Diabetes News: Microworms That Monitor Blood Sugar; New Approach to Bariatric Surgery; Stem Cells to Cure Diabetes

It is now recognized that it is the low- and middle-income countries that face the greatest burden of diabetes. However, many governments and public health planners still remain largely unaware of the current magnitude, or, more importantly, the future potential for increases in diabetes and its serious complications in their own countries.

However, seeing the business potential of investing in diabetes research, pharmaceutical companies are now feverishly developing new drugs and technologies to cater to a booming market. Companies are now moving beyond just drug research and are pushing the frontiers of science from nanoworms that monitor blood sugar to a permanent cure for diabetes using stem cells.

In today’s post I’m highlighting three exciting developments which, if successful, spell new hope for diabetics.

Glowing Microworms to Monitor Blood Sugar

Tiny, glowing 'microworms' implanted under the skin could be used to give blood sugar readings for diabetics, or other biomedical information, say researchers at MIT and Northeastern.

Their tube-shaped microparticles, unlike existing spherical versions, won't be swept away from the initial site over time, they say. The tubes’ narrow width keeps their contents close to blood or body tissue, while their length keeps them anchored for months on end.

The nanoparticles are created by using chemical vapor deposition (CVD) to coat an aluminum oxide layer that's been etched to contain tiny pores. Then, the coated material is dissolved away, leaving a series of hollow tubes where the pores used to be.

Before that, though, another material can be added that fluoresces in the presence of a specific chemical such as glucose. This means that when the 'microworms' are injected under the skin, they form a glowing tattoo that could be used to monitor diabetic patients.

"Tight control over glucose levels can help individuals stave off the devastating side-effects of diabetes - the number-one cause of kidney failure, blindness in adults, nervous system damage, and amputations," says MIT chemical engineering professor Karen Gleason.

"In principle, this could open the way for avoiding blood tests, which need a central lab, expert nurses, extra time and extra costs. It could be done in a doctor's office, or even at home," says Professor Raoul Kopelman of the University of Michigan. "It will also avoid complications for patients with 'difficult', or 'used-up' veins, patients on blood thinners, etc."

However, he warns that there could be concerns about long-term toxicity and bio-elimination, as well as complications such as blood clots.

Minimally Invasive Approach to Bariatric Surgery

There are scores of startups offering different approaches to obesity and diabetes eager to address the $174 billion in costs related to diabetes each year.

Now, MetaModix, a Minnesota medical device company, is moving ahead with plans to develop a minimally invasive approach to bariatric surgery and better solve the problem of type 2 diabetes.

The company is “developing a cost-effective minimally invasive therapy for type 2 diabetes” that mimics “certain elements of bariatric surgery through an endoscopic procedure.”

The process would be an out-patient procedure that would last about 30 minutes, according to Kedar Belhe, the company’s chief executive officer.

Bariatric surgery often eliminates a patient’s type 2 diabetes. However, there are concerns over the procedure itself: from post-operative side effects to the long-term impact of the surgery.

Meanwhile, the U.S. Food and Drug Administration just broadened the use of Allergan’s Lap-Band device to include more patients, for example, and other approaches range from stomach stapling, embedding sensors or inserting sleeves in the body.

Stem Cell Research Seeks Permanent Cure for Diabetes

In India, which has about 50.8 million people suffering from diabetes, another start-up, Stempeutics Research, is investing in stem cell research in the hope of discovering a permanent cure for diabetes.

Stempeutics Research has received clearance from the Drug Controller General of India (DCGI) for its investigational medicinal product Stempeucel for conducting phase II clinical trials on patients with diabetes.

“Stem cell therapy aims at addressing the root cause of the disease rather than the symptoms. Our goal is to bring out stem cell based drug in the near future. We will hit the market with our first product by end of 2011.

While the initial foray of Stempeutics is in bone marrow derived mesenchymal stem cells, Stempeutics is investing heavily on its R&D to bring out some innovative products in the near future based on adult stem cells.

There will be continuous research for each disease so as to improve product development for effective therapy. Research will be conducted on effective cell number, route of transplantation,” Stempeutics Research president BN Manohar President said.

According to the procedure, 10 patients will get one particular dosage of stempeucels, another 10 will get a higher dosage and the remaining 10 will get placebo (no drugs). “It will take at least 12 to 14 months to complete the study,” said Manohar.

Abbot’s Recall of 359 BS Million Test Strips Should Have Make Front Page

Came across this Letter to Editor in Chicago Tribune. The writer rightly wonders: “Why was that article (on Abbot recalling 359 million BS test strips) in the business section on page 29?” Indeed, most news (good, bad, ugly) relating to the Pharma industry is routinely relegated to the business pages just because the holy stock price is more important that life-and-death issues. Community members must write to Editors to register their protest and educate them in basic journalistic practices (“if it affects a large number of people, it must be news”).

Having had Type 2 diabetes for the past 25 years I was pleased to find your article in the Tribune regarding the recall of certain test strips (Dec 23). I e-mailed the address listed and I found that the strips from Abbot Labs were listed in the recall. Before the article I could not figure out why my blood sugar readings lower than normal. As I said, I e-mailed them and they verified that those strips were defective. I was sent new strips to replace the bad ones. They also sent a new meter.

Why was that article in the business section on page 29? I am sure that I wasn’t the only person affected by those defective strips. Diabetes is a serious disease and cause death, especially for people who have Type 1. I presume the article was there because Abbott‘s stock went down a few dollars the day before, but who cares when your life is at stake? I believe it should have been in section 1 listed as a health recall alert. Thank you for alerting me to the situation anyway.
Harry Clinkunbroomer, Northbrook

US Drugmaker Abbot Labs Recalls 359m Blood Sugar Testing Strips

US drug maker Abbott Laboratories on Wednesday announced a recall of up to 359 million diabetes testing strips due to safety hazards.

The recall was initiated because the strips used by diabetics could give false low readings, the company said in a statement.

Abbott uncovered the problem after a routine internal review found that certain lots of the strips took too long to absorb the blood from a patient's finger, which could lead to inaccurate low readings of their blood sugar levels, the statement said.

The affected products should not be used and would be replaced at no cost, said the statement.

Meanwhile, the Food and Drug Administration (FDA) issued a warning that inaccurately low measurements by the strips may lead patients to raise their blood sugar levels unnecessarily or fail to detect dangerously high blood sugar levels.

The recalled strips were made between January and May and sold both to consumers and healthcare facilities, the FDA said.

"FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future," said Alberto Gutierrez, head of FDA's Office of In Vitro Diagnostics.

The lots of affected products were only distributed in the U.S. and Puerto Rico, according to Greg Miley, director of public affairs for Abbott Diabetes Care.

The products were marketed under a half-dozen brand names, including Precision Xceed Pro., Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima, the Abbott statement said.

Saxagliptin/Metformin Combo Pill Approved By FDA

The Food and Drug Administration (FDA) in the US has given approval for a combination pill featuring saxagliptin and extended-release (XR) metformin HCl to treat glycemic control in adults suffering from type 2 diabetes mellitus.


The combined pill, which is taken once a day, provides an alternative treatment for those nearly half of adult diabetes patients who are unable to control blood sugar levels . The approval was based on findings from two double-blind, 24-week, phase 3 clinical trials of saxagliptin and metformin immediate-release (IR), which were given as separate tablets, and compared with metformin IR alone.


Howard Hutchinson, chief medical officer at AstraZeneca, who developed the treatment, commented “Patients with type 2 diabetes in the United States can be taking four or five medications for various diseases and conditions, which can lead to complicated medication schedules. Kombiglyze XR combines two effective diabetes medications in a simple once-a-day dose for adult patients who need A1c reductions.”


The combination incorporates the complimentary mechanisms of saxagliptin, which is a dipeptidyl peptidase 4 inhibitor, with metformin, a biguanide . The therapy fights against the main defects in type 2 diabetes by increasing insulin secretion in a glucose-dependent manner, suppressing hepatic gluconeogenesis, and also helping insulin sensitivity.


As type 2 diabetes is a chronic, progressive disease with many factors involved in its development, patients often need more than one pill to treat the multiple defects associated with the disease.

How Long Does it Take to Lower Your A1C Levels?

Red blood cells and the hemoglobin they contain have an average life span of 120 days during which glucose molecules are exposed to the red blood cells and form glycated hemoglobin. Therefore, in theory, changes in your A1C levels won’t be apparent for at least the 120 days it takes for the affected red blood cells to complete a life cycle.

The amount of time it takes to lower your A1C depends on how big of a change you are trying to achieve. If your A1C is in the double digits, it may take a matter of 2 or 3 months to see a significant change if your diabetes management is consistent and tight. If your A1C is a point or two away from ADA/AACE recommendations, getting to goal may take a little longer.

“Lowering your HbA1c from a [high] number to an 8.0 or 7.5 is much easier than lowering it from a 7.5 to 6.5,” said dLife Expert CDE Claire Blum in response to a question about lowering A1C levels. “Tightening of control that occurs at the lower numbers takes a lot of fine tuning. Our bodies also require some time to adapt to the change of improved [levels].”

There are no special tricks to getting your A1C to a level more acceptable to you and your doctor. Lowering your A1C is doing just what your doctor has always told you was best for good diabetes management.

What Is Prediabetes? Is It A Serious Condition?

Recently, a friend wrote saying she was "mildly diabetic". I wrote back straight away saying: "There's nothing like being 'mildly diabetic'; you're probably prediabetic..."

Anyway, that set me off on a hunt to find a precise definition of "prediabetes". I got the most reasonable answer from Michael Dansinger, MD at WebMD. This is what he has to say: 

Many folks come to the diabetes community upon being diagnosed with "prediabetes". These people are usually concerned about progressing to type 2 diabetes and want to know how to delay or prevent such progression. The diagnosis of prediabetes also typically serves as a "wake-up call" to make healthier lifestyle choices.

Interestingly, the term "prediabetes" was recently discredited by the concensus panel of diabetes experts. The experts encouraged replacing "prediabetes" with the concept of "increased risk of diabetes" which is reflected by a continuum of risk ranging from A1c levels of around 5.8 to 6.5. The experts argued that not everyone in this range progresses to diabetes and it is more accurate to see it as a risk spectrum rather than as a category unto itself.

I personally favor the old system of calling it "prediabetes" rather than "increased diabetes risk". I just like the name better. It used to be called "borderline diabetes", but that name seems so outdated to me. In any case, I urge people to see this as a strong warning that diabetes is probably coming, and lifestyle changes are the main way to slow or stop the progression.

I, too, think "prediabetes" is a much more forceful term than "increased risk of diabetes" - the former rings alarm bells, as it should, while the latter seems like a problem that can be taken care of later after more pressing issues like planning a vacation or buying a new computer are taken care of. Bad idea.

Remember, prediabetes (technically "impaired glucose tolerance") is a health condition with no symptoms. It is almost always present before a person develops the more serious type 2 diabetes. Million of people over age 20 have prediabetes with blood sugar levels that are higher than normal, but are not high enough to be classified as diabetes.

More and more, doctors are recognizing the importance of diagnosing prediabetes as treatment of the condition may prevent more serious health problems. For example, early diagnosis and treatment of prediabetes may prevent type 2 diabetes as well as associated complications such as heart and blood vessel disease and eye and kidney disease. Doctors now know that the health complications associated with type 2 diabetes often occur before the medical diagnosis of diabetes is made.

 

Who's at Risk for Developing Type 2 Diabetes?

Those at risk for type 2 diabetes include:

• People with a family history of type 2 diabetes.
• Women who had gestational diabetes or have had a baby weighing more than 9 pounds.
• Women who have polycystic ovary syndrome (PCOS).
• African Americans, Native Americans, Latinos, and Pacific Islanders, minority groups that are disproportionately affected by diabetes.
• People who are overweight or obese, especially around the abdomen (belly fat).
• People with high cholesterol, high triglycerides, low good 'HDL' cholesterol, and a high bad 'LDL' cholesterol.
• People who are inactive.
• Older people. As people age they are less able to process sugar appropriately and therefore have a greater risk of developing type 2 diabetes.

 

What Are the Symptoms of Prediabetes?

Although most people with prediabetes have no symptoms at all, symptoms of diabetes may include unusual thirst, a frequent need to urinate, blurred vision, or extreme fatigue.

A medical lab test may show some signs that suggest prediabetes may be present.

 

Who Should Be Tested for Prediabetes?

You should be tested for prediabetes if:

• You're over 45 years of age.
• You have any risk factors for diabetes.
• You're overweight with a BMI (body mass index) over 25.
• You belong to a high risk ethnic group.
• You were known to previously have an abnormal glucose tolerance test (see below) or have an impaired fasting glucose level (see below).
• You have a history of gestational diabetes or delivering a baby that weighed more than 9 pounds.
• You have clusters of problems seen in the metabolic syndrome. These problems include high cholesterol and triglycerides, high LDL cholesterol and low HDL cholesterol, central obesity, hypertension, and insulin resistance.
• You have polycystic ovary syndrome.

 

How Is Prediabetes Diagnosed?

To determine if you have prediabetes, your doctor can perform two different blood tests – the fasting plasma glucose (FPG) test and the oral glucose tolerance test (OGTT).

During the FPG blood test your blood sugar level is measured after an 8 hour fast. This laboratory health screening can determine if your body metabolizes glucose correctly. If your blood sugar level is abnormal after the fasting plasma glucose (FPG) test, you could have what's called "impaired fasting glucose," which suggests prediabetes.

 

Understanding the FPG Test Results

Condition	FPG
Normal	Less than 100 mg/dL (milligrams per deciliter)
Prediabetes	100 mg/dL - 125 mg/dL
Diabetes	Greater than 126 mg/dL on two or more tests

The other laboratory health screening test your doctor can perform is the oral glucose tolerance test (OGTT). During this test, your blood sugar is measured after a fast and then again 2 hours after drinking a beverage containing a large amount of glucose. Two hours after the glucose beverage, if your glucose is higher than normal, you have what's called "impaired glucose tolerance," which suggests prediabetes.

 

Understanding the OGTT Test Results

Condition	OGTT
Normal	Less than 140 mg/dL
Prediabetes	140 mg/dL to 199 mg/dL
Diabetes	Greater than 200 mg/dL

 

Why Is It Important to Recognize and Treat Prediabetes?

By identifying the signs of prediabetes before diabetes occurs, you can prevent type 2 diabetes altogether and lower your risk of complications associated with this condition, such as heart disease.

A large 3-year medical study in patients at risk of developing type 2 diabetes found that lifestyle changes with exercise and mild weight loss, and treatment with medications that work to sensitize a person to the actions of insulin, can decrease the chance that a person with prediabetes will get type 2 diabetes by up to 60%. 

Changing a person's lifestyle habits with increased physical activities and mild weight loss was more effective than medications at reducing the risk of developing type 2 diabetes. For some people with prediabetes, intervening early can actually return elevated blood sugar levels to the normal, healthy range.

 

What's the Treatment for Prediabetes?

To successfully treat prediabetes:

• Eat a heart healthy diet and lose weight. A 5% to 10% weight loss can make a huge difference.
• Exercise. Try to exercise 30 minutes a day, 5 days a week. The activity can be split into several short periods: 3 sessions of 10 minutes. Select an activity that you enjoy such as walking. In the study mentioned above, the total amount of exercise per week was 150 minutes.
• Stop smoking.
• Treat high blood pressure and high cholesterol. 

Light May Replace Lancets For Testing Blood Sugar

Checking sugar levels without pricking yourself

A quick and painless way to measure blood sugar is highly sought-after by diabetes sufferers, who currently have to prick their fingers to draw blood several times a day. Now, researchers in the US may have found a solution – a device that works by simply shining a light on skin.

The vision is to create a laptop-sized device that could be kept at home or carried around. Rather than having to pierce the skin to obtain blood samples, the device measures sugar levels by simply placing a scanner against the skin. Because measurement is fast and easy, it is hoped that the device may encourage people with diabetes to check their blood sugar more often, giving them better control over their condition.

At the heart of the device is a Raman spectrometer (named after CV Raman, the Indian Nobel Laureate physicist), which can identify chemical compounds by measuring how near-infrared laser light scatters on contact with molecules. The idea of using Raman spectroscopy to measure sugar levels in blood was first suggested 15 years ago by Michael Feld at the Massachusetts Institute of Technology (MIT). Although Feld sadly passed away in April this year, his team is now starting to realize his vision.

 

Keeping Up With The Sugar Rush

The problem until now has been that near-infrared light can only penetrate a short distance into the skin. The technique therefore detects glucose in the fluid surrounding skin cells (the interstitial fluid), rather than in the bloodstream. This is a problem because blood glucose levels can change rapidly, such as after eating, while there is a time lag of 5–10 minutes before the sugar changes can be seen in the interstitial fluid.

The MIT team has now resolved the problem by developing an algorithm to relate blood glucose to interstitial glucose levels. "We’ve incorporated a mass-transfer model into the overall Raman spectroscopic algorithm, which allows us to seamlessly transform between blood and interstitial fluid glucose," explains Ishan Barman, lead author of the research.

Using an early version of the device, the team tested the blood-sugar levels of some human volunteers and found that the accuracy and precision of the test was just as good as conventional finger-prick tests. In addition, the new algorithm allows the test to predict impending episodes of high or low blood sugar (hyperglycemia and hypoglycemia) by extrapolating the rate of change of sugar concentration.

 

Downsizing

The next challenge is to strip down the Raman system and build a miniaturized device that would be suitable for home use. A prototype has been made and is already scheduled for clinical testing, but reducing the complexity of the system and shrinking down bulky components could take a while.

"We are in a proof-of-concept stage in terms of device development – and we envision a laptop-sized or hand-held unit that could cost as little as $200," he told physicsworld.com. "It is difficult to predict due to market variations and FDA regulations, but one could anticipate an optical device for glucose monitoring in the next 5–7 years."

Randall Jean, an expert in remote sensing at Baylor University in Texas, US, is impressed by the work. "This research addresses a real problem and appears to provide an important means for improving the calibration of non-invasive sensors," he says. "It may also be helpful in the development of a so-called 'artificial pancreas' – where insulin can be dispensed automatically in response to sugar levels."

Thank you Lewis Brindley/Physics World