Author: admin

2023-06-19T07:31:00

(BPT) – Meal Detection™ Technology* provides real-time insulin adjustments and corrections to help cover undercounted carbs and occasionally missed meal doses

Isabel (Izzi), a ninth-grade student and active teenager, is passionate about playing the violin in her school orchestra, as well as guitar and participating in several musical groups. In addition, she and her family enjoy outdoor activities like skiing and hiking. But unlike other teens, Izzi faces the challenge of managing type 1 diabetes (T1D) since her diagnosis in 2020.

“I remember it being Friday the 13th,” says her mom, Liz. “I knew the signs to look for because my mom, sister, and several aunts and uncles also had type 1. It’s a relentless disease. I lost my mom, an aunt, and two uncles to complications from type 1 diabetes, and I was determined not to let this happen to Izzi. I wanted her to be healthy, and more than that, I wanted her to continue to be a teenager — one that was not constantly worrying about her health.”

Approximately 1.6 million Americans, including Izzi, live with type 1 diabetes, an autoimmune disease that impairs the body’s ability to produce insulin, the hormone needed for glucose to enter cells and produce energy. Without daily management of blood sugars, hypoglycemia (low blood sugars) can be life-threatening and hyperglycemia (high blood sugars) can be dangerous over an extended period of time and lead to complications like kidney damage, heart problems, and cognitive decline.[i]

On average, someone living with diabetes makes up to 180 diabetes-related decisions a day, including counting their carbohydrate intake before snacks and meals and then determining how much insulin to give themselves to cover for those carbs. It can feel like a constant math problem, and it’s cited as the biggest pain point for most. Nearly 50% of people consider carb counting the most burdensome aspect of diabetes care.[ii] When tested on carb-counting accuracy, people with T1D underestimate carbs 63% of the time[iii] and many forget or even skip them intentionally. This has an adverse impact on clinical outcomes and can lead to frequent highs.

Izzi needed a solution that would allow her to think less about her diabetes and just be a kid. Fortunately, she had the opportunity to participate in a clinical trial studying the MiniMed™ 780G system with Meal Detection™ Technology. The pump automates the delivery of insulin every five minutes and even covers for the times Izzi occasionally skips a meal bolus or underestimates her carbs.**

“As a mom, there’s nothing more I can ask for than a system that watches over her without us constantly needing to worry about whether she is going high or low — especially at night when the fear of her not waking up can feel incredibly stressful. It gave Izzi more independence and it really pushed her diabetes into the background,” says Liz. “It was a godsend.”

The clinical outcomes were the best they’d experienced, with Izzi spending over 90% of her time in her target glucose range. “With other technology, my highs and lows were much more severe, and we all lost a lot of sleep,” shared Izzi. “It was stressful for our whole family and my parents were even nervous about letting me drive eventually, because they didn’t think it would be safe. Now they’re not worried about that.”

Dr. Greg Forlenza, Associate Professor, Pediatrics-Barbara Davis Center, University of Colorado, and also Izzi’s doctor, says that mealtimes can be difficult. “Clinical outcomes are historically worst in adolescents — particularly when it comes to meal management and forgetting to bolus, but the MiniMed™ 780G system can bring them back into range quickly and safely.” Dr. Forlenza continues, “If you make a mistake, it’s okay because the system auto corrects in real-time. It also cuts down on potential conflicts between kids and their parents when they forget to bolus, and also ultimately allows parents to ease up a bit and give them more independence.”

With the MiniMed™ 780G system now approved in the U.S., Izzi is eager to get back on the system and is excited about her next big adventure: obtaining her learner’s permit!

“The MiniMed™ 780G system just makes life easier. I set my glucose target, and the pump does most of the work,” Izzi said. “Instead of spending time managing my glucose numbers, I can now focus on the things that I love! The best part is that my parents don’t have to worry about me as much.”

For more information about the MiniMed™ 780G, please visit www.medtronicdiabetes.com/780G.

Important safety information: MiniMed^™ 780G system with SmartGuard^™ technology with Guardian^™ 4 sensor

The MiniMed^™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed^™ 780G system includes SmartGuard^™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed^™ 780G system consists of the following devices: MiniMed^™ 780G insulin pump, the Guardian^™ 4 transmitter, the Guardian^™ 4 sensor, One-press serter, the Accu-Chek^™ Guide Link blood glucose meter, and the Accu-Chek^™ Guide test strips. The system requires a prescription from a healthcare professional.

The Guardian^™ 4 sensor is intended for use with the MiniMed^™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian^™ 4 sensor is indicated for up to seven days of continuous use.

The Guardian^™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed^™ 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ 4 sensor. The Guardian^™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian^™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

WARNING: Do not use the MiniMed^™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard^™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library

2023-06-15T08:01:00

(BPT) – New parents who either currently use or are looking to start using formula are faced with a multitude of options these days, making it hard to feel confident in choosing the right one for their baby. The research feels endless and so many formulas provide the same, if not similar, ingredients and benefits, making it difficult to land on your choice. Look for formulas that go beyond the basics to provide your child with important nutrients during a critical growth period in their lives.

Infant formulas have vitamins and minerals to support baby’s wellness — like calcium, iron and vitamin A. DHA and probiotics are also important for supporting brain development and immune health. But only one leading formula brand has lactoferrin (added as an ingredient), a key ingredient in Enspire Optimum™, making it Enfamil’s closest formula to breast milk.

What is lactoferrin?

Lactoferrin is an important protein found in breast milk and colostrum, the very early breast milk that is dense in nutrients. Lactoferrin helps support digestive and immune health for newborns during the first year of life.

What does lactoferrin do?

Clinical studies have shown lactoferrin’s ability to support immune and respiratory health for infants and toddlers, which gives parents peace of mind. It also supports gut health.

What makes Enspire Optimum special?

Through the maker of Enfamil^® formulas’ extensive research of human milk, they are able to better understand not only the nutrients in breast milk, but also the benefits of these nutrients for infants. Enfamil was able to identify a key component in breast milk that was largely absent from other formulas. Because Enfamil believes this component will help support an infant’s start in life, they created Enspire Optimum, the only leading formula with lactoferrin added as an ingredient.

This attention to detail means parents who choose to feed their child Enspire Optimum can feel confident they’re supporting their baby’s best start in life from a brand they can trust.

In addition to lactoferrin, Enspire Optimum also has a global expert-recommended amount of brain-building omega-3 DHA to support brain development and HMOs to support immune health. If you are interested in learning more about Enspire Optimum, by Enfamil, the No. 1 trusted infant formula brand by pediatricians and parents, visit Enfamil.com/enfamil-enspire/.

2023-06-16T16:45:00

(BPT) – Lunch is an important part of your daily routine, but you may not always look forward to what you’ve packed in your lunchbox. You’re not alone. According to the Galileo Sandwich Report, over 55% of Americans feel bored with their lunch options, and over 52% are looking for lunch recipe inspiration.

Don’t settle for a boring, uninspiring lunch. Check out these three tips on switching things up and taking your midday meal to the next level.

1. Don’t skimp on sandwiches

Sandwiches are a classic lunch meal for a reason! They’re quick, easy to make, and convenient to pack and eat anywhere your day takes you. Also, sandwiches remain a popular meal choice, with 72% of Americans saying they enjoy sandwiches, according to the Sandwich Report. However, it’s easy to get into a rut if you make the same sandwich again and again.

Add variety to your lunch by experimenting with breads, fillings and condiments. If you usually use white sandwich bread, pick up ciabatta rolls, a croissant or a loaf of sourdough bread during your next grocery run. If you enjoy mayo and mustard, look for different flavors of your favorite condiments to spice things up. Search the deli aisle for cheeses that you have yet to try. No matter what you pick, make sure they’re ingredients that you enjoy!

Of course, no meal is complete without a solid protein. When looking for lunch meats, try adding Galileo^® brand cured meats like salame to your sandwiches. Galileo Salame is made using quality ingredients and timeless methods so you can enjoy high-quality pork flavored with a unique blend of herbs and spices. Use it to make a savory Italian classico sandwich or a light and fluffy salame and cheese croissant sandwich! You can also add the Galileo sliced pepperoni to make a truly decadent sandwich. For more recipe inspiration, visit GalileoSalame.com.

2. Step up your salad game

While leafy greens like romaine or iceberg lettuce are the base of many popular salads, you can experiment with different ingredients and dressings. Just about anything can go into a salad. You can combine crunchy vegetables, fruits, nuts, cheese and any of your favorite proteins to create a salad you’ll look forward to eating.

The next time you pack a lunch, grab some baby spinach and top it with strawberries, walnuts, goat cheese and a raspberry vinaigrette to create a refreshing and sweet meal. If you want a twist on a classic, try a La Scala chopped salad, which features thin strips of Galileo salame and/or pepperoni, shredded parmesan or pecorino cheese, romaine lettuce and a mustard dressing.

Another way to play around with salad recipes is to choose foods with different textures. For example, you can combine diced cucumber, cherry tomatoes, and feta cheese for a crunchy and filling salad to get you through the midday slump.

Keep trying new recipes and combinations. You’ll soon find that you have a few favorites you can make and customize to keep lunch interesting.

3. Get creative with a charcuterie board

Turn a snack pack into a meal by making a charcuterie board for lunch! While you may think of a charcuterie board as a happy hour snack or dinner appetizer, it’s a delightful and satisfying lunch choice. Best of all, you can make as many combinations as you want, so you’ll never get bored with this lunch option.

Start by selecting cured meats like pepperoni and Galileo salame, cheeses, vegetables like carrots or pickles, fresh or dried fruits, nuts, bread and crackers. Portion them out into small containers or sandwich bags so you can easily arrange them on a plate. You can also bring some jam, butter or hummus for added flavor and variety.

Make sure to put your lunchbox in the fridge when you arrive at work and put any leftovers away as soon as you finish eating. You can also make a charcuterie board as lunch on weekends when you’re not sure what to eat or want a bit of everything!

Whether your lunchtime routine is at home, in the office or on the go, you can make and take interesting, nutritious and delicious lunches to help you power through the rest of your day. Let these three lunch options inspire you to get creative and make every lunch a meal to look forward to.

2023-06-15T10:29:00

(BPT) – Article is sponsored and developed by Sanofi. Nancy and Dr. Bai were compensated by Sanofi. This is not medical advice.

At 84 years old, Nancy has always been described as an active, high-energy person. With her husband, two sons, and two grandsons, her family often spends quality time hiking, fishing, and cheering on their favorite baseball team. But a few years ago, Nancy was diagnosed with a rare blood disorder that threatened the active lifestyle she cherished.

Living with Cold Agglutinin Disease (CAD)

After knee replacement surgery in 2016, Nancy’s bloodwork showed she lost an abnormally large volume of her body’s hemoglobin, a protein found in red blood cells.¹ She was referred to a hematologist who diagnosed her with cold agglutinin disease (CAD), a rare autoimmune hemolytic anemia in which the body mistakenly attacks and destroys red blood cells, also known as hemolysis.²

According to her test results, Nancy’s body was destroying red blood cells faster than replacing them. Since red blood cells are vital for carrying oxygen to organs and tissues, she quickly developed symptoms.¹

Nancy experienced sudden, overwhelming fatigue during simple daily activities like cooking, cleaning, and grocery shopping. “I found that I couldn’t even climb stairs anymore,” she said, and she no longer had the energy to help care for her friends and family.

According to Dr. Wei Bai, board certified oncologist and hematologist, fatigue is one of the most common symptoms for patients with CAD, which can significantly impact their quality of life. Other symptoms may include weakness, shortness of breath, light-headedness, chest pain, and bluish color or discomfort in the hands and feet.³

A Treatment to Take Back Control

Nancy began working with Dr. Bai in 2021, before an approved treatment for CAD was available.⁴ They tried a variety of tactics like cold avoidance and related medications, but nothing successfully maintained her hemoglobin levels. Despite growing frustrated with fatigue that continued to interfere with her daily life, she never stopped fighting. “My life wasn’t fun anymore. I wanted to get it back,” she said.

New hope for Nancy came in 2022 with the U.S. Food and Drug Administration (FDA) approval of Enjaymo^® (sutimlimab-jome), the first and only medication for adults with CAD.^4,5

Understanding the Research Behind Enjaymo

Enjaymo is a prescription medicine used to treat hemolysis in adults living with CAD. Its FDA approval is supported by findings from two Phase 3 studies: a single-arm, open-label study in patients with CAD with a recent history of blood transfusion (within the past 6 months), and a double-blind, placebo-controlled clinical trial of adults with CAD without a recent history of blood transfusion (within the past 6 months).^4,5 It is recommended that Enjaymo should not be taken by patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

In one Phase 3 study, Enjaymo demonstrated fast and lasting improvement in hemoglobin levels. The trial met its composite primary endpoint – 73% of patients (16/22) showed an increase in hemoglobin of at least 1.5g/dL from baseline to Week 26 compared to 15% (3/20) on placebo, as well as remained transfusion-free from Week 5 through 26, and required no additional CAD treatment during the same time period. Additional data showed a mean increase from baseline hemoglobin levels. Further, average bilirubin levels from baseline to Week 26 returned to normal among 17 patients taking Enjaymo.^4,5

Patients taking Enjaymo also reported a significant improvement in the symptoms and impact of fatigue as measured by The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 months. In the clinical trial, patients on Enjaymo had an average 11-point improvement from baseline (improving from an average baseline score of 31.67 points to an average score at treatment assessment of 42.5 points) vs a 2-point improvement in patients on placebo. Higher scores on the survey meant a person felt less fatigue. The overall safety results were consistent with the safety profile of Enjaymo from the pivotal study.^4,5

Nancy’s Comeback from CAD with Enjaymo

Dr. Bai reviewed Nancy’s history to ensure she had or received the right vaccinations before starting Enjaymo. Together, they discussed the potential side effects of Enjaymo, including increase in blood pressure, urinary tract infection, respiratory tract infection, bacterial infection, swelling in lower legs or hands, joint pain, headache, nausea, runny nose, bluish color to the lips and skin, dizziness, feeling tired or weak, cough, changes in color or sensation in the fingers and toes (Raynaud’s phenomenon).⁵

Dr. Bai also advised Nancy on the infusions for Enjaymo, which are weekly for the first two weeks, then biweekly thereafter.⁵ She looks forward to her infusions as a time to relax, read a book, and take a few moments for herself away from daily responsibilities.

Since starting Enjaymo, Nancy’s hemoglobin has risen significantly (almost 4 g/dL) to normal levels (11.5 to 16 g/dL for women¹) and she hasn’t needed other treatments to manage her CAD. Today, Nancy reports significantly less fatigue than prior to starting Enjaymo. Once again, she has enough energy for grocery shopping, cooking, and caring for her loved ones. “I’m living the life I want with my husband, kids, grandkids, and friends,” she said, “I look forward to going to Alaska next year to fish for salmon and halibut with my family.”

Patient experiences on Enjaymo may vary so please talk to your doctor when making treatment decisions. To learn more, visit Enjaymo.com.

Important Safety Information and Indication

IMPORTANT SAFETY INFORMATION

Do not receive ENJAYMO if you are allergic to sutimlimab-jome or any of the ingredients in ENJAYMO.

ENJAYMO can cause serious side effects, including:

• Serious Infections: ENJAYMO is a prescription medicine that affects your immune system. ENJAYMO can lower the ability of your immune system to fight infections. People who take ENJAYMO may have an increased risk of getting infections caused by certain kinds of bacteria such as Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae. These infections may be serious or life-threatening. Some infections may quickly become life-threatening or cause death if not recognized and treated early.
  • You need to receive vaccinations against infections caused by certain kinds of bacteria at least 2 weeks before your first dose of ENJAYMO. You may need to have additional vaccinations during treatment.
  • If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should receive vaccinations as soon as possible.
  • Vaccinations may reduce the risk of these infections, but do not prevent all infections. Call your healthcare provider or get medical help right away if you get any new signs and symptoms of an infection, including:
    • fever
    • severe headache with stiff neck or back
    • pain during urination or urinating more often than usual
    • cough or difficulty breathing
    • flu-like symptoms
    • pain, redness, or swelling of the skin
• Infusion-related reactions: Treatment with ENJAYMO may cause infusion-related reactions, including allergic reactions that may be serious or life-threatening. Your healthcare provider may slow down or stop your ENJAYMO infusion if you have an infusion-related reaction and will treat your symptoms if needed. Tell your healthcare provider right away if you develop symptoms during your ENJAYMO infusion that may mean you are having an infusion-related reaction, including:
  • shortness of breath
  • decrease in blood pressure
  • chest discomfort
  • rapid heartbeat
  • nausea
  • injection site reaction
  • flushing
  • headache
  • dizziness
  • rash
  • itchy skin
• Risk of autoimmune disease: ENJAYMO may increase your risk for developing an autoimmune disease such as systemic lupus erythematosus (SLE). Tell your healthcare provider and get medical help if you develop any symptoms of SLE, including:
  • joint pain or swelling
  • rash on the cheeks and nose
  • unexplained fever
• If you have CAD and you stop receiving ENJAYMO, your healthcare provider should monitor you closely for the return of your symptoms after you stop ENJAYMO. Stopping ENJAYMO may cause the breakdown of your red blood cells due to CAD return. Symptoms or problems that can happen due to red blood cell breakdown include:
  • tiredness
  • shortness of breath
  • rapid heart rate
  • blood in your urine or dark urine

The most common side effects of ENJAYMO include:

• increase in blood pressure
• urinary tract infection
• respiratory tract infection
• bacterial infection
• swelling in lower legs or hands
• joint pain
• headache
• nausea
• runny nose
• bluish color to the lips and skin
• dizziness
• feeling tired or weak
• cough
• changes in color or sensation in the fingers and toes (Raynaud’s phenomenon)

These are not all the possible side effects of ENJAYMO. Call your doctor for medical advice about side effects.

Before receiving ENJAYMO, tell your healthcare provider about all of your medical conditions, including if you:

• have a fever or infection, including a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• have an autoimmune disease such as systemic lupus erythematosus (SLE), also known as lupus.
• are pregnant or plan to become pregnant. It is not known if ENJAYMO will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ENJAYMO passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

INDICATION

ENJAYMO® is a prescription medicine used to treat the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD).

It is not known if ENJAYMO is safe and effective in children.

Please see Full Prescribing Information, including Medication Guide.

References

1. Farid Y, Bowman NS, Lecat P. Biochemistry, Hemoglobin Synthesis. StatPearls. 2022.
2. Collie JC. Cold agglutinin disease. Practice Essentials, Pathophysiology, Etiology. Medscape. Updated February 7, 2022. https://emedicine.medscape.com/article/135327-overview.
3. Joly F, Schmitt LA, Watson PAM, et al. JMIR Form Res. 2022;6(7):e34248.
4. Röth A, Berentsen S, Barcellini W, et al. Blood. 2022;140(9):980-991.
5. Enjamyo (sutimlimab-jome) [package insert]. Sanofi; 2023.

MAT-US-2303524-v1.0-05/2023

© 2023 Genzyme Corporation. All rights reserved.

ENJAYMO and Sanofi are registered trademarks of Sanofi or an affiliate.