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Anthony Anderson's character, Dre Johnson (L), is diagnosed with type 2 diabetes in the ABC hit ... [+] show, black-ish. Tracie Ellis-Ross (R) plays his wife. (Eric McCandless via Getty Images)

Walt Disney Television via Getty Images

"If you keep eating cakes and cookies, you'll get diabetes like me and your father." Rolling my bored, undergrad eyes, I clarified, "That's not how you get diabetes, Ma."

Twenty years later, my mother no longer believes that sugary foods are the culprit behind the chronic, systemic disease. Another common misconception - based on prior reality - is that type 2 diabetes affects only older adults, a.k.a. "adult-onset diabetes." Not the case, nor has it been for a while now. In fact, a recent study in the U.K. reveals that 1 in 8 new cases of type 2 diabetes is occurring in 18-40 year-old adults vs. 1 in 10 back in 2000.

Art is also imitating life as far as the blood sugar disease goes. Diagnosed at age 32, Emmy-nominated Anthony Anderson is a passionate advocate for diabetes awareness, education and treatment. And in a December 2017 episode, "Sugar Daddy," the actor used one of his biggest platforms - his hit television show, black•ish - to feature his character, Dre Johnson, with a type 2 diabetes diagnosis.

Another study this year in Medscape Medical News reported that teenagers diagnosed with type 2 diabetes had "alarmingly" high rates of diabetes-related complications by their mid-20s.

A patient undergoes dialysis. Diabetes is a leading cause of kidney failure. (AP Photo/Rich ... [+] Pedroncelli)

ASSOCIATED PRESS

Diabetic Complications

The complications of this blood glucose disorder can be deeply upsetting. As a general internist and former primary care physician, I have seen patients experience blindness from diabetic retinopathy; attend dialysis three times per week because of diabetic nephropathy-induced kidney failure; and become wheelchair-bound after undergoing below-the-knee amputations caused by severe nerve and arterial damage.

By the time these complications manifested, most of my patients were in their 50-60s, if not older. But going blind or getting a foot cut off at 21? Devastating. Especially in light of the grim mortality data: people with type 2 diabetes have an average life expectancy of 55 because of their higher risk of heart attacks, strokes and kidney disease.

Why Is Diabetes Affecting More And More Young Adults?

Dr. Naveed Sattar from the University of Glasgow thinks it could be that we are simply doing a better job of screening for the type 2 diabetes at a younger age. But the study found that nearly 75% of the younger adults had alarmingly high levels of the "bad" LDL cholesterol, a known risk factor. Yet only 4% were taking lipid-lowering medications like statins.

In addition, the study showed that 3/4 of young adults were obese compared to less than half of those diagnosed with type 2 diabetes in their 70s.

Oscar-winning actress, Halle Berry, was diagnosed with diabetes at age 22. She has since reversed ... [+] the illness. (Photo by Gregg DeGuire/FilmMagic)

FilmMagic

Female Trend

Another striking pattern: females in the youngest age group (18-40 years) had a higher incidence of type 2 diabetes compared to women 40-60. A known risk factor for cardiovascular disease, diabetes confers a nearly 6-fold higher rate of occlusive vascular mortality (i.e. ischemic heart disease and stroke) in women aged 35-59, according to Anna Norhammar in The Lancet.

Prevention and Treatment Work!

Comedian Sherri Shepherd, diagnosed with diabetes in 2007, made changes to her diet, started ... [+] metformin and over time, lost 30 lbs. (Photo by: Charles Sykes/Bravo/NBCU Photo Bank via Getty Images)

NBCU Photo Bank via Getty Images

Studies show that these steps can not only treat but even reverse type 2 diabetes:

Healthier Meal Plan: plant-based meals with lean meats (chicken, turkey, fish) and whole grains is the leading recommendation. Add some flavor with garlic, black pepper and paprika!

Increased Physical Activity: you don't need to run a marathon. Just 20 minutes of brisk walking 4-5 times per week can be impactful.

Medications: metformin, glyburide and insulin are a few of a long list of meds that can treat diabetes. Aspirin and statins can lower this risk of heart attacks and strokes.

The rising rates of this chronic illness in young adults adds to the global epidemic where the number of people with diabetes has nearly quadrupled from 108 million in 1980 to 422 million in 2014, according to the World Health Organization. But with aggressive public health campaigns including childhood, elementary and high school education, we can slowly reverse these numbers.

Poor diabetes control was responsible for £3 billion in potentially avoidable hospital treatment in England in the operational year 2017-2018, according to new research comparing the costs of hospital care for 58 million people with and without diabetes.

The findings, being presented at this year's European Association for the Study of Diabetes (EASD) Annual Meeting in Barcelona, Spain (16-20 September), reveal that on average, people with type 1 diabetes require 6 times more hospital treatment (£3,035 per person per year), and those with type 2 diabetes twice as much care (£1,291; after adjusting for their older age), than people without diabetes (£510).

Other than age, diabetes is the largest contributor to healthcare cost and reduced life expectancy in Europe. In England, two-thirds of people with type one diabetes and a third of those with type 2 diabetes have poor control over the blood sugar levels, increasing the risk of multiple long-term health problems ranging from kidney disease to blindness, and the need for additional hospital care.

In this study, researchers used data from the NHS Digital Hospital Episode Statistics in England and the National Diabetes Audit (2017-2018) to compare the cost of hospital treatment provided to people with type 1 and type 2 diabetes to people without diabetes, after adjusting for the effect of age.

Data on elective (planned) and emergency admissions, outpatient visits, and accident and emergency department (A & E) attendances for 58 million people including 2.9 million with type 2 diabetes, and 243,000 with type 1 diabetes between 2017 and 2018 were analysed. This included 90% of all hospital care provided across England.

Of total hospital costs of £36 billion in 2017-2018, the NHS in England spent around £5.5 billion on hospital care for people with diabetes. Of that sum, an estimated £3 billion (8%) was excess expenditure on diabetes (after accounting for age)—almost 10% of the NHS hospital budget.

Compared to people without diabetes, the average annual cost of elective care was more than two times higher for people with type 2 diabetes (£759 vs £331), and the average cost of emergency care was three times higher (£532 vs £179), having allowed for their age difference. Similarly, average costs for people with type 1 diabetes were five-fold greater for elective care (£1,657 vs £331) and eight-fold higher for emergency care (£1,378 vs £179).

"People with diabetes are admitted to hospital more often, especially as emergencies, and stay on average longer as inpatients. These increased hospital costs, 40% of which come from non-elective and emergency care, are three times higher than the current costs of diabetes medication. Improved management of diabetes by GPs and diabetes specialist care teams could improve the health of people with diabetes and substantially reduce the level of hospital care and costs", says author Dr. Adrian Heald from Salford Royal Hospital in the UK.

The authors note that the study did not include the indirect costs associated with diabetes, such as those related to increased death and illness, work loss, and the need for informal care.

Citation: Poor diabetes control costs the NHS in England 3 billion a year in potentially avoidable hospital treatment (2019, September 19) retrieved 29 September 2019 from https://medicalxpress.com/news/2019-09-poor-diabetes-nhs-england-billion.html

This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

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Related Video: Utah School Won't Accommodate Diabetic Boy, Lawsuit Claims (Provided by CBS News)

A family in Utah has filed a lawsuit arguing that the school district is preventing their son from going back to school after a disagreement about his diabetes treatment plan. Caly Watkins' 8-year-old son – whose first name we've agreed not to share – spent his summer fishing and hosting his own YouTube show, but now that the school year has started, instead of joining his third grade classmates he's learning his lessons alone in his kitchen. 

Diagnosed before age 2, he requires up to eight insulin injections a day. In a recently filed lawsuit, the family claims the school made several potentially dangerous mistakes with his dosage in 2018. So they requested they be allowed to prepare his diluted insulin and pre-fill the syringes at home. The school district will not allow that, saying pre-filled syringes must be prepared by a pharmacist.

"He has doctor's orders that state he needs this with him at all times. Utah law says he can carry anything prescription or non-prescription. But yet they refuse," Watkins said.  

The lawsuit alleges that due to the school district's "refusals to accommodate" his "disability and medical needs, he has been denied his right to attend school with his non-diabetic peers." It also argues the district's request would require the parents to "pay several hundred dollars out of pocket "for a completely unnecessary service" not "covered by insurance." 

"It's pretty clear that when there is an individual with a disability, a qualified individual, schools have to make modifications to policies to enable people with disabilities to have the same access," said Nate Crippes, who represents the Watkins.

 

The Office of the Utah Attorney General, which is representing the Jordan School District, says it "is unable to comment directly on the allegations" but says "approximately 130 students with Type 1 diabetes receive direct nursing services."  They also say the "issues raised in this case highlight" the difficulty in balancing "the specific requests of individual students … with the need to provide a safe learning environment for all students."

Dr. Deena Adimoolam, an endocrinologist at New York's Mount Sinai, says lack of staffing and concerns over liability can affect children's care in school.

"We are seeing an increased number of these cases in schools," she said. "It is a 24-hour, 7-day a week illness that requires self-care and management. The needs of these kids need to be taken care of all day long in order to be successful with their disease." 

On a national level, the Department of Education's Office for Civil Rights says so far in the 2019 fiscal year, it has received 50 complaints about how school districts handled diabetes-related cases.

The Watkins family hopes their legal battle will help others.

"It's heartbreaking," Caly Watkins said. "There's no reason why he should not be with his peers."

Among adults with type 2 diabetes older than 75 years, those in poorer health were more likely to use insulin whereas those in better health were less likely to continue using it, a new large health plan database study has found.

The results, from more than 20,000 individuals aged 75-79 years, were published online September 23 in JAMA Internal Medicine by Jonathan Z. Weiner, MD, MPH, of the Division of Research, Kaiser Permanente of Northern California, Oakland, and colleagues.

The study findings are contrary to the authors' hypothesis that adults with poor health would be more likely to discontinue insulin after age 75 years.

"The observed pattern of insulin discontinuation in the present study runs contrary to what we would expect to find based on [American Diabetes Association] and other guideline recommendations that suggest relaxed glycemic control in adults with poor health status," Weiner and colleagues write.

But one expert on treating the elderly with diabetes tells Medscape Medical News that the findings aren't necessarily a surprise. 

Little Guidance on Treatment, None on Insulin Use, in Older Patients

Despite the fact that type 2 diabetes affects more than 20% of people over the age of 75 years in the United States, there is little evidence to guide treatment in that age group as they are usually excluded from clinical trials, Weiner and colleagues point out.  

And any benefits of tight glycemic control may not appear during the remaining lifespans of such individuals and their risk of hypoglycemia is greater than in younger people.

Professional societies advise higher glycemic targets for older adults on an individualized basis, but none specifically address the use of insulin, the authors note.

"Existing...guidelines provide frameworks for prescribers to contemplate deintensification but do not necessarily provide practical recommendations to implement this process into everyday practice...More trials are needed to provide clinicians with practical tools and protocols to reduce the use of high-risk, low-benefit medications," they write.

Simplification of Therapy Can Still Mean Insulin Use

The findings of the new trial make sense to one expert, however.

"I'm not surprised that people in poor health are on insulin because they often don't have other options," said Medha N. Munshi, MD, director of Joslin Geriatric Diabetes Programs at Beth Israel Deaconess Medical Center, and associate professor of medicine at Harvard Medical School, Boston, Massachusetts.

Other oral glucose-lowering medications are often contraindicated in such patients, for example because of renal insufficiency, she explained.

Moreover, Munshi, who was a coauthor of the 2012 ADA consensus report on diabetes in the elderly and a 2016 ADA statement on diabetes care in residential facilities, noted that the goal for older adults with type 2 diabetes isn't "de-prescribing" of insulin per se, but to make sure the treatment regimen aligns with patients' needs and goals, which change as they age.

"We should be focusing on making sure the complexity fits the patient. Simplification could still include insulin, and in some cases, there aren't other options," said Munshi. 

She also lamented that current guidelines are based largely on expert opinion because of the lack of data in older adults.

"We have to stop that and start doing studies focused on aging and diabetes, and not just epidemiological and observational studies and subpopulation analyses," she said.

Those in Poorer Health Most Likely to Continue Insulin

The study by Weiner and colleagues included 21,531 individuals older than 75 years with type 2 diabetes for a mean duration of 9.4 years.

At baseline, 51.3% were classified as having good health, defined as less than two comorbidities or two comorbidities yet still with evidence of physical activity. Another 40.1% had intermediate health, defined as more than two comorbidities or two comorbidities without evidence of physical activity. The other 8.6% had poor health, defined as having any end-stage disease regardless of the number of comorbidities.

Overall, 18.9% used insulin in the year prior to turning 75 years old, with a mean 7.9 years' duration of use. The proportions using insulin among those in poor, intermediate, and good health were 29.4%, 27.5%, and 10.5%, respectively (P < .01).

Compared to those with good health, adjusted risk ratios for insulin use were 1.85 for intermediate health and 2.03 for poor health (both P < .01). 

Over a mean follow-up of 3.7 years, 32.7% of the overall group who were using insulin at age 75 years discontinued using it, at a mean of 1.6 years, while insulin regimens were simplified in 7.9%.

Insulin discontinuation was significantly more likely among patients with a last measured hemoglobin A1c of 7.0% or less.

The proportions of patients who discontinued insulin among those with good, intermediate, and poor health were 38.9%, 32.7%, and 27.6%, respectively (P < .01).

However, the opposite pattern was seen with insulin continuation, which occurred in 4.7%, 7.8%, and 10.9%, respectively (P < .01).

Compared with good health, adjusted risk ratios for continued insulin use were 1.47 for poor health and 1.16 for intermediate health (both P < .01).

More Study Needed to See if Insulin Continuation Appropriate or Not

According to Weiner and colleagues, "The results of this study suggest that neither prevalent insulin use nor subsequent insulin discontinuation among older patients is closely aligned with current recommendations to incorporate health status (in conjunction with life expectancy and patient preferences) when making treatment decisions."

But Munshi cautioned, "The findings should not be interpreted as saying patients need to be taken off treatment...More focused studies need to be done to say whether it's appropriate or not."

Earlier this week, Munshi led a 2-day meeting of about 30 experts interested in diabetes and aging. Among the topics discussed were the available evidence to guide decision-making in older adults with diabetes, the current knowledge gaps, and both short- and long-term solutions. A white paper is planned.

Internal funding for the study was awarded by Kaiser Permanente of Northern California. Weiner has also reported receiving support from the Division of Research Delivery Science Fellowship Program. Munshi has reported being a consultant for Sanofi and Eli Lilly.

JAMA Int Med. Published online September 23, 2019. Abstract

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

Share on PinterestJDRF and others are stepping up efforts to find a biological (cell-based) cure for type 1 diabetes.

JDRF is establishing a string of type 1 diabetes cure research "Centers of Excellence" around the country, with the first already launched in Northern California.

In the biggest cure-focused acquisition ever, Boston-based Vertex Pharmaceuticals has acquired nearby diabetes stem cell biotech startup Semma Therapeutics.

Researchers at Johns Hopkins have discovered mysterious "Hybrid X Cells" that may play a big role in the development of autoimmunity and possibly trigger type 1 diabetes.

New research shows that eating too much gluten in the first 18 months of life may also be a trigger to developing T1D.

Newsflash, Folks: We aren't expecting to see a cure for diabetes at any point soon. But there are dedicated researchers out there working non-stop to pave the path, and they've made some interesting headway recently.

Among the progress is JDRF's launch of a new model for a cure research center, a bio-startup working on beta cell replacement that was just acquired by a large established Pharma company, and new research results presented at the big EASD (European Association for the Study of Diabetes) conference in Spain last week. That event also produced some key new information about the impact of gluten on type 1 diabetes.

Here's a brief look at these diabetes cure topics making headlines at the moment:

JDRF launches first cure-focused 'Center of Excellence'

The JDRF announced Sept. 4 that it's opened the first "Center of Excellence" aimed at T1D cure research, and plans to establish more at already-existing university and other research spots around the country and world. The first one is a collaboration between Stanford University and the University of California at San Francisco (UCSF), based on their shared work in immune system, beta and stem cell research.

Specifically, researchers there will concentrate on "the interaction of immune cells with insulin-producing beta cells; generating islets and immune cells from stem cells for next-generation therapies; and developing ways to transplant insulin-producing cells into people with T1D without requiring immunosuppression."

Since insulin cell transplantation isn't widely available for a variety of reasons -- including organ and cell donation limitations, and immunnosuppresion drugs that must be taken afterward for life -- the JDRF Northern California Center of Excellence will try to address those obstacles through continued research in beta cell biology and immunology.

The new designation means the JDRF and California researchers will work together to make sure the best people and necessary funding are funneled to this particular center. The same rationale will apply to future centers the JDRF opens and whatever their particular focus is.

For its part, the JDRF says this new model will provide these Centers of Excellence with "the stability to drive longer-term projects, as well as the flexibility to be nimble as new science emerges. The innovative funding model promotes collaboration and provides longer-term stability to institutions that have demonstrated excellence in T1D research. Each will be initially funded for five years. Funding beyond year three will be confirmed after a review and evaluation."

The T1D organization also notes that these centers will serve as central pillars of JDRF's broader strategy on cure research, and they're sponsored through donor contributions. For this first Northern California center, the JDRF credits these individual donors: Karen and Jeff Jordan, Michelle Griffin and Tom Parker, and Karen and Joe Niehaus.

Of course, we're curious how this will transform JDRF's cure research and better focus the resources and efforts happening around the U.S. and globally, and what this will mean for scientists and entites already working in these areas. In the past, cure research efforts definitely seemed a bit scattered, with many dots nots effectively connected. Hopefully, this new model will eliminate duplication and help hone in research where it matters most.

Largest T1D cure research acquisition ever

Also announced at the start of September, a huge corporate acquisition made headlines in the arena of diabetes cure research. Boston-based company Vertex Pharmaceuticals, largely focused on cystric fibrosis to date, bought the diabetes stem cell biotech startup in Cambridge, MA, known as Semma Therapeutics. That company was started in 2014 by high-profile researcher and D-Dad Dr. Douglas Melton, who's been working for over a decade on the creation of new insulin-producing cells.

You may remember that Melton made huge news back in 2013 with what was largely hailed as a breakthrough, though a few years later his research was retracted and called into question. His startup Semma came about in 2015 and was interestingly one of the first funding projects for JDRF's venture philanthropy T1D Fund (see our recent coverage here) in 2017.

Vertex has now shelled out $950 million to tap into the work Semma's been doing. The JDRF describes this as likely the largest T1D cure-focused transaction to ever occur.

Semma's approach has been two-pronged:

Working to create a new supply chain of beta cells from human-derived stem cells, with the aim of transplanting these new cells directly into the liver, where they can produce insulin to naturally regulate BG levels.

Creating a device that can be implanted with the new insulin-producing cells housed inside, protecting them from the immune system attack. (Others working on this include ViaCyte, Eli Lilly with Sigilon Therapuetics, and the Diabetes Research Institute with its BioHub).

Semma's work remains in early clinical trials involving animals at this time, and there's certainly no guarantee it will pan out. But it's a huge potential boost to have a company like Vertex now devoting energy and resources to the effort.

Melton says, "Semma was founded to dramatically improve the lives of patients with type 1 diabetes. Vertex is ideally suited to accelerate the achievement of this goal."

Leaders at JDRF's T1D Fund seem to agree.

"This is a major milestone in our fight to cure type 1 diabetes, in two respects," says the T1D Fund's Executive Chairman Sean Doherty. "First, a terrific company like Vertex has the resources and expertise to achieve Dr. Melton's vision, which JDRF shared and supported for many years. Second, we think that investors and industry will take notice of such a substantial value placed on promising type 1 diabetes therapies and look for opportunities to invest in other T1 diabetes efforts in a new, developing market."

Hunting down rogue cells that cause diabetes

Researchers at Johns Hopkins in Baltimore have apparently discovered a mysterious group of "previously unknown cells" lurking in the body that may play a big role in the development of autoimmunity and possibly trigger type 1 diabetes. They've named this enigmatic new entity "Immune Cell X" because of its ability to morph into two other types of cells.

Supposedly, scientists have long believed these hybrid cells could not exist, but if they did, then they were likely just a tiny population along the lines of 7 out of every 10,000 white blood cells. Per Dr. Abdel-Rahim A. Hamad, an associate professor of pathology at Johns Hopkins who co-authored this latest study. For whatever reason, these so-called "rogue cells" get confused and transition into another type that the body deems foreign, and that starts the immune attack that eventually leads to T1D.

Not everyone in the research community is convinced of this, though. Because while other environmental and genetic triggers for T1D may also be at play, it's also possible that the apparent hybrid X cells are actually some of the other "normal" cells and not rogue imposters at all; they may simply serve two functions.

What's clear is that more research is needed on this front, and no doubt that will take time.

Assassinating Rogue Cells

Whether these hybrid X cells are important or not, other new findings presented at the #EASD2019 conference in Barcelona present a way to combat whatever the true T1D-triggering culprit may be at the cellular level.

Belgian clincial-stage company Imcyse is developing immunotherapeutics that might help treat and prevent chronic conditions like T1D, by developing peptides that could be injected or implanted into the body in order to identify and kill off the cells that attack the immune system -- as in the case of T1D.

Early trial data suggests that Imcyse's does indeed increase the number of protective cells in the body. These results are now expected to buoy the company's efforts and help fund a next-phase of research in 2020.

The diabetes-gluten effect?

One more new study presented at EASD caught our eye -- on gluten and diabtes, more in the realm of prevention than cure, but important nonetheless.

The impact of gluten on T1D has been a long-explored topic. It goes along with cow's milk and other potential environmental triggers of type 1 diabetes (especially in children).

This newest study shows that a child's intake of gluten at 18 months old led to a whopping 46% increased risk of developing T1D for each extra 10g of gluten consumed per day. However, there was no link between the prospective mother's intake of gluten during pregnancy and type 1 in her child. This research came from Oslo University Hospital and the Norwegian Institute of Public Health in Norway.

The study authors note, "Our observations may motivate future interventional studies with reduced gluten intake to establish whether there is a true causal association between amount of gluten intake in the child's early diet and type 1 diabetes in susceptible individuals."

Why this gluten effect, you might ask?

The researchers suggest it could be based on gluten influencing the gut microbiota and inducing inflammation in a so-called 'leaky gut' fashion. It could also be that gluten sometimes works with other triggers or environmental factors at play -- including a virus or genetic predispostion in children -- to push a child toward type 1.

Interestingly, the study authors specifically say their findings are not enough to push people away from eating gluten, especially cereal and bread that are such common gluten sources. And of course, more research is necessary.

Bottom line

The headlines around "diabetes cure" never seem to stop. It's important to be realistic about the incremental nature of scienfitic discoveries and not inflate false hope.

But it's equally important to know just how much research is underway, and follow the progress being made. So much investment and effort is bound to lead us at least to some effective interventions and 'functional cures' in the near future.

Are elderly people with diabetes being overtreated?

A new study suggests that's so: Older, sicker patients tend to be the ones most likely to still be using insulin to manage their blood sugar, despite guidelines that suggest it's often safer to lower diabetes treatment intensity with age.

The study found that nearly 20 percent of people with Type 2 diabetes older than 75 were still using insulin treatment. And almost 30 percent of people with diabetes over 75 in poor health were taking insulin.

One of the most significant side effects of insulin is low blood sugar (hypoglycemia). This can leave you feeling shaky, sweaty, irritable, confused and dizzy. It can also cause an irregular heartbeat, and may lead to fainting. At its most serious, hypoglycemia can cause death, though this happens rarely, according to the American Diabetes Association.

Major health organizations -- including the American Diabetes Association, the U.S. Department of Veterans Affairs and the American Geriatrics Society -- recommend that healthy older patients can maintain tighter blood sugar control. But for patients in poor health, with shorter life expectancies, these groups suggest less aggressive lowering of blood sugar levels.

"It seems a little counterintuitive after you spend decades working hard to control your blood sugar to think about not doing that," said study author Dr. Richard Grant.

"But, as with most things in medicine, there's a risk-benefit ratio, and for most years, there's a much bigger benefit than risk to taking insulin. But as life expectancy decreases, tight blood sugar control provides less benefit than risk," Grant said. He's a research scientist in the division of research at Kaiser Permanente of Northern California, in Oakland.

Grant said patients are often concerned if doctors bring up the idea of treating their diabetes less aggressively. "It's not abandoning care, it's maybe taking half a step back to reduce the risk from treatment," he explained.

The findings were published online Sept. 23 in JAMA Internal Medicine.

Another study published online Sept. 16 in the same journal found that patients don't always follow the guidelines for stepping down their treatment. The study -- led by Dr. Nancy Schoenborn at Johns Hopkins University School of Medicine in Baltimore -- found that 60 percent of people surveyed didn't agree with the guidelines and thought the longer you live with diabetes, the more aggressive your treatment should be.

These findings suggest that patients need better information about why doctors are recommending certain treatments plans over others, Schoenborn said in a university news release. Reducing treatment levels can lower the risk of side effects and improve quality of life, she said.

Grant's study included almost 22,000 people with Type 2 diabetes. Their health was followed for up to four years, beginning at age 75.

Their health was defined as good if they had fewer than two additional medical conditions, or had two additional conditions but stayed physically active. Intermediate health was defined as having more than two additional conditions or having two additional conditions and no weekly exercise. People in poor health had end-stage lung, heart or kidney disease, or dementia or advanced cancer.

People in poor health had double the risk of being treated with insulin compared to those in good health. Those in intermediate health had an 85 percent higher risk of being treated with insulin than those in good health, the findings showed.

Those most likely to continue using insulin throughout the four-year study were those in poor health. People in good health were least likely to stay on insulin.

Grant said, "It's very important for doctors to reassess the goals and treatment of older patients from time to time."

Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, said, "We have to start thinking a bit more about how we treat elderly patients and the impact of treatment on their quality of life."

Zonszein said preventing low blood sugar levels (hypoglycemia) is even more important in older patients, and that there are newer types of insulin and other medications that can be used that have less risk of causing hypoglycemia.

The bottom line, according to the experts, is to maintain an ongoing conversation with your doctor. Anytime your health status changes, talk with your doctor about the benefits and risks of all the treatments you're taking.

More information

Learn more about living with diabetes as you age, from Johns Hopkins Medicine.

Copyright 2019 HealthDay. All rights reserved.

HAMMOND â€" Learn more about the link between sleep and diabetes by attending North Oaks Diabetes Education’s next free group meeting on Oct. 8.

The meeting will be held 5 p.m. to 6 p.m. in the E. Brent Dufreche Conference Center’s Meeting Room C, in North Oaks Diagnostic Center, 15837 Paul Vega, M.D., Drive. No provider referral or preregistration is required.

Dr. Lauren Davis will lead the discussion. Davis is medical director of North Oaks Sleep Disorders Center.

She will explain how diabetes can affect sleep, including how lack of sleep can impact blood-sugar levels and lead to diabetes complications. Davis also will talk about the common types of sleep problems and treatment options. 

For information about upcoming meetings, call the North Oaks Education Department at (985) 230-5723 from 8 a.m. to 4:30 p.m. weekdays or visit northoaks.org/diabetes.

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Some things you expect to be different for men and women â€" puberty, facial hair, periods, the ability to give birth â€" but the way genders experience medical conditions can also be quite different.

Just as science shows the “man flu” might actually be a thing (sorry ladies), diabetes can also manifest differently for women than it does for men.

In a nutshell, men and women experience unique diabetes symptoms because of their differing hormones. For women, diabetes can show up in the form of infections and hormonal imbalances that often affect the reproductive system.

Knowing what to look for is an easy way to stay on top of your health. So ladies, grab a seat. Here’s what we know so far about diabetes and the female body:

Type 1 diabetes often shows up in younger people, typically between the ages of 4 and 7 or 10 and 14. It can sometimes appear as a person gets older, but the likelihood of diagnosis decreases with age. Look out for a few other telltale signs you could be at risk for this condition:

Risk factors for type 2 diabetes are slightly different and have more to do with lifestyle, although genes do play a role. If you’re over 45 years of age and fit into one or more of the following criteria, you could be at risk for type 2 diabetes:

being physically inactive (exercing fewer than 3 times per week)

being overweight

family history (if a parent or sibling has type 2 diabetes, you’re at a higher risk for developing it)

prediabetes (If your blood sugar levels are higher than normal, you’re at risk for developing type 2 diabetes. This is very common ans according to the CDC, 1 in 3 American adults have prediabetes. It can be determined using a blood sugar test.)

Though diabetes is a condition that affects your blood sugar levels, it shows up in the female body in ways you might not expect â€" like around your lady parts.

Diabetes can send your hormone levels out of whack, which explains why it can sometimes have an effect on your reproductive organs. While these situations aren’t usually a sure sign that you have diabetes, they could be early warning signs.

Vaginal yeast infection. If you feel a burning sensation around your vagina and vulva, experience pain during intercourse or urination, see thick, white discharge, or a rash of any kind, you might have a yeast infection. This can happen when the body has an overload of blood sugar, and if it comes back multiple times within a year, it might be a symptom of a larger problem such as diabetes.

Urinary tract infection. Often, diabetes affects the immune system’s natural ability to fight off infection. It can also cause the bladder to have trouble emptying fully, which sometimes leads to UTIs in women. You may notice a constant need to urinate and a burning sensation whenever you do get to go.

Polycystic ovarian syndrome. PCOS is a condition that causes infertility in 6 to 12 percent of American women of reproductive age. It’s also closely linked to type 2 diabetes. Because PCOS can make it difficult for the body to use insulin effectively, it can also be a risk factor for (and ultimately a symptom of) diabetes, especially for women over 40.

Some diabetes symptoms affect men and women equally. For type 1 diabetes, they’ll commonly show up in childhood, but for type 2, they may manifest in older adults. Some things to look for:

frequent urination

constant hunger or thirst

excessive fatigue

numbness in the hands or feet

blurry vision

extreme weight loss

Especially for people with type 2 diabetes, these symptoms can sneak up very slowly and be difficult to spot. If you know you have a family history of diabetes, or if you’ve been diagnosed with prediabetes, monitor your blood sugar closely and ask for frequent check-ins with your doctor.

When a woman with no personal diabetes history begins to develop diabetes symptoms during pregnancy, she is experiencing something called gestational diabetes.

According to the CDC, this typically shows up in the second trimester, and doctors will test for it between 24 and 28 weeks of pregnancy.

Often, gestational diabetes can be managed with a regular exercise regimen and healthy eating habits, though it may sometimes be necessary to take insulin as well.

As long as the condition is treated, there’s little risk of adverse complications to a pregnancy. However, if left unaddressed, gestational diabetes can increase the likelihood of a large baby, premature delivery, or cesarean section.

Women who have gestational diabetes have a higher chance of developing type 2 diabetes after giving birth â€" and later in life as well. Once your pregnancy is over, continue to monitor your blood sugar and look out for any telltale signs of early diabetes.

If you’re concerned you may have type 1 or type 2 diabetes, check in with your primary care physician.

Your doctor can conduct a glycated hemoglobin test to determine your blood sugar levels over the past few months, or a fasting blood sugar test to determine your body’s resting blood sugar levels. You could also be asked to take a test that requires you to drink a sugary liquid and spike your blood sugar.

If results are inconsistent, you may end up taking a series of tests before the diagnosis becomes clear. Regardless, these tests will show whether you have type 1, type 2, gestational, prediabetes, or none of the above. From there, you can start to look ahead to forming a treatment plan.

Depending on which type of diabetes you’ve been diagnosed with, your treatment plan may look a little different. Since gestational diabetes is often limited to the length of the pregnancy, a change in diet and routine may solve the problem on its own. In more serious cases, your doctor may recommend that you take insulin until you give birth.

Typically, with type 1 diabetes, you’ll take insulin as a pill or injection several times throughout the day. Your doctor may also prescribe high blood pressure medications, aspirin (for your heart), or cholesterol-lowering drugs.

One thing to be aware of for women with type 1 diabetes is that birth control pills can sometimes exacerbate your symptoms. Taking hormones often impacts your blood glucose levels, so you may need to switch to a contraceptive method with lower hormone doses, like the IUD or low dose birth control pill.

Type 2 diabetes is also treated with insulin and other medications. Symptoms can be further lessened with regular exercise, a cleaner diet, and weight loss. There’s no cure for type 2 diabetes, but if you treat it carefully, it can sometimes be reversed almost entirely.

The short version

Diabetes symptoms show up differently in women than in men.

While both sexes may experience changes in appetite, fatigue, body numbness, and blurry vision, women specifically might notice reproductive health issues that signal a deeper problem.

If you have frequent yeast infections, UTIs, or are dealing with PCOS, you should pay close attention to your body for other signs of diabetes.

If you’re concerned, your healthcare provider can test your blood sugar levels to see whether you might have diabetes or a high risk for developing it.

If caught early, the condition can be treated quickly â€" and depending on the type, you may be able to reverse its effects.

Survey results of a national sample of elderly people with type 2 diabetes suggest that many long-time patients downplay medical and social factors that underpin professional recommendations for fewer medications and less aggressive treatment of high blood sugar.

The survey study, conducted by Johns Hopkins Medicine researchers, concludes that many older adults with diabetes, when deciding to stop diabetes medicines, don't value factors recommended to individualize diabetes treatment. Instead, they voted in the opposite direction than the suggested American Diabetes Association (ADA) guidelines on several factors.

A report on the findings appears in the September 2019 of the Journal of the American Medical Association (JAMA) Internal Medicine.

An estimated 30 million adults in the United States are living with type 2 diabetes, a condition marked by the body's inability to produce enough or properly use insulin to regulate glucose, a main source of energy for cells. While weight loss, good diet, exercise and medications can control high blood sugar levels, treatment guidelines developed by the ADA and other professional groups are designed to be adjusted as people age, life expectancy shortens, and such factors as drug side effects, treatment compliance and quality of life issues play different roles.

"What our study found is that many geriatric patients, 65 years or older, with type 2 diabetes perceive their treatment plans much differently than do their care providers, and may be more likely to choose a more aggressive treatment plan than what guidelines recommend, which poses greater risk for complications, injury or even death," says Nancy Schoenborn, M.D., associate professor of geriatric medicine at the Johns Hopkins University School of Medicine and leader of the research team.

The researchers found that many patients especially did not agree with recommendations to stop a medicine.

"The current American Diabetes Association guidelines for managing type 2 diabetes aren't intuitive to patients, and we need to do a better job helping them understand the benefits and consequences of making changes to treatment regimens that must evolve over time on an individualized basis," Schoenborn says.

One reason that the Johns Hopkins Medicine researchers decided to study the patient-versus-provider perspective on diabetes care and management was to assess whether ADA-recommended guidelines about individualized diabetes care—which doctors often use as a reference for patient treatment—were intuitive to patients or if patients had different perceptions about their care. They also wanted to learn how patient preferences about their diabetes care evolved.

For the study, the researchers created and conducted an online survey using Knowledge Panel, the nation's largest probability-based online questionnaire format representing the U.S. adult population. Data were collected for 818 participants between December 2018 and January 2019 of a representative sample of people age 65 and older living with type 2 diabetes for up to 20 years. The average age of participants was 74 years, and 54% were male. Participants identified as white (68%), African American (15%), Hispanic (9%) and other (8%). `

The study subjects were asked to rate seven factors reflected in treatment guidelines including ADA guidelines: length of time with diabetes, development of any diabetes-related complications, other health conditions, life expectancy, risk of side effects from treatment, treatment cost and treatment effort.

Specifically, participants were asked to share their perceived importance of each of the seven pre-defined factors in deciding to add or stop a medication; and in deciding which patients should receive less aggressive or more aggressive diabetes treatment.

The ADA guidelines recommend generally less aggressive diabetes treatment for patients who have had long-standing diabetes. However, the researchers found that 60% of the people surveyed were in opposition to the guidelines and felt instead that the longer one lived with diabetes, the more aggressive treatment should be. The guidelines also recommend less aggressive diabetes treatment for patients who have many other health conditions and those who already have developed complications from diabetes. However, the researchers found that 76% of the people surveyed felt that those who already have complications from diabetes should be treated more aggressively than those without complications, and 67% felt that people with many other health conditions should be treated more aggressive than those with no other health conditions.

According to Schoenborn, the ADA guidelines take into consideration life expectancy and treatment side effects. Thus, more aggressive diabetes treatment is appropriate for patients with longer life expectancies, a recommendation with which 78% of the study participants agreed.

The challenges arise, Schoenborn says, when physicians and patients must come to a consensus about treatment tradeoffs and measures based on disease progression, complications from other health problems, and medication side effects and compliance. Approximately forty-seven percent of participants did not think that any of the seven factors were important enough to stop a medication, and only 8% considered stopping a medication if they were required to spend a lot of effort managing their diabetes.

Schoenborn says the study findings suggest that physicians who care for older people with diabetes could benefit from materials that better explain to patients why they recommend certain treatment options over others.

"It's often hard for patients to understand the rationale behind the treatment options," says Schoenborn. "Physician awareness of the disconnect along with an individualized approach to each patient may result in a better, more acceptable plan."

Next steps for Schoenborn and her team involve looking at the impact of altering or stopping medications for older adults with diabetes, a process known as deprescribing.

"Past research has shown that deprescribing efforts can reduce the risk of medication side effects and drug-drug interactions, and improve quality of life," Schoenborn says.

Citation: Survey suggests elderly patients with diabetes may favor more aggressive blood sugar control (2019, September 24) retrieved 24 September 2019 from https://medicalxpress.com/news/2019-09-survey-elderly-patients-diabetes-favor.html

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RICHMOND, Va., Sept. 23, 2019 (GLOBE NEWSWIRE) -- ALR Technologies, Inc. (OTCPINK: ALRT) has created an algorithm for advancing medication therapies for patients with non-insulin dependent type 2 diabetes mellitus. The algorithm assists prescribers in making evidence-based medication therapy selections in accordance with the latest clinical practice guidelines set forth by the American Diabetes Association (https://care.diabetesjournals.org/content/42/Supplement_1).

ALRT Diabetes Solution is an FDA-cleared, HIPAA-compliant, remote diabetes patient management system that leverages blood glucose data patterns to improve diabetes outcomes.   The system includes patent pending predictive A1C and FDA cleared insulin dose adjustment features to assist healthcare providers to manage patients who use insulin therapy. The new algorithm expands the functionality of the current ALRT system to support therapy advancement decisions for the myriad of diabetes patients who are not using insulin.

The ADA has a well-vetted decision tree to help prescribers advance medication therapies for patients throughout the continuum of diabetes care. The new NID algorithm directly follows ADA guidelines, and will allow the ALRT Diabetes Solution to assist prescribers in proceeding with evidence-based treatment options, from the most basic non-insulin regimen up to basal/bolus insulin therapy. We will be offering the complete package bundled with and at the cost of very competitively priced blood glucose testing supplies. Using the ALRT platform, primary care physicians and their teams will be able to titrate medication therapies in shorter time frames and rapidly measure the impact of those therapy changes. Diligent patient management in the primary care setting improves clinical outcomes and dramatically reduces healthcare delivery costs.

About ALR Technologies Inc.ALR Technologies is a medical device company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes: an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices; a patent pending Predicative A1C to track treatment success between lab reports; FDA-cleared Insulin Dosing Adjustment that suggests insulin dosing changes  per evidence based guidelines to optimize drug therapy; and, performance tracking to ensure best practices are followed. Currently, the Company is focused on diabetes and will expand its services to cover other chronic diseases anchored on verifiable data. More information about ALR Technologies, Inc. can be found at www.alrt.com.

Contact:    Ken Robulak:   727.736.3838                       email: info@alrt.com 

This release contains certain "forward-looking statements" relating to ALR Technologies' business, and these statements reflect the current views of ALR Technologies with respect to future events and are subject to certain risks, uncertainties and assumptions. When used, the words "estimate", "expect", "anticipate", "believe" and similar expressions are intended to identify such forward-looking statements. There are many factors that could cause the actual results, performance or achievements of ALR Technologies and its products to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Further management discussions of risks and uncertainties can be found in the Company's quarterly filings with the Securities Exchange Commission.

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A popular household plant could hold promise as a new and effective way for people to manage their diabetes in the future â€" maybe even without side effects.

Research suggests that juice from the drought-resistant aloe vera plant could help people with diabetes manage their blood sugar levels.

People have embraced aloe vera â€" of the genus Aloe â€" for its medicinal properties for centuries. Aloe vera has a long-standing reputation for its anti-inflammatory and healing properties, including healing sunburns and other wounds.

In fact, aloe vera contains 75 active components, including:

vitamins

minerals

enzymes

amino acids

Although experts caution that more research is still needed, in recent years, researchers have been delving into aloe vera’s potential to help people lower their high blood sugar levels and keep their diabetes in check.

In 2016, a team of researchers reviewed a number of research studies that examined the use of aloe vera in people with diabetes and prediabetes. Some of those studies looked at aloe vera’s impact on important factors that affect the health of a person with diabetes.

Aloe vera may help lower:

The report so far is that aloe vera does seem to have a positive impact on glycemic control.

Research suggests that aloe vera juice or supplements could have a number of possible benefits for people with diabetes:

Lower fasting blood glucose levels. A 2015 study suggests that taking aloe vera gel can help people achieve better fasting blood glucose levels, as well as reduce body fat and weight.

Few side effects. As the authors of a review of studies published in the Journal of Clinical Pharmacy and Therapeutics noted, most people who have participated in studies involving aloe vera preparations seemed to tolerate the aloe vera and didn’t experience any adverse side effects.

Lower HbA1c averages. Another review of studies found that the research results on this are currently mixed. One clinical trial involving laboratory rats found that aloe vera helped the animals reduce their HbA1c levels, which could bode well for people with diabetes, too. However, an earlier clinical trial involving people didn’t achieve the same results. More research is needed to determine if and how aloe vera could be used to help improve HbA1c levels.

More people might take it. People with type 2 diabetes don’t always take their medications as directed. In fact, one study notes that less than half of people with type 2 diabetes are able to achieve their blood glucose goals. It could be a matter of cost, a matter of coping with side effects, or a combination of factors.

Some of the purported benefits of aloe vera could actually be drawbacks.

For example, the National Center for Complementary and Integrative Health (NCCIH) cautions that oral aloe vera could lower your blood sugar levels. That’s one of the reasons that scientists are so interested in exploring aloe vera products as a possible diabetes management tool.

But if you’re already taking a medication to control your blood sugar levels, drinking a big glass of aloe vera juice or taking some other aloe vera preparation could send your blood sugar crashing.

You could wind up developing hypoglycemia, a condition in which your blood sugar levels are dangerously low and can result in loss of consciousness.

Also, some people swear by aloe vera for its laxative effects and as a good antidote to constipation. But taking any substance that has a laxative effect can reduce the effectiveness of any other oral medications that you might be taking.

Your body won’t absorb those other medications as well, and you could experience problems, such as high blood glucose, if your oral diabetes medications aren’t working.

The Mayo Clinic also cautions against oral use of aloe latex, which acts as a laxative, as it may have serious and potentially fatal side effects.

First, a word of caution. The research into using aloe vera to manage diabetes is still preliminary.

Don’t race out to the grocery store to pick up a container of aloe vera juice or bottle of aloe vera supplements just yet. Don’t stop taking your current diabetes medications, either.

Currently, there’s no official recommendation for people with diabetes to take aloe vera supplements or drink aloe vera juice. Why? In part, there’s no consensus right now about the type of preparation or dosage amount that would be most appropriate.

As the authors of the review of studies published in the Journal of Clinical Pharmacy and Therapeutics found, participants in many of the research studies used a wide variety of types and dosage amounts of aloe vera.

Some drank aloe vera juice, while others consumed a powder containing a component from the aloe vera plant called acemannan, a polysaccharide that can enhance the body’s immune responses.

With such a wide variety, it would be hard to determine an optimum dose and delivery method without additional research.

If you’re interested in giving aloe vera a try, first check with your doctor to make sure it won’t conflict with any medications you’re already taking. Then, you can consider your options.

Aloe vera does seem to hold promise for people with diabetes who want to maintain their goal blood sugar levels. However, the scientific community hasn’t reached a consensus yet about recommending aloe vera as a diabetes management strategy.

Plus, more research is needed to determine the correct type of preparation and dosage.

Until we know more about the best use of aloe vera to manage diabetes, talk to your doctor before consuming aloe vera products.

It’s important to know how aloe vera could affect you and your blood sugar levels, especially if you’re already using other medications to control your diabetes.

If you have Type 2 diabetes, keeping your blood sugar levels stable over time may be key to living longer.

New research finds that people who have more swings in their blood sugar levels were more than twice as likely to die early, compared to folks with more stable blood sugar management.

The study authors used a test called hemoglobin A1C to measure blood sugar. This commonly used test provides a rough estimate of about two to three months of average blood sugar levels.

Although treatment decisions are usually individualized based on age and other factors, most people with diabetes generally aim for an A1C of 7 percent or lower. Higher numbers may indicate the need to change medications or lifestyle factors.

"In addition to reaching the hemoglobin A1C goal, fluctuation of hemoglobin A1C level is also associated with adverse events of diabetes," said study author Dr. Sheyu Li, an endocrinologist from West China Hospital at Sichuan University in Chengdu, China.

A number of factors can affect A1C levels, including how well the body's insulin-producing cells work, body weight, lifestyle management, other illnesses and diabetes medications, according to Li, who is currently a visiting research fellow at the University of Dundee in Scotland.

The researchers calculated A1C variability in up to 21,000 patients from Scotland who had newly diagnosed Type 2 diabetes when the study began. Any office visit where A1C levels varied by more than 0.5 percent was included in their calculations. The median follow-up time was just over six years, Li said.

The patients were then split into five groups based on their A1C variability over time. For example, if someone had 4 visits out of 10 with more than 0.5 percent variation, their A1C variability would be 40 percent.

Li said a change of 0.5 percent from visit to visit isn't rare. In fact, he noted that about one-third of people in the study had such a change. This could indicate improved management (when the number is going down) or it might indicate a need for a change in medication or lifestyle (when the number goes up).

When such a change occurs, Li said someone may have had a medication added to their regimen, or they may have stopped using a medication on their own. They may have changed certain health habits, or the change may indicate a new illness.

When variability was 60 percent or higher, the researchers found more than double the risk of heart disease, twice the risk of stroke and three times the risk of heart failure, nerve damage and chronic kidney disease. The researchers also found high variability was linked to a five times greater risk of a foot ulcer and a sevenfold increase in the risk of diabetic eye disease.

The risk of death was more than twice as high for people with more A1C variability.

Because the study looked at what happened in the past, it cannot show a cause-and-effect link between A1C variability and negative health outcomes. It can only show a link between these things.

Li said that means the researchers can't say if reducing A1C variability would improve outcomes for people with Type 2 diabetes. At this point, he said doctors need to keep a closer watch on patients with a higher variability.

Dr. Joel Zonszein is director of the Clinical Diabetes Center at Montefiore Medical Center in New York City. He agreed that people with more glucose variability often have more health problems.

But, Zonszein said, "It's the chicken-and-egg question. A high A1C may cause complications, but things like liver disease and heart failure can change A1C, so it's hard to know which came first, especially in an observational, epidemiological study."

Still, "A1C is a good marker for outcomes. People who bounce up and down usually develop more complications," Zonszein said.

The findings were presented Wednesday at the European Association for the Study of Diabetes meeting, in Barcelona. Findings from meetings are typically viewed as preliminary until they've been published in a peer-reviewed journal.

More information

Learn more about managing your blood sugar from the American Diabetes Association.

Copyright 2019 HealthDay. All rights reserved.

Dapagliflozin, a drug that is already used to successfully treat type 2 diabetes (T2D) and prevent development of heart failure, can also be used to treat pre-existing heart failure, even in patients without T2D.

These are the conclusions of research presented at this year's Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain (16-20 September), and simultaneously published in the New England Journal of Medicine (NEJM). The study is by Professor John McMurray, Professor of Cardiology at the Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, and colleagues.

"The most important finding of all is the benefit in patients without diabetes," explains Professor McMurray. "This shows dapagliflozin is truly a treatment for heart failure and not just a drug for diabetes."

Heart failure occurs when the heart is no longer able to pump blood around the body as well as it should. In patients with heart failure, the percentage of blood pumped out by the left ventricle per heartbeat (called the ejection fraction) goes down. Certain conditions, such as coronary artery disease (narrowed arteries in the heart) or high blood pressure, gradually leave your heart too weak or stiff to fill and pump efficiently. The prevalence of heart failure in people with T2D is around double than in the general population without diabetes.

Dapagliflozin is one of the relatively new class of diabetes drugs called Sodium-glucose cotransporter 2 (SGLT-2) inhibitors. Previous studies have shown that SGLT-2 inhibitors not only help control blood sugar levels, but can also improve a number of cardiovascular outcomes, including promoting weight loss, reducing blood pressure and reducing the risk of cardiovascular mortality.

Dapagliflozin has already been proven to reduce the risk of developing heart failure in patients with type 2 diabetes. In this new study, the investigators analysed whether the drug could also be used to treat patients with T2D in whom heart failure had already developed (established heart failure), and also heart failure in patients without type 2 diabetes.

The trial (the DAPA-HF study) enrolled 4,744 patients with heart failure and reduced ejection fraction in 20 countries, of whom 45% had T2D, and 55% did not have T2D. Patients were randomly allocated to either dapagliflozin 10 mg once daily or matching placebo. The primary endpoint was a combination of a first episode of worsening heart failure (hospitalisation for heart failure or an urgent heart failure visit requiring intravenous therapy) or death from cardiovascular causes.

The treatments in the study were given on top of standard care: 94% received an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker or angiotensin receptor-neprilysin inhibitor; 96% took a beta-blocker; and 71% took a mineralocorticoid receptor antagonist (all these are drugs that reduce hospital admissions and death rates in heart failure, thus this new study was adding dapagliflozin or placebo to the currently best-available therapies).

The researchers found that, over a median follow-up of 18.2 months, the primary outcome occurred in 386 of 2,373 patients (16.3%) in the dapagliflozin group and in 502 of 2,371 patients (21.2%) in the placebo group, translating to a 26% reduced risk in the dapagliflozin (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.65-0.85; p<0.00001). The results were similar in the groups with T2D (HR 0.75 / 25% reduced risk) and without T2D (HR 0.73 / 27% reduced risk).

The components of the primary outcome were also analysed separately. A total of 237 patients (10.0%) receiving dapagliflozin and 326 patients (13.7%) receiving placebo experienced a first episode of worsening heart failure, thus showing a 30% reduced risk in the dapagliflozin group (HR 0.70; 95% CI 0.59-0.83; p<0.00004). And 227 (9.6%) and 273 (11.5%), respectively, died from cardiovascular causes, meaning an 18% lower risk in the dapagliflozin group (HR 0.82; 95% CI 0.69-0.98; p=0.03). All-cause mortality was reduced by 17% (HR 0.83, 95%CI 0.71-0.97; p=0.22). Symptoms, as assessed by the Kansas City Cardiomyopathy Questionnaire were also improved (p<0.001).

Regarding side effects, 178 patients (7.5%) in the dapagliflozin group had an adverse event related to volume depletion (which can cause dehydration, low blood pressure and fainting) compared to 162 (6.8%) in the placebo group, with no significant difference between groups. Adverse events related to kidney dysfunction occurred in 153 patients (6.5%) in the dapagliflozin group versus 170 patients (7.2%) in the placebo group, with no significant difference between groups. Major hypoglycaemia and lower limb amputation and fracture were infrequent and occurred at similar rates in the two treatment groups.

Professor McMurray says: "Adverse events rarely required the discontinuation of treatment. There was no notable excess of any serious adverse event in the dapagliflozin group."

He concludes: "The trial shows that dapagliflozin reduces death and hospitalisation, and improves health-related quality of life, in patients with heart failure and reduced ejection fraction, with and without diabetes. The clinical implications are potentially huge—few drugs achieve these results in heart failure and dapagliflozin does even when added to excellent standard therapy."

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Contrary to management guidelines, older adults with type 2 diabetes may overemphasize additional health conditions and complications when participating in decisions to enhance or de-intensify therapy, according to findings published in JAMA Internal Medicine.

"The take-home message is that the guidelines about individualized blood sugar targets are not intuitive to patients, and better communication is needed, as is more research to better understand patients' perspectives and preferences," Nancy L. Schoenborn, MD, MHS, associate professor in the division of geriatric medicine and gerontology at Johns Hopkins University School of Medicine, told Endocrine Today. "To our knowledge, there have not been prior studies about how patients perceive guidelines on individualized blood sugar targets in older adults, that was the reason we conducted this study. Better understanding patient perspectives allows doctors to provide more patient-centered care."

Schoenborn and colleagues assessed which  factors patients believed were most important in making treatment decisions based on responses to surveys completed by 818 adults aged at least 65 years with type 2 diabetes (mean age, 74 years; 46.3% women) who were participants in KnowledgePanel, an online survey platform. Participants completed a survey that asked about either adding diabetes medications (n = 410) or reducing diabetes medications (n = 408) between Dec. 13, 2018, and Jan. 3, 2019, based on random assignment. All participants were asked to rank each factor based on its importance and identify factors that should lead to more aggressive treatment. Participant responses allowed the researchers to rank each factor on a scale of 0 to 100 based on a conditional logistic regression model.

Among those asked about good reasons to add diabetes medications, 62.8% identified a short duration of diabetes, 54.6% identified a low chance of adverse effects due to the new medication, 53.4% identified minimal effort required for taking the medication, 51.9% identified having a long life expectancy, 51.2% identified low cost, 48.8% identified having no significant diabetes complications and 45.6% identified having a limited number of additional health conditions. The surveys also revealed that each factor was deemed a good reason to add a medication by 23.3% of respondents, and no factors provided a good enough reason for 14% of the respondents.    

 

Contrary to management guidelines, older adults with type 2 diabetes may overemphasize additional health conditions and complications when participating in decisions to enhance or de-intensify therapy.

Source: Adobe Stock

Among those asked about good reasons to discontinue a diabetes medication, 37.7% said increased odds of an adverse effect, 18.4% said the presence of diabetes complications, 15.1% said the presence of additional health conditions, 14.8% said high cost, 9.6% said a shorter life expectancy, 9.4% said longer diabetes duration and 8.4% said excessive effort required to take the medication. The surveys also revealed that all factors were deemed good reasons to discontinue a medication by 0.5% of respondents, and none of the factors were deemed a good reason by 46.9% of the respondents. 

When including all respondents, the chance for adverse effects, life expectancy and the presence of additional health conditions were the highest ranked while how much effort and cost a treatment required were the lowest ranked for deciding whether to add or discontinue a medication. More respondents thought aggressive treatment was necessary for someone with diabetes for at least 15 years (60.1%) vs. someone with diabetes for 5 years or fewer (39.9%), for someone with more severe complications (75.6%) vs. someone with no complications (24.4%) and for someone with additional health conditions (67.5%) vs. someone with no additional health conditions (32.5%), which the researchers said was contrary to current guidelines. Respondents were in agreement with guidelines when it came to considering life expectancy and adverse effects, according to the researchers, with 78.2% saying aggressive treatment was needed for patients at lower risk for adverse events and 72 .7% saying aggressive treatment was needed for someone with a life expectancy of at least 15 years.

"Clinicians need to be aware of the potential discrepancy between patient perspective and guideline recommendation," Schoenborn said. "It would be important for clinicians to proactively elicit the patients' views and preferences when deciding about how aggressively to treat diabetes and explain the rationale behind individualized blood sugar targets." – by Phil Neuffer

For more information:

Nancy L. Schoenborn, MD, MHS, can be reached at nancyli@jhmi.edu.

Disclosures: Schoenborn reports she has received grants from the National Institute on Aging and American Cancer Society. Please see the study for all other authors' relevant financial disclosures.

BARCELONA, Spain ― For patients newly diagnosed with type 2 diabetes, the recommended strategy of initiating treatment with metformin and then stepping up treatment with a second agent if monotherapy fails to control blood glucose might not be ideal, a new large, 5-year trial suggests.

Rather, initial dual therapy may be better.

Among patients with newly discovered diabetes whose HbA1C level was 6.5% to 7.5% (48 â€" 58 mmol/mol), those who initially received combination therapy with metformin plus the dipeptidyl peptidaseâ€"4 (DPP-4) inhibitor vildagliptin (Galvus, Novartis) were less likely to experience sustained treatment failure (HbA1C ≥7% [≥53 mmol/mol]) during a 5-year period.

Lead investigator David R. Matthews, DPhil, EASD president and professor emeritus of diabetic medicine, University of Oxford, in the United Kingdom, and two coinvestigators presented these findings from the Vildagliptin Efficacy in Combination With Metformin for Early Treatment of Type 2 Diabetes (VERIFY) trial here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting. The findings were simultaneously published in the Lancet.

This is the largest long-term prospective trial to test the durability of glycemic control in patients with diabetes who were initially treated with dual combination therapy, Ofri Mosenzon, MD, and Gil Leibowitz, MD, from Hebrew University of Jerusalem, Israel, write in an editorial that accompanies the Lancet article.

The study should "reassure" clinicians that initial dual therapy with these two agents "is well tolerated, safe and effective," they note.

Moreover, this finding was not unexpected, because these medications have synergistic mechanisms: metformin increases insulin sensitivity, and vildagliptin enhances beta-cell function.

The study "strengthens the notion that early combination therapy could have long-term clinical benefits regarding glycemic durability," they summarize.

They note, however, that in recent years, a number of large trials have shown that newer glucose-lowering agents, mainly GLP-1-receptor agonists and SGLT2 inhibitors, "have cardiovascular and renal benefits and the place of metformin as the first drug for all patients with type 2 diabetes is [now] questioned."

VERIFY coauthor Michael Stumvoll, MD, University Hospital Leipzig, Germany, told Medscape Medical News that VERIFY was begun long before most current GLP-1 agonists and all SGLT2 inhibitors were available.

Study Validates Off-Label Use of Initial Dual Therapy

When recruitment for VERIFY began in 2012, "we were in a world where gliptins were just becoming fashionable," Stumvoll said.

"Vildagliptin ― a beta-cell-preserving, weight-neutral, safe drug ― was leading the market," he said.

Vildagliptin is still widely used around the world, he stressed.

"It's a 'fire and forget' type of thing, a fixed dose, one in the morning and in the evening," and clinicians don't need to worry about impaired kidney function, weight gain, or hypoglycemia, he said.

Some practitioners have been using initial combination therapy off label, he added. This trial provides evidence to support this practice.

About 40% of patients did not experience treatment failure on metformin monotherapy.

However, Matthews said, "The point is, you don't know who these patients [who do well on monotherapy] are."

"What I think is important," senior author Stefano Del Prato, MD, University of Pisa, Italy, told Medscape Medical News, is that this is the first large, randomized clinical trial that shows that "a combination of the two drugs that are known to be safe...can preserve glycemic control over time." His words echo the comments of the other speakers and editorialists.

He said that further study is needed to see whether improved glycemic control lowers risk for cardiovascular disease.

Start With Metformin or Two Therapies?

VERIFY was designed to determine whether clinicians should start with combined therapies or use a stepwise approach (starting with metformin and then adding vildagliptin if metformin failed to provide adequate glycemic control) for patients with diabetes, Matthews said.

From 2012 to 2014, VERIFY enrolled 2001 patients who had been newly diagnosed with type 2 diabetes in 254 centers in 34 countries.

The patients were 18 to 70 years old and had been diagnosed with type 2 diabetes within the previous 2 years.

In these patients, the range of HbA1C, level was narrow, at 6.5% to 7.5%, Stumvolt noted. Body mass index values ranged from 22 to 40 kg/m².

The patients were randomly assigned either to the early combination treatment group (998 patients) or to the initial metformin monotherapy group (1003 patients).

Those in the combination therapy group received metformin at a dose of 1000 mg, 1500 mg, or 2000 mg per day, plus vildagliptin at a dose of 50 mg twice daily.

The patients in the monotherapy arm received the same daily doses of metformin plus twice-daily placebo.

If at any time from 6 months to 5 years from the start of the trial the HbA1C level was not maintained below 7.0% with initial treatment (confirmed at two consecutive scheduled visits that were 13 weeks apart), patients in the metformin monotherapy group were given vildagliptin 50 mg twice daily (instead of placebo) in addition to metformin.

About 80% patients in each group completed the 5-year study.

During the first phase of the study (before therapy was stepped up for any patients receiving monotherapy) 429 patients (43.6%) in the combination treatment group and 614 patients (62.1%) patients in the monotherapy group experienced treatment failure.

The median time to treatment failure was 36 months in the monotherapy group; treatment failure had not occurred by 5 years in the combination therapy group.

The risk for treatment failure was 49% lower with initial combination therapy than with initial monotherapy (hazard ratio, 0.51; P < .0001).

Both treatment approaches were safe and well tolerated. There were no unexpected or new safety findings, and no deaths occurred that were related to study treatment.

Early combination therapy was not associated with risk for hypoglycemia or increased body weight, Del Prato noted.

"New Era" in Diabetes Treatment?

An ADA-EASD consensus report states that currently, "While there is some support for initial combination therapy due to the greater initial reduction of A1C than can be provided by metformin alone, there is little evidence that this approach is superior to sequential addition of medications for maintaining glycemic control or slowing the progression of diabetes."

According to Del Prado, on the basis of VERIFY, the wording should be changed to "there is now evidence...."

The study can only generate hypotheses regarding cardiovascular risk, because it was not designed to examine this. He believes, however, that the study is "opening up a new era" in diabetes treatment strategies.

VERIFY demonstrated durable glycemic control in a heterogeneous population that reflects typical patients with newly diagnosed type 2 diabetes who are seen in clinical practice, he summarized

"Whether early combination treatment strategy should be applied to all patients with type 2 diabetes" needs to be studied further, according to Mosenzon and Leibowitz.

The findings from VERIFY "suggest that early normalisation of blood glucose has a beneficial legacy effect that attenuates diabetes progression," the editorialists write.

Other studies have shown that normalizing blood glucose during the first year after diagnosis "was associated with decreased risk of microvascular and macrovascular complications," they state.

Often in clinical practice, treatment intensification is delayed, and patients are exposed to prolonged hyperglycemia.

"Early combination therapy with two or more glucose-lowering agents might become an effective strategy to prevent clinical inertia," they suggest.

On the other hand, combination treatment might increase the risk for side effects and is more costly. "Additional studies are needed to confirm that early combination treatment indeed halts the progression of diabetes," they write.

Many type 2 diabetes drugs are currently available that could be combined as initial dual therapy. Thus, "Further studies to assess the effects of different combination therapies on glycaemic durability and more importantly on the risk of late complications are necessary," they write.

The study was funded by Novartis. Matthews has served on advisory boards or as a consultant for Novo Nordisk, GlaxoSmithKline, Novartis, Eli Lilly, Sanofi-Aventis, Janssen, and Servier. He is currently the president of the European Association for the Study of Diabetes and has given lectures for Novo Nordisk, Servier, Sanofi-Aventis, Eli Lilly and Company, Novartis, Janssen, and Aché Laboratories. Stumvolt has received speaker's honoraria and consulting fees from Novartis, Novo Nordisk, AstraZeneca, Aegerion, Eli Lilly and Company, and Boehringer Ingelheim. Del Prato serves or has served on advisory boards for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline, Hanmi Pharmaceuticals, Intarcia, Janssen Pharmaceutics, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi, Servier and Takeda; serves or has served on the speakers' bureau for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen Pharmaceutics, Merck Sharp & Dohme, Novartis, N ovo Nordisk, Sanofi and Takeda; and has received research support from Boehringer Ingelheim, Merck Sharp & Dohme, and Novartis. The three other coauthors are employed by and own stock in Novartis. Mosenzon has received advisory board and speaker's fees and a research grant through her institution from Novo Nordisk; advisory board and speaker's fees from Eli Lilly, Sanofi, Merck Sharp & Dohme, and Boehringer Ingelheim; advisory board and speaker's fees and a research grant through her institution from AstraZeneca; and speaker's fees from Teva that are unrelated to the editorial topic. Leibowitz has received advisory board and speaker's fees from Novo Nordisk; speaker's fees from Eli Lilly & Company; and advisory board and speaker's fees from Sanofi and AstraZeneca that are all unrelated to the editorial topic.

European Association for the Study of Diabetes (EASD) 2019 Annual Meeting: Presented September 19, 2019.

Lancet. Published online September 18, 2019. Abstract, Editorial

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