wouldnt be the first,

nor last, to feel that way. And how much more could we expect from Jackie Robinson? A

hero only has so much heroism to give.

But we can expect more from others. To sustain her husbands legacy, Rachel founded

continued on page 8

When a fan asked him

to sign a baseball, he

said, Im sorry. I cant

see it.

Now, at a time when

type 2 diabetes is

ravaging the African

American community,

some medical leaders

recognize that

Robinsons secretiveness

represents a lost

opportunity.


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8

the Jackie Robinson Foundation, which provides college scholarship money and mentoring

to minority youths. The Web site, which includes a biography of Jackies life, makes no

reference to diabetes.

Mrs. Robinson, who is now in her 80s, looked radiant during her speech at Dodger

Stadium last month to celebrate the anniversary of Jackies arrival in the Major Leagues.

But asked to be interviewed for this column, a spokeswoman, Barbara Tribble-Sawyer, said

She does not want to be interviewed on this subject.

test drive

Test Driving Insulets OmniPod SystemBy Kelly Close

Ive said that I would sacrifice my cell phone for an OmniPod and those who know me will

tell you that is huge. For me, its the best product that has come along in a decade. Symlin

actually comes close, and then the other pumps are way up there, but the quality- of-life

improvements that OmniPod offers have been enormous. It truly is a breakthrough, and

really, so few breakthroughs come along in this diabetic life.

The OmniPod, of course, is by definition an insulin pump, and there are many important

reasons for using a pump (see this issues Learning Curve). As a group here at diaTribe,

we think its fantastic that insulin therapy can be more physiologic, or more similar to the

bodys natural functions. In other words, the pump, continuously supplying small amounts

of insulin, approximates a functioning pancreas much more closely than do multiple daily

injections of insulin. Honestly, its crazy to me that only 20% of type 1s and a very small

percentage of insulin-using type 2s are using pumps. Insulet, which makes OmniPod, was

until recently a small private company; in May, it went public with the goal of expanding

capacity, and I foresee OmniPod making a difference in how many diabetics use pumps.

The Device

There are two pieces to the system: one is a Personal Diabetes Manager, or PDM,which is kind of like a Palm Pilot or a big Blackberry. This controls the other piece, the pod,

which is attached to the patient. The PDM has a FreeStyle blood glucose meter built in. Its

about three by four by one inch, bigger than most meters, but not significantly. When you

get the PDM, you work with your healthcare team to program it.

Basal rates (mine varied between 0.5 0.7 mg/hour until I got pregnant recently

then they were 1.0 1.5 mg/hour!)

Target glucose levels (mine was 100 mg/dL until pregnancy, then it went to 80 mg/dL

hypoglycemia was very rare for me in pregnancy, so it was safe to reduce this)

Insulin-to-carb ratio (mine was 14 units per carb pre-pregnancy, and five during the

last few months of pregnancy!)

Insulin sensitivity (this means how much 1 unit of insulin lowers your blood glucose mine was over 50 mg/dL pre-pregnancy and 45 mg/dL during pregnancy)

You can also program a bunch of other choices, like whether you want a reminder an

hour (or two or three) after you eat to tell you to check your blood glucose, if youve missed

a bolus dose, or whether you want any sound at all on your meter

The programming takes about 5-10 minutes, and then youre ready to start your

OmniPod. When you take the pod out of the packaging, you fill it with insulin, which

takes about 30 seconds. Then the PDM (it is so friendly!) asks you if youd like to put

on a pod. Why, yes! So it instructs you just like that! to fill the pod with insulin. You

receive a syringe with every pod, and you just withdraw the amount of insulin (minimum

T1/2

continued on page 9

I foresee OmniPod

making a difference in

how many diabetics

use pumps.


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9


85 units - maximum 200 units) you require for three days and fill the pod

through a fill port on the underside of the pod. Two hundred units of insulin

is the maximum, which is a drawback I never used to use so much insulin,

but I found in pregnancy, it barely lasted the three days, so for some type

2 patients, this wouldnt be enough. Then the PDM asks if you are ready

(again, so friendly! I really get the impression, crazy as this sounds, that it

cares about me), and you take off the pods adhesive backing and place it

on your stomach, back of arm, or leg plenty of flexibility because you arent

constrained by tubing. You can put it anywhere there is fat tissue.

Then you press start on the PDM and I always do this gleefully, because

I never feel it go! You hear a little click, click, click which I find reassuring, and then

the needle goes in at 1/200 of a second and then comes right back out, leaving the cannula

under your skin. Im not sure if it is because I dont see it go in, or because its so fast, or

because its automated, but for such a long time, this auto-insertion was my favorite thing

about the pod. I didnt feel it, while the insertion of my other pumps had always been my

least favorite thing about them. After insertion, youre off and running with your basal

insulin. You wear the pod continuously for three days (it tells you when its time or insulin

is running out) and then remove it and throw it away. Swapping to another pod only takes

about 90 seconds super fast and easy basically just filling the new pod with insulinand saying go. This device is very easy to maintain you dont need to clean anything.

You do get in trouble if you forget to take a pod and you need to switch your existing one

because the alarm is very, very loud and you can only quiet the alarm intermittently, but

if the pod wants to get your attention, you cant ignore it!

While youre wearing the pod, you use the wireless PDM to program doses or adjust

basal rates. To program a bolus, you first take a blood glucose test, just like with a regular

FreeStyle meter, and you get your result, and then press next. I love how all this works. My

husband is very technical, and he was helping me and he said Nice UI approvingly the

first time I tried it. Thanks! I said, pleased with my score of 122 mg/dL. No, sweetie,

he laughed. Youre lovely, but I was talking about the PDM. Nice UI. That means nice

user interface. This means I like how its so logical. Press next! I did, and the PDM askedif I was planning on eating, which I was enter 30 carbs! Then there appeared the bolus

dose it was telling me to take. This wasnt unlike my old pumps I also think the bolus

estimator function on pumps has been a breakthrough but the screen on this is pretty

big, and I just liked the PDMs personality. Then I hit go and a wireless signal was sent

to the pod, which delivered my bolus dose of insulin. Insulet is working on combining the

OmniPod with FreeStyles soon-to-be-available continuous glucose monitoring system,

Navigator I think this holds a lot of promise, but I imagine that will take a couple of years

Even though the interface on the PDM is easy to set up and learn, the PDM still has

all the sophisticated options that a serious patient would want, like a bolus wizard (which

determines your bolus) and an insulin on board feature (which deters overdosing). The

PDM also has a food database, reminders, a quiet alarm (some like it loud, but I dont);

and, best of all, it doesnt need to be connected to me!

Its also worth noting that Insulets customer service desk is excellent perhaps because

all its members are type 1 patients who also wear the pod. (Now, thats standing behind

your product.) Ive only had to call the desk a few times, but when I have, the reps were

extremely knowledgeable and efficient.

An evolution in pumps

As I described in an interview with a top teen Web site for diabetes (diabetesteentalk.

com), over the past 10 years I have worn both the MiniMed and Animas pumps. The

continued on page 10

The OmniPod

PHOTO:DAN

IELBELKIN

I really get the

impression, crazy as

it sounds, that [the

OmniPod] cares

about me...

Ive only had to call

the [customer service]

desk a few times,

but when I have, the

reps were extremely

knowledgeable and

efficient. Turns out they

are all type 1 diabetics!


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MiniMed 507 was the first series of pumps I started on life changing. I cringe when I

think of what I did before that from the late 1980s to the mid 1990s on a fixed insulin

dose for most of that time, mainly NPH and regular. I was in and out of the emergency

room for hypoglycemia at least once a year, and I can still vividly feel what it was like to

wake up in the ambulance. It always felt the same Oh, not this again and I would close

my eyes and hope it was a dream.

It was in the mid-1990s, when I was working on Wall Street, that I was asked to

develop an opinion for investors on MiniMed as a small public company. I had been very

against pump therapy probably, I was just against thinking actively about my diabetes.

The body-image stuff really bugged me, and I didnt want a constant reminder of my

diabetes anywhere, much less to wear. My A1c at the time was 7 percent or so, and my

doctors would assure me that below 8 percent was very good this was before everyone

was so focused on the importance of tight control! Anyway, I said I would go on the pump

for a week to determine whether MiniMed was a positive investment. Going to MiniMed

to meet the leaders, I learned about the benefits of physiologic therapy the more you can

mimic an actual pancreas, the better. With a way to mimic my pancreas insulin secretion

every minute, four shots a day suddenly seemed like a very blunt tool.

Inside a day, I vowed never to go off pump therapy. I felt so much better on it, almost

immediately. Life was more flexible: I could exercise without fears of hypos, I could eat

more, I could give a shot just by pushing a few buttons. Now, not all was rosy I found

the insertion painful, I hated when my infusion set pulled out accidentally, and sometimes

I just wanted people to stop asking about it. When MiniMed was bought by Medtronic in

2002, I started having problems with customer service and stumbled upon Animas at a

conference. I used Animas all through the 1200 series. I thought the pumps were sleek and

worked well, and I loved the insulin on board and the other smart pump features. At

this time, there seemed to be so much innovation more than we had seen in years.

So why the move to OmniPod? When I volunteered for the clinical trial I love clinical

trials I didnt think anything could prompt me to change permanently from Animas. I was

intrigued by the no tubing concept, but the idea of leaving it on for three days seemed like

a deal breaker. To my surprise, I loved it. It was more discreet than other pumps, which forme was so key. It was faster and easier than my other pumps, and it really was as smart as

my old pump. It was a good time for change I had just had my daughter, Coco, who would

pull out my infusion sets, which was incredibly depressing. It was nothing I couldnt get

over, but putting those in was the worst part of being on a pump, and the OmniPods auto-

insertion is so much less stressful for me.

Because it has no tubing, it is easily hidden. Ive worn it nearly everywhere, though Ive

noticed that my abdomen has the best absorption (this varies from person to person). Many

wear it on the back of the arm, possibly the least cumbersome location. I love hiding it.

Even though Im pretty glass-half-full about my diabetes, I do get sick sometimes of telling

my story whenever someone asks about my pump (before that, my pen, or syringe). I am

still asked sometimes, and typically Im pretty upbeat about it because I feel lucky, but

Im not now answering in response to my pump, because its never really visible. Its small

about half the size of a regular pump and of course Im hoping it gets even smaller

and its always hidden under my clothes.

Since the OmniPod is always attached to me, some people ask whether I can suspend the

flow of insulin, for exercise, for example. Yes, you can. I walk a lot and I always suspend it

half an hour before my walk. If I dont, my BG drops 50 points minimum. I would do that

with any pump. The pod is waterproof, so theres no issue with showering or swimming.

Apparently, the insulin in the pod may have problems in hot tubs, but you can prepare for

that by putting it in your upper arm. Technically, the company says it can only be immersed

10


continued on page 11

...I can still vividly feel

what it was like to wake

up in the ambulance.

It always felt the same

Oh, not this again and I would close my

eyes and hope it was a

dream.

With a way to mimic

my pancreas insulin

secretion every minute,

four shots a day

suddenly seemed like a

very blunt tool.

I was intrigued by the

no tubing concept, but

the idea of leaving it on

for three days seemed

like a deal breaker.


11/20

www.diaTribe.us



8 feet for 30 minutes, but thats not really very restrictive unless youre a scuba diver, which

Im not (I made the mistake of admitting I was diabetic when going for training a couple of

years back Ill have to not tell the truth next time!)

Continue reading about Kellys experience with the Omnipod online at www.diaTribe.

us/issues/4/test-drive.php with the device and how to sample one.

diaTribe dialogue

Lars Rebien SorensenLars Rebien Sorensen does not have diabetes, but he may be the most important

business leader in the field today. As president and chief executive officer of Novo Nordisk,

he heads the worlds largest insulin company its products are used by 15 million people

around the globe each day and Novo has taken the lead on raising awareness of the

epidemic. Most recently, it sponsored the Global Changing Diabetes Leadership Forum in

New York, which we attended in early March, and former President Bill Clinton was the

keynote speaker. He emphasized that three things are needed to slow down the pandemic:

vision, leadership, and money. Right now, Mr. Sorensen and his company are providingall three. In a conversation with Kelly Close and Jim Hirsch, Mr. Sorensen discussed the

need for governments to recognize that health care is not about treating diseases but

about investing in the future, the development of Novos next generation of insulins, and

the reasons why the pharmaceutical industry needs to repair its reputation.

Kelly: Thank you so much for taking the time to speak with us. What steps would you like

to see industry, government, and health care professionals take to improve diabetes care?

Mr. Sorensen: I think were basically talking about a problem of chronic disease, which

is the biggest public health threat we have in many societies. And we believe diabetes is

a model that can be used for how to deal with it, how to monitor it, how to treat it. Butno single institution is able to solve this problem on its own, and therefore, we need to

come together patient associations, health professionals, governments, NGOs (non-

governmental aid organizations), and industry because otherwise we cant solve this.

Jim: But once everyone comes together, what should they be doing?

Mr. Sorensen: Well, I think we need to recognize that we each can play a role, and if we

work together, I think theres a win/win situation possible. For example, ideally, we should

create health care systems that are capable of preventing chronic disease, but if thats not

possible, health care systems should diagnose and treat early rather than treating late.

Then its a win/win situation for everybody because diabetes is not costly if diagnosed and

treated early, but its very, very costly if its left untreated. So theres an industry interest,

looking upon it from our perspective: more awareness will lead to more diagnoses, which

will lead to more advanced and more aggressive therapies, which leads to more business for

the pharmaceutical industry. This would also reduce patients suffering and complications.

It would help society with reduced health care costs in the long run. So I think there is

legitimate interest on behalf of all stakeholders in working together.

Kelly: How has the global diabetes epidemic affected Novo Nordisk its product line, its

research and development, or its mission?

T1/2

Lars Rebien Sorensen

...Ideally, we should

create health care

systems that are

capable of preventing

chronic disease...


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Mr. Sorensen: Therapies today are not sufficient for people with diabetes to live normal

lives. So there is a lot more that we can do from the research side there are still new

drugs, and Levemir and GLP-1 therapy in particular are ways of addressing this. (Note:

Liraglutide, Novos GLP-1 mimetic, is currently in phase 3 clinical trials. It works through

the same mechanism as Amylins Byetta.) There are a lot of therapies that are being

promoted today DPP-4 inhibitors from Merck (Januvia) and Novartis (Galvus, not yet

approved) in the future, as well. These are all new therapies, including inhaled insulins,

which are more convenient for the patient. And then there is still a lot that can be done in

terms of developing clinical practice guidelines and dietary guidelines so our people can

appropriately treat themselves. Theres an amazing lot of work that can still be done.

Kelly: Its fair to say that your biggest product, insulin, is under prescribed or under

used, certainly in the US, because therere so many people who are taking it who are not

at glycemic target. What do you think Novo or the other insulin companies should do to

increase the use of the product?

Mr. Sorensen: It is interesting that diabetes and severe diabetes have often been

associated with insulin therapy, so physicians would often encourage patients to treat

themselves properly, otherwise they would be put on insulin. So historically insulin wasused as a threat in some ways, and to many patients, it was viewed as the end stage of the

disease. Insulin had a bad connotation. But clinical studies have shown that diabetes needs

to be treated as aggressively and as early as possible, to reach near-normal glycemic levels.

That is where the new therapies, like GLP-1, are important, because patients are

concerned about going directly from oral agents to insulin. Insulin has traditionally had the

side effects that youd gain weight and that there may be hypoglycemia, though the latter is

not very significant as it relates to type 2 diabetes - its more significant for type 1 diabetes.

So GLP-1 has presented itself recently as an intermediate step between oral therapy and

insulin.

So we expect these new therapies will all find their own niche, and its up to the

physician and the patients themselves to decide how aggressively do they want to treatthemselves, because we have to understand that the more aggressively the patients treat

themselves, the more they infringe on their personal and private life in terms of either

having to monitor blood sugar or having to take injections or multiple injections. And so it

is a balance between the patient wanting to have a quality of life and the risk of developing

complications long term.

Kelly: What has to happen to make diabetes the urgent issue that it should be?

Mr. Sorensen:Well, I think youre touching on a very central thing, which is also one

thing that I asked President Clinton about. Its going to be interesting to see how we will

make significant change unless we also look at the financing of the health care system.

In my country, where we have a public health system, we view prevention and early

intervention as investments long-term investments in the future well-being of the

population. Whereas in insurance-based systems, its often difficult to see how they are able

to invest, because people keep moving to different companies. And therefore the interest

in investing in long-term prevention and health is significantly less. So in the US context,

I think the main thing we need to get is major employers involved. We need to get the

government involved because the government at the end will have the responsibility when

uninsured individuals develop the complications of diabetes. And large employers will often

carry the responsibility of their workforce for an extended period of time.


Insulin had a bad

connotation. But

clinical studies have

shown that diabetes

needs to be treatedas aggressively and

as early as possible,

to reach near-normal

glycemic levels.

In my country, where

we have a public

health system, we

view prevention and

early intervention as

investments long-

term investments in the

future well-being of the

population. Whereas

in insurance-based

systems, its often

difficult to see howthey are able to invest,

because people keep

moving to different

companies.


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Kelly: Maybe you could talk a little bit about your mission to defeat diabetes and what that

means to you and what you think it means to your employees.

Mr. Sorenson:Well, it comes from a simple recognition, and that is if we align ourselves

with the interests of people with diabetes, theyre interested in getting rid of that disease. If

I could just brush aside that wish by saying its not technically or scientifically feasible, then

we could go on selling our products. But I cant do that. We know there is scientific progress

that seems to indicate there might be something we can do stem cells and other therapies

And therefore we also have to engage in this and do our part, and as I tell my employees,

its better that we eradicate diabetes than somebody else. And well find another business as

part of the process. Or if nothing else, we just made the final commitment to the disease. So

if it can be done, it will be done.

Kelly: In light of that, what keeps you up at night? What do you worry about the most in

terms of your business?

Mr. Sorensen:Well, I just spoke to a lot of our employees today [about this]. And one of

the things I worry the most about is the quality of our products. We service about 15 million

people with their daily needs of insulin, and if we dont make the proper quality and havethe proper controls of our product, somebody is going to get hurt, and thats the worst thing

that could happen. We know there are risks involved in drug research, and thats a publicly

understood risk. Its a risk that people that enter into these clinical trials understand, and

they commit to that risk because they want to further research. So there are problems, of

course. We try to avoid it but thats an inevitable risk we run. But not being able to supply

adequate quantities of a high-quality product could affect millions of peoples lives.

Thats the worse fear I have.

Jim: Regarding your products, can the insulins get better than where we are now, or is it

now just a matter of finding smarter ways of dosing?

Mr. Sorensen: That is the most exciting thing. Right now we are working on developing

yet another generation of insulins. So Levemir, when you look at it, is fantastic basal

insulin, but it still has a duration of action which is slightly less than 24 hours. It has

the benefit that youre not gaining as much weight as the traditional NPH or long-acting

insulin. When we look at our research portfolio, we have in early research and clinical trials

new and further improved basal insulins, which might even be formulated as premixes.

This may not be available for another five years, but its very, very encouraging research

that were seeing at the moment.

Kelly: This would be even beyond the rapid-acting analogs like Novolog and Humalog, like

a super analog or something like that?

Mr. Sorensen:Yes. Whether we can improve it even further from that, I dont know at

this point, but this will give significant benefit to those that use our products. Im quite

certain about that.

Kelly: Theres been a lot of coverage in the media about obesity as the driving force behind

diabetes. What do you think can be done about that?

Talking with the chief

medical officer of Novo

Nordisk, Dr. Alan Moses

Q:For some very poor people

in the US and around the

world, insulin is too expensive

to purchase. Do you believe

that an insulin company has aresponsibility to provide insulin

for free to any diabetic who

cannot afford it?

A: Access to health is something

Novo Nordisk has worked actively

to address for a number of years.

Among other things, we

helped found the independent

non-profit organization, the

World Diabetes Foundation

(WDF), in 2001 with a grant

of 500 million Danish crowns

(about 67 million euros or 90

million dollars) to be spent over

10 years. The WDF works to

build capacity, infrastructures

and access to diabetes care in

the poorest parts of the world.

To date the WDF has started 57

ongoing projects in more than

65 countries with an estimated

direct impact on 24 million

people in the developing world.

Novo Nordisk also offers

human insulin to the public health

systems in the 50 least developed

countries (LCDs), as defined by

the UN, at prices not to exceed

20% of the average price in NorthAmerica, Europe and Japan. In

2005, Novo Nordisk offered this

pricing policy to all 50 countries

and sold human insulin in a total

of 32 countries at or below this

price.

Compared to many other

drugs, insulin is already a low

cost medication that most

health care systems can afford.

However, lowering costs of

medicine or giving away free

products are not the sustainable

answer to a long-term problem.Indeed, in some countries it is

not the cost of the insulin but the

distribution systems within the

country that prevent access for

patients in need of this life-saving

treatment. We need initiatives

that address the root cause of

the problem of limited access

to health care providers and

medications.


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Mr. Sorensen: I dont believe that obesity prevention and treatment is a medical

problem, in general. Its a social and cultural and societal problem that we need to deal

with from a different perspective. But when we then see that there are groups of individuals

having had unsuccessful attempts to diet or exercise or at counseling then we start to talk

about medical intervention. And in that case, I think that perhaps GLP-1s might play a

significant role in the future because we know the GLP-1 product actually reduces weight.

But treating people who are just slightly overweight is absolutely not something that we

want to do.

Continue reading online about developing countries, the pharmaceutical industrys

reputation, and inhaled insulin online at http://www.diaTribe.us/issues/4/diabetes-

dialogue.php.

profile

The Durable Diabetic: Gladys Dull Relies OnThe Basics To Make Medical History

By James S. HirschShe was three years old when both her parents died from the Great Influenza. Her four

siblings scattered to live with relatives, but she was taken in by neighbors in Granville,

North Dakota. She grew up on a wheat farm, which fell on hard times during the Great

Depression. The Dust Bowl finally drove the family off the land.

Gladys Dull ended up in Walla Walla, Washington, and now at 90 years old, she is an

American survivor but not just for the hardships endured by so many of her generation.

In November of 1924, at age seven, Gladys became deathly ill and was diagnosed with

diabetes. Her doctor didnt know how to treat it, other than to instruct the girl to eat meat.

(Carbohydrates would further raise her blood sugar.) Insulin had been discovered two

years earlier, but very few clinics had the drug and certainly none on the wind-swept plains

of North Dakota. Her parents scraped up the money for a train to Rochester, Minnesota,

where they took their adopted daughter to the Mayo Clinic.

There, Gladys received her first insulin shot. Since then, shes taken 60,000 more and

has been on insulin therapy for 83 years longer than any person in history.

Ive never missed a shot in all those years, she says. Not one shot.2

Gladys Dulls longevity is partly attributed to genetics, which can play a role in

protecting against diabetic complications. Dull has virtually none, so her genes have clearly

served her well. But other long-time patients have taken full advantage of the new tools

and technology in diabetes care, giving them maximum opportunities to reduce their

health risks and extend their twilight years. Oddly enough, Gladys has avoided therapeutic

advancements for most of her life. She began using disposable syringes only five years ago

she was still using glass syringes with replaceable steel needles and she began home-

glucose monitoring only five years ago as well. (She was still testing her urine.)

So for 78 years, Dull had little idea what her actual blood sugar was and, truth be told,

she would just as soon go back to the urine tests. I liked that more, she says. The finger

sticks dont feel so good, and you cant get the blood out.

Her durability is a tribute to her rigorous self-discipline, a commitment to an old-

fashioned ethic that is easily lost in the high-tech age of downloadable glucose meters,

synthetic analogs, and continuous sensors. Whats her secret? A strict diet, regular

injections, and a healthy lifestyle.


T1/2

Gladys Dull

2 All quotes from Gladys Dull came from an interview with Dr. Irl Hirsch; the interview was filmed by her son, Norman, and

sponsored in part by the Animas Corporation.

She has been on insulin

therapy for 83 years

longer than any person

in history.


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The result has been a full and rich life. Growing up, she farmed wheat and rode horses,

motorcycles, and snowmobiles; later she held a full-time job at a photo studio and helped

found a humane society in Walla Walla. In 1943, she married George Dull (he would

work in construction after the war), and four years later Gladys delivered their only child,

Norman. The doctor said I would never have any children, but I showed him, she says.

And she remained physically active, tending to a family cottage in the Blue Mountains.

Hiking and camping that was her greatest love, Norm says.

Dull is part of dwindling cadre of insulin pioneers who were among the first to use the

drug in the years following its discovery in 1922. There are only five patients in the US who

have been taking insulin for at least 75 years, according to Eli Lilly, which manufactured

the product after its discovery. Lilly only found out about its most loyal customer last year

after Dulls principal caretaker contacted the company. Lilly confirmed her medical history

by investigating the records at the Mayo Clinic; she then received a Lilly for Life Award for

75 years on insulin. Never mind that she passed that milestone the previous decade. The

award doesnt go high enough, Norm says.

That she survived her childhood is itself a miracle. Had she developed diabetes even

one year earlier, the Mayo Clinic may not have had the insulin to save her. When she was 9

years old, she had her appendix removed, after which she went into a coma. Few diabetics

survived surgery in that era. They took me back to Rochester, Dull says. I think I wasin a coma for a couple of days. I still remember my good old doctor, Russell M. Wilder.

He picked me up and kissed me after I came out of that coma. Ill always remember that, I

guess.

Her mother played a large role in helping Gladys adjust. By todays standards, for

example, the early needles were large and painful, but they do not inspire bad memories

for Dull. A 7-year-old doesnt like shots, she says, but my mother wouldnt let me have

one bite to eat unless she gave me that shot. And I got on to it . . . It didnt hurt that bad, I

guess.

From the outset, Mayos clinicians emphasized a strict low-carb diet. Wax figures of food

demonstrated portion size. Scales were used at every meal. Thick books gave calorie counts

I followed the whole deal, Dull says. But Ive done it for so long, I dont weigh anymore. Idont even have the scales. But I can look at something and know how many grams.

While she likes ice cream I will cheat every once in awhile she rarely strays from

her diet, nor does she drink alcohol or smoke. As Norm says, In 1993, for her fiftieth

anniversary, I saw her eat one piece of cake, and I just about fell to the floor.

Most striking is how rigid Dulls care has been over the years. As a girl, her mother

would test her urine by mixing it with Benedicts solution, bringing it to a boil, and

observing the color. Youre supposed to stay blue, but if its a brick color, youre loaded

with sugar, Gladys says.

But the family couldnt adjust her insulin without consulting the doctors at the Mayo

Clinic, and even as an adult, Dull says she never really changed her regimen two shots a

day, same insulin doses.

By the time she was in her eighties, she began experiencing more hypoglycemia, but

she was reluctant to adjust. Then five years ago, her husband died, and three days later,

she suffered a stroke. Things had to change. When a doctor asked Norm what her mothers

blood sugar was, he said, Grayish-brick.

He couldnt understand what I was talking about, Norm says. He couldnt believe that

she had never taken a blood test.

The home glucose monitoring has helped stabilize Gladyss blood sugars; the glass

syringes were also discarded. She continues to live by herself, in the house that she and

George had shared for most of their married lives. And she remains fiercely independent.


Gladys as a child

The doctor said I would

never have any children,

but I showed him.


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She does her own laundry, occasionally gardens, and does not use a cane. Her walker stays

in the bedroom. She does acknowledge some limitations: with impaired vision from non-

diabetic causes, a caretaker comes twice a day to prepare her meals, give her injections, and

straighten up. Im not a very good house keeper anymore, she concedes.

Her black dog, a Schipperke named Coalie, is her protector.

Her four siblings have all passed away, so Norm, who runs a video production company

in a nearby town, takes her to dinner each Tuesday, and Gladys calls him each evening at 9

p.m., to tell him her blood sugar and confirm shes eaten her snack.

Says Norm: Its peanut butter and jelly sugarless and it holds her through the

night.

NewNowNext

An easier way to take Lantus

For those on or considering the basal insulin Lantus, a new

disposable pen is out. Approved by the FDA on April 30, this new option

for Lantus called the SoloStar will be made available across the US

this year. Lantus users now deliver with the refillable pen OptiClik or with the traditional

vial and syringe. We think its great to see this new pen, since the OptiClik has had various

delivery problems, and were waiting to see how patients like the SoloStar and whether its

covered by insurance. The pen is pre-filled with Lantus and can dose up to 80 units per

injection, which is more than any other disposable pen. According to Sanofi-Aventis, which

makes the pen, it requires less injection force, which may be good for those with limited

hand strength, though we cant verify yet that you can really tell the difference. A SoloStar

pre-filled with the rapid-acting insulin Apidra has already been approved in Europe; we

may see that in the US in the next few years.

Januvia + metformin = Janumet

Less is more with this new diabetes pill out from Merck. It combines two favoritesin one formulation one is metformin, a veteran of diabetes drugs, and the other is

Januvia, a promising rookie. If its appropriate for you to be on both these drugs, this new

combination pill means one co-pay and an easier routine. Metformin and Januvia, a DPP-4

inhibitor, target different areas of the body: metformin decreases glucose production by

the liver and Januvia increases insulin secretion by the pancreas, both acting in different

ways against hyperglycemia. Weve heard from doctors that the drugs work better together.

The pill is taken twice a day, rather than Januvias once a day, though metformin is also

once or twice a day. Doctors may prefer you start with metformin, as they may want to

determine your optimal dose of that drug first (metformin dosing differs person to person),

and insurance may not cover starting directly on the combination. Insurers may change, as

more health care professionals are calling for earlier and more aggressive therapy.

Lights, camera, cure: Health fairs spread across America

Jenna Scarsi, a diabetes educator from the Chicago area with type 1 diabetes,

recently won the Bayer Dream Fund, an annual $100,000 fellowship to help people

accomplish something that might not have been possible unless they were in control of

their diabetes. The fund is helping Jenna expand a program she created a few years ago

called Lights, Camera, Cure. What was an annual, mostly local event can now be bimonthly

and in various cities across the US. Scarsis events are geared toward kids and consist of

small diabetes health fairs followed by family movies, for which the events are themed.



T1/2

T2

T1/2

The SoloStar for Lantus

The combination pill, Janumet


17/20

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For example, the next event, in Philadelphia in June, will show Surfs Up, a mockumentary

slated for release this summer about surfing penguins, so activities at the event will include

a hula-hoop contest and other island-inspired adventures. Two aspects we love differentiate

Scarsis events. The people providing information at each of the fairs stations (what is

diabetes, pumping, exercise, BG monitoring, and so on) are not educators or doctors, but

youth advocates, or young people ages five to 21 with diabetes. Also, the money raised

stays in the city in which it was raised a hospitals diabetes unit, a diabetes center, or

anything that does something positive for the diabetes community in that city, says

Scarsi. Scarsi says she created the program because its one thing to know what we have

to do to intensively manage our diabetes, and its another thing to do it on a daily basis.

Upcoming events will also be in Philadelphia in June, Portland (with a Grease sing-along),

Nashville (likely with an IMAX showing of Polar Express), and San Antonio. Details can

be found at www.lightscameracure.com, and if youre interested in applying for your

own Dream Fund, applications are now being accepted at www.bayerdreamfund.com/

tellusurdrea_form.php.

A no-coding meter out from FreeStyle

In April, the FDA approved the FreeStyle Lite meter, which requires no coding.

Its similar to the very small FreeStyle Flash, though apparently wont be replacing itat this stage. Only Bayer meters had no-coding (or auto-calibration) before now. The

Freestyle Lite is supposed to be simple and easy-to-use, two descriptors we love to hear for

devices. Jane Seley, a member of our advisory board and a noted educator from New York

Presbyterian Hospital, praised the meter for its killer combination of no-coding, smallest

blood drop size, and an excellent backlight, which she thought really does make a difference

in speed and convenience.

FingerSticks

17

T1/2

The FreeStyle Lite

Winner of the Dream Fund,

Jenna Scarsi


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conference pearls

The American Association of Clinical Endocrinologists (AACE) 16th Annual

Meeting & Clinical Congress took place in early April in Seattle. The main

themes, we found, were the lowering of glycemic targets (like A1c) and the

growing recognition of the harmful effects of glycemic variability (when blood glucose

fluctuates). Better, tighter glycemic control is always a theme at this meeting. This year,

the focus was on postprandial glucose management and the greater use of combination

therapy to push A1c values below 6.5 percent. The American College of Endocrinology

(ACE) and AACE will soon publish a joint roadmap for the prevention and care of

diabetes. We were able to get a preview: Compared to the ADAs guidelines, it will

emphasize a lower A1c target as well as the need for patients to receive different treatments

depending on their A1c level.

Fasting and postprandial glucose make different contributions to overall

hyperglycemia. We note that this is based on the work of Dr. Louis Monnier, who

published an important paper in 2003 that showed that post-meal glucose spikes are a

bigger contributor to overall hyperglycemia for patients at lower A1c, while high fastingglucose is a bigger contributor for patients at higher A1c. For example, for patients with A1c

10.3 percent. For patients with A1c between 7.4 percent and 10.3 percent,

postprandial and fasting glucose make equal contributions to overall hyperglycemia.

Combination therapy is needed to treat both fasting and postprandial

glucose. The logic, then, is that in order for patients to achieve lower A1c targets, they

need a combination of treatments that target both fasting and postprandial plasma glucose

levels. Examples of drugs that focus on fasting plasma glucose are: basal insulin (Lantus

and Levemir), metformin (generic), and sulfonylureas (generic). Examples of drugs that

focus on postprandial plasma glucose are: rapid-acting insulin analogs (Novalog, Humalog,

and Apidra), pramlintide (Symlin), exenatide (Byetta), DPP-4 inhibitors (Januvia), and

thiazolidinediones (Actos and Avandia). ACE/AACE recommends that diabetic patients

achieve fasting plasma glucose


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of complications in people with early type 2 diabetes. The trial results will likely be unveiled

in 2010. Speakers at AACE also advocated earlier use of meal-time as well as basal insulin

this again echoes Dr. Monniers work, which showed that controlling mealtime glucose

excursions is crucial for people at lower A1cs.

Lots of focus on driving down A1c targets some well-known

endocrinologists recommended A1c


20/20


Importantly, all of these patients had been diagnosed with type 1 diabetes within six

weeks of their enrollment in this trial. There is some research that suggests that even

people who have had type 1 diabetes for decades are still producing some beta cells, but the

underlying autoimmune condition that is responsible for type 1 destroys these new cells as

soon as they are created, perpetuating the disease. In Dr. Voltarellis trial, the idea was that

if the autoimmune condition can be removed early in the course of disease, the remaining

beta cells can be rescued and recovered, thus reversing the disease. Presumably this would

be much less helpful in people with longstanding type 1 diabetes, who have few if any beta

cells left and thus would not benefit from having the autoimmune condition removed.

The mechanism for how AHSCT restores beta-cell function is unknown. In an

accompanying editorial to the Voltarelli paper, noted Miami endocrinologist Dr. Jay Skyler

points out that while the goal of AHSCT is to eliminate autoimmune white cells and replace

them with new, healthy white blood cells, this may not be the whole story. The process of

AHSCT itself may somehow reset the immune system to be more tolerant of the bodys

own beta cells. Alternatively, the re-infused HSCs may themselves be somehow growing

into beta cells, or perhaps the treatment process mobilizes stem cells in the pancreas or

bone marrow to become beta cells this is a somewhat more controversial idea, but we

simply dont know enough about this exciting new technique to determine what exactly is

happening.Dr. Skyler identifies a few future directions of research. Ideally, doctors and scientists

will want to see Dr. Voltarellis results replicated in a large, randomized controlled trial

with a longer follow-up period to see if patients really do remain insulin independent in

the long term. Having a randomized control group is particularly important because newly

diagnosed type 1 patients often have a honeymoon period during which they can stay

relatively insulin independent, and it will be important to distinguish between the effects of

the honeymoon period and the effects of the AHSCT procedure. Having a longer trial will

also help because the honeymoon period doesnt last very long, whereas we would hope

that a cure for type 1 diabetes does. Finally, Dr. Skyler would like to see biological studies

carried out to discover exactly how AHSCT works whether it eliminates autoimmune cells

or helps beta cells regenerate or acts through a different mechanism altogether. We agree,and we cant wait to see more work done in this field!

Bottom line: There was a lot of hype in the press about a stem cell cure for diabetes

in April. The study was exciting, though small and short, and it is important that more be

done before we know whether this is meaningful. No embryonic stem cells were used, and

no immunosuppression was required. Cells from a patients bone marrow were extracted,

the patient underwent a sort of radiation therapy, and these cells were reintroduced.

Indeed, most of the subjects of this small 15-person group did go off insulin, at least for a

time.

Voltarelli JC, Couri CEB, Stracieri ABPL, Oliveira MC, Moraes DA, Pieroni F,

Coutinho M, Malmegrim KCR, Foss-Freitas MC, Simoes BP, Foss MC, Squiers E, Burt

RK. Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly

Diagnosed Type 1 Diabetes Mellitus. JAMA 11 April 2007. 297(14):1568-76. Skyler

JS. Cellular Therapy for Type 1 Diabetes: Has the Time Come? JAMA 11 April 2007.

297(14):1599-1600.

diaTribe publishes information about diabetes products and research This information is not a substitute for medical advice and should not be used to

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Insulin Pumpers:Support and Information

for Adults and Children

with Diabetes

www.insulin-pumpers.org

diaTribe: A great forumfor those on a pump or

considering one!

CHEATING DESTINYby James S. Hirsch

The book that people whocare about diabetes have beenwaiting for.

The Washington Post

diatribe - research and product news for people with diabetes - issue #4

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