Monthly Archives: October 2022

Researchers at GW hosted clinical trials for four diabetes drugs and found two type 2 diabetes treatments were more effective than others at lowering blood glucose levels in a study published late last month by the National Institutes of Health.

The clinical trials hosted by GW and funded by the National Institutes of Health are a part of a study which found patients who received the drugs liraglutide and insulin glargine, which control blood sugar levels, experienced controlled blood glucose levels for about six months longer than patients who received the other two drugs in the trial. Researchers said the study, titled Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness gives two more treatment options for patients and healthcare providers to lower patients blood glucose levels.

John Lachin, a professor of biostatistics and bioinformatics at GW and the senior statistician for the GRADE study, said the drugs worked immediately in lowering patients blood glucose levels, and lowered patients likelihood of developing diabetes-related cardiovascular disease. But he said he was disappointed in the results of the study because the effectiveness of the drugs dropped after six months.

I, for one, am somewhat disappointed that the study wasnt able to do better, Lachin said. And its not the fault of the study. Its the drugs we chose to use just simply werent as good in the long term as we had hoped they would be.

Lachin said the GRADE study, which lasted for eight years, helped fulfill a need for long-term research on existing diabetes treatments. He said researchers test type 2 diabetes treatments for about six to 12 months when they are undergoing Food and Drug Administration approval, short-term research that is insufficient to study the durability of these medicines since diabetes is generally a lifelong disease.

We felt that it was very important to obtain an assessment of the properties of these drugs over a longer window, Lachin said.

The GRADE study is the first to test four popular type 2 diabetes drugs against each other without a placebo, according to the NIH.

The study also found that when metformin an antidiabetic medication combines with the higher-performing drugs of the study, it results in effective glucose levels about six months longer than patients who took sitagliptin, an antidiabetic medication.

Lachin said GWs Biostatistics Center received funding for the study from the NIH, provided a statistical design and collected and analyzed the data. He said the trials can help procure research funds that can attract first-rate biostaticians and professors to teach at GWs Biostatistics Center because GW has the resources to lead major projects like the GRADE study trials.

At GW, weve established systems and procedures so that we excel in our ability to coordinate and conduct these studies, Lachin said.

Metformin the primary medicine prescribed for type 2 diabetes is often insufficient to keep blood glucose levels in check alone, and other drugs, like the four tested in the GRADE study in combination with metformin, are needed to supplement it.

GRADE study researchers said they hope the study opens up opportunities for future research in the field of diabetes and gives healthcare providers more treatment options.

David Nathan, a professor at Harvard Medical School and the director of the Massachusetts General Hospital Diabetes Center, said he served as the chair of the GRADE study since its creation more than a decade ago and worked with Lachin during the GW trials. Nathan said he constructed the study to compare new and older drugs instead of testing against placebos like other studies do.

Nathan said further research is needed to perfect treatment for type 2 diabetes, because none of the treatments proved to be particularly effective in keeping patients in the target blood glucose range through the entire eight-year period.

What that means is that we need to generate new treatments and new strategies for treating these folks, Nathan said. Type 2 diabetes is really hard to take care of, and thats kind of one of the overarching messages that we came out with.

Robert Cohen, a site investigator for the GRADE study and a professor of medicine at the University of Cincinnati, said patients taking metformin and liraglutide were the least susceptible to cardiovascular disease, but also experienced the highest rates of gastrointestinal symptoms. He said patients using the drugs in the trials were more likely to experience low blood sugar levels and the fraction of people who experienced extreme side effects from the drugs was remarkably small.

Do we have the answer with the tools that we have available? Or do we need new drugs? Cohen said. So I think in that sense, GRADE is going to affect policy decisions about driving the research community to develop new classes of drugs.

Cohen said type 2 diabetes treatment has improved in the last 25 years due to the creation of new drugs and more aggressive goals toward treatments. He said even though doctors have made improvements in diabetes medicine, most drugs arent effective at maintaining blood glucose levels on a long-term basis and the study can provide alternative options for controlling glucose levels.

I am hoping that we are going to come out with some sort of personalized medicine approaches based on the implications of GRADE, Cohen said.

This article appeared in the January 10, 2022 issue of the Hatchet.

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Researchers study long-term effectiveness of diabetes drugs - GW Hatchet

Every day is a good day to think about your mental and physical well-being. But leading up to World Mental Health Day on October 10, theres a new focus on the intersection between the two, thanks to a new campaign by Beyond Type 1 called MenTalkHealth. This initiative is encouraging conversations between menthrough community connections and resourcesabout mental wellness. Its specifically tackling how your mind can be affected by challenging chronic illnesses like Type 1 Diabetes (T1D), which affect large numbers of people but can feel really isolating. What you need to know:

Many people think Type 1 Diabetes is a condition that arises in childhood, and that if you werent diagnosed then, you wont be as an adult. Thats not the case: Recent data finds that half of all new cases of T1D are diagnosed in adults; its estimated that 1.4 million adults are currently living with the disease in the U.S. A new review paper shows that men are more likely to present with adult T1D than women. Risk factors include genetics and family history.

Some details on T1D you might not know: its a condition in which your pancreas makes little to no insulin. Without enough insulin, sugar wont move into your cells as it should, but instead will start to build up in your bloodstream. This can be dangerous and lead to life-threatening complications including heart problems, kidney damage, nerve damage, vision loss, and severe infections.

If you experience symptoms like feeling extra-thirsty, having to pee all the time, losing weight without dieting, feeling suddenly irritable, or getting hit with blurry vision, definitely see your doctor.

If youre diagnosed with T1D, you need to monitor your health carefully. This often means checking your blood sugar at regular intervals throughout the day, giving yourself insulin shots, and making sure you eat the right food. Having TID can feel like playing whack-a-mole, says Mark Heyman, PhD, a Certified Diabetes Care and Education Specialist and the author of Diabetes Sucks and You Can Handle It. Something is always popping up. Trying to keep on top of it all can quickly become stressful, and leads many men to put a ton of pressure on themselves.

This is where Beyond Type 1 comes in. The non-profit organization is dedicated to changing what its like to live well with diabetes through education and advocacy. Nick Jonasyes, of the Jonas Brotherswho has T1D, has worked with Beyond Type 1 to spread awareness. His story is major inspo for thriving with the disease. In a lead up to World Mental Health Day on October 10, Beyond Type 1 will launch the MenTalkHealth campaign, where men can learn from each other by sharing their experiences on social media. The campaign also offers a powerful video in which men and boys share their challenges in order to help others like themselves (you can see the video at the main MenTalkHealth page here).

Get support. Unless a person has T1D, they really dont get it, says Heyman. But you can help them with thattalk to your partner and other family members in detail about your daily routine and its challenges. They need all those details to fully understand so they can give you the kind of help thats truly helpful.

Break down your T1D challenges into small chunks. Pick one thing to work on that will help you control your blood sugar best. Focus on that and youll find that other things will fall into place, Heyman says. Just dont pressure yourself to be perfect about it. With diabetes, good enough is OK, Heyman says. Remember that your point is to take away the stress of dealing with diabetes by doing this, not add to it. If you're stuck on how to do this, it's worth checking in with other men with T1D for ideas and support.

Continued here:
Dealing With Type 1 Diabetes - Nick Jonas Behind New Men's Mental Health Initiative - Men's Health

News Release

Wednesday, September 28, 2022

Next-generation technology maintains blood glucose levels by automatically delivering insulin.

A device known as a bionic pancreas, which uses next-generation technology to automatically deliver insulin, was more effective at maintaining blood glucose (sugar) levels within normal range than standard-of-care management among people with type 1 diabetes, a new multicenter clinical trial has found. The trial was primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, and published in the New England Journal of Medicine.

Automated insulin delivery systems, also called artificial pancreas or closed-loop control systems, track a persons blood glucose levels using a continuous glucose monitor and automatically deliver the hormone insulin when needed using an insulin pump. These systems replace reliance on testing glucose level by fingerstick, continuous glucose monitor with separate insulin delivery through multiple daily injections, or a pump without automation.

Compared to other available artificial pancreas technologies, the bionic pancreas requires less user input and provides more automation because the devices algorithms continually adjust insulin doses automatically based on users needs. Users initialize the bionic pancreas by entering their body weight into the devices dosing software at the time of first use.

Users of the bionic pancreas also do not have to count carbohydrates, nor initiate doses of insulin to correct for high blood glucose. In addition, health care providers do not need to make periodic adjustments to the settings of the device.

Keeping tight control over blood glucose is important in managing diabetes and is the best way to prevent complications like eye, nerve, kidney, and cardiovascular disease down the road," said Dr. Guillermo Arreaza-Rubn, director of NIDDKs diabetes technology program. The bionic pancreas technology introduces a new level of ease to the day-to-day management of type 1 diabetes, which may contribute to improved quality of life.

The 13-week trial, conducted at 16 clinical sites across the United States, enrolled 326 participants ages 6 to 79 years who had type 1 diabetes and had been using insulin for at least one year. Participants were randomly assigned to either a treatment group using the bionic pancreas device or a standard-of-care control group using their personal pre-study insulin delivery method. All participants in the control group were provided with a continuous glucose monitor, and nearly one-third of the control group were using commercially available artificial pancreas technology during the study.

In participants using the bionic pancreas, glycated hemoglobin, a measure of a persons long-term blood glucose control, improved from 7.9% to 7.3%, yet remained unchanged among the standard-of-care control group. The bionic pancreas group participants spent 11% more time, approximately 2.5 hours per day, within the targeted blood glucose range compared to the control group. These results were similar in youth and adult participants, and improvements in blood glucose control were greatest among participants who had higher blood glucose levels at the beginning of the study.

Our observation that this system can safely improve glucose control to the degree we found, and do so despite requiring much less input from users and their health care providers, has important implications for children and adults living with diabetes, said Dr. Steven Russell, study chair, associate professor of medicine at Harvard Medical School, and staff physician at the Massachusetts General Hospital in Boston.

Hyperglycemia, or high blood glucose, caused by problems with insulin pump equipment, was the most frequently reported adverse event in the bionic pancreas group. The number of mild hypoglycemia events, or low blood glucose, was low and was not different between the groups. The frequency of severe hypoglycemia was not statistically different between the standard of care and bionic pancreas groups.

Four companion papers were also published in Diabetes Technology and Therapeutics, two of which provided more detailed results among the adult and youth participants. The third paper reported results from an extension study in which the participants from the standard-of-care control group switched to using the bionic pancreas for 13 weeks and experienced improvements in glucose control similar to the bionic pancreas group in the randomized trial. In the fourth paper, results showed that using the bionic pancreas with a faster-acting insulin in 114 adult participants improved glucose control as effectively as using the device with standard insulin.

NIDDKs decades-long investment in developing advanced technologies for diabetes management has reached another promising milestone and continues to provide significant return, said NIDDK Director Dr. Griffin P. Rodgers. While we continue to search for a cure for type 1 diabetes, devices like the bionic pancreas can allow people to worry less about their blood-glucose levels and focus more on living their fullest, healthiest lives.

Dr. Edward Damiano, project principal investigator, professor of biomedical engineering at Boston University, and founder and executive chair of Beta Bionics, Inc., concurs. The completion of this study represents a major milestone for the bionic pancreas initiative, which simply would not have been possible had it not been for the support provided by the NIDDK over the years.

The study is one of several pivotal trials funded by NIDDK to advance artificial pancreas technology and look at factors including safety, efficacy, user-friendliness, physical and emotional health of participants, and cost. To date, these trials have provided the important safety and efficacy data needed for regulatory review and licensure to make the technology commercially available. The Jaeb Center for Health Research in Tampa, Florida, served as coordinating center.

Funding for the study was provided by NIDDK grant 1UC4DK108612 to Boston University, by an Investigator-Initiated Study award from Novo Nordisk, and by Beta Bionics, Inc., which also provided the experimental bionic pancreas devices used in the study. Insulin and some supplies were donated by Novo Nordisk, Eli Lilly, Dexcom, and Ascensia Diabetes Care. Partial support for the development of the experimental bionic pancreas device was provided by NIDDK Small Business Innovation Research (SBIR) grant 1R44DK120234 to Beta Bionics, Inc.

The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic, and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see https://www.niddk.nih.gov/.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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Bionic pancreas improves type 1 diabetes management compared to standard insulin delivery methods - National Institutes of Health (.gov)

Infections, especially urinary tract infections (UTIs), are common experiences for people with diabetes. UTIs are also often more severe in people with diabetes than they are in those without diabetes. UTIs may lead to serious kidney problems in those with diabetes, such as renal abscesses, emphysematous cystitis and pyelonephritis, and renal papillary necrosis.

In type 1 diabetes, the pancreas stops producing insulin that regulates blood glucose levels. In type 2, cells become less sensitive to insulin. With both types, excessive glucose levels in the blood can reduce the effectiveness of ones immune system.

Dr. Jason Ng of the University of Pittsburgh Medical Center, not involved in the study, explained to Medical News Today, The higher sugars create a series of impaired defense mechanisms which people use to protect against UTIs.

Now, a study from researchers at Swedens Karolinska Institutet investigates the mechanism behind glucoses effect.

The study finds that high glucose levels in diabetes reduce levels of one of the bodys natural antibiotics, the antimicrobial peptide psoriasin, an important barrier against infection.

Urologist Dr. S. Adam Ramin, also not involved in the research, described the usual role of psoriasin to MNT:

Its known that this particular protein is an initial line of defense against certain bacterial infections. And now, based on this study, it appears that this particular protein is downregulated meaning that it is not made at as high a concentration as in people who dont have diabetes and therefore may be one of the pathways that makes diabetic patients more susceptible to infections.

We have observed that patients with diabetes have [a] higher risk of UTIs, said Dr. Ng. So this process could further elucidate why this observation exists.

The researchers analyzed urine, urinary bladder cells, and blood serum samples from adult volunteers who were non-diabetic or who had prediabetes or diabetes. The study did not include people with current UTI diagnoses.

The analysis revealed that participants with prediabetes or diabetes had reduced levels of psoriasin.

The researchers confirmed the findings in follow-up studies using mice with type 2 diabetes and human uroepithelial cell lines.

Study principal investigator, Prof. Annelie Brauner, tells Karolinska Institutet News that such reduced levels weakens the cells protective barrier function and increases the risk of bladder infection.

Dr. Ramin explained:

Essentially, this is a protein that inhibits the binding of bacteria to epithelial cells and endothelial cells, and if these bacteria cannot bind to the epithelial cells of the bladder, then they may not grow. They will be inhibited from growth, and therefore they cant propagate inside the bladder.

When bacteria propagate, thats when infection occurs because essentially infection is an overgrowth of bacteria within an organ like the bladder, as opposed to a situation in which psoriasin would be inhibiting the growth of the bacteria.

Prof. Brauner also pointed out an interesting finding.

We found that high glucose concentrations reduce the levels of the antimicrobial peptide psoriasin, while insulin has no effect [on psoriasin levels], she said.

Previous research by Prof. Brauners group found that estrogen helps restore the protective function of bladder cells. The new study confirms that estrogen can restore psoriasin levels.

Dr. Ramin said the current studys results are consistent with earlier findings on postmenopausal women with low estrogen who are at a higher risk of developing UTIs. He said the recurrence of UTIs significantly decreased among women after using prescription estrogen vaginal creams, and this was a pathway to learning that estrogen can help prevent UTIs.

Dr. Ramin said the topical treatment is generally safe for most women.

Topical estrogen or estrogen creams in the vagina do not get absorbed systemically, so were not concerned about causing cancer or any other issues, he said. In fact, many women who have had gynecologic cancers in the past, and they have been cured, are still eligible to get estrogen vaginal cream.

Prof. Brauner also noted:

All medical treatment must be given with caution. Estrogen given locally (in the vagina) is a common treatment in postmenopausal women, and very few side effects have been observed. However, estrogen should not be given orally due to possible adverse effects and since oral administration has no proven effect in the treatment of UTI.

Prof. Brauner added that experts do not recommend treating men with estrogen.

Dr. Ng also expressed caution:

Without further research, I would not promote estrogen use to reduce the risk of UTIs via promoting psoriasin levels. We have to be careful since estrogen medications have significant side effects as well.

Well-controlled diabetes is important to prevent infections as well as other complications, said Prof. Brauner. It is of course not always easy to keep low-to-normal blood glucose levels.

Dr. Ng said the best way to prevent UTIs in patients with diabetes is to practice good hygiene habits and improve sugar control as much as possible.

Dr. Ramin offered some tips that can help people avoid UTIs:

We know that patients who are constipated, theyll get translocation of bacteria from their rectum into the bladder or from the large intestine to the bladder, so its important to avoid constipation, Dr. Ramin explained.

Women who are sexually active should exercise good hygiene, meaning that after sexual activity it is important for them to go to the bathroom and urinate relatively quickly, he added. Its important to keep good vaginal health, and keep that area clean.

Dr. Ramin also noted that some people can benefit from taking or drinking pure cranberry juice because the acid level may kill bacteria and prevent bacterial formation.

In the future, we hope to be able to target ways to locally increase psoriasin in the urinary bladders. We hope and believe that this could have positive effects on the prevention of infections in the bladder, Prof. Brauner concluded.

See the article here:
Why people with diabetes have more UTIs and how to prevent infections - Medical News Today

In a recent meta-analysis, researchers found that new direct oral anticoagulants (NOACs) demonstrated lower rates of stroke or systemic embolism (SSE), ischemic stroke, and hemorrhagic stroke in patients with nonvalvular atrial fibrillation (NVAF) and diabetes mellitus compared with warfarin. Additionally, NOACs did not significantly increase the risk of major bleeding. The results were published in the Journal of Translational Medicine.

The researchers assessed 5 retrospective studies and 4 subgroup analyses of randomized controlled trials from the PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov databases. The pooled cohort included 267,272 patients.

According to the authors, NOACs significantly reduced SSE risk compared with warfarin (pooled hazard ratio [HR], 0.80; 95% CI, 0.74-0.85) in both types of studies. NOACs also appeared to reduce major bleeding risk for patients with atrial fibrillation and diabetes mellitus (pooled HR, 0.85; 95% CI, 0.73-0.99), though the authors noted there was significant heterogeneity among the included studies.

Additionally, the researchers found differences between NOACs and warfarin in risk for the following outcomes:

Despite limitations, including not assessing additional diabetes mellitus biomarkers, as well as potential biases across the included studies, the authors ultimately suggested NOACs may be a better choice for anticoagulation in patients with NVAF and diabetes.

Find Related Articles and Interviews at the Atrial Fibrillation Knowledge Hub

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NOACs or Warfarin in Atrial Fibrillation With Diabetes - DocWire News

New research reports that type 1 diabetes may be tougher on girls than boys due to higher blood sugar levels, weight issues, and higher cholesterol.

Girls may also deal with higher rates of depression and have lower overall scores gauging quality of life.

The review of 90 previous studies done by researchers at Amsterdam University Medical Centers stated there are some consistent patterns in how type 1 diabetes affects girls and boys differently.

The findings were presented at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

The review has not been published yet in a peer-reviewed journal.

In their review, the researchers reported, girls showed higher A1C levels a measure of blood sugar control over the previous three months than boys. Girls also had a higher rate of obesity and high cholesterol, along with lower scores on the quality of life surveys.

Type 1 diabetes usually occurs in childhood and affects more than 1.45 million people in the United States

It involves a persons immune system mistakenly attacking pancreatic cells that produce insulin a hormone responsible for moving food sugar into body cells for energy. Without insulin, sugar builds up in the blood, starving body cells. That requires people with type 1 diabetes to take synthetic insulin.

In terms of this research about type 1 diabetes being tougher on girls than boys, when it comes to weight gain and blood sugar levels, this information is new to the medical community, but its not necessarily surprising Dr. Abiona Redwood, an instructor in the Family Medicine residency Program at Community Health of South Florida, told Healthline. Thats because when it comes to weight gain, girls and women experience three periods of weight gain: puberty, which the report touched on, pregnancy, and menopause. Its a lot harder for girls and women to lose weight when they go through those things.

Just imagine adding to that type 1 diabetes and the different hormonal changes caused by menstruation that can also have an effect and happens 12 times a year for girls and women with ordinary period cycles, Redwood added. Girls also arrive at puberty two years before boys do, and as early as age eight.

Girls, especially during puberty, experience frequent hormonal changes, whereas with boys, hormonal changes tend to be gradual, and they dont experience these monthly changes, Redwood noted. A lot of this is physical, especially when the hormonal changes affect blood sugar. The up-and-down hormonal movements are going to prove a significant factor when it comes to weight gain.

Also, historically, girls have had greater issues about body image, she added. What I have seen among my patients, is that as girls with type 1 diabetes enter their teens the pressures of family and social obligations can make them prone to neglecting their diabetes treatment. Too often parents assume, as their girls enter their teens, they will be more responsible about their diabetes, but quite often its the opposite and this is precisely the time when these girls need extra parental support when it comes to maintaining medication discipline. This is a time of increasing and competing concerns for these girls, after all.

Dana Ellis Hunnes a senior clinical dietitian at UCLA Medical Center and assistant professor at UCLA Fielding School of Public Health, told Healthline that women and girls have typically not received as much attention as study subjects as men.

That could explain why girls having more difficulty with type 1 diabetes is only now coming to light.

I believe there are more pressures on girls, even at a younger age, to appear in certain ways or behave in certain ways, Hunnes said. There is, of course, also the biological component, girls according to this study had higher BMI at diagnosis and poorer glucose control so some of that may be biological insulin/hormone production -and some of it may be psychological.

Girls may have earlier onset of beta-cell destruction the cells that secrete insulin than boys do, which is why they are diagnosed at a younger age, she added. It may also be that they live with the condition longer before diagnosis and so that could leave them with higher blood sugar levels. It may also be psychological in the sense that girls may want to fit in more at a younger age than boys and so, may be more willing to assimilate their eating habits to the crowd.

Dr. Eva Shelton, a physician at Brigham and Womens Hospital in Seattle, told Healthline there could also be a body composition issue.

Women tend to have more adipose tissue (used for fat storage) as opposed to lean muscle, compared to men, Shelton said. Women are also more likely to eat as a coping mechanism than boys. The increase in adipose tissue and lipid content in women predisposes to insulin resistance, and that combined with uncontrolled snack eating leads to high blood sugars and more severe diabetes.

Dr. Robin Dickinson is a family practitioner in Englewood, Colorado. Shes also the founder of Dr. Robins School, a human biology program for children in third to eighth grade.

Dickinson told Healthline that teaching kids about type 1 diabetes stands out to her, and not just because she pokes her finger with a lancet to demonstrate how kids check their blood sugar.

More than any other condition, the kids with diabetes are constantly receiving messages from people around them teachers, friends parents, other kids about what they should and should not be doing, Dickinson said. Kids with diabetes, especially girls, are often told that they shouldnt eat particular foods or shouldnt be exercising or should worry about their blood sugar or weight by anyone who knows they are diabetic or sees them checking their sugars.

Dickinson said its important not to alienate children who do develop diabetes.

As in so many other areas, girls come in for more of this, Dickinson said. People worry more, try to limit their physical activity more, try to limit their eating more. Yes, they need to watch their sugars, but that isnt everyones business. The best way to be a friend to a girl with diabetes is to treat them like a normal kid and not invade their privacy with lots of shoulds and shouldnts.

Hunnes added that the research shows doctors should treat girls with type I diabetes differently than boys.

We know from adults that women experience heart attacks differently than men do and, as such, should be treated differently, as far as determining the diagnosis, she said. We know that women have menstrual cycles each month (on average) that can affect hormones all over their body, and as such, may need different varieties of treatment than boys, psychologically, and possibly medically/biologically as well.

If there are psychological components to higher blood sugars, then I also think it is important for the doctor to understand what is happening there as well. Medicine cannot be one-size-fits-all, Hunnes added.

Excerpt from:
Why Type 1 Diabetes Is Tougher on Girls Than Boys - Healthline

STOCKHOLM Recent study results confirm that two agents from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class can significantly cut the incidence of adverse cardiovascular events in patients with heart failure with reduced ejection fraction (HFpEF), a disease especially common in people with type 2 diabetes, obesity, or both.

And findings from secondary analyses of the studies including one reported last week during the European Association for the Study of Diabetes (EASD) 2022 Annual Meeting show that these SGLT2 inhibitors work as well for cutting incident adverse events (cardiovascular death or worsening heart failure) in patients with HFpEF and diabetes as they do for people with normal blood glucose levels.

But delivering treatment with these proven agents, dapagliflozin (Farxiga) and empagliflozin (Jardiance), first requires diagnosis of HFpEF, a task that clinicians have historically fallen short in accomplishing.

When a year ago, results from the EMPEROR-Preserved trial with empagliflozin and when a few weeks ago results from the DELIVER trial with dapagliflozin established the efficacy of these two SGLT2 inhibitors as the first treatments proven to benefit patients with HFpEF, they also raised the stakes for clinicians to be much more diligent and systematic in evaluating people at high risk for developing HFpEF because of having type 2 diabetes or obesity, two of the most potent risk factors for this form of heart failure.

"Vigilance for HFpEF needs to increase because we can now help these patients," declared Lars H. Lund, MD, PhD, speaking at the meeting. "Type 2 diabetes dramatically increases the incidence of HFpEF," and the mechanisms by which it does this are "especially amenable to treatment with SGLT2 inhibitors," said Lund, a cardiologist and heart failure specialist at the Karolinska Institute, Stockholm.

HFpEF has a history of going undetected in people with type 2 diabetes, an ironic situation given its high incidence as well as the elevated rate of adverse cardiovascular events when heart failure occurs in patients withtype 2 diabetes compared with patients who do not have diabetes.

The key, say experts, is for clinicians to maintain a high index of suspicion for signs and symptoms of heart failure in people with type 2 diabetes and to regularly assess them, starting with just a few simple questions that probe for the presence of dyspnea, exertional fatigue, or both, an approach not widely employed up to now.

Clinicians who care for people with type 2 diabetes must become "alert to thinking about heart failure and alert to asking questions about signs and symptoms" that flag the presence of HFpEF, advised Naveed Sattar, MBChB, PhD, a professor of metabolic medicine at the University of Glasgow, United Kingdom.

Soon, medical groups will issue guidelines for appropriate assessment for the presence of HFpEF in people with type 2 diabetes, Sattar predicted in an interview.

"You can't simply ask patients with type 2 diabetes whether they have shortness of breath or exertional fatigue and stop there," because often their first response will be no.

"Commonly, patients will initially say they have no dyspnea, but when you probe further, you find symptoms," noted Mikhail N. Kosiborod, MD, co-director of Saint Luke's Cardiometabolic Center of Excellence in Kansas City, Missouri.

These people are often sedentary, so they frequently don't experience shortness of breath at baseline, Kosiborod said in an interview. In some cases, they may limit their activity because of their exertional intolerance.

Once a person's suggestive symptoms become known, the next step is to measure the serum level of N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker considered to be a generally reliable signal of existing heart failure when elevated.

Any value above 125 pg/mL is suggestive of prevalent heart failure and should lead to the next diagnostic step of echocardiography, Sattar said.

Elevated NT-proBNP has such good positive predictive value for identifying heart failure that it is tempting to use it broadly in people with type 2 diabetes. A consensus report from the American Diabetes Association that was published earlier this year says that "measurement of a natriuretic peptide [such as NT-proBNP] or high-sensitivity cardiac troponin is recommended on at least a yearly basis to identify the earliest HF [heart failure] stages and implement strategies to prevent transition to symptomatic HF."

But because of the relatively high current price for an NT-proBNP test, the cost-benefit ratio for widespread annual testing of all people with type 2 diabetes would be poor, some experts caution.

"Screening everyone may not be the right answer. Hundreds of millions of people worldwide" have type 2 diabetes. "You first need to target evaluation to people with symptoms," advised Kosiborod.

He also warned that a low NT-proBNP level does not always rule out HFpEF, especially among people with type 2 diabetes who also have overweight or obesity, because NT-proBNP levels can be "artificially low" in people with obesity.

Other potential aids to diagnosis are assessment scores that researchers have developed, such as the H2FPEF score, which relies on variables that include age, obesity, and the presence of atrial fibrillation and hypertension.

However, this score also requires an echocardiography examination, another test that would have a questionable cost-benefit ratio if performed widely for patients with type 2 diabetes without targeting, Kosiborod said.

A prespecified analysis of the DELIVER results that divided the study cohort on the basis of their glycemic status proved the efficacy of the SGLT2 inhibitor dapagliflozin for patients with HFpEF regardless of whether or not they had type 2 diabetes, prediabetes, or were normoglycemic at entry into the study, Silvio E. Inzucchi, MD, reported at the EASD meeting.

Treatment with dapagliflozin cut the incidence of the trial's primary outcome of cardiovascular death or worsening heart failure by a significant 18% relative to placebo among all enrolled patients.

The new analysis reported by Inzucchi showed that treatment was associated with a 23% relative risk reduction among those with normoglycemia, a 13% reduction among those with prediabetes, and a 19% reduction among those with type 2 diabetes, with no signal of a significant difference among the three subgroups.

"There was no statistical interaction between categorical glycemic subgrouping and dapagliflozin's treatment effect," concluded Inzucchi, director of the Yale Medicine Diabetes Center, New Haven, Connecticut.

He also reported that among the 6259 people in the trial with HFpEF, 50% had diabetes, 31% had prediabetes, and a scant 19% had normoglycemia. The finding highlights once again the high prevalence of dysglycemia among people with HFpEF.

Previously, a prespecified secondary analysis of data from the EMPEROR-Preserved trial yielded similar findings for empagliflozin that showed the agent's efficacy for people with HFpEF across the range of glucose levels.

The DELIVER trial was funded by AstraZeneca, the company that markets dapagliflozin (Farxiga). The EMPEROR-Preserved trial was sponsored by Boehringer Ingelheim and Eli Lilly, the companies that jointly market empagliflozin (Jardiance). Lund has been a consultant to AstraZeneca and Boehringer Ingelheim and to numerous other companies, and he is a stockholder in AnaCardio. Sattar has been a consultant to and has received research support from AstraZeneca and Boehringer Ingelheim, and he has been a consultant to Eli Lilly, Afimmune, Amgen, Hammi, Merck Sharpe & Dohme, Novartis, Novo Nordisk, Pfizer, Roche, and Sanofi-Aventis. Kosiborod has been a consultant to and has received research funding from AstraZeneca and Boehringer Ingelheim and has been a consultant to Eli Lilly and numerous other companies. Inzucchi has been a consultant to and has given talks on behalf of AstraZeneca and Boehringer Ingelheim. He has also been a consultant to or has served on trial committees for Abbott, Esperion, Lexicon, Merck, Novo Nordisk, Pfizer, and vTv Therapetics.

European Association for the Study of Diabetes (EASD) 2022 Annual Meeting:Presented September 22, 2022.

Mitchel L. Zoler is a reporter with Medscape and MDedge based in the Philadelphia area. @mitchelzoler

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

You can also follow Medscape on Instagram, YouTube and Linkedin.

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Improve Diagnosis of Type of Heart Failure Common in Diabetes - Medscape

Knockout of TXNIP improves diabetes-associated hyperglycemia and hyperglucagonemia.

Anath Shalev, M.D.In groundbreaking diabetes research over the past two decades, Anath Shalev, M.D., has shown that the protein TXNIP regulates survival and function of beta cells, the pancreatic cells that produce the hormone insulin to lower levels of glucose in the blood. Downregulation or inhibition of TXNIP in beta cells protects against diabetes in mouse models, and a repurposed clinical drug that inhibits TXNIP shows promising results in people with recent-onset Type 1 diabetes.

Beta cells play a key role in the pathogenesis of both Type 1 and Type 2 diabetes. However, pancreatic islets also have alpha cells that produce the hormone glucagon, which acts to raise glucose blood levels. Together, insulin and glucagon keep blood glucose levels stable.

To further understand the role of TXNIP in pancreatic islet biology and glucose control, Shalev and colleagues at the University of Alabama at Birmingham now report the effect of knocking out TXNIP in alpha cells.

While not as dramatic as beta-cell TXNIP knockouts, the alpha-cell knockout improved diabetes-associated hyperglycemia and hyperglucagonemia in a mouse model of streptozotocin-induced diabetes. Hyperglycemia and hyperglucagonemia excess levels of glucose and glucagon in the blood are hallmarks of diabetes.

The alpha-cell knockouts, known as aTKO mice, had normal glucose homeostasis and no gross abnormalities when fed on regular chow food. However, when the aTKO mice were fed a high-fat diet for 30 weeks to create glucose intolerance, they had a reduced high-fat diet-induced glucose intolerance compared to control mice on the high-fat diet. Glucose intolerance is an impaired ability to respond to a surge of dietary glucose.

In the knockout mice, there was no change in the architecture of the aTKO islets and the alpha cell numbers were unchanged. Furthermore, the expression levels of the glucagon gene and key islet transcription factors showed no change. However, glucagon secretion was decreased more than twofold in the aTKO islets compared to controls.

Out of five proteins recently reported to be involved in alpha cell glucagon expression, only one, Grp78, had significantly changed expression in the aTKO islets. This protein was recently confirmed to interact with glucagon in secretory granules, and it acts as a molecular chaperone in the cells endoplasmic reticulum, the transportation system of the cell where proteins are produced.

Thus, it appears that downregulation of alpha cell TXNIP can inhibit alpha cell glucagon secretion, which in turn may help explain the improvement in hyperglucagonemia and hyperglycemia observed in diabetic aTKO mice.

Interestingly, we recently found that pharmacological inhibition of TXNIP with a small molecule inhibitor also resulted in decreased alpha cell glucagon secretion in vitro in alphaTC1-6 cells and in vivo in different diabetes mouse models, said Shalev, director of the UAB Comprehensive Diabetes Center and professor in the Department of Medicine Division of Endocrinology, Diabetes and Metabolism. These findings strongly support our current results using genetic TXNIP deletion and together suggest that alterations in TXNIP regulate alpha cell glucagon secretion.

Co-authors with Shalev on the paper, Alpha cell TXNIP deletion improves diabetes-associated hyperglycemia and hyperglucagonemia, published in the journal Endocrinology, are Brian Lu, Junqin Chen, Guanlan Xu, Truman B. Grayson, Gu Jing and SeongHo Jo, all members of the UAB Comprehensive Diabetes Center and the UAB Department of Medicine, Division of Endocrinology, Diabetes and Metabolism.

Support came from National Institutes of Health grants DK078752 and Human Islet Research Network DK120379.

At UAB, Shalev holds the Nancy R. and Eugene C. Gwaltney Family Endowed Chair in Juvenile Diabetes Research. Medicine is a department in the Marnix E. Heersink School of Medicine.

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Diabetes: TXNIP involved in increased secretion of glucagon from pancreatic alpha cells - University of Alabama at Birmingham

DUBLIN, Sept. 30, 2022 /PRNewswire/ -- The "Next Generation Diabetes Therapy and Drug Delivery Market By Product, By Demographic, By Indication, By End User: Global Opportunity Analysis and Industry Forecast, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

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The global next generation diabetes therapy and drug delivery market was valued at $7,080.6 million in 2020 and is projected to reach $28,044.23 million by 2030, registering a CAGR of 14.28% from 2021 to 2030.

The next generation diabetes therapy and the drug delivery devices are the advanced form of diabetic products that improve the quality of life of diabetic patients. These products help in the management of the blood glucose level of diabetic patient in minimally invasive manner. Oral and inhalable insulin introduce a different mode of insulin delivery in diabetic patients. It is a painless mode of introducing insulin than the injectable insulins, reducing the risk of skin irritation caused due to needles.

In addition, the dose volume is easily calculated in oral & inhalable insulin and helps to maintain the dosage time. Advanced diabetic therapy in the form of insulin patches, continuous glucose monitoring systems (CGMS), and artificial pancreas helps to improve management of blood sugar level and reduces the risk of any diabetic-related complications.

The main factors that drive the growth of the next generation diabetes therapy and the drug delivery market include, the benefits of using these advanced devices over conventional products and rise in the healthcare expenditure.

In addition, rise in incidences of diabetes globally and increase in the disposable income among the diabetic patients, further supplement the global next generation diabetes therapy and drug delivery market growth.

Conversely lack of awareness, cost restrains in the developing regions, and less variability in products are expected to obstruct the growth of the market during forecast years. On the other hand, development of affordable products with fewer side effects and presence of undiagnosed diabetic patients globally are expected to offer profitable opportunities for the growth of the market during the forecast period.

The global next generation diabetes therapy and drug delivery market is segmented based on product, demographic, indication, end user, and region. On the basis of product, it is classified into inhalable insulin, oral insulin, insulin patches, CGM systems, and artificial pancreas. On the basis of demographics, it is bifurcated into adult population (>14 years) and child population (?14 years). By indication, it is divided into type 1 diabetes and type 2 diabetes. On the basis of end users, it is categorized into diagnostics/clinics, ICUs, and home healthcare. Region-wise, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

The key market players profiled in the report include Abbott Laboratories, Medtronic, Inc., Sanofi S.A., Novo Nordisk, MannKind Corporation, Eli Lilly and Company, Dexcom, Inc., Senseonics Holding, Inc., Glysens Incorporated, and Johnson & Johnson.

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Key Benefits For Stakeholders

This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the next generation diabetes therapy and drug delivery market analysis from 2020 to 2030 to identify the prevailing next generation diabetes therapy and drug delivery market opportunities.

The market research is offered along with information related to key drivers, restraints, and opportunities.

Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.

In-depth analysis of the next generation diabetes therapy and drug delivery market segmentation assists to determine the prevailing market opportunities.

Major countries in each region are mapped according to their revenue contribution to the global market.

Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.

The report includes the analysis of the regional as well as global next generation diabetes therapy and drug delivery market trends, key players, market segments, application areas, and market growth strategies.

Key Topics Covered:

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET OVERVIEW3.1. Market definition and scope3.2. Key findings3.2.1. Top investment pockets3.3. Porter's five forces analysis3.4. Top player positioning3.5. Market dynamics3.5.1. Drivers3.5.2. Restraints3.5.3. Opportunities3.6. COVID-19 Impact Analysis on the market

CHAPTER 4: NEXT GENERATION DIABETES THERAPY AND DRUG DELIVERY MARKET, BY PRODUCT4.1 Overview4.1.1 Market size and forecast4.2 Inhalable Insulin4.2.1 Key market trends, growth factors and opportunities4.2.2 Market size and forecast, by region4.2.3 Market analysis by country4.3 Oral Insulin4.3.1 Key market trends, growth factors and opportunities4.3.2 Market size and forecast, by region4.3.3 Market analysis by country4.4 Insulin Patches4.4.1 Key market trends, growth factors and opportunities4.4.2 Market size and forecast, by region4.4.3 Market analysis by country4.5 CGM Systems4.5.1 Key market trends, growth factors and opportunities4.5.2 Market size and forecast, by region4.5.3 Market analysis by country4.6 Artificial Pancreas4.6.1 Key market trends, growth factors and opportunities4.6.2 Market size and forecast, by region4.6.3 Market analysis by country

CHAPTER 5: NEXT GENERATION DIABETES THERAPY AND DRUG DELIVERY MARKET, BY DEMOGRAPHIC5.1 Overview5.1.1 Market size and forecast5.2 Adult Population (>14years)5.2.1 Key market trends, growth factors and opportunities5.2.2 Market size and forecast, by region5.2.3 Market analysis by country5.3 Child Population (14years)5.3.1 Key market trends, growth factors and opportunities5.3.2 Market size and forecast, by region5.3.3 Market analysis by country

CHAPTER 6: NEXT GENERATION DIABETES THERAPY AND DRUG DELIVERY MARKET, BY INDICATION6.1 Overview6.1.1 Market size and forecast6.2 Type 1 Diabetes6.2.1 Key market trends, growth factors and opportunities6.2.2 Market size and forecast, by region6.2.3 Market analysis by country6.3 Type 2 Diabetes6.3.1 Key market trends, growth factors and opportunities6.3.2 Market size and forecast, by region6.3.3 Market analysis by country

CHAPTER 7: NEXT GENERATION DIABETES THERAPY AND DRUG DELIVERY MARKET, BY END USER7.1 Overview7.1.1 Market size and forecast7.2 Diagnostic/Clinics7.2.1 Key market trends, growth factors and opportunities7.2.2 Market size and forecast, by region7.2.3 Market analysis by country7.3 ICUs7.3.1 Key market trends, growth factors and opportunities7.3.2 Market size and forecast, by region7.3.3 Market analysis by country7.4 Home Healthcare7.4.1 Key market trends, growth factors and opportunities7.4.2 Market size and forecast, by region7.4.3 Market analysis by country

CHAPTER 8: NEXT GENERATION DIABETES THERAPY AND DRUG DELIVERY MARKET, BY REGION

CHAPTER 9: COMPANY LANDSCAPE9.1. Introduction9.2. Top winning strategies9.3. Product Mapping of Top 10 Player9.4. Competitive Dashboard9.5. Competitive Heatmap9.6. Key developments

CHAPTER 10: COMPANY PROFILES10.1 Abbott laboratories10.1.1 Company overview10.1.2 Company snapshot10.1.3 Operating business segments10.1.4 Product portfolio10.1.5 Business performance10.1.6 Key strategic moves and developments10.2 Dexcom, Inc10.2.1 Company overview10.2.2 Company snapshot10.2.3 Operating business segments10.2.4 Product portfolio10.2.5 Business performance10.2.6 Key strategic moves and developments10.3 Eli Lilly and Company10.3.1 Company overview10.3.2 Company snapshot10.3.3 Operating business segments10.3.4 Product portfolio10.3.5 Business performance10.3.6 Key strategic moves and developments10.4 Glysens Incorporated10.4.1 Company overview10.4.2 Company snapshot10.4.3 Operating business segments10.4.4 Product portfolio10.4.5 Business performance10.4.6 Key strategic moves and developments10.5 Johnson & Johnson10.5.1 Company overview10.5.2 Company snapshot10.5.3 Operating business segments10.5.4 Product portfolio10.5.5 Business performance10.5.6 Key strategic moves and developments10.6 MannKind Corporation10.6.1 Company overview10.6.2 Company snapshot10.6.3 Operating business segments10.6.4 Product portfolio10.6.5 Business performance10.6.6 Key strategic moves and developments10.7 Medtronic plc10.7.1 Company overview10.7.2 Company snapshot10.7.3 Operating business segments10.7.4 Product portfolio10.7.5 Business performance10.7.6 Key strategic moves and developments10.8 Novo Nordisk A/S10.8.1 Company overview10.8.2 Company snapshot10.8.3 Operating business segments10.8.4 Product portfolio10.8.5 Business performance10.8.6 Key strategic moves and developments10.9 Sanofi S.A.10.9.1 Company overview10.9.2 Company snapshot10.9.3 Operating business segments10.9.4 Product portfolio10.9.5 Business performance10.9.6 Key strategic moves and developments10.10 Senseonics Holdings, Inc.10.10.1 Company overview10.10.2 Company snapshot10.10.3 Operating business segments10.10.4 Product portfolio10.10.5 Business performance10.10.6 Key strategic moves and developments

For more information about this report visit https://www.researchandmarkets.com/r/1ixrhs

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Insights on the Next Generation Diabetes Therapy and Drug Delivery Global Market to 2030 - Rising Incidences of Diabetes Globally and Increase in the...

A registered nurse explains how peanut butter and diabetes can coexist in a healthy meal plan. In fact, the salty snack may even help you control your blood sugar.

Rich and creamy with the right amount of salty sweetness, peanut butter is a staple for a reason. It adds a punch of protein to quick snacks and keeps you full until dinnertime.

Its also a high-calorie food, so it can be confusing for people with diabetes. Here are a few tips to keep in mind before scooping up a spoonful of healthy peanut butter.

Yes, in moderation. Natural peanut butter is considered safe for people with diabetes. Its best to avoid the low-fat varieties of peanut butter. They sound healthybut most brands simply add more sugar to make up for less fat. This can spike blood sugar levels and leads to more daily carbohydrates.

Studies have shown that when people with type 2 diabetes follow a low-carb diet, they can reap health benefits from adding peanuts to their diets. By replacing certain foods with peanuts or natural peanut butter, its possible to lose weight, improve blood sugar control and regulate the amount of fat in the blood (also known as blood lipid level).

Peanut butter also helps control blood sugar in those who dont have diabetes. In fact, eating peanut butter may even lower the risk of developing type 2 diabetes. Peanut butter is rich in unsaturated fats that help the body regulate insulin and blood sugar levels. Peanuts are also rich in magnesium. Research shows that diets rich in magnesium can be protective against diabetes.

Not a fan of peanut butter? You can reap many of the same benefits with almond butter.

Peanut butter can get a bad rap for being high in calories. A two-tablespoon serving of peanut butter contains about 188 calories, 7.7 grams of protein, 6.9 grams of carbohydrates and 2.4 grams of saturated fat. When enjoyed in moderation, peanut butter can be a healthy part of your diabetes-friendly meal plan.

No, natural peanut butter will not raise blood sugar. In fact, it could stabilize your numbers.

A 2018 study found that eating two tablespoons of peanut butter with white bread and apple juice led to a significantly lower blood glucose spike when compared with white bread and juice alone. The protein and healthy fats in peanut butter help our bodies avoid a blood sugar spike (and eventual crash).

Adding peanut butter to your breakfast routine may aid in blood sugar control throughout the day. A 2012 study found that when women with obesity ate peanuts or peanut butter in the morning, they were more likely to be able to manage their blood sugar levels throughout the day.

Peanut butter is a high-calorie food, so its important to enjoy in moderation. Try replacing some refined carbs or processed meats with peanut butter. This will help avoid adding too many calories to your healthy eating plan.

When choosing peanut butter at the store, opt for a natural variety with as few ingredients as possible. Avoid any brands that add sugar or other sweeteners. Ditch any low-fat varieties because they are typically loaded with sugar. Some brands use partially hydrogenated oils in their peanut butter. These oils have been linked to heart disease, so skip those as well.

To choose the best peanut butter for you and your health, start by reading the ingredient list. Crazy Richards 100% Peanuts Peanut Butter has one ingredient: peanuts! Learn more about how to shop for healthy peanut butter.

You can eat peanut butter with all kinds of healthy diabetes snacks. Here are a few of our favorite ideas:

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Peanut Butter and Diabetes: Can They Work Together? - Taste of Home