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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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.  Send a letter to your legislator Call or Tweet your members of Congress urging them to support this important legislation by becoming a cosponsor.  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.

It’s not too late to finish your homework!

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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!”

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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

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Here at Diabetes Education Services we strive to keep our community up-to-date on all the latest developments in healthcare and diabetes. We also love keeping in touch with our community before, during and after preparing to become an educator. 

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Bacteria may eat what we don’t! A recent study shows that gut microbiome may play a role in the effectiveness of weight loss.  Each person has their own unique microbiome community. An individual’s microboime makeup exerts a powerful influence over weight loss success or not.

In this study, the participants with an increased amount of the gut bacteria, Phascolartobacterium, were more successful in loosing the weight than participants with the bacteria, Dialister, who had a greatest risk of failure. 

The study suggests that certain gut bacteria may digest parts of food that we are unable to and create a byproduct. The byproduct then turns into additional calories. “Somewhere between 5 to 15 percent of all our calories come from that kind of digestion, where the microbes are providing energy for us, that we couldn’t [otherwise] get,” Blaser explains.

Although the study was small, it raises an interesting question, are those extra byproduct calories an unwanted gift? As research continues and results discovered are similar, this may mean more gut bacteria tailored diets in the future. 

“What we would hope to do is to be able to individualize care for people,” Kashyap says. “And we’d also try to develop new probiotics, which we could use to change the microbial makeup.”

To learn more – “Diet Hit A Snag? Your Gut Bacteria May Be Partly To Blame” by NPR

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Level 4 – New Horizons – Getting to the Gut 1.0 CE – $29

Join us to learn about the exciting advances in our understanding of the pathology of diabetes and novel approaches to prevention with our New Horizons – Gut Bacteria webinar.

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.

 

30% of American Indians on the White Earth Reservation have Type 2, which is three times the national average.

Accessibility to fresh fruits and vegetables plays an integral role in a community’s health. Often we stumble upon “food deserts – regions where grocery stores with fresh, healthy options simply don’t exist.” 

This summer, a new food truck has set out to make healthy eating more accessible to those who are not near grocery stores. White Earth Nation purchased a “healthy” food truck to help tribal members have access to healthy, locally produced and traditional foods. 

Unhealthy eating habits are often tied to generations with limited access to fresh foods and can lead to chronic long-term health problems. 

The goal of the new food truck is to provide more choices, as the White Earth Food truck travels to reservation villages in the summer with fresh produce and in the winter with other foods like squash, wild rice and preserves made from summer crops.

To learn more about the new food truck – White Earth hopes food truck puts reservation on road to better health by MPRnews

Please also enjoy our Plant Based Resource page

The FreeStyle Libre is a continuous glucose monitor (CGM), which automatically measures glucose readings day and night. This technology helps track glucose levels and in turn, manage diabetes. A new study suggest that CGM helps decrease health costs as it improves treatment adherence. Although people are still advised to perform standard glucose tests to confirm the accuracy, the monitor is reading and reporting glucose levels automatically through out the day. 

The study suggest that from a cost perspective, the CGM saves money due to the lessened frequency of testing and materials necessary. The study also found that people with Type 1 and 2 experienced a reduction in hypoglycemia when using the CGM. 

“For people with T1DM or T2DM who use MDI therapy, flash CGM has demonstrated improved adherence to the ADA recommendation as well as reduced acquisition cost when compared with routine SMBG.” 

Learn more with – FreeStyle Libre boosts testing adherence and lowers costs during MDI treatment, US study reports by Diabetes.co.uk

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View our July Newsletter

For this issue, we discuss the differences and similarities of human and analog insulin. Topics covered include:

• Insulin, Analogs or Human Insulin?
• The ADA Petition to keep insulin affordable
• Human Insulin for Medicare Beneficiaries
• and more!

Click here to read our newsletter!