StemCell Therapy

Its often said that Alzheimers disease is the medical condition people fear mosteven more than cancer. This is understandable, considering the staggering statistics around Alzheimers and the fact that, at least so far as we currently know, there are no truly effective treatments and no cure. (According to the Alzheimers Association in the US, between the years 2000 and 2017, deaths from Alzheimers disease (AD) increased 145%,1 while deaths from other noncommunicable conditions, such as heart disease, actually decreased. In the US alone, approximately 5.8 million people are living with Alzheimers, and this is projected to more than double to about 13.8 million people by 2050.)

Alzheimers may seem mysterious, and the lack of progress toward treatments has been disheartening, but a robust body of scientific evidence suggests that this illness may be a metabolic condition rooted in dysregulated glucose metabolism and insulin signaling.2,3 With this in mind, lets take a closer look at the connections between type 2 diabetes and Alzheimers.

Alzheimers disease is sometimes referred to as type 3 diabetes and has also been described as brain insulin resistance.4,5 In fact, associations between metabolic syndrome (a.k.a. insulin resistance syndrome6) and cognitive impairment are so strong that researchers have coined the term metabolic cognitive syndrometo emphasize these links.7,8,9 The primary malfunction in the brain of someone afflicted with AD is that neurons in affected regions lose the capacity to metabolize glucose properly.10,11 Being unable to harness energy from glucose, these cells atrophy and wither, and the resulting breakdown in neuronal communication may be what leads to the memory loss, cognitive impairment, personality changes, and other hallmarks of the illness.12

Weve known since the research of Rosalyn Yalow in the 1960s that T2D is a disease of too much insulin (unlike type 1 diabetes in which there is not enough insulin). Many researchers believe T2D is the final stage of chronically elevated insulin. Another factor affecting proper insulin secretion and development of type 2 diabetes is the accumulation of fat in the pancreas. (Compromised liver function resulting from the buildup of fat in the liver is called non-alcoholic fatty liver disease, or NAFLD. The analogous condition in the pancreas is non-alcoholic fatty pancreas disease15, although it is not as widely recognized as NAFLD.) Abnormal accumulation of fat in the pancreas may interfere with healthy beta cell function and insulin secretion, and is associated with increased risk for type 2 diabetes and metabolic syndrome.16,17,18

In some people, chronically elevated insulin can precede a T2D diagnosis by a decade or more. Theres a parallel in Alzheimers: in people at risk for AD, reduced brain glucose metabolism is measurable when theyre in their 30s and 40s.19 At this young age, though, they are cognitively healthy and show no signs or symptoms of AD. Even though the brains energy supply from glucose is already compromised, the brain is able to compensate and overcome this fuel shortage. Its only when the damage is so severe and widespread and the brain is no longer able to compensate that problems with cognition and memory begin to manifest.

Turning back to T2D, for many people, the elevated fasting blood glucose or A1c that would trigger a diabetes or pre-diabetes diagnosis is a late developmentin the disease process. Chronically high insulin preceded this for some length of time, going undetected because measuring insulin levels is not a routine part of a checkup or standard bloodwork. In the same way, its possible that the memory problems and cognitive impairment associated with AD are late developments, becoming apparent after years or possibly decades during which the brain has suffered from a progressive decrease in energy.20

Disruptions in either the supply of fuel to the brain or the brains ability to usethis fuel can have catastrophic consequences for cognitive function. The brain accounts for just 2% of a typical adults body weight, but it consumes as much as 20-25% of the bodys glucose and oxygen:

Given the high energy requirement of the brain and its critical dependence on the delivery of a constant supply of fuel, the consequences of leaving such an energy shortfall untreated can be dire. When the brains energy supply is insufficient to meet its metabolic needs, the neurons that work hardest, especially those concerned with memory and cognition, are among the first to exhibit functional incapacity (e.g., impairment of memory and cognitive performance).21

People with type 2 diabetes have an increased risk for Alzheimers disease and other types of dementia compared to those without diabetes.22,23,24 However, even in the absence of high blood sugar, people with chronically high insulin are also at greater risk for AD. In fact, one study showed that risk for AD was highest among people with elevated insulin but who were notdiabetic.25 In a study of subjects with newly diagnosed T2D or pre-diabetes who had seemingly normal cognitive function, greater insulin resistance was associated with reduced brain glucose metabolism and subtle cognitive impairments.26 Its possible that hyperinsulinemia and a disruption in brain fuel usage are the first dominos to fall in the Alzheimers cascade, setting the stage for future cognitive decline.

An interesting point to note is that while elevated insulin in the bloodappears to be a major risk factor for AD, many AD patients havelowerthan normal insulin levels in the brain.27,28 Insulin is not required to transport glucose across the blood-brain barrier, nor for neurons to take up and use glucose. However, insulin receptors are scattered richly throughout the brain, and insulin is believed to play a role in facilitating healthy cognition and the viability and proper functioning of neurons.29,30

Chronically elevated blood glucose and/or insulin have negative impacts on nearly every organ and tissue system in the body: the eyes, the kidneys, the skin, the liver, the ovaries, the prostate gland, nerve cells, and more. The brain is no less susceptible to the detrimental effects of deranged glucose metabolism. In fact, owing to its high energy demands, it might even be moresusceptible than other parts of the body, and Alzheimers disease could be the most severe manifestation of this.

Written by Amy Berger, MS, CNS

Amy Berger, MS, CNS, is a U.S. Air Force veteran and Certified Nutrition Specialist who specializes in using low-carbohydrate and ketogenic nutrition to help people reclaim their vitality through eating delicious foods, and showing them that getting and staying well don't require starvation, deprivation, or living at the gym. Her motto is, Real people need real food! She blogs atwww.tuitnutrition.com, where she writes about a wide range of health and nutrition-related topics, such as insulin, metabolism, weight loss, thyroid function, and more. She has presented internationally on these issues and is the author ofThe Alzheimer's Antidote: Using a Low-Carb, High-Fat Diet to Fight Alzheimers Disease, Memory Loss, and Cognitive Decline.

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The Connection Between Type 2 Diabetes and Alzheimer's Disease - A Sweet Life

A recent paper outlines an intriguing new theory. The authors ask whether the microbes that inhabit the human body could transfer diseases such as diabetes and heart disease from person to person.

The importance of the microbiome is currently at the forefront of scientific discourse. Experts and the public are equally absorbed by the fascinating influence of microbes on human health.

A new theoretical paper, published in the journal Science, takes the discussion one step further. The authors ask whether conditions such as cardiovascular diseases, cancer, and chronic respiratory illnesses could be transmitted from one individual to another via the bacteria, fungi, and viruses that live on and in us.

The paper, which is titled Are noncommunicable diseases communicable? is likely to spark lively debate and a glut of new research. Because scientists now believe that the microbiome plays a role in many diseases, the authors ask whether it could also play a part in transmitting diseases among individuals.

Heart disease, cancer, and lung conditions are called noncommunicable diseases (NCDs) because they result from genetic, environmental, and lifestyle factors: Therefore, they cannot be passed from person to person.

Over the last 100 years, mortality rates from communicable diseases, caused by infectious microbes, have fallen dramatically. During the same period, mortality rates from NCDs have risen sharply, now accounting for 71% of deaths globally.

Researchers have demonstrated that changes in the microbiome accompany a wide range of diseases, including diabetes, Parkinsons disease, heart disease, and cancer.

At the same time, scientists have found that the composition of our microbiome appears to mirror those of the people we live among.

For instance, the paper explains that unrelated people who live together have more similar gut bacteria than close relatives who live apart. Scientists currently believe that this similarity results from the shared diet and environment of people who cohabit; but could there be more to it?

The authors of the current paper synthesize these ideas; they explain that Some NCDs could have a microbial component and, if so, might be communicable via the microbiota. This would make NCDs communicable.

As it stands, evidence for this brave new theory is circumstantial, but it certainly merits further scrutiny.

The authors refer to a study of 12,067 individuals that spanned 32 years and report that Having an obese friend was associated with a 57% higher chance of being obese, and there was a 40% higher chance of obesity if a sibling was obese.

Once again, this association could be due to diet, environment, and genetics. Friends and siblings may be more likely to live in similar locations and eat similar foods. But aside from shared behaviors, the authors of the present paper wonder whether individuals might pass along certain microbes that increase the risk of developing obesity.

Obesity is a risk factor for type 2 diabetes, and if we suppose that obesity is transmissible from our microbiome to anothers, it would imply that diabetes could also be considered a communicable disease.

Of course, this is a theory based on a theory, and there is only circumstantial evidence to back it up. As an example of this evidence, the authors explain that Within a year of a [type 2 diabetes] diagnosis, spouses have a higher chance of developing [type 2 diabetes], and this trend remains over 3 years after the initial diagnosis.

Again, this could just as easily be explained by two people sharing an environment and dietary habits.

More convincingly, the authors refer to results of various studies that have found that transferring feces from one mouse with a certain disease to another mouse without that disease can cause the second animal to develop the illness; they write:

[Fecal microbiota transplant] of dysbiotic microbiota from individuals with various NCDs into healthy animals results in disease, such as [cardiovascular disease, irritable bowel disorder, type 2 diabetes], and many others.

In short, the authors explain that disturbances in the microbiome can produce disease and that when scientists transplant these microbial communities into another animal, that animal becomes sick. They continue:

These observations suggest that the microbiota could be a causal and transmissible element in certain diseases that have been traditionally classified as NCDs.

This theoretical road may run both ways, too; the authors outline how transmissible microbiota, especially early in life, may also have a protective role against NCDs.

To date, bacteria are the most studied components of the microbiome, but it is possible that viruses which outnumber resident bacteria could also play a role in making NCDs transmissible.

As the authors write, scientists will need to carry out specific research to prove whether NCDs can, in fact, be communicated. Distinguishing between the effects of environment and any effects of microbial transfer will be challenging indeed.

This recent paper, however, is not meant to convince us that gut bacteria are transferring NCDs throughout the population. The authors simply hope that their hypothesis stimulates additional discussion and research. It is sure to do just that.

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Can you 'catch' heart disease, cancer, and diabetes? - Medical News Today

MCALLEN, Texas Just a day before Matthew Garrett and his family were to celebrate his 3rd birthday, matthew became lethargic and was not himself. Even wanting to cancel his Chuck E. Cheese birthday party. It was the weekend so his parents researched his symptoms online.

Harlan Garrett, Matthews father, We really didnt like what we were reading. We didnt tell each other because we were really hoping and praying that we were wrong.

First thing on a Monday morning a visit to his pediatrician showed Matthew had a blood sugar reading of 654.

He goes your son had diabetes. Ive already contacted the hospital we have a room ready for him to go in there. You do not go home, you do not go get clothes. Said Harlan Garrett.

Matthew had Type 1 Diabetes and it took 8 days to stabilize him, leaving his parents time to wonder what they did wrong. Harlan Garrett says after leaving the hospitalhe was lost and wanted answers. The answers would from the South Texas Juvenile Diabetes Association.

Debra Franco, Executive director, STJDA, We work really hard to work with our local hospitals to make sure that families know upon diagnosis that they are not alone in their journey. That theres a local organization thats there for them.

Debra Franco says the organization was born out of sheer need. It was founded 8 years ago after her own son was diagnosed with Type 1 Diabetes and sent to Driscoll Childrens Hospital in Corpus Christi for treatment. She said there were no doctors or hospitals in the Valley who could treat him.

Its just really frightening not to have a support system when you have a child that has been diagnosed with a chronic disease. Said Franco.

The organization is often the first resource for parents through programs like the Shot Spot Bears Program. With Type 2 Diabetes on the rise with children in the Valley, educational outreach programs like Stomp Out Diabetes, which reached more than 22,000 children.

Felipe Salinas, Board President STJDA, Families receive that box along with helpful literature books to get them started in the journey and a form they can fill out asking them for information so they can reach out to them.

Matthew Garrett is now 5 and has his diabetes under control. Thanks to a monitor which test his blood sugar every five minutes sending a notification to his parents smartphone.

Matthews doctor says his diabetes stems form a virus which attacks cells in his pancreas blocking it from producing insulin.

Harlan Garrett says he cant say enough good things about STJDA and all the support his family has received.

Franco adds, We are there to support families. We ourselves are families dealing with this disease. The compassion is there, the empathy is there and the support system is there.

Thanks to the work the South Texas Juvenile Diabetes Association does, there are now three pediatric endocrinologists in the Valley and every hospital can now treat children with diabetes.

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South Texas Juvenile Diabetes Association helping families struggling with the disease - KVEO-TV

With 2019 being such an environmentally-focused year. It is no surprise that this years CES 2020 was focused on renewable energy, but it didnt stop there. Health technology is always an important sector at CES 2020. There were two wearable devices that allow diabetics to control their glucose levels through non-invasive methods in a new, innovative way. There are advantages for users, but they also have their limitations.

The Add Care Glutrac

The Glutrac by Add Care aims to provide non-invasive continuous glucose monitoring. Considering that more than 29 million people in the United States have diabetes, the Glutrac hasnt fully made good on their promise to do so.

While achieving the level of accuracy not only helps a person monitor their glucose levels without pricking their finger, it provides the data you need at any given moment. Currently only the thing that is close to this are sensors that enter interstitial fluid, which require a small amount of penetration. The watch claims to be able to detect glucose levels from just optical sensors. Add Care, which is a company from Hong Kong, needs to prove the upmost accuracy to get approved by the FDA.

The goal of Glutrac is to monitor blood sugar without pricking your finger to get blood. These new technologies use artificial intelligence to estimate the persons glucose levels. In its early stages, this technology could expect to see more of these products at CES.

Basically the Glutrac is a smartwatch that will measure blood sugar. It watches your vital signs, including heart rate and uses AI to calculate glucose. According to the site MoneyPug, which is known as a platform to find the best health insurance, the watch has sensors on the back of the watch that can record health data every 15 minutes, providing data on where your blood sugar is at interminably. Furthermore there is a sensor to watch where you can take on-demand readings. The process takes about one minute to measure and analyze in the cloud and deliver measurements.

AerBetic

Believe it or not, dogs can smell when your blood sugar is fluctuating. AerBetic was designed a device using this idea. Not only can this help you recognize the pain and expense of traditional diabetes management, it can help you keep track of your glucose levels. For a while there has needed to be a change in the way we approach diabetes. AerBetic uses the latest gas-sensing technology to create a truly non-invasive, affordable, and wearable diabetes product.

AerBetic is a non-invasive wearable diabetes monitor that continuously provides your blood sugar levels. It also comes with an application that allows the user to set up alerts in order to communicate to a network of health care providers.

To monitor the changes in blood sugar levels, the AerBetic uses a nano sensor that detects gases humans emit. Scientists have identified that this can be an early indicator of conditions such as hypoglycemia or hyperglycemia.

Nano sensors are the core technology of the AerBetic. These devices are customized to the application. The sensors acts like a dogs nose, and it has the ability to sense multiple gases simultaneously. These low detection levels are necessary to monitor your blood sugar.

Health & Tech

Like renewable energy, the health industry is going to be revolutionized by technology. There is seemingly no end to the innovations that technology will provide for health and health care. As the health of our world continues to fluctuate with foods full of sugar and fat and we exercise less and sit at our desks. With such a pervasive disease like diabetes, new technologies are essential.

Despite that renewable energy and eco-friendly products took center stage at CES 2020, health will continue to be a focus of the conference. Not only is creating a closed loop insulin dispenser a key issue for diabetes, these non-invasive wearables will sense when your blood sugar is fluctuating. Diabetes isnt the only disease that could be facilitated by technology, the whole industry will change as new technologies like these become more commonplace. It will continue to be a focus of the CES conference, just like renewable energy products.

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Two Innovative Wearables Took Diabetes Control to the Next Level at CES 2020 - HealthTechZone

In this section:

Diabetes is a disease that occurs when your blood glucose, also called blood sugar, is too high. Blood glucose is your main source of energy and comes from the food you eat. Insulin, a hormone made by the pancreas, helps glucose from food get into your cells to be used for energy. Sometimes your body doesnt make enoughor anyinsulin or doesnt use insulin well. Glucose then stays in your blood and doesnt reach your cells.

Over time, having too much glucose in your blood can cause health problems. Although diabetes has no cure, you can take steps to manage your diabetes and stay healthy.

Sometimes people call diabetes a touch of sugar or borderline diabetes. These terms suggest that someone doesnt really have diabetes or has a less serious case, but every case of diabetes is serious.

The most common types of diabetes are type 1, type 2, and gestational diabetes.

If you have type 1 diabetes, your body does not make insulin. Your immune system attacks and destroys the cells in your pancreas that make insulin. Type 1 diabetes is usually diagnosed in children and young adults, although it can appear at any age. People with type 1 diabetes need to take insulin every day to stay alive.

If you have type 2 diabetes, your body does not make or use insulin well. You can develop type 2 diabetes at any age, even during childhood. However, this type of diabetes occurs most often in middle-aged and older people. Type 2 is the most common type of diabetes.

Gestational diabetes develops in some women when they are pregnant. Most of the time, this type of diabetes goes away after the baby is born. However, if youve had gestational diabetes, you have a greater chance of developing type 2 diabetes later in life. Sometimes diabetes diagnosed during pregnancy is actually type 2 diabetes.

Less common types include monogenic diabetes, which is an inherited form of diabetes, and cystic fibrosis-related diabetes.

As of 2015, 30.3 million people in the United States, or 9.4 percent of the population, had diabetes. More than 1 in 4 of them didnt know they had the disease. Diabetes affects 1 in 4 people over the age of 65. About 90-95 percent of cases in adults are type 2 diabetes.1

You are more likely to develop type 2 diabetes if you are age 45 or older, have a family history of diabetes, or are overweight. Physical inactivity, race, and certain health problems such as high blood pressure also affect your chance of developing type 2 diabetes. You are also more likely to develop type 2 diabetes if you have prediabetes or had gestational diabetes when you were pregnant. Learn more about risk factors for type 2 diabetes.

Over time, high blood glucose leads to problems such as

You can take steps to lower your chances of developing these diabetes-related health problems.

[1] Centers for Disease Control and Prevention. National diabetes statistics report, 2017. Centers for Disease Control and Prevention website. http://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf (PDF, 1.3 MB) . Updated July, 18 2017. Accessed August 1, 2017.

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What is Diabetes? | NIDDK

NEW YORK, Jan. 21, 2020 /PRNewswire/ --

The global diabetes care devices market is expected to reach US$ 39,382.3 Mn in 2027 from US$ 23,354.3 Mn in 2018. The market is estimated to grow with a CAGR of 6.1% from 2019-2027.

Read the full report: https://www.reportlinker.com/p05774503/?utm_source=PRN

The market is driven by the factors such as, rising incidence of diabetes, growing geriatric population, increasing prevalence of obesity across the globe, and rapid technological advancement in diabetes care devices. However, the factors restraining the market growth are high cost of diabetes care devices and risks associated with the insulin delivery devices.Obesity, sedentary lifestyle and improper diet play a major role in increasing diabetes among the population worldwide.Physical activity is important to maintain the blood glucose level.

Lack of exercise and unhealthy diet such as diet high in fat and calories increase the risk for the development of obesity and diabetes.Obesity is one of the major problem and the biggest concern in all the communities across the globe.

Currently, more than one in two adults and nearly one in six children are obese.Obesity is one of the major issue affect people of all ages and incomes globally.

According to World Health Organization (WHO), in 2016, more than 1.9 billion adults aged 18 years and older were overweight. And out of these over 650 million adults were obese. Therefore, owing to these factors the market is likely to witness growth during the forecast period.Global diabetes care devices market was segmented by product and end user.The product segment was further divided as glucose monitoring devices and insulin delivery devices.

The glucose monitoring devices is further segmented into Glucometers, Lancets, Testing Strips and Other Glucose Monitoring Devices.The insulin delivery devices is further segmented into insulin pens, insulin syringes, insulin pumps and other insulin delivery devices.

The glucose monitoring devices is expected to dominate its market share in 2027 owing to the rise in the prevalence of the diabetes.Based on the end user the diabetes care device market is segmented into hospitals and clinics and home care.

The homecare held the major market share among the end user segment owing to ease of use, availability, and accessibility of insulin delivery devices.Some of the major primary and secondary sources included in the report for the diabetes care devices market are World Health Organization, American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes UK, Centers for Disease Control and Prevention, Chinese Diabetes Society, International Diabetes Federation and others.

Read the full report: https://www.reportlinker.com/p05774503/?utm_source=PRN

About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The global diabetes care devices market is expected to reach US$ 39,382.3 Mn in 2027 from US$ 23,354.3 Mn in 2018 - Yahoo Finance

Danish company Novo Nordisk specializes in the diabetes market. The company appears to be making an entry into the Alzheimers market, which isnt as unusual or unexpected as it initially sounds.

It has been postulated for some time that Alzheimers disease is related to blood glucose levels and has been dubbed type 3 diabetes. Type 1 is an autoimmune disease, sometimes referred to as insulin-dependent diabetes. Type 2 is typically acquired and appears more related to insulin resistance and is related to obesity.

Back in 2017, Mayo Clinic participated in a multi-institution clinical trial evaluating an insulin nasal spray on Alzheimers patients.

This study has furthered our understanding of the gene that is the strongest genetic risk factor known for Alzheimers disease, said Guojun Bu, a Mayo neuroscientist, at the time. About 20% of the human population carriers this riskier form of [the gene] APOE, called E4.

About 50% of Alzheimers cases are associated to APOE4 according to the study, which was published in the journal Neuron. And people with type 2 diabetes have a higher risk of Alzheimers disease, although the reasons for it are not completely clear. In fact, type 2 diabetes almost doubles the risk of developing Alzheimers disease. One possible reason is reduced blood flow to the brain because of damage to blood vessels caused by diabetes.

Now, Novo Nordisk is involved in a clinical trial using the companys GLP-1 analogue diabetes drug Victoza to evaluate if the drug can improve brain function and cognition in Alzheimers patients. It is a Phase IIb clinical trial. In laboratory studies it has been shown to improve Alzheimers symptoms and decrease the amount of amyloid plaques in the brain, which are associated with the disease.

In an update on the trial site, it was noted that patients receiving the drug had a perceived change in their symptoms after they stopped taking it. As a result, at the end of the 12-month trial, all patients will be offered the opportunity to join a 12-month open-label extension trial.

Novo Nordisk shares recently popped, and Evaluate Pharma speculates that this was related to the companys participation in the trial after the Danish newspaper Brsen made the link. They also cited a recent note by analysts at Bernstein titled Is Alzheimers type 3 diabetes? suggesting a role for GLP-1 drugs.

Despite the evidence, not a lot of clinical trials have been conducted testing the hypothesis. Evaluate Pharma notes, Correlation does not equal causation, and a skeptical pharma sector has remained on the sidelines. Indeed, it is striking that the number of clinical trials testing the hypothesis can be counted on the fingers of one hand, and none has a corporate pharma company sponsor.

These include studies by the University of Aarhus, which published data in 2016, the third Military Medical University, whose trial was completed last year but has not published the data yet, the trial mentioned earlier with the Imperial College London and Victoza, one by the Universitaria di Parma, with results expected last year, and an ongoing trial by the National Institute on Aging due in December 2022.

The trial of Victoza by the Imperial College London will enroll 204 patients with mild Alzheimers dementia and is a double-blind, placebo-controlled design that will last 12 months. Its primary endpoint is measuring rates of glucose metabolism in the brain. Secondary endpoints will look at various measures of cognition, including Adas, CDR-sum of boxes and ADSC-ADL.

The University of Aarhus study demonstrated that six months of Victoza was linked to an increase in glucose metabolism compared to placebo but was not deemed statistically significant.

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Is Alzheimer's Type 3 Diabetes? Novo Nordisk is Willing to Find Out - BioSpace

New cell treatment could help maintain healthy blood sugar levels

A new cell treatment to enhance islet transplantation could help maintain healthy blood sugar levels in Type 1 diabetes without the need for multiple transplants of insulin producing cells or regular insulin injections, research suggests.

In Type 1 diabetes the insulin-producing cells of the pancreas are destroyed. Insulin injections maintain health but blood glucose levels can be difficult to control. Currently in the UK it is estimated that approximately 400,000 people in the UK have type 1 diabetes.

The current recommendation for people with type 1 diabetes who have lost awareness of low blood glucose levels is the transplantation of islets the insulin producing part of the pancreas.

A study in mice found that transplanting a combination of islets with connective tissue cells found in umbilical cords known as stromal cells - could potentially reduce the number of pancreases required for the procedure.

Mice that received the islet-stromal cell combination were found to have better control of blood glucose and less evidence of rejection of islets after seven weeks, compared to those that received islets alone.

In humans, more than two donor pancreases, which are scarce, are often needed because islets can be rejected and are slow to form new blood supplies.

Therefore, multiple islet transplantations and anti-rejection medication are required to control blood sugar levels in people with Type 1 diabetes. Scientists at the University of Edinburgh hope their findings could be a way of overcoming these issues.

The researchers found that islets combined with stromal cells successfully returned normal blood glucose levels just three days after transplantation.

Other studies have used cells sourced from bone marrow and fat. This is the first to use stem cells from umbilical cords and has produced superior results.

The research is published in the journal Science Translational Medicine and funded by Chief Scientist Office in Scotland and Diabetes UK.

Shareen Forbes, Professor of Diabetic Medicine at the University of Edinburgh and Lead Physician for the Islet Transplant Program in Scotland, said: Should this research prove successful in humans, we could reduce the number of islets needed to control blood sugar levels using this co-transplantation approach. This would mean more people with Type 1 diabetes could be treated using islet transplantation while significantly reducing the waiting time on the transplant list.

John Campbell, Professor and Associate Director Tissues, Cells & Advanced Therapeutics at the Scottish National Blood Transfusion Service has said that further work is needed to establish the long-term safety of using this type of stromal cell in this setting before proceeding to clinical trials in humans.

Dr. Elizabeth Robertson, Director of Research at Diabetes UK, said: Islet transplants have been life changing for some people with Type 1 diabetes, treating dangerous hypo unawareness. But there currently arent enough donated pancreases to go around, and the procedure itself isnt yet as effective as it could be.

This new research from the University of Edinburgh is a promising step forward, and one we hope will lead to islet transplants becoming both more effective and more widely available in the future.

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Cell therapy trialed in mice offers diabetes treatment hope - SelectScience

A new study by researchers from Boston University School of Public Health (BUSPH) and Chulalongkorn and Mahidol Universities in Bangkok, which was published in the journal PLOS ONE, found that the majority of Thai adults with diabetes were never diagnosed, but that most of those who were diagnosed did receive treatment and got the condition under control.

The study focused on the strengths and weaknesses of diabetes care in Thailand's universal health system, using the 2014 Thai National Health Examination survey (NHES V), the largest cross-sectional, noninstitutionalized population representative survey in Thailand, completed every five years.

TOPLINE DATA

Of the 15,663 Thai adults included in the study, 8.8% appeared to have diabetes based on their blood samples and/or reporting being treated for diabetes. Of those who appeared to have diabetes, the researchers found that 67.0% reported ever being screened for diabetes, 34.0% reported being diagnosed, 33.3% had been treated, and 26.0% had their diabetes under control.

KEY FINDINGS

There were several key findings from the report. The researchers identified significant unmet need for diabetes care in the Thai adult population, with 74% of those with diabetes having an unmet need for care across levels of screening, diagnosis, treatment, or control. Additionally, the high unmet need for diabetes care was found to be largely attributable to loss at the stages of screening and diagnosis, which each contributed 33% to total unmet need.

INISIGHTS & RECOMMENDATIONS

The study highlighted the need for stronger investment to strengthen primary health care in Thailand. An independent assessment after a decade of the Thai Universal Coverage Scheme (UCS) indicated that the focus on curative care may have contributed to lower resources for public health functions. While several national policies to improve diabetes screening and care have been passed, and a dedicated chronic care fund was established under UCS to strengthen screening and primary care for diabetes and hypertension in 2011, large gaps remain in disease detection.

Future steps might include expanding primary health care clinics and staff, in addition to auxiliary health providers like community pharmacists, who in prior studies have successfully managed diabetes and hypertension in conjunction with primary care providers.

Better health information systems that allow every Thai to access their personal health information, including diabetes risk and screening records, could also contribute to reducing unmet need.

ON THE RECORD

"Thai healthcare systems may have put emphasis on expanding coverage both in terms of population coverage and medical care benefit packages, which they did quite well with relatively low cost (and limited resources). Nevertheless, this paper highlights the importance of improving the quality of care, especially primary care and public health promotion and disease prevention," said study co-author Dr. Piya Hanvoravongchai, lecturer in the Department of Preventive and Social Medicine in the Faculty of Medicine at Chulalongkorn University in a statement.

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Researchers discover unmet needs in Thai diabetes care - Healthcare IT News

Tandem Diabetes (NASDAQ:TNDM)today announced the commercial launch of the newest version of its flagship insulin pump in the U.S. market. The company's signature t:slim X2 insulin pump will also now come with Control-IQ technology, which is meant to help stabilize blood sugar levels via an automated insulin dosing system.

Insulin pumps are a type of insulin delivery device that simulate the way the pancreas works by delivering small doses of insulin throughout the body. Tandem's main product is its t:slim X2 pump, one of the top insulin pumps in the market right now, with sales having seen dramatic growth over the past couple of years.

An insulin pump. Image source: Getty Images.

"Control-IQ technology has been described by study participants and investigators as 'life-changing,' 'easy to use,' and 'a new standard of care in insulin therapy management'," said Tandem CEO John Sheridan. This technology, which will be made available to existing t:slim users via a software update, is only compatible with one other insulin monitoring system out there,Dexcom's G6 continuous glucose monitoring tool (the G6, however, is not an insulin pump).

The Food and Drug Administrationapproved Tandem's Control-IQ platform back in December, and now that it's officially hitting the market, investors are excited to see how this will change Tandem's sales figures.

But there still are some serious biotech competitors that could pose a threat to Tandem's position in the market. The most notable isInsulet (NASDAQ:PODD), which is developing its own insulin pump, the Omnipod Horizon, that should be available sometime in late 2020. It's quite likely that Insulet's new pump will siphon off market share from Tandem.

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Tandem Diabetes Launches a New Version of Its Insulin Pump - The Motley Fool

A new study found a protein linked to Alzheimers Disease also contributes to problems with diabetes and obesity.

Its called the amyloid precursor protein or APP. Thats the same amyloid believed to form plaque that may cause cognitive decline. The study, published in Nature Metabolism, found APP occurs in far higher levels in the fat cells of mice and humans who are obese.

The studys senior author is Dr. Philipp Scherer of UT Southwestern Medical Centers Touchstone Center for Diabetes Research. Scherer talked with KERA about how APP causes problems in the bodys fat cells.

The KERA Interview with Dr. Philipp Scherer

INTERVIEW HIGHLIGHTS:

The Link Between APP And Diabetes

It turns out that high fat diets actually lead to the production of APP within the fat cell themselves. Then as the fat cell becomes challenged and less functional, we actually progress towards a type 2 diabetic state where we have high levels of insulin resistance.

The Diabetes Of The Brain

What's interesting is that we know from the Alzheimer's field that there is an association between type 2 diabetes and Alzheimer's disease. You sometimes hear Alzheimer's disease is the diabetes of the brain. This is based on the fact that the nerve cells become insulin resistant. We have high sugar levels in the brain that can actually enhance the formation of these plaques.

Even though we don't have plaque formation in our fat tissue, the very fact that the induction of APP can actually lead to this high level of dysfunction of our fat tissue is an interesting new spin, and we can certainly now also check in the brain whether or not a similar mechanism is associated with that neurodegeneration.

Perhaps Another Clue To What May Cause Alzheimers

We certainly have gained a lot of insights into what actually leads to the problems that we see in our fat tissue as we gain weight but I think we can also learn the lesson for the brain from this.

What we now see in the fat cells could actually also potentially apply to our nerve cells in the brain. They may actually engage in an energetic deficit, because within the nerve cells this APP protein may mislocalize and cause similar troubles that it causes in adipose (fat) tissue.

RESOURCES:

APP Study

UT Southwestern: Protein associated with Alzheimer's also causes dysfunction in fat cells, increasing obesity, diabetes risk

What Is Alzheimers Disease?

American Diabetes Association

Answers have been edited for clarity and brevity.

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UTSW Study Links Alzheimer's-Related Protein To Diabetes And Obesity - KERA News

The American Diabetes Association (ADA) has made its annual changes to its Standards of Medical Care in Diabetes.

This year there is a strong recurring message of individualising patient care, including recommendations for treatment of cardiovascular disease, special considerations for older adults with type 1 diabetes, and revised recommendations and additional supporting evidence for use of rapidly changing diabetes technology.

The Standards are developed by the ADAs multidisciplinary Professional Practice Committee, made up of physicians, diabetes educators, and other expert diabetes healthcare professionals.

The guidelines are based upon the most current evidence-based recommendations for diagnosing and treating adults and children with all forms of diabetes.

Dr John Buse Ph.D., the Verne S. Caviness Distinguished Professor of Medicine, Division Chief of Endocrinology and Metabolism, and Director of the NC Translational and Clinical Sciences (TraCS) Institute, led the writing of the update, which includes:

To read the document in full, click here.

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American Diabetes Association release updated Standards of Care - The Diabetes Times

Staff reports

MondayJan20,2020at1:12AM

HORNELL Informational sessions on the National Diabetes Prevention Program (NDPP) offered by the Steuben County Public Health department are set for February.

The two-year NDPP program helps participants lose weight, become more physically active, lower stress, and reduce their Type 2 diabetes risk. Participants must be at risk for developing Type 2 diabetes but not previously diagnosed with Type 1 diabetes.

Information on the program will be presented at:

Noon, Feb. 4 in the Steuben County Annex Room A, East Morris Street, Bath. Classes are set for noon-1 p.m. Tuesdays beginning Feb. 25.

5:45 p.m. Feb. 25 in the Hornell YMCA Art Room, 18 Center St., Hornell. Classes are set for 5:45- 6:45 p.m. Tuesdays beginning March 10.

Classes for the two-year program will be held weekly for four months; then meet biweekly and eventually meet every month.

The cost of the program is covered by Medicare, Medicaid and Steuben County employees participating in the countys Wellness program. Private pay for the program in $150.

To register, or for more information on the program, qualifying blood work or other questions, call (607) 664-2438, email lwagner@steubencountyny.gov, or register online.

For information on the Corning YMCAs Type 2 diabetes prevention program, call (585) 341-4064.

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Steuben Diabetes prevention programs slated to begin soon - Hornell Evening Tribune

QYResearch Published GlobalRound Guide Rail SystemsMarket 2025 Report: Industry Growth, Opportunities, Vendors, Shares, Competitive Strategies And Forecasts

Los Angeles, United State, January 2020: This latest report provides a deep insight into theGlobal Round Guide Rail SystemsMarket 2019 covering all its essential aspects. Global Round Guide Rail Systems Market report provides pin-point analysis for changing competitive dynamics through comprehensive View of the key market dynamics. The research study provides market introduction, Round Guide Rail Systems market definition, regional market scope, sales and revenue by region, manufacturing cost analysis, Industrial Chain, market effect factors analysis, Round Guide Rail Systems market size forecast, 100+ market data, Tables, Pie Chart, Graphs and Figures, and many more for business intelligence.

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ThomsonRobert Bosch GmbHWickensNook IndustriesLOTEC Loh GmbHCo.KGVARIO Fertigungstechnik GmbHVenture GrindingWerkzeugmaschinenfabrik Glauchau GmbHErwin Junker Maschinenfabrik GmbHNUM AGBhrer AG

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QY Research is committed and dedicated to assisting its clients in reaching towards their goals. We offer a comprehensive range of research reports and support our customers by providing them a solution across times zones. We understand the necessity of accurate data and therefore providing an in-depth analysis of the markets is our primary responsibility. The analytical mind of our expert team recognizes the need for the excellent quality control system, which validates data. This is why QY Research is one of the few consulting firms that gives importance to provide accurate and highly reliable data.

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Diabetes Treatment Market 2019 Industry Growth, Competitive Analysis, Future Prospects And Forecast 2025 - Melanian News

A University of WisconsinMadison alumnus is now selling a patented device to help diabetics safely and easily inject insulin with just one hand. Once the Steady Shot device is mounted on a standard insulin injector, its two plastic wings compress the skin, raising a bulge of fat to receive the injection.

Fat is the target because when injected into muscle, insulin, the hormone that regulates blood sugar, can cause seizures if absorbed too quickly. Traditionally, the user forms the bulge with the thumb and one finger, while holding the injector with the other hand. The need to use two hands limits the area that can be injected.

With the ability to do a one-hand injection, suddenly diabetics can spread out the injections and preserve their skin. Photo courtesy of Steady Shot

Allowing one-handed injection has multiple benefits, says inventor Shawn Michels, a 2018 graduate of the Wisconsin School of Business and type I diabetic.

Normally, you need one hand to compress the skin, and the other to operate the insulin pen, which does the injection, he says. That means youre limited to the abdomen and thighs, but lifelong diabetics are injecting several times a day, which causes scarring and lipohypertrophy, a buildup of fat globules after repeated injections.

These globules are not only unsightly, but because they cause uneven insulin absorption, these structures impair consistent control of blood sugar.

Now that he can inject in the back, buttocks and back of the legs, even the arm, his available injecting area is almost doubled, Michels says.

Michels invention received a utility patent last month. As an over-the-counter device, it needs no FDA clearance.

The injection innovations on the market all have moving parts and much greater complexity, compared to Michels one-piece attachment.

Shawn Michels, 24, invented a new insulin-injection device in 2016 while earning a B.A. in business at University of WisconsinMadison. Steady Shot is now on the market. Photo courtesy of Shawn Michels

Michels began germinating the idea while in business school at UWMadison. Back when I was an undergraduate, I was thinking about how to inject you may have to do it while driving, or in an airplane, and its always awkward when reaching certain injection sites, Michels says. I saw these other devices, and had the Aha! moment when I realized that if you press these two wings against the skin, a bulge of skin and fat would rise up. That realization led me to a much simpler design without moving parts.

The wings have other benefits, Michels says. First off, they tend to hide the needle, reducing the fear response that needles often initiate.

Second, when the device presses against the skin, the user initially feels the wings, which make a much bigger impression than the needle. When they feel the arms on the skin, they will not feel the needle going in, Michels says.

Thats particularly helpful for young people with a new diagnosis, Michels says. They are often scared of the needle, but Steady Shot obscures the sight of the needle, without impairing the injection.

Third, moving the injections around the body is better for the skin, and easier on the user, he says. We do this multiple times a day, and that can produce fat globules and scarring. Any way we can spread the injection around should give the skin a rest and reduce these side effects while allowing us to receive our lifesaving medicine.

Unlike some injection innovations, Steady Shot relies on no moving parts. The wings bunch up the skin to ensure that insulin is injected into fat, not muscle. Photo courtesy of Steady Shot

Michels benefited from several business plan competitions while at UWMadison. What helped most, however, was Discovery to Product, or D2P, a program to help university students, faculty and staff evaluate promising ideas and usher them toward the market.

D2P funding supported creation of the Steady Shot mold, and the group provided contacts at professional networks. They connected me with UW Health, which helped me understand the lay of the land in the hospital. I thought initially this could be used inpatient in the hospital for all sorts of injections, but they convinced me it would be best for outpatients, for self-injectors.

D2P also provided a link to business mentors, Michels added. They helped me select the best part of market to tackle first, and talked about the lean startup model. When I started, I was completely in the dark. I did not know anything about entrepreneurship; I was starting at ground level.

On Monday, Michels launched a crowd-funding campaign at Indiegogo. The most surprising part of the journey was how long things take, he says. You think, I have this really simple device, its plastic, one piece. You think you could get market instantly but that hasnt been the case. But now is the time. Were really happy with the reviews and testimonials were getting. This simple device solves real problems.

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Diabetic's invention is an injection innovation - University of Wisconsin-Madison

Diabetes Professional Care Charity of the year, X-PERT Health, has appointed digital healthcare agency, Pulse, to transform their ground-breaking diabetes education programme onto a digital platform.

The new platform, which will be accessible via an app or website, will enable X-PERT Health to scale up its current group based programme, allowing hundreds of thousands more patientsto develop the knowledge, understanding and confidence to make lifestyle changes to prevent or manage Type 2 diabetes, further strengthening X-PERT Healths educate not medicate philosophy.

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The educational content will be interactive and engaging, including animated videos, games and quizzes to support discovery learning in a fun and easy-to-use way. The digital programme will also include features such as real-time tracking for diet, physical activity, health results, medication requirement and mood and sleep helping users to manage and improve their lifestyle and health. This information can then be shared with the users healthcare professional as part of their regular check-up.

Users will also have continued support from a 24/7 chatbot; group chats; access to the X-PERT health forum, and the ability to book a call with an X-PERT Health coach. In addition, users will be able to access a large database of recipes, tailored for patients with Type 2 diabetes, and they will also be able to submit their own recipeswhich can be shared with other patients.

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X-PERT Health Founder, DrTrudi Deakin, said:

The X-PERT Programmes have reached and benefitted over 300,000 patients through collaborations with the NHS, for over a decade. We selected Pulse to help us seizethe opportunity in this digital age to overcome accessibility barriers to structured education by releasing a truly innovative means of delivering our evidence based programme at scale: X-PERT Health Diabetes Digital. This programme encompasses behaviour change philosophies, lifestyle change and state-of-the-art integrations and functionalities to meet the needs of the patients and improve overall health and wellbeing.

Pulse Chief Digital Officer,Leo Miller, added:

Were delighted to have been chosen to take X-PERT Healths diabetes education programme into the digital space, and we are very much looking forward to working together with the X-PERT Health team to support patients in preventing or managing Type 2 diabetes.

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Leading Digital Healthcare Agency, Pulse, Selected to Innovate Award-Winning Diabetes Education Programme - AiThority

Imbalances in glycemic control, blood pressure, and diuretic use between treatment and placebo arms could have biased the cardiovascular and renal outcomes of recent large trials in favor of the study drugs for treating type 2 diabetes, some experts assert.

The cardiovascular outcomes trials (CVOTs) were mandated by the US Food and Drug Administration in 2008 to ensure the safety of newer agents being developed for type 2 diabetes following the debacle of rosiglitazone.

Results from some of the CVOTs and other subsequent dedicated trials showing cardiovascular and renal benefits have influenced clinical guidelines for type 2 diabetes and led to FDA approval of additional indications for some of the drugs beyond glucose lowering.

In nearly all these manufacturer-funded trials of a number of drug classes dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide 1 (GLP-1) agonists, and sodium-glucose cotransporter 2 (SGLT2) inhibitors glycemia and blood pressure were not strictly controlled but were left to the discretion of the treating physician, although some studies did include "rescue criteria."

Now in an article recently published online in the Journal of Pharmaceutical Policy and Practice, Japanese researchers Rumiko Shimazawa, PhD, of the Department of Clinical Pharmacology at Tokai University School of Medicine, and Masayuki Ikeda, MD, point out that A1c levels were significantly higher in placebo groups than in treatment groups in all of the CVOTs.

Those imbalances, they argue, placed patients in the placebo groups at potentially higher cardiovascular risk and thereby biased the results in favor of the study drug.

"Reanalysis with adjustment for the [A1c] imbalance is absolutely indispensable for the correct evaluation of the CVOTs," Ikeda, of the Department of Medical Informatics at Kagawa University Hospital, Japan who had no disclosures told Medscape Medical News.

Similar views were expressed in 2018 by former Bristol-Myers Squibb investigators Simeon I. Taylor, MD, PhD, an endocrinologist now at the University of Maryland, Baltimore, and nephrologist Bruce R. Leslie, MD, now of Seventh Doctor Consulting, Princeton, New Jersey.

Taylor and Leslie additionally pointout that blood pressures were also imbalanced between the CVOT study arms.

And, Leslie told Medscape Medical News in an interview, those same imbalances as well as in diuretic use also occurred in more recent dedicated trials of the effect of SGLT2 inhibitors on kidney function and heart failure, including CREDENCE and DAPA-HF.

"The imbalance is baked into how these studies are done. Whether intentional or inadvertent, there's an imbalance," asserts Leslie, who owns stock in Bristol-Myers Squibb, Pfizer, and Lilly.

Asked for comment, Silvio Inzucchi, MD, director of the Yale Medicine Diabetes Center, New Haven, Connecticut, and a senior investigator for several of these trials, told Medscape Medical News: "It is extremely difficult to conduct a trial with absolutely equal A1c levels between the treatment groups when you allow an extra drug in one arm."

"So, all of the CVOTs have shown about a 0.4% to 0.7% difference [in A1c] between the groups, sometimes even more depending on the potency of the drug. To have equal A1cs in both groups, the study sites would have to assume complete responsibility for glucose management. That would be a much more complex and much more expensive study...It's also no longer a reflection of 'real-world' practice," he explained.

And in response to similar arguments about the imbalances made in a letter to the New England Journal of Medicine following publication of the renal results of the EMPA-REG Outcome trial with the SGLT2 inhibitor empagliflozin (Jardiance, Lilly/Boehringer Ingelheim),Inzucchi and two other EMPA-REG coauthors called the differences in glycemic and blood pressure control "subtle."

They write, "Treatment with SGLT2 inhibitors results in a reduction in hyperglycemia and blood pressure, and these effects may indeed have contributed to the improved outcome with empagliflozin."

"However, the magnitude and duration of the observed reductions are unlikely to fully account for the positive renal effects...it is more likely that the effects of empagliflozin on reducing intraglomerular hypertension played a more fundamental role than glycemic or hypertension control in mediating the renal effects," they state.

In their article, Shimazawa and Ikeda analyzed results from 12 CVOTs published through December 2018 that followed the FDA's 2008 guidance.

These included three studies of SGLT2 inhibitors (EMPA-REG OUTCOME, CANVAS, and DECLARE-TIMI 58),four of DPP-4 inhibitors (CARMELINA, EXAMINE, SAVOR-TIMI 53, and TECOS),and five of GLP-1 agonists (LEADER, SUSTAIN-6, HARMONY, EXCEL, and ELIXA).

In most of the trials, patients had a high risk of atherosclerotic cardiovascular disease (CVD) or established CVD with baseline A1c levels ranging from 7.2% to 8.7%.

All received active drug or placebo, but they weren't truly "placebo-controlled" trials, as additional glucose-lowering medications were allowed, Shimazawa and Ikeda point out.

There was significantly greater use of additional glucose-lowering drugs in the placebo groups of the 10 trials that reported such data.

But regardless of use of such additional medications, A1c levels were significantly higher in the placebo groups in all the trials, ranging in percentage point difference from 0.27 (in ELIXA) to 1.00 (in SUSTAIN-6).

And despite better glycemic control in the treatment groups, heart failure rates were higher in the treatment groups in EXAMINE and SAVOR-TIMI, leading to warnings regarding this on the labels of two DPP-4 inhibitors.

Ikeda told Medscape Medical News that it shouldn't be difficult to resolve the imbalance problem by adjusting for A1c, as the CVOT investigators "have the critical data of their own, and the post-hoc analyses with adjustment for the imbalance are elementary statistics."

In fact, he noted that this was actually done in one of the CVOTs, ELIXA, resulting in a loss of a significant advantage for lixisenatide in percent change in urinary albumin-to-creatinine ratio (from P = .004 to P = .07).

Leslie is less convinced that the imbalance in glycemic control would have made a major difference in cardiovascular outcomes, at least in the short-term.

"The duration of studies is relatively short. For 3- to 5-year follow-up it seems unlikely that differences in glycemic control can explain the cardiovascular benefit," said Leslie.

However, regarding the CVOTs and other major trials of SGLT2 inhibitors, Leslie said, "My belief is that the difference in outcomes is mostly due to blood pressure difference and diuretic use imbalance, which are intimately related."

He points to evidence including some of his own work that SGLT2 inhibitors have diuretic propertiesand that they enhance the renoprotective effects of reninangiotensinaldosterone system (RAAS) inhibitors by potentiating their antihypertensive and antiproteinuric actions.

Indeed, in a letter to the New England Journal of Medicine following publication of CREDENCE, which showed renal benefit for the SGLT2 inhibitor, Leslie and coauthor Leslie E. Gerwin, JD, of Princeton University, New Jersey, write: "In this trial, canagliflozin a drug with diuretic properties was administered to patients with diabetic kidney disease, nearly all of whom were receiving a [RAAS] inhibitor."

"In the placebo group, however, fewer than half the patients were taking diuretics," they pointout.

There was also a blood pressure imbalance in CREDENCE of 3.30 mmHg (systolic) and 0.95 mmHg (diastolic).

Leslie told Medscape Medical News that the same is true of the CVOTs of SGLT2 inhibitors, including CANVAS, EMPA-REG, and DECLARE TIMI 58, potentially influencing the heart failure outcomes.

"It was the same structure. Less than half of the placebo group was being treated with a diuretic at baseline, but all the treatment group patients got a diuretic [as well as] an SGLT2 inhibitor along with RAAS inhibitors," noted Leslie.

Thus, he said, "all the SGLT2 inhibitor CVOTs, as well as CREDENCE, contain an unbalanced therapeutic design...that leaves unanswered the question of whether the cardiovascular and renal benefits they describe can be reproduced by inexpensive generic thiazide diuretics."

In response to Leslie and Gerwin's letter, CREDENCE lead investigator Meg J. Jardine, MB, PhD, of The George Institute for Global Health, Sydney, Australia, and two coauthors replied: "Diuretics have not been shown to prevent kidney failure."

"The benefits observed in the CREDENCE trial were also consistent, regardless of baseline diuretic use, so we think it is unlikely that the diuretic effect explains the benefits of canagliflozin," they note.

Leslie commented, "Diuretics don't prevent kidney failure, but neither do SGLT2 inhibitors. They just slow it down, same as diuretics."

Inzucchi, who has multiple disclosures relating to the companies conducting these trials, told Medscape Medical News he disagrees with Leslie's assertion that the diuretic effects of SGLT2 inhibitors are the same as those of thiazide diuretics.

"I don't agree that SGLT2 inhibitors are 'just like thiazides.' They work in a totally different part of the nephron, and although they are relatively weak natriuretics, their effect on sodium excretion may be more sustained than with other diuretics," he said.

"This is perhaps because they inhibit sodium reabsorption proximal to the macula densa, so the resultant loss of urinary sodium and subsequent volume contraction does not appear to simulate the normal neurohormonal compensatory mechanisms like conventional diuretics that serve to attenuate efficacy over time. These hormonal changes increases in catecholamines, renin, aldosterone, and antidiuretic hormone may also have deleterious effects on the heart," he explained.

In addition, Inzucchi said, "Thiazides have never been shown to reduce heart failure hospitalizations or mortality as do the SGLT2 inhibitors. So the gliflozins may be unique diuretics."

And in response to another letter expressing concern about the glycemia and blood pressure differences in CREDENCE, Jardine and colleagues write: "Pooled analyses of intensive blood pressure and glucose lowering have not shown clear renal benefits, so these are also unlikely explanations, particularly given the modest differences between the two groups."

"The trial protocol encouraged investigators to deliver the best guideline-based care to patients according to blood pressure and glucose and lipid levels. None of these interventions (ie, the use of diuretics and intensive blood pressure and glucose lowering) has been shown to have benefits of the magnitude observed in the CREDENCE trial, despite multiple trials," they state.

In their letter regarding CREDENCE to the New England Journal of Medicine, Leslie and Gerwin suggesta clinical trial could be conducted comparing canagliflozin added to RAAS inhibition with a generic thiazide diuretic added to RAAS inhibition in patients with diabetic kidney disease and otherwise controlled hyperglycemia.

This, they argue, "could help to determine whether the renoprotective qualities of canagliflozin are anything more than those of an expensive diuretic."

And, as for the CVOTs, Leslie told Medscape Medical News he agrees with the Japanese researchers that post-hoc analyses could provide some answers.

With regard to the diuretic question, the sponsors could address the concern with the data they already have by performing a subanalysis comparing cardiovascular or renal outcomes for patients taking study drug without a concomitant diuretic to the outcomes for patients taking a diuretic and placebo.

"This sort of post-hoc analysis is not as pure as a prespecified one, but at least the data are readily available," said Leslie.

But of course, Leslie and Gerwin also note, the fact that the companies have no incentive to conduct such analyses "exemplifies a deficiency in the pharmaceutical regulatory system."

"Sponsors are not required to ascertain whether the results of [SGLT2 inhibitor] therapy and those of more cost-effective diuretic therapy might be similar," they conclude.

Ikeda has reported no relevant financial relationships. Leslie has reported owning stock in Bristol-Myers Squibb, Pfizer, and Lilly. Inzucchi has reported serving on clinical trial executive/steering/publications committees for AstraZeneca, Novo Nordisk, Boehringer Ingelheim, and Sanofi-Lexicon; advisory boards for AstraZeneca, Novo Nordisk, vTv Therapeutics, and Abbott/Alere; and has accepted lecture fees from Boehringer Ingelheim and Merck.

J Pharm Policy Pract. Published online November 18, 2019. Full text

For more diabetes and endocrinology news, follow us on Twitter and Facebook.

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Have the Blockbuster Diabetes Drug Trials Been Biased? - Medscape

ARLINGTON, Va., Jan. 15, 2020 /PRNewswire/ --The American Diabetes Association (ADA) announced formal endorsement of three bills aiming to reduce the high cost of insulin and prescription drugs: the Insulin Price Reduction Act, the Safe Step Act, and the Chronic Condition Copay Elimination Act. The three bills were analyzed using ADA's newly launchedEngagement Platform.

"More than 5,000 bills and resolutions are introduced annually into Congress, and if we want to truly help people with diabetes thrive, we must cut to the chase and make it clear which bills truly impact their lives," said Tracey D. Brown, CEO of the American Diabetes Association. "By focusing on the most important insulin and drug pricing bills and giving our community easy ways to communicate their views with Congress, we will elevate the conversation from words into meaningful action."

The Engagement Platform demystifies the political rhetoric of drug pricing policies for the diabetes community. In addition to providing easy-to-understand explanations of why the ADA supports various bills, it also empowers and equips people living with diabetes and their loved ones with the tools they need to spur Congress to action.

"As the Co-Chair of the Congressional Diabetes Caucus and the father of a type 1 diabetic, I applaud the American Diabetes Association's latest initiative to analyze and endorse bills that address the skyrocketing costs of insulin and other diabetes drugs," said U.S. Representative Tom Reed (R-NY). "We care about hearing from our constituents on issues that are important to themjust like these important bills. I look forward to working with the ADA on future bills that will provide relief to the diabetes community."

ADA carefully analyzes legislation using three guiding questions. The bills that have the most potential to change the course of diabetes care are highlighted on the Platform.

"It is critical that the broader diabetes community come together to advocate for legislation that will truly improve their lives," said Kelly Close, founder and co-Chair of the Board of the diaTribe Foundation. "As someone living with T1D for nearly 35 years, I am thrilled that the American Diabetes Association has taken this step to make understanding legislation easy for the more than 30 million of us in the diabetes community. Our voices matter and the ADA's new Platform will help ensure they are heard!"

Learn more about the Platform and make your voice heard on these bills and other legislation that will improve the lives of all those living with diabetes atdiabetes.org/advocacy/platform.

About the American Diabetes AssociationEvery day more than 4,000 people are newly diagnosed with diabetes in America. Nearly 115 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).

Contact: Alex Day, 703-253-4843press@diabetes.org

SOURCE American Diabetes Association

http://www.diabetes.org

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Bills Addressing Drug and Insulin Affordability Endorsed by American Diabetes Association - PRNewswire

A new study helps illuminate how weight loss can contribute to the remission of type 2 diabetes and how putting pounds back on can cause the disease to return.

The findings, published in December 2019 in Cell Metabolism, suggest that individuals with type 2 diabetes who achieve remission after weight loss may relapse if they regain weight in part because this leads to an accumulation of fat in the liver.

Researchers examined data on 57 overweight and obese people with type 2 diabetes who participated in a prior study, which was published in March 2019 inThe Lancet Diabetes & Endocrinology. Those study authors goal was to see if following a low-calorie diet for three to six months would help participants lose at least 15 kilograms (about 33 pounds) and lower their blood sugar levels enough to achieve remission of diabetes. Researchers checked participants weight, blood sugar, and fat levels in the liver and pancreas after 5, 12, and 24 months.

After five months, 28 people achieved the targeted weight loss and diabetes remission. By the end of two years, however, 13 of them had relapsed. People who achieved lasting remission lost more weight initially, kept more weight off than those who relapsed, and had less fat in the liver and pancreas by the end of the study.

Excess calorie intake over many years will initiate vicious cycles of fat accumulation within both the liver and the pancreas that eventually causes diabetes, says lead study author Ahmad Al-Mrabeh, PhD, of Newcastle University in the England.

Decreasing liver fat can lead to remission of diabetes, Dr. Al-Mrabeh says. When you do, he adds, the liver stops sending out excess fat to the rest of the body, and therefore pancreas fat levels decrease.

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Type 2 diabetes is a multifactorial disease, with genetics and lifestyle both contributing to risk. The disease is also associated with obesity and inactivity, and develops when the body cant effectively use the hormone insulin to regulate blood sugar, according to the World Health Organization. The pancreas produces insulin, and must increase production when the body doesnt use this hormone efficiently. Yet theres a limit to how much insulin the pancreas can make, and diabetes results when the pancreas can no longer keep up with the bodys insulin demands to keep blood sugar levels in check.

Left untreated, type 2 diabetes can increase the risk of kidney failure, heart attacks, strokes, blindness, lower limb amputations, and other potentially life-threatening complications.

Regular exercise, eating well, and maintaining a healthy weight can help prevent type 2 diabetes. These lifestyle habits can also help lower blood sugar and minimize complications when people do develop diabetes, according to the World Health Organization.

While weight loss has long been linked to diabetes remission, the current study offers fresh insight into how the two are related, says senior study author Roy Taylor, MD, also of Newcastle University.

When people cut calories, the body will get the energy it needs by burning up fat thats stored under the skin, Dr. Taylor says. By contrast, when people consume too much food, these fat stores fill up and then excess fat starts accumulating in the liver.

Excess liver fat will lead to higher supply of fat to all tissues, including the pancreas, Taylor says.

When fat builds up in the pancreas, this interferes with insulin production, making it harder for the body to regulate blood sugar and contributing to diabetes. When people achieve diabetes remission through weight loss, regaining weight can restart the process of fat accumulation in the liver, and then the pancreas, and lead to relapse, according to the study.

RELATED: Which Types of Diabetes Can Be Put in Remission?

At the start of the study, all of the participants tended to have higher A1Cs. A1C is a blood test used to diagnose diabetes and determine how well blood sugar is being controlled. It shows the percentage of hemoglobin (a molecule on red blood cells) that is coated with sugar, and reflects average blood sugar levels over two to three months. Readings above 6.5 signal diabetes, according to the Mayo Clinic.

People who never achieved remission in the study started out with more severe diabetes, with average A1C readings of 7.9, compared with average A1C readings of 7.4 among people who did experience remission.

Weight loss initially brought about similar reductions in the percentage of fat in the liver and pancreas for people who achieved diabetes remission, as well as for those who didnt.

After five months, people in remission had 3.4 percent liver fat compared with 2.6 percent in people who didnt achieve remission but this difference wasnt statistically meaningful.

Participants also experienced similar decreases in fat levels in the pancreas after five months: a decline of 0.91 percentage points among people who went into remission and 0.17 points for those who didnt. This difference also wasnt statistically meaningful.

By the end of the two-year follow up period, though, pancreatic fat levels had dropped by 1.65 percentage points among people with sustained remission and only 0.51 percentage points among those who didnt.

One limitation of the study is that it was small, and researchers based their two-year analysis on only 20 people who sustained remission and 13 people who relapsed.

Its also not clear from the study whether people took medication for diabetes, what they ate, or how much they exercised factors that can influence whether people achieve remission.

It would have been helpful if the study included more information about how weight loss was accomplished, says Sheri R. Colberg, PhD, professor emerita of exercise science at Old Dominion University in Norfolk, Virginia.

RELATED: 6 Great Exercises for People With Diabetes

The most important message is that people have to do whatever they can with their lifestyle to improve their insulin sensitivity, says Dr. Colberg, who wasnt involved in the study. Insulin sensitivity refers to how efficiently the body can use the hormone to convert sugars into energy.

Dietary restriction can help with this and insulin resistance decreases even before significant weight loss but weight regain is very common, Colberg adds. Both a low-carb diet and consistent workouts can help people with diabetes lose weight and lower blood sugar, she says.

But many people who rely on diet alone to maintain weight loss regain many of the pounds they lose, Colberg says. Exercisers, on the other hand, can keep weight off when they continue to be active.

Physical activity is likely the most important way to keep muscles insulin sensitive and to avoid excess carbs being converted into fat and stored in the liver and pancreas, Colberg says.

RELATED: 7 Exercise Motivation Tips for People With Type 2 Diabetes

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Study Sheds Light on How Fat Loss Can Put Type 2 Diabetes in Remission - Everyday Health

All those who suffer from type 2 diabetes are in a constant tug of war with their blood sugar levels (in other words, blood glucose). Managing the condition requires being mindful of what you eat and drink. When you crave a little bit of sweetness in your life, research has shown that theres a certain sweetener that can help control blood sugar levels.

Dr Grace Farhat, a lecturer from Liverpool Hope University in food science and nutrition, revealed: Stevia a naturally-occurring sweetener could be a new player against obesity and diabetes.

Stevia is a plant-based alternative to sugar that has been used by the indigenous people of South America for thousands of years.

Previous studies have suggested certain non-nutritive (also known as artificial) sweeteners may increase appetite while also altering the make-up of the gut bacteria, resulting in several human conditions such as obesity and diabetes, added Dr Farhat.

In her experiment, test subjects were asked to drink either plain water, water mixed with 60g of sugar, or water mixed with just 1g of stevia sweetener (a non-nutritive sweetener), before having an unlimited pizza lunch half an hour later.

We wanted to see if stevia led to people eating more, because thats the presumption when theres sweetness without the calories, said the doctor.

The non-nutritive sweetener (stevia) adds a sweetening effect without adding carbohydrates or calories.

But what we found was that there was no difference in food intake between stevia, water or sugar, continued Farhat.

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People ate the same amount of food after these different preloads.

This finding suggests stevia doesnt increase your appetite to compensate for the lack of calories, like some other sweeteners.

Whats also important, added Farhat, is to note that those who consumed stevia were less hungry than when they just had plain water.

It shows we can reduce hunger without the need for consuming more calories.

And thats important, because if were going to control diabetes and obesity we need to control appetite and blood sugar levels.

Results such as these reveal that consuming stevia will help prevent people from overeating and consuming more carbohydrates which affects blood sugar levels.

With the NHS spending 14 billion each year - 10 percent of its overall budget - treating diabetes and its complications, and an estimated 1.2 million increase in the number of people suffering from the condition by 2030, this breakthrough study gives a glimmer of hope to more easily controlling blood sugar levels.

Dr Farhat added: While further studies are needed, our research shows stevia could be a promising option when it comes to controlling energy intake.

Therefore, it could have a beneficial effect when it comes to obesity and diabetes.

Published in the journal Nutrients, Dr Farhat concluded: Stevia lowers appetite sensation and does not further increase food intake and post-lunch glucose levels.

It could be a useful strategy in obesity and diabetes prevention and management.

Diabetes UK has reported that stevia is 200300 times sweeter than sugar and is heat stable, so it can be used in cooking and baking.

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Type 2 diabetes: This popular sugar-alternative could be key weapon in fighting condition - Express