The PROTECT Study

This content originally appeared on Beyond Type 1. Republished with permission.

By Makaila Heifner

Let’s face it, there are a lot of research studies out there, and we mean… a lot. But one you should definitely know about is The PROTECT Study. Especially if you or a loved one was recently diagnosed with type 1 diabetes (T1D).

The PROTECT Study aims to understand how the investigational medicine, teplizumab, works in children and young adults who have recently been diagnosed with T1D, as well as assessing if there are any side effects while taking the medication. This treatment is still being evaluated in clinical studies and has not been approved by the FDA for treating T1D. In previous studies of high-risk individuals, teplizumab was shown to delay the onset of T1D an average of nearly 3 years (35 months).

Who Is Eligible for the Study?

This study will include 300 children and adolescents in clinics across the United States, Canada, and Europe that meet the following criteria:

  1. Age 8-17 years old
  2. Diagnosed with T1D in the previous 6 weeks
  3. Positive for 1 of 5 T1D autoantibodies (test to be done as part of the study) 4. Ability to produce a minimum amount of your own insulin (test to be done as part of the study)
  4. Otherwise generally healthy, with no other significant medical conditions, recent or history of infections, or taking medicines that might interfere with teplizumab

If you meet all the criteria, the next step is to visit a study clinic, where the study team will:

  • Discuss the study in more detail and explain what participation would mean for you or your child.
  • Talk through the potential benefits and risks of being involved in the study.
  • Ask questions and carry out medical tests to determine whether you or your child are right for the study and the study is right for you or your child.

If you and/or your child are interested in potentially participating in the PROTECT study, click here to find a study clinic near you.

Before the study begins, you/and your child must agree to and sign an Informed Consent Form which explains the study in detail, any potential risks or benefits of participation, as well as your rights and responsibilities as a participant of the study.

All study-related treatment and care will be provided to eligible patients without charge; however, patients will not receive any compensation for their participation in the study. Patients who decide to participate are able to withdraw from the study at any time for any reason.

Participants do not have to change their primary doctors as the study provides short-term study-related care only. Patients are encouraged to tell their regular doctors about taking part in a clinical research study. Some medicines are prohibited to take while part of the study so a patient’s doctor may want to contact the study physician to request additional information.

How Does It Work?

If you/or your child are selected to be part of this study, you/your child will be placed in one of two groups, either the teplizumab group or the placebo group (meaning you/your child will receive no treatment). Deciding who will be placed in each group is chosen at random by a computerized system, and neither you/your child nor the study doctor will know which treatment group you/your child was placed in. This is done so that results from the different groups can be handled the same way.

Over the duration of the study, you/your child will receive 2 courses of study medicine given by intravenous (IV) infusion. The IV infusion usually lasts about 30 minutes and will be given daily over 12 days on 2 separate occasions, 6 months apart.

The study will last just over a year and a half (the study reports the study will last up to 84 weeks) and require 36 study clinic visits, including the initial screening, treatment courses, and observation periods.

During visits to the study clinic, you/your child will be asked several questions and perform a series of study-related medical tests. These tests are done in order to understand how the treatment is affecting you/your child and how well the body is responding to the medication.

Identifiable information (for instance, name or address) will not be accessible to anyone who is not directly part of this study; additionally, The Sponsor (the company carrying out the study) will not have access to any personal information that is submitted through the study’s website.

Why?

The treatment works by interfering with the cells that destroy the insulin-producing beta cells in the pancreas. If the treatment successfully interferes with these cells (T cells) patients who are taking teplizumab may be able to continue producing their own insulin and reduce their need for insulin injections, have better control over their blood glucose, and experience fewer complications from T1D.

Visit theprotectstudy.com to learn more about PROTECT.

Source: diabetesdaily.com

Will Insulin in a Pill Soon Become a Reality?

Since insulin was first discovered and isolated for therapeutic use nearly 100 years ago, most everyone with insulin-dependent diabetes has had to rely on exogenous insulin, given in the form of injections, whether via an insulin pump or multiple daily shots every single day of their lives (inhalable insulin was approved by the FDA in 2014, but its use is not widespread).

While research and development have come a long way in that time, the reality for millions (and over 7 million people in the United States alone) has been thousands upon thousands of invasive injections, oftentimes causing scarring, bruising, and pain. However, that may be about to change.

Researchers from the New York University in Abu Dhabi have successfully developed a pill using nanomaterial layers that disseminate insulin in rats safely without being destroyed by their stomach acids. This could be life-changing for the millions of people around the world who rely on insulin to live.

“Imagine being able to take insulin in a pill instead of injecting it a couple of times a day,” said first author Farah Benyettou, a research scientist in the Trabolsi Research Group at the New York University in Abu Dhabi. “The insulin was loaded in a system that protects it from the acidic environment of the stomach. Once in the body, the system can sense the blood sugar level and can release the loaded insulin on demand.”

A pill form of insulin has the potential to radically change the daily management of diabetes for the better: It would make treatment easier for children and people with a fear of needles, safer for both patients and clinicians in hospital and clinic settings, more effective, and patient-friendly.

Nearly 30% of people with diabetes rely on insulin injections, and while it might not be for everyone, this revolutionary advancement would be the first of its kind in the world.

Other attempts at orally administering insulin have been made in the past but faced roadblocks in the gastrointestinal tract, where stomach acids and bile quickly destroy insulin and any effectiveness it has.

This is different from common type 2 diabetes drugs like Metformin that aren’t insulin but simply improve the efficacy of insulin that their body already makes.

The research team in Abu Dhabi thinks it has solved the problem of the insulin-destroying stomach bile issue by encapsulating insulin within nCOF nanoparticles in a capsule that is resistant to such acids but responsive to sugar, reacting quickly when it senses blood glucose in the body is rising but survives the dangerous journey down the G.I. tract to reach the bloodstream.

This new advancement also has the potential to reduce or eliminate low blood sugars, as the release of insulin shuts off as soon as it senses blood sugars have fallen. This creates a helpful feedback loop and prevents an overdose of insulin, which for many, is an almost a daily occurrence on injections, where people are constantly walking a balance beam to prevent both high and low blood sugars in a world of stress, meals, exercise, and normal everyday living.

While this is all excellent news, it’s important to remember that the study’s success was only observed in rats, and human bodies are very different. The team will next test different nanomaterials to see what may be appropriate for human trials, and potentially, widespread market availability.

“Our revolutionary technology developed at NYUAD will dramatically improve the well-being of diabetic patients worldwide in a very simple and straightforward way,” says senior author Ali Trabolsi, an associate professor of chemistry at the New York University in Abu Dhabi.

While taking a daily insulin pill may is far from a functional cure, managing diabetes could become easier than ever, especially if the threat of low blood sugars is greatly reduced or eliminated.

The team hopes that diabetes management can soon be a lot less stressful, painful, and dangerous for the millions of people around the world who currently rely on insulin.

Source: diabetesdaily.com

New Study Shows Greater Risk for Severe COVID-19 Among People with Diabetes

This content originally appeared on diaTribe. Republished with permission.

By Eliza Skoler

New results from the CORONADO study reveal that one in five people with COVID-19 and diabetes die within 28 days of hospital admission. The main predictors of severe illness are older age and diabetes complications. 

In May, the CORONADO study revealed that one in ten people with COVID-19 and diabetes died within seven days of hospital admission. Read our early article on the study here.  New findings from the same study show that one in five people with COVID-19 and diabetes died within 28 days of hospital admission.

In the spring of 2020, the study followed 2,796 people with diabetes in France for 28 days after being admitted to the hospital for COVID-19. The analysis looked at rates of death and rates of discharge from the hospital during the 28-day period. The results revealed that after 28 days, 50% of individuals had been discharged and 21% of individuals had died (29% were still hospitalized). The analysis also looked at other factors in the study population:

  • Average age was 70 years old
  • About 40% had long-term microvascular (such as eye or kidney) or macrovascular (such as heart or leg) complications; 11% had heart failure
  • 78% had high blood pressure
  • Almost two thirds were men
  • 88% had type 2 diabetes, and 12% had type 1 diabetes

Older age, diabetes complications (especially heart disease and high blood pressure), difficulty breathing, use of anticoagulant (blood thinning) medication, and biological markers of inflammation were associated with a lower chance of hospital discharge. Similarly, older age, longer duration of diabetes, and a history of microvascular complications were associated with severe illness and poor outcomes from COVID-19 infection. On the other hand, younger age and metformin use were associated with leaving the hospital by the end of 28 days. As discussed in a previous article, while metformin use was associated with a more favorable health outcome, it was not shown to cause better health. Overall, the factors associated with death were the mirror-opposite of those associated with hospital discharge.

Long-term blood sugar management (measured by A1C) was not found to affect COVID-19 outcomes, though high plasma glucose levels at the time of hospitalization were strongly associated with death. Because glucose levels may be tied to COVID-19 outcomes, careful diabetes management remains important for preventing severe illness.

People with diabetes do not have a higher risk of getting COVID; rather, they are more likely to experience severe illness and worse outcomes if infected with COVID-19. It remains important for people with diabetes, as well as their contacts and loved ones, to do everything possible to stay healthy and safe: get vaccinated as soon as you can, continue to social distance, and wear one (or two!) masks in public. To learn more, read “What You Should Know About COVID-19 Vaccines and Diabetes” and “COVID Variants, Double Masks, Diabetes, Oh My!

Source: diabetesdaily.com

Metformin May Reduce Your Risk of Death from COVID-19 Infection

This content originally appeared on diaTribe. Republished with permission.

By Eliza Skoler

The use of metformin – the most common initial medication for people with type 2 diabetes – was associated with a lower rate of mortality from COVID-19 among people with diabetes in a study in Alabama, confirming five previous studies.

Do you take metformin? It’s the first-line therapy used to lower glucose levels in people with type 2 diabetes. A recent study found that metformin use was associated with a lower rate of COVID-related death among people with type 2 diabetes. Since people with diabetes are at increased risk for severe illness from COVID-19, including hospitalization and death, the relationship between metformin and COVID outcomes in this report may be of interest to many people around the world who take the medication.

Want more information like this?

The study looked at the electronic health data from 25,326 people tested for COVID at Birmingham Hospital in Alabama, including healthcare workers, between February and June of 2020. Of those tested, 604 people were positive for COVID-19 – and 239 of those who were positive had diabetes. These results showed that the odds of testing positive for COVID were significantly higher for people, particularly Black people, with certain pre-existing conditions, including diabetes. This does not mean people with diabetes are more likely to get COVID-19, only that people with diabetes were more likely to test positive at this hospital.

Importantly, the study found an association between metformin use and risk of death – the study reported that people who were on metformin before being diagnosed with COVID-19 had a significantly lower chance of dying:

  • People taking metformin had an 11% mortality (or death) rate, compared to 24% for those with type 2 diabetes not on metformin when admitted to the hospital.
  • This benefit of metformin remained even when people with type 2 diabetes and kidney disease or chronic heart failure were excluded from the calculations. This is important because people with kidney or heart disease are often advised against taking metformin. By removing this population, it helps to support the notion that metformin may be involved in this difference.
  • Body weight and A1C were not associated with mortality among people with diabetes taking metformin. This suggests that the association of metformin use with reduced COVID-related deaths was not due to the effects of the medication on weight or glucose management.

The data suggest that being a person with diabetes who takes metformin may provide some level of protection against severe COVID-19 infection among people with diabetes. Other studies have shown similar results, though it is not known whether metformin may itself reduce COVID-related deaths among people with type 2 diabetes. The authors discussed some previously reported effects of metformin beyond lowering glucose levels, such as reducing high levels of inflammation (the body’s natural way of fighting infection), which has been described as a risk factor in severe COVID infection. Severe infection with COVID-19, resulting in hospital admission, can lead to damage to the kidneys and decreased oxygen supply to the body’s tissues – and in these circumstances, serious side effects of metformin can occur.

“Given that COVID leads to higher mortality rates and more complicated hospital courses in people with diabetes, it is important to consider whether specific diabetes medications can provide some relative degree of protection against poor COVID outcomes,” said Dr. Tim Garvey, an endocrinologist at the University of Alabama at Birmingham. “This study adds to growing evidence that people with type 2 diabetes treated with metformin have better outcomes than those not receiving metformin.”

Dr. Garvey also cautioned: “Of course, these case-control studies show associations and do not rise to the level of evidence that might be found by a randomized clinical trial. For example, people with diabetes not treated with the first-line drug, metformin, may have a larger number of diabetes complications or longer duration of disease compared with people not on metformin – which could explain the more severe outcomes. In any event, we advocate for early administration of COVID-19 vaccines and other protective measures for people with diabetes.”

Professor Philip Home, a professor of diabetes medicine at Newcastle University in the UK, agreed, saying, “Multiple studies have now addressed the issue of whether metformin and insulin use are associated with better or worse outcomes in people with diabetes who contract COVID-19. In line with previous literature on other diseases, it was expected that people on metformin would do better, and people on insulin worse, than people with diabetes not using these medications. This is confirmed.”

Home continued: “It is believed to happen because people using metformin are younger and have better kidney function than those not taking the medication, while those on insulin tend to have other medical conditions. The good news is that if you have type 2 diabetes and are taking metformin, you are likely to be fitter than if you have type 2 diabetes and do not take the medication – but there is no evidence that metformin itself will make a difference to your outcome if you do get COVID-19. So, get vaccinated as soon as possible!”

To learn more about metformin, read “Everything You Always Wanted to Know About Metformin, But Were Afraid to Ask.”

Source: diabetesdaily.com

How Racial Bias Impacts Health Outcomes

COVID-19 is killing black Americans at three times the rate of white Americans. But it is not just COVID-19. Four hundred years of systematic discrimination has created systems that leave black people with dramatically worse health outcomes than others. Many living with diabetes have faced discrimination in their lifetime. Diabetes still poses barriers to getting fair treatment in our society, whether in school or work, exclusion from sports teams, or mismanagement in the hospital setting. All too often, living with diabetes as a person of color will compound these barriers.

Studies have shown that there are systemic, negative biases against people of color embedded in our healthcare system. This is layered on top of inequitable social determinants of health that people of color face, leading to poorer health outcomes, additional complications, and earlier deaths.

Black People Have a Higher Rate of Diabetes

Black people are more likely to have diabetes. There are 4.9 million non-Hispanic African Americans aged 20 years or older who have diabetes in the United States, according to the CDC. They are 77% more likely to have diabetes than non-Hispanic Caucasians. Part of this trend may be genetic, but one’s environment and socioeconomic status play a significant role in the development of type 2 diabetes, especially in a society without a robust social safety net.  Among racial and ethnic groups, African Americans have the highest poverty rate at 27.4% (compared to Hispanics at 26.6% and whites at 9.9%). Additionally, 45.8% of young black children under the age of 6 live in poverty, compared to 14.5% of white children.

There are many factors that contribute to this, but a history of institutionalized racism (the legacy of slavery, redlining and Jim Crow laws) have largely prevented African Americans from cultivating intergenerational wealth (which for most Americans comes from buying and selling real estate), and breaking the cycle of poverty proves to be nearly impossible in most circumstances.

Poorer, segregated (de facto segregation) black neighborhoods are more likely to face food deserts (areas where there are few or no grocery stores), lack access to healthy foods (including fresh fruits and vegetables), families may lack access to reliable meals (especially in the summer, when schools are no longer serving children breakfast and lunch), and unsafe streets and a lack of green space (few or no public parks). Neighborhoods of lower socioeconomic status are all risk factors for obesity and the eventual development of type 2 diabetes. 

Black People Have Higher Rates of Complications and Death

Black children and families are more likely to develop diabetes, and when they do, they face graver health outcomes. One recent study found that black youth have an average HbA1c of 10.6% compared to 8.3% for their white peers, and black children are twice as likely as white children to die from diabetes. Blacks are also more likely to experience greater disability from diabetes complications such as amputations, blindness, kidney failure, and increased risk of heart disease and stroke. Diabetic retinopathy is 46% more prevalent in African Americans than non-Hispanic whites, and African Americans are at least 2.6 times more likely to have end-stage renal disease due to diabetes than Caucasians. Most telling: the premature death rates for blacks with diabetes are 27% higher than for whites with diabetes.

racism and diabetes

Photo credit: iStock

Racism Is Built into Our Healthcare System

Implicit bias plays a large role in the unfair treatment of black people in the health care setting. In 2005, the National Academy of Medicine released a study that found that “racial and ethnic minorities receive lower-quality health care than white people, even when insurance status, income, age, and severity of conditions are comparable.” This suggests that poverty and lower socioeconomic status does not account for the whole picture of poorer health outcomes in black people with diabetes.

The report continued, “…minority persons are less likely than white persons to be given appropriate cardiac care, to receive kidney dialysis or transplants, and to receive the best treatments for stroke, cancer, or AIDS. It concluded, “some people in the United States were more likely to die from cancer, heart disease, and diabetes simply because of their race or ethnicity, not just because they lack access to health care.” Simply put: people are dying at higher rates just because the color of their skin is darker.

One study of 400 hospitals in the United States showed that black patients with heart disease received older, cheaper, and more conservative treatments than white patients presenting with the same disease and symptoms. Black patients with diabetes have higher rates of amputations than white patients, even when less invasive interventions are available. Additionally, another study showed that physicians were more likely to prescribe pain medications to white patients, mistakenly believing that black people “feel less pain”.

COVID-19 is killing black Americans at three times the rate of white Americans.

Where Do We Go from Here?

Social determinants of health, physician and healthcare workers’ implicit bias and systemic racism in our healthcare system all contribute to higher rates of disease, complications, and death. Neighborhoods and schools remain dramatically segregated and unequally funded.

The United States has a two-tiered health care system that provides fantastic care to those who can afford private health insurance, and little to none to those who cannot (aside from Emergency Department visits). We, as a society, do not value or fund preventive health care as much as we should. We don’t prioritize feeding our babies healthy food, or making sure they have space and safety to exercise regularly. We step in with too little too late for those who need help the most. We are biased in our healthcare decisions and have not fought against institutionalized racism early or long or loud enough. Now is not the time to “not be racist”, but to actively dismantle institutionalized racism from the inside out.

We need more black physicians, and nurses, and emergency medical technicians. We need to put our dollars into segregated neighborhoods and schools and prevent diabetes before it devastates underserved communities even more. We need to listen to black patients in hospitals. We need to trust black people when they voice their health concerns. We need more black voices in the diabetes online community. We need to lift up the voices of black people.

We need to do more for those that we have failed for far too long. We have already lost so much, and we need to act before it is too late.

Source: diabetesdaily.com

How a Vitamin D Deficiency Affects Diabetes

This content originally appeared on Integrated Diabetes Services. Republished with permission. More studies are being done on the implications of vitamin D deficiency in persons with diabetes. As much as pharmacology and medical science are unlocking the impacts of different chemicals on our bodies, the basic vitamins on the side of our Flintstones bottles still […]
Source: diabetesdaily.com

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