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Serious genital infection alert with SGLT2 inhibitors

FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors 

The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene.

Please let patient know about this new warning to be added to the prescribing information of all SGLT2 inhibitors.

Patients should seek medical attention immediately if they experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.

Health care professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.

Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. The bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect. Having diabetes is a risk factor for developing Fournier’s gangrene; however, this condition is still rare among diabetic patients. Overall published literature about the occurrence of Fournier’s gangrene for men and women is very limited. Publications report that Fournier’s gangrene occurs in 1.6 out of 100,000 males annually in the U.S., and most frequently occurs in males 50-79 years (3.3 out of 100,000).1-3 In our case series, however, we observed events in both women and men.

In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor. This number includes only reports submitted to FDA* and found in the medical literature,4-6 so there may be additional cases about which we are unaware. In 2017, an estimated 1.7 million patients received a dispensed prescription for an SGLT2 inhibitor from U.S. outpatient retail pharmacies.7 Although most cases of Fournier’s gangrene have previously been reported in men, our 12 cases included 7 men and 5 women. Fournier’s gangrene developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases. All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died. In comparison, only six cases of Fournier’s gangrene (all in men) were identified in review of other antidiabetic drug classes over a period of more than 30 years.

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving SGLT2 inhibitors or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box.

For more information, please see the FDA Warning Post

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“Savory Foods May Help Promote Healthy Eating”

Humans are said to have five basic tastes: salty, sweet, bitter, sour, and the least known, umami. Umami is a Japanese word “used to express a delicious, savory meal.” Recent studies are beginning to show that healthy eating habits may be influenced by consuming savory foods.

Glutamate, a key component of Umami taste, is an amino acid that is commonly found in savory foods with higher protein values. Previous studies have shown that consuming glutamate via broth can decrease overall appetite and intake. This is especially helpful for individuals who struggle with overeating and weight gain. A study by the Journal of Neurophyschopharmacology found that the participants, “had more focused gazes during the meal and had more engagement of a brain area that is linked to successful self-regulation during food choice.”

Further research may help encourage and facilitate healthier eating patterns and reduce the amount of individuals at risk for developing type 2 diabetes and becoming obese.

To learn more about Umami and its prevalence in weight loss and appetite control, visit Savory Foods May Help Promote Healthy Eating.

“Children who drink fruit juice with breakfast are 50% more likely to be overweight”

“Children who drink fruit juice with breakfast are more likely to become overweight or obese.”

A recent study by the Medical University of Vienna reported that “children who had orange or apple juice with their breakfast were 50% more likely to be overweight.” On the alternative end, the children consuming water in the study decreased their risk for obesity by 40%. The study also evaluated the children’s overall eating habits and whether or not they skipped breakfast. The study found that the children who ate breakfast every morning were generally three pounds lighter than the children who skipped it all together.

The experts in the study recommended to look for fruit juices with lower added sugar and very simple ingredients. The increased risk of obesity is likely due to the the added sugars as well as the overall higher energy content. A small glass of freshly squeezed orange juice with no added sugar is a better, low-calorie option since it contains beneficial vitamins and minerals that are vital for children’s development. The fiber content in natural fruit juices is also beneficial for promoting good digestive health. Of course, enjoying the whole fruit is always the best option.

In summary, fruit juice does not necessarily need to be eliminated altogether.  Consider it a special treat. But better choices include eating the fruit instead or diluting the juice with 50% water (sparkly water works great) to decrease overall sugar and energy content.

To read more about this topic, visit Children who drink fruit juice with breakfast 50% more likely to be overweight.

Written by: Sofia Sepulveda

Fermented Foods Guide to Boost Microbiota Health

Maintaining a wide diversity of gut microbiome is vital for good health. A large amount of these microbes can be acquired through fermented foods like yogurt, kombucha, and sauerkraut. Fermented foods and the microbes they provide have proven to improve digestion of lactose, aid in weight management, lower risk of type 2 diabetes, and lower risk of developing cardiovascular disease.

This guide to fermented foods provides a quick and dirty guide to increasing gut bacteria diversity and through fermented foods.

Want to learn more? Join the wonderment as we explore the role of our Microbiome with our “New Horizons – Getting to the Gut” webinar

Join us to learn about the exciting advances in our understanding of the pathology of diabetes and novel approaches to prevention. We will discuss trends in diabetes diagnosis and classification.  The role and importance of gut bacteria in the pathology of type 1 and type 2 will explored. A detailed discussion on emerging research and clinical trial on interventions to delay or prevent diabetes is also included.

Topics Include:

  • Describe trends in diabetes
  • Discuss current research in the importance of gut bacteria.
  • Describe 2 interventions to delay or prevent diabetes

We need more time to provide diabetes education – let legislators know!

More time needed to provide diabetes education – Support Medicare Expansion Bill

3 things you can do today

On August 22, Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced the Expanding Access to Diabetes Self-Management Training (DSMT) Act (S. 3366) in the U.S. Senate. This is the Senate companion to legislation introduced in the U.S. House of Representatives on May 10 by Representatives Tom Reed (R-NY) and Diana DeGette (D-CO). AADE worked in collaboration with the Diabetes Advocacy Alliance and our Senate champions to introduce this important piece of legislation. 

Now that legislation has been introduced in the House and the Senate, we need the help of all diabetes educators to build support for these bills on Capitol Hill. 

  1. Send a letter to your legislator
  2. Call or Tweet your members of Congress urging them to support this important legislation by becoming a cosponsor. 
  3. Share this post with your friends and colleagues

 

Why is this bill important?

As diabetes educators, we know that self-management can be a path to a better quality of life. However, barriers within the Medicare benefit keep some of our most vulnerable citizens from accessing DSMT. The Expanding Access to DSMT Act (H.R. 5768 and S. 3366) will reduce barriers and improve Medicare beneficiary access to DSMT services in the following ways:

  • Allows the initial 10 hours of DSMT during the first year to remain available until fully utilized. If there’s a determination of medical necessity, then an additional 6 hours of training/ education may be added.
  • Allows 6 hours of DSMT in subsequent years, up from 2 hours. 
  • Removes the restriction related to coverage of DSMT and Medical Nutrition Therapy (MNT) services furnished on the same day.
  • Excludes DSMT services from Part B cost-sharing and deductible requirements.
  • Permits physicians and qualified non-physician practitioners who are not directly involved in managing an individual’s diabetes to refer them for DSMT services. An example would be a specialist treating a comorbidity like gangrene or vision loss, or an emergency room doctor.
  • Revises the Medicare Benefit Policy Manual to allow DSMT services to be furnished in a community-based location.]
  • Establishes a 2-year demonstration of virtual DSMT, potentially paving the way for future Medicare coverage of virtual DSMT services.

Back to School – Extend your Courses and Save!

It’s not too late to finish your homework!

Not able to complete your Online University courses?
Go “Back to School” and extend your courses for an additional year!

Online Course Bundle Extensions

Have you run out of time to study, but still want to access your courses?

Extend your courses for one additional year for a small fee. You can purchase the extension while your courses are still accessible, or when they expire.

 

10 Spots Remaining | Diabetes Ed Course

10 Spots Remaining at the Diabetes Educator Course | San Diego, CA – September 5th-7th, 2018

Sign up now to reserve your spot, space is very limited!

“More than a course, it’s an experience!”

Top 5 Reasons to Join >>

Come join us at our Level 2, Diabetes Educator Course in sunny San Deigo, California. Whether you are new to diabetes or a seasoned expert, you’ll leave our live seminars with the latest research plus teaching tools  you can immediately apply to your clinical practice. Beverly and her teaching team translate the complex science of diabetes into understandable terms, while keeping it real, practical and fun.

Dates:  September 5th – 7th, 2018

Diabetes Educator Course San Diego Brochure

Diabetes Educator Course Agenda

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“Pre-workout breakfast could prime body to burn carbs”

 

Free stock photo of bread, food, fruits, snack

Many people wonder if they should eat breakfast before working out or hold off on consuming calories until after exercise. Recent research by the University’s Department for Health at the universities of Birmingham, Newcastle, and Stirling has shown that the pre-workout breakfast can actually increase post meal glucose utilization.

In this study, 12 healthy males were given a control breakfast and were required to rest for three hours prior to exercise. Blood glucose levels and muscle glycogen levels were then tested post exercise and rest. Researchers found that consuming breakfast actually made the body more effective at burning carbohydrates during exercise, “as well as increasing the rate the body digested and metabolised food eaten after exercise too.”

They compared the results to participants who skipped breakfast. The researchers found that fasting before exercise actually had the opposite effect and made the body far less efficient at burning carbohydrates during exercise. Researchers also discovered that the subjects were not only burning carbohydrates from their breakfast but from their muscle glycogen stores as well. This provides explanation for why there is rapid clearance of blood sugar after lunch.

This study has only assessed short term effects. Therefore, further research must be performed to discover long term implications. 

To learn more about carbohydrate metabolism, visit Eating breakfast burns more carbs during exercise and accelerates metabolism for next meal.

Contributed by Sofia Sepulveda