DiaTribe - Research and Product News for People With Diabetes - Issue #4
Transcript of 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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5continued on page 6
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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6continued on page 7
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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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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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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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
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
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
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.
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11continued on page 12
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.
12continued on page 13
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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13continued on page 14
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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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
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.
14continued on page 15
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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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
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.
15continued on page 16
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.
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
16continued on page 17
T1/2
T2
T1/2
The SoloStar for Lantus
The combination pill, Janumet
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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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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
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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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
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
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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
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.
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CHEATING DESTINYby James S. Hirsch
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