Category Archives: Diabetes

United States Department of Justice – ADA Complaint – Filed Against Menifee Girls Softball – USA Softball – ASA Softball

Posted on by

United States Department of Justice – ADA Complaint – Filed Against Menifee Girls Softball – USA Softball – ASA Softball

Menifee Girls Softball President – Jennifer Martinez and the MSG Board – Censor a MSG 8u Manager – Selectively Punish Him in Violation of Their Own Rules While Protecting Fellow Board Members Who Violated Code of Conduct – Appeal Met with Corruption

A United States Department of Justice ADA Complaint was filed against Menifee Girls Softball, ASA Softball and USA Softball, alleging willful discrimination and retaliation against 8 year old Type 1 Diabetic Menifee Girls Softball Player – Gracie Sevilla and her parents.

Gracie Sevilla, age 8, is a Type 1 Diabetic Athlete who suffered total pancreatic failure at age 4 and is Insulin dependent, requiring multiple daily injections of Insulin to metabolize the carbohydrates she eats in her meals and snacks throughout the day; in a healthy individual, this is the job of the functioning Pancreas. Gracie also wears a Dexcom Continuous Glucose Monitoring System; a small device with a filament that inserts below the skin and continuously tests the interstitial fluid for accurate Glucose levels, then brings the reading back to her parents’ mobile device every 5 minutes. The Dexcom alerts both high and low Glucose levels for immediate treatment decisions.

Gracie has endured Blood Glucose Levels as high as 600 + and as low as 24. Both exceedingly high or low levels, such as these, can result in Diabetic Coma or Ketoacidosis, both of which can be fatal in a short matter of time.

Gracie’s father, Tommy Sevilla, was Manager of Menifee Girls Softball (MSG https://www.menifeegirlssoftball.com) 8u 3-0 Florida Gators team and was one of 5 different Managers that were ejected by overzealous umpires on one day and weekend; Sevilla pointed out an illegal Coach Pitching motion that allowed for the opposing player to easily hit the ball and score runs, in violation of MSG Rules but was rebuffed by the Umpire – who arrived to the game in a foul mood 25 minutes after it had started. According to MSG rules, a Manager who is ejected during a game, must also serve an additional game suspension and must immediately leave the premises – not owned by MSG – and cannot be physically present for the next game. However, in retaliation for his free speech and non-threatening comments about overzealous umpires on the MSG Coaches Social Media Thread, Coach Sevilla was censored, as Board Member at Large, Alysa Mugica, her husband and others; including MSG Board Vice-President, David Miller – openly disparaged him on the thread, both before and after he was censored, and while Board President, Jennifer Martinez did nothing but allow the open disparagement; thus violating MSG’s Social Media Policy and Code of Conduct; they were not punished in any form but within minutes of censoring Sevilla on the thread, a vote was taken by the MSG Board to remove him as Manager of the team and thus also nullifying the requirement for him to have to serve the additional game suspension as Manager.

Coach Sevilla appealed their game loss officially, on the grounds that the opposing team won the game due to runs scored with an illegal soft toss underhand pitching motion by the opposing coach that was recorded on video, as well as the game not being a “regulation game” since the game started almost 20 minutes late on account of the Umpire showing up late and the game having to be started by a Board Member acting as an Umpire. However, the MSG Board would attempt to delay and suppress the Appeal by first demanding a $35 fee to hear the Appeal then fail to provide a method or mode of payment for the Appeal when Coach Sevilla was diligent in trying to pay the fee then, not showing up to the designated meeting place (practice field) to pick up Coach Sevilla’s payment. Official witnesses and evidence provided by Sevilla for his Appeal was not considered, in violation of League Appeals Policy and without notice and unbeknownst to Coach Sevilla, the Appeal was heard illegitimately, falsely and corruptly; claiming video evidence not supplied by Coach Sevilla – with no witness testimony and Sevilla not present or being invited to attend; the Board would lie and falsely claim that the opposing Coach pitched in a League approved pitching motion and essentially that the game started on time, despite abundant evidence to the contrary.

Gracie Sevilla subsequently, was not allowed to play in the next game because despite being warned of a potential ADA violation (Americans with Disabilities Act Title II Regulations; Part 35 – non-Discrimination on the Basis of Disabilities, et. al….), because her mother, Melodie Sevilla couldn’t attend the game and her father, who is trained to be able to manage her Diabetes, was banned from the game now as her parent, due to the unprofessionalism, spite and retaliation from MSG Board President, Jennifer Martinez and fellow Board Members: David Miller, Vice-President, Steven Cordova, Coaches Agent, Rachelle Wade, Player Agent, Lindsey Duffy, Treasurer, Ashley Vidal, Secretary, Kyle Titterness, UIC and others. Ultimately, Board President, Jennifer Martinez refused to make a reasonable accommodation for Gracie to play in the game and scoffed at the requirement of law and remained deliberately indifferent to Gracie’s qualifying disability, bent on punishing her father as a parent. Jennifer Martinez would threaten to call law enforcement if Gracie’s father, the censored Coach were to show up but backed off that threat when she was appraised of the fact that she had no authority to do so on private property not owned by but only used buy the league; Marion Ashley Park is a public facility. However, Martinez would then threaten to punish the entire Gators’ team of 8 year old girls with a “forfeit” if their Coach – Sevilla – were to be at the game to watch the team and his daughter play and also be there to treat her Diabetes so that she could play in the game.

Gracie’s mother, Melodie Sevilla, would reach out to Martinez then the USA Softball Board of Directors; including but not limited to: State Commissioner, Christina Drumm, President, Mike Schuck, who never responded to calls and emails and when she reached out to Rhonda Shirey, the Eastern District Commissioner, she was again met with deliberate indifference as Shirey promised to intervene and get back to Mrs. Sevilla by days end, she never did and ignored all follow up urgent phone calls and voicemails left and emails sent to her by Mrs. Sevilla.

Menifee Girls Softball Board President, would openly scoff at the issue, make no effort to provide a reasonable accommodation in accordance with Federal Law, focus on Coach Sevilla now being punished as a Parent, while no longer a Manager of a Team, and ultimately causing tremendous undue stress and trauma upon Gracie and her family, as well as the team itself, who now lost their Manager, faced forfeit scenarios and a season ruined by Menifee Girls Softball Board of Directors politics.

Gracie Sevilla was deprived of the opportunity to play in the game in question and subsequently, several additional games due to this controversy and the deliberate indifference and attitude toward her disability by the MSG board of Directors, ASA Softball and USA Softball, who refuse to intervene and honor the American with Disabilities Act.

On June 8, 2021, a Complaint was filed with the Department of Justice alleging that Jennifer Martinez, et al, the MSG Board, USA softball and ASA Softball, have willfully discriminated and retaliated against 8u girls softball player – Gracie Sevilla and her family.

Gracie Sevilla is a Folkstyle Youth Wrestling Champion for Team So. Cal of Temecula, winning her first two tournaments in Bakersfield, California and Phoenix, Arizona, even being awarded the “Most Outstanding Wrestler Award” as an athlete new to the sport of competitive wrestling. Gracie also excels in Gymnastics, Basketball, Soccer; she was the quarterback on her fathers Friday Night Lights Football team;  and is a Pitcher on her Menifee 8u Girls Softball team, recording 8 strikeouts against 9 batters faced in her first ever game as Pitcher.

Easet1d: Upcoming Type 1 Diabetes Meet Ups – Southern California

Posted on by

Upcoming Type 1 Diabetes Meet Ups – Southern California

 

​
EaseT1D Meet-up

When: Sunday, November 17th

Time: 11:30 a.m. to 1:15 p.m.

Location: Graziano’s Pizza Restaurant, 333 Magnolia Ave., Corona, 92879 (Banquet Room)

Let’s meet-up! Join us for food, fun and friends as we celebrate National Diabetes Awareness Month!

PLEASE STAY TUNED… MORE EVENTS ARE COMING!

​
www.EASE T1D.org

grace for the cure

PRESS RELEASE: Type 1 diabetes and the developing brain in children

Posted on by

SAN FRANCISCO (June 10, 2019) – A study co-led by Dr. Nelly Mauras at Nemours Children’s Health System in Jacksonville, Florida found that children with type 1 diabetes (T1D) have slower growth in brain areas associated with mild cognitive deficits compared to children without T1D. The study, presented today at the American Diabetes Association’s® (ADA’s) 79th Scientific Sessions®, found significant differences in total brain and regional gray and white matter growth based on a series of three structural magnetic resonance imaging (MRI) studies.

“Even with new insulin and technologies that can significantly improve care, children with Type 1 Diabetes are still exposed to significant swings in sugar control, creating potential risks to the developing brain,” said Nelly Mauras, MD, co-principal investigator of the study, chief of the division of endocrinology, diabetes & metabolism at the Nemours Children’s Health System in Jacksonville, Florida, and professor of pediatrics at the Mayo College of Medicine. “Understanding the early effects of blood sugar control on brain development is a necessary step towards developing strategies for reducing these risks and the public health implications of diabetes-related cognitive dysfunction later on in life.”

As part of a multi-site study of the Diabetes Research in Children Network (DirecNet), researchers aimed to determine the extent to which glycemic exposure adversely impacts the developing brain in children with early-onset T1D. The study enrolled 138 children with T1D with a median age of seven years. The participants had a disease duration on average of 2.4 years at the beginning of the study. MRIs were performed at three time points (baseline visit, 18 months and approximately 2.9 years after the second visit) to measure gray and white matter volumes in key brain regions. Total cumulative hyperglycemic exposure was determined using lifetime blood sugar, using hemoglobin A1c (HbA1c) values from the time of diagnosis. Researchers compared the MRI results of T1D participants to those of a control group of 66 age-matched children who did not have diabetes.

Researchers found that the group with T1D had slower growth of total cortical and subcortical gray and white matter than the control group at all time points. In particular, a set of metabolically active brain regions associated with other brain disorders, known as the “default mode network,” showed less growth in the T1D group compared to the control group. These regions of slower growth were associated with higher lifetime blood sugar, as measured by HbA1c values.

“Ongoing research is investigating whether diligent maintenance of blood sugar levels in the normal range through advanced diabetes technologies can impact these findings to reduce the risk for cognitive dysfunction,” said Mauras.

###

The DirecNet includes Nemours Children’s Health System JAX, Stanford University, University of Iowa, Washington University in St Louis, and Yale University. The research is supported through funding from the National Institutes of Health’s Special Type 1 Diabetes Funds and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Mauras and her co-principal investigator, Allan Reiss, MD, Howard C. Robbins Professor of Psychiatry and Behavioral Sciences and Professor of Radiology at Stanford University School of Medicine, will present these findings in a press briefing on Sunday, June 9, 2019 from 12-1 p.m. PT at the American Diabetes Association’s 79th Scientific Sessions in San Francisco.

About Nemours Children’s Health System

Nemours is an internationally recognized children’s health system that owns and two free-standing children’s hospitals: the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., and Nemours Children’s Hospital in Orlando, Fla., along with outpatient facilities in five states, delivering pediatric primary, specialty and urgent care. Nemours also powers the world’s most-visited website for information on the health of children and teens, KidsHealth.org, and offers on-demand, online video patient visits through Nemours CareConnect. Nemours ReadingBrightstart.org is a program dedicated to preventing reading failure in young children, grounded in Nemours’ understanding that child health and learning are inextricably linked, and that reading level is a strong predictor of adult health.

Established as The Nemours Foundation through the legacy and philanthropy of Alfred I. duPont, Nemours provides pediatric clinical care, research, education, advocacy and prevention programs to families in the communities it serves.

Long-term islet transplant recipients show near-normal glucose control

Posted on by

FOR IMMEDIATE RELEASE:

Continuous glucose monitoring demonstrates improved time-in-range, key metabolic data compared to hybrid closed-loop systems

Diabetes Research Institute Foundation

Continuous glucose monitoring (CGM) evaluations in islet transplant recipients who have been insulin independent for an average of 10 years show near-normal glycemic profiles and time-in-range metrics, according to data presented by the Diabetes Research Institute at the University of Miami Miller School of Medicine. The findings, which were accepted as a late-breaking poster at the American Diabetes Association (ADA) 79th Scientific Sessions, June 7 – 11, 2019 in San Francisco, CA, demonstrate that islet transplantation can be a successful long-term cell therapy for select patients with type 1 diabetes.

The DRI team evaluated five of its adult subjects who received intrahepatic (in the liver) islet transplants between 2002 – 2010 and have since remained insulin independent for seven to 16+ years. During their last study follow-up, the subjects completed a 7-day, non-blinded CGM to assess their glycemic profiles. Compared to current recommended CGM goals for adults with type 1 diabetes on a hybrid closed-loop system, all patients demonstrated improved CGM time-in-range, reduction in glucose variability, and prevention of hypoglycemia. A sampling of the results is as follows:

CGM Glucose Range CGM % Time-in-Range recommended goals for hybrid closed-loop system CGM % Time-in-Range in DRI islet transplant subjects with long-term insulin independence
(mg/dL)
70-180 ≥70 96.4
<70 ≤3 0.9
<54 ≤1 0.1

In addition, time in the more stringent glucose range of 70-140 mg/dL was 83.1%, with a mean sensor glucose (SG) value of 116 mg/dL and an average HbA1c of 5.7%. The ADA’s recommended HbA1c goal is <7% for adults with diabetes.

“Using continuous glucose monitoring, we now have the ability to accurately evaluate patients’ glucose profiles and their variability. The CGM data we have obtained from our islet transplant patients clearly demonstrates that islet transplantation can result in glucose levels that are close to those in people who do not have type 1 diabetes, even 10 years or more after undergoing the cell-replacement procedure,” said David Baidal, M.D., assistant professor of medicine and member of the DRI’s Clinical Islet Transplant Program. One of the principal investigators of the study, Dr. Baidal is presenting the results at the ADA conference.

“Although not all subjects remain insulin independent, like the subjects described in this presentation, after an islet transplant a significant number of them continue with excellent graft function for over 10 years that allows them to have near-normal glucose metabolism in the absence of severe hypoglycemia on small doses of insulin,” said Rodolfo Alejandro, M.D., director of the Clinical Cell Transplant Program and also a principal investigator of the study. Dr. Alejandro will be presenting these results at the upcoming 17th World Congress of the International Pancreas & Islet Transplant Association, July 2-5, 2019 in Lyon, France.

“This report confirms the superiority of transplantation of insulin-producing cells compared to insulin therapy, with glucose control results that were even better than the goals of CGM in hybrid closed-loop systems. Hopefully, this will be of assistance in bringing islet transplantation closer to FDA approval, allowing the treatment to be made available to U.S. patients, as has already been the case in several other countries, for many years,” said Camillo Ricordi, M.D., Stacy Joy Goodman Professor of Surgery and director of the Diabetes Research Institute, who was recently named the world’s leading expert in islet transplantation by Expertscape. Dr. Ricordi is well-known for inventing the machine (Ricordi Chamber) that made it possible to isolate large numbers of islet cells from the human pancreas and for performing the first series of successful clinical islet transplants that reversed diabetes after implantation of donor purified islets into the liver of recipients with diabetes.

In type 1 diabetes, the insulin-producing islets cells of the pancreas have been mistakenly destroyed by the immune system, requiring patients to manage their blood sugar levels through a daily regimen of insulin therapy. Islet transplantation has allowed some patients to live without the need for insulin injections after receiving a transplant of donor cells. Some patients who have received islet transplants have been insulin independent for more than a decade, as DRI researchers have published. Currently, islet transplantation remains an experimental procedure limited to a select group of adult patients with type 1 diabetes.

In 2016, the National Institutes of Health-sponsored Clinical Islet Transplantation Consortium reported results from its Food and Drug Administration (FDA)-authorized Phase 3 multi-center trial, of which the DRI was a part, indicating that islet transplantation was effective in preventing severe hypoglycemia (low blood sugar levels), a particularly feared complication in type 1 diabetes that can lead to seizures, loss of consciousness and even death. The study was a significant step toward making islet transplantation an approved treatment for people with type 1 diabetes and reimbursable through health insurance, as it is in several other countries around the world.

###

About the Diabetes Research Institute

The Diabetes Research Institute at the University of Miami Miller School of Medicine leads the world in cure-focused research. As one of the largest and most comprehensive research centers dedicated to curing diabetes, the DRI is aggressively working to develop a biological cure by restoring natural insulin production and normalizing blood sugar levels without imposing other risks. Researchers have already shown that transplanted islet cells allow patients to live without the need for insulin therapy. Some study participants have maintained insulin independence for more than 10 years. The DRI is now building upon these promising outcomes through its BioHub strategy, a multidisciplinary, three-pronged approach for addressing the major challenges that stand in the way of a cure: eliminate the need for anti-rejection drugs, reset the immune system to block autoimmunity, and develop an unlimited supply of insulin-producing cells. For more information, please visit DiabetesResearch.org, call 800-321-3437, or Tweet @Diabetes_DRI.

Soliqua®Phase 3 results significantly lowered blood sugar levels compared to GLP-1 receptor agonist treatments

Posted on by

Soliqua®Phase 3 results significantly lowered blood sugarlevels compared to GLP-1 receptor agonist treatmentsPatients switched to Soliqua reached anaverage blood sugarbelowthe American Diabetes Association recommendedlevel of 7%FullPhase 3 data presentedtodayat the American Diabetes Association(ADA)79th Scientific Sessions PARIS–June 9, 2019–In a Phase 3 study1evaluating adults with type 2 diabetes inadequately controlled by GLP-1 receptor agonist (GLP-1 RA) treatments, Soliqua®/Suliqua®2(insulin glargine 100 Units/mL and lixisenatide) met the primary study objectivebydemonstrating astatistically superior reduction of average blood sugar level (HbA1c)after26weeks, compared with continuing GLP-1 RA treatment.The LixiLan-G study included either a daily or once-weekly GLP-1 RA treatmentas comparator. Morepatientswho switched to Soliqua achieved HbA1clevelsbelow 7%, a target recommended by the ADA, compared with those who stayed on previous GLP-1 RA therapy. More patients who switched to Soliqua also achieved the composite endpoint of HbA1cbelow 7% without documented symptomatichypoglycemia(low blood sugar levels).The study showed a safety profile consistent with the established profiles of the treatments studied: the most common classes of adverse event were gastrointestinal events (i.e., nausea, diarrhea and or vomiting) and hypoglycemia.1Blonde L et al, Presentation #149 OR, American Diabetes Association 79th Scientific Sessions, June 9, San Francisco, CA, U.S.2Soliqua®is an injectable prescription medicine that contains two diabetes medicines, insulin glargine and lixisenatide.Soliqua®is marketed in the EU as Suliqua®, where it is indicated in combination with metformin for the treatment of adults with type 2 diabetesmellitus to improve glycemic control when this has not been provided by metformin alone ormetformin combined with another oral glucose lowering medicinal product or with basal insulin. It is marketed in the U.S. as Soliqua®100/33, where it is indicatedas an adjunct to diet and exercise to improve glycemiccontrol in adults with type 2 diabetes mellitus.It is marketedas Soliqua®in other geographies where it is approved

The full Phase 3 data results were presented today for the first time as an oral presentation at the 79thScientific Sessions of theADAin San Francisco.“We are committed to providing people living with diabetes a broad range of options thatcan help support personalized care,”said Rachele Berria, Global Head of Diabetes Medical Affairs at Sanofi. “As the first comparison between Soliqua and both daily and weekly GLP-1 RA treatments, this study provides physicians with new data that they could use when consideringSoliqua as a part of a personalizedtreatment plan.”About the studyThe LixiLan-G study included 514 adults with type 2 diabetes who were inadequately controlled on a GLP-1 RA (either once-daily liraglutide or twice-daily exenatide, or once-weekly exenatide extended release, albiglutide or dulaglutide) and metformin (with or without pioglitazone, with or without a sodium-glucose transport protein 2 inhibitor [SGLT2i]).Participants were randomized to either switch to Soliqua or continue theirprevious GLP-1 RA treatment, while maintaining their other pre-trial anti-diabetic medication. Adherence to allocated treatment was monitored and reinforced throughout the study.The primary objective was to demonstrate superior reduction of HbA1cwith Soliqua versus continuation ofthe previousGLP-1 RA after 26 weeks. Secondary objectivesincludedcomparison of the overall efficacy and safety ofSoliqua to continued GLP-1 RA treatment. After 26 weeks, patients who switched to Soliqua saw a 0.6% greater reduction in HbA1cversus continuing treatment with a GLP-1RA:SoliquaGLP-1 RAMean HbA1cat baseline7.86%7.88%Mean HbA1cat Week 266.7%7.4%Reduction in HbA1c-1.02%-0.38%Least squares mean difference-0.64%95% Confidence interval-0.77to -0.51p-value<0.0001More patients who switched to Soliqua achieved HbA1cbelow the 7%target recommended by the ADAversus those treated with GLP-1RA(difference: 36%, p<0.0001).The study also evaluated compositetargets

of HbA1cbelow 7% without documented symptomatic hypoglycemia(<54mg/dL or ≤70mg/dL, respectively):SoliquaGLP-1 RA% of patientsachieving HbA1c< 7%62%26%% of patients achieving HbA1c<7% with no documented (≤70 mg/dL) symptomatic hypoglycemia43%25%% of patients achieving HbA1c<7% with no documented(<54 mg/dL) symptomatic hypoglycemia57%25%The study showed a safety profile consistent with previous studies:22% of patients who switched to Soliqua experienced gastrointestinal events (nausea, diarrheaor vomiting), compared with 10% of patients who continued previoustreatment with GLP-1 RA. Rates of hypoglycemiawere also consistent with the established safety profiles of thetreatments: 9% of patients who treated with Soliqua experienced at least one event, compared with <1% who remained on previous GLP-1 RA therapy.Participants treated with Soliqua were followed for a further 26 weeks. Data from this extension period will be presented at a later date.About SanofiSanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.Sanofi, Empowering LifeMedia Relations ContactAshleigh KossTel.: +1 908-981-8745Ashleigh.Koss@sanofi.comInvestor Relations ContactGeorge GrofikTel.: +33 (0)1 53 77 45 45ir@sanofi.comSanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actualresults and developments to differ materially fromthose expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or

government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, includingfuture clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise anyforward-looking information or statements.