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Merck Buys SmartCells, Inc, Bringing SmartInsulin into the Lime Light!

This morning's announcement of Merck Pharmaceutical's acquisition of SmartCells made my day!  SmartCells, Inc, CEO Dr. Todd Zion started at MIT in chemical engineering.  Talking to his cousin who had type 1 diabetes, at a family gathering Dr. Zion realized the daily struggle of multiple injections and the frustration of having an external device that patients have to deal with. From that single conversation, Dr. Zion's engineering imagination went into warp drive, creating a product called SmartInsulin

 

What Dr. Zion believed he could do was develop a biodegradable polymer that would hold insulin.  The polymer would sense whether to withhold insulin or secrete insulin based on the blood glucose level, thus reducing daily injections to once a day!  In other words, it has the potential to regulate your blood sugar so to avoid hypoglycemia, which can often be a death sentence to diabetes patients.

 

When Dr. Zion introduced this idea a few years ago, patients were excited by the concept!  Insulin has had many reiterations, but few breath taking reinventions.  The idea was so inspired that Dr. Zion won a $50,000 award giving him the seed money to begin the process of breathing life into this invention.  JDRF stepped up to the plate with a 1million dollar grant furthering his work.

 

The SmartInsulin technology works like this.  SmartInsulin uses modified insulin attached to a biodegradable polymer containing sticky sugar groups.  They mix it in a solution with a sugar-binding molecule and, in the absence of any other sugars, immediately binds to the sugar groups attached to the insulin.  As more sugar binding molecules grab on to the modified insulin, a network forms to hold the insulin in place. When glucose is added to the system, it pushes the insulin bound sticky sugar groups out of the way releasing the insulin into the body. The more glucose that is present, the more insulin is shed from the dissolving sticky sugar network or polymer.

 

About a month ago, I heard that Dr. Zion had secured approval for a small phase 1 human clinical trial to begin in February in Belgium.  While clinical and regulatory goals will have to be met and the trials will need to embrace larger numbers of patients, this experimental insulin holds hope and promise for all of us!

 

Today it was announced that Merck paid SmartCells, Inc, $500 million dollars for the rights to SmartInsulin giving this novel therapy a boost for getting into the marketplace.  Perhaps, some people will feel that's outrageous.  But the fact is that for new drug development, the average cost from petri dish to marketplace runs 1.4 billion dollars! Five hundred million dollars sounds about half way there, and, if you think about it, that is about where SmartCells is in the process of getting SmartInsulin into our hands!

 

To Dr. Zion, I send my congratulations and look forward to your visit to DC in January for our JDRF Research Summit, which is open to the public.

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With 1 Click, You Can Give A Child In Need Diabetes Supplies And Insulin

Life with diabetes is never easy and for children with diabetes, it’s a different set of rules that you learn to live by. From birth, children thrive and grow on routine and consistency, but children with diabetes are dependent on the routine of insulin.  Children in poverty face obstacles we often can’t imagine, but one obstacle that all of us living with diabetes can grasp is the consequences faced from lack of insulin. 

 

November 14th celebrates the discovery of insulin. Ironically, it took nearly 20 years after the discovery of insulin to ensure everyone living with diabetes had access to this lifesaving medication. Nothing could be more frustrating then knowing a life saving treatment is available, but financially out of reach! 

 

This year lets make insulin available to those most in need by joining the Big Blue Test on TuDiabetes.  By clicking this link and watching the video, Roche will make a donation of diabetes supplies to children in need.

 

In the spring of 2010, Roche decided to join forces with Diabetes Hand Foundation to help underwrite the Big Blue Test in an effort to reach two vital goals.  Help people understand what moderate exercise can do to improve diabetes management and funding vital programs that benefit children with diabetes in some of the poorest countries in the world! 

 

For every view this video receives between now and Nov 14th Roche will make a donation to Diabetes Hand Foundation. In turn, DHF will donate all the funds to Life of a Child program and Insulin for Life.  These two humanitarian assistance programs are solely focused on diabetes issues faced by the world’s poorest children. 

 

If we, the diabetes online community, can reach 100,000 views, Roche will donate $75,000. A simple click is the difference between life and death! For the next week, have coworkers, friends and family click and give life saving insulin to child in need!  < http://www.youtube.com/watch?v=nkLHgK94Z0E >

 

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Speaking Up for Yourself - You Know Your Body the Best

 

(I also write over at HealthCentral's Diabeteens.com! Also, check out my work as a cognitive-based Health & Chronic Illness Coaching Specialist.)

 

When it comes to managing Type 1 diabetes, there are things you know about your body better than anyone else. Even if your blood sugars aren’t as “great” as you’d like them to be, even if your A1C is higher than you’d like it to be, even if your diet isn't as healthy as you’d like it to be. In the end, there are still things YOU know about your body that no doctor or parent or friend can know better than you.

 

I’ve experienced two circumstances in which I felt like I would be in a dangerous situation if I didn’t speak up and argue with doctors about insulin and dosing. The first experience was during my hospital stay in 2003. I had spent all evening stringing Christmas lights for the movie theater I worked at, but I was outside in the freezing New Hampshire cold and the temperature killed the insulin potency in my insulin pump. I didn’t realize until the next morning when I woke up in severe DKA, puked at least a dozen times throughout the morning until I got to the hospital.

 

During my hospital stay, stringed with IVs pumping saline through my veins, two med-students stood before me and said they would give me 10 units per hour of rapid-acting insulin to bring

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FDA Listens to Expert Panel On Artificial Pancreas For Possible Field Test

Last Wednesday, the FDA listened experts outline possible next step for the development of the Artificial Pancreas. So far the Artificial Pancreas has demonstrated that the technology does improve blood glucose control in a hospital or clinical setting.  But clinical settings are not real life and the obvious next step for the artificial pancreas to be tested in our daily lives away from hospitals and clinics!

 

To date, there are a couple of artificial pancreas devices in trial.  Medtronic has their version in clinical trial and they also have a low glucose suspend pump called the VEO and JDRF has partnered with Animas and Dexcom to create an artificial pancreas device.  The VEO is on the market in Europe and Canada, but not here. 

 

Diabetes experts in the field of the Artificial Pancreas met with the FDA and NIH to provide the clinical information and recommendations for the next steps in the development of the artificial pancreas.  Clinicians, researchers and industry leaders agreed that outpatient studies for both low-glucose suspend and artificial pancreas systems are the next step!

 

In addition to clinical experts, JDRF assembled a panel of patients to give advice on how to transition from inpatient to outpatient settings.  The patient panel offered transitional steps before moving to outpatient setting:

Patients need to demonstrate the ability to operate the system

Be responsible for calibration without intervention from medical personnel.

 

Here’s the link to JDRF clinical recommendations

 

For many pump systems are great advancement in

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Type 1 Diabetes and Dead in Bed Syndrome

This week has been a difficult week for the diabetes community, when it was revealed that young girl of 13 never woke up.  There have been 4 deaths of type 1 teens recently reported and many of us remember Cynthia Kahn who passed away earlier this year.  We have lost some great people simply “while they were sleeping”, which is commonly referred to as “dead in bed syndrome”.  It is always alarming, and probably more disappointing that we don’t have an answer for how someone, in otherwise good health, could go to bed and never wake up.   

 

Statistics show that per 100,000, 20-60 people with type 1 diabetes under the age of 40 will suffer dead in bed syndrome.  The reason is not clear because autopsies cannot reveal hypoglycemia, but it is thought that a low blood sugar occurs and followed by sudden death caused by cardiac arrhythmia. 

 

An arrhythmia is a disturbance of the heart rhythm, sometimes it is detectable with a stethoscope and sometimes, especially in the young, it is not detectable until it is to late. Every year there seems a story about a robust high school athlete who dropped dead with no apparent heart health history. These are the stories of missed heart arrhythmia.

 

For the diabetes community, this is a great reason to challenge the FDA to approve the integration of pump and continuous glucose monitor (CGM) technology that stops the flow of insulin when a low is detected. The technology is out there, Canada just approved the Veo, which has been available in Europe for over a year.  And all of this validates the need for the Artificial Pancreas!

 

Another concern should be the lack of research on this phenomenon involving a heart arrhythmia.  Is there a link between type 1 diabetes, low blood sugar and increased risk for arrhythmia? 

 

The best we can do is arm ourselves with the information and watch the basal rate at night to make sure we are not running low.  For families with teens, I think it best to watch for nighttime lows and investing in a cgm is not a bad idea. Awareness and action could make the difference!

 

Here is a list of sites that offer valuable information about heart arrhythmia and some info on “Dead in Bed Syndrome":

 

The Heart Rhythm Society- an international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and primary resource on heart rhythm disorders. (I have linked it to the patient page, but the information is deep on this site.  For those with familial heart health issues check out the difference between Electro Physiologist and cardiologist to make sure you are getting the proper tests.  EPs are the doctors who specialize in heart arrhythmia!) 

 

Children with Diabetes - older information about Dead in Bed Syndrome (dated 2001), but still interesting read!

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The Buzz About Kimchi

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