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Best podcasts about complications trial

Latest podcast episodes about complications trial

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. FDA warns Dexcom, Inreda dual-chambered pump, using insulin with GLP-1 meds studied, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Mar 28, 2025 8:20


It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Learning more about the FDA letter sent to Dexcom, news from ATTD including a bihormonal pump from a Dutch company, time in tight range update, more studies about using insulin and GLP-1 medications, eating chili to prevent gestational diabetes (really!) and more..  Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Our top story this week: Dexcom Dive Brief: A warning letter posted Tuesday by the Food and Drug Administration revealed quality control issues with Dexcom's continuous glucose monitors. The FDA raised concerns with a design change to a component used in the resistance layer of Dexcom's sensors. The sensors with the new component were less accurate than those with the original component, according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component, but the company's response did not address affected G6 sensors. J.P. Morgan analyst Robbie Marcus wrote in a research note Tuesday that the letter concerns a chemical compound that the sensor wire is dipped in. Dexcom began producing the compound internally to add redundancy to its supply chain.   Dive Insight: Dexcom Chief Operating Officer Jake Leach said in an interview with MedTech Dive last week that the company does not expect the warning letter to affect future product approvals, including a 15-day version of its G7 CGM, and there's no need yet to recall products. Dexcom has submitted the device to the FDA and anticipates a launch in the second half of the year.   Marcus, after speaking to company leadership and a quality control expert, wrote that many of the issues outlined in the letter could be addressed quickly. He added that the warning letter could explain minor delays in approval to the 15-day sensor, but Dexcom is still within the 90-day window for a 510(k) submission.   “While there's always a risk this could impede future product approvals,” Marcus wrote, “we do not expect this to materially delay the 15 day G7 sensor approval.”   The warning letter followed an FDA inspection last year of Dexcom's facilities in San Diego and Mesa, Arizona. Marcus wrote that after the FDA requested additional information and a separate 510(k), Dexcom stopped in-sourcing the compound and reverted back to the external supplier.   Dexcom's devices were misbranded because the company did not submit a premarket notification to the FDA before making major changes to the sensors, according to the warning letter. The sensors with the changed coating “cause higher risks for users who rely on the sensors to dose insulin or make other diabetes treatment decisions,” the letter said.     The FDA raised other concerns in the warning letter, including procedures to monitor the glucose and acetaminophen concentrations used in testing of the G6 and G7 CGMs. The FDA also cited problems with Dexcom's handling last year of a deficiency in its G6 sensors with dissolved oxygen content values, a key input for measuring blood glucose levels. https://www.medtechdive.com/news/dexcom-warning-letter-cgm-coating-change/743597/ XX Lots of studies and info out of the recent ATTD conference. One highlight that has been sort of under the radar: a Dutch company has been using a Bihormonal fully closed-loop system for the treatment of type 1 diabetes in the real world. This is a company called Inreda (in-RAY-duh). The Inreda AP® is an automatic system (closed loop) and independently regulates the blood glucose level by administering insulin and glucagon. The AP5 is certified in Europe and is being used in multiple studies and projects. The AP®6 is currently under development. https://www.inredadiabetic.nl/en/discover-the-ap/ https://pubmed.ncbi.nlm.nih.gov/38443309/ XX Let's talk about time in tight range. If you follow me and diabetes connections on social, you likely saw a video I made about this – it blew up last week. If not.. time in range has been a metric for a short while now.. in 2019 there was a consensus report advising a goal of 70% of time in the 70-180 mg/dL range for most people with type 1 diabetes (T1D) and type 2 diabetes (T2D), with modifications for certain subgroups. Recently we've been hearing more about 70-140 mg/dL — for longer periods as “time in tight range (TiTR).” At ATTD there was more talk about calling that range TING, or “time in normal glycemia.     There's a great writeup that I'll link up from the great Miriam Tucker on Medscape about a debate that happened at ATTD. On March 22, 2025, two endocrinologists debated this question at the Advanced Technologies & Treatments for Diabetes (ATTD) 2025. Anders L. Carlson, MD, medical director of the International Diabetes Center (IDC), Minneapolis, took the positive side, while Jeremy Pettus, MD, assistant professor of medicine at the University of California San Diego, who lives with T1D himself, argued that it's too soon.   https://www.medscape.com/viewarticle/should-time-tight-range-be-primary-diabetes-goal-2025a100073q?form=fpf   XX Sequel Med Tech announces its twist pump will be firs paired with Abbott's FreeStyle Libre 3 Plus. The twist has FDA approval for ages 6 and up and is set to begin its commercial launch by the end of June. The pump—designed by inventor Dean Kamen's Deka Research & Development—also incorporates the FDA-cleared Tidepool Loop software program, to record CGM blood sugar readings, make predictions based on trends and adjust its background insulin levels accordingly. https://www.fiercebiotech.com/medtech/sequel-med-tech-connects-twiist-insulin-pump-abbotts-cgm-ahead-market-debut XX Dexcom's longer-lasting CGM sensor looks promising, based on study results presented at the conference. The trial showed that the new 15-day G7 system is slightly more accurate than the current G7. The accuracy of CGM can be measured using MARD (mean absolute relative difference), which shows the average amount a CGM sensor varies from your actual glucose levels (a lower number is better).  The 15-day G7 has a MARD value of 8.0%, about the same as the Abbott Freestyle Libre 3. The Dexcom G7 15 Day is awaiting FDA approval and is not yet available in the U.S.   XX Little bit of news from Modular Medical.. they plan to submit their patch pump to the FDA late summer or fall of this year. The MODD1 product, a 90-day patch pump, features new microfluidics technology to allow for the low-cost pumping of insulin. Its new intuitive design makes the product simple to use and easier to prescribe. It has a reservoir size of 300 units/3mL. Users can monitor the pump activity with their cell phone and do not require an external controller. The pump uses a provided, single-use, disposable battery. Modular Medical picked up FDA clearance for MODD1 in September. The company also raised $8 million to end 2024. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem's t:slim pump. By developing its patented insulin delivery technologies, the company hopes to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem's t:slim pump. https://www.drugdeliverybusiness.com/modular-medical-announces-12m-private-placement/ XX More from attd – type 2 news? https://www.drugdeliverybusiness.com/biggest-diabetes-tech-news-attd-2025/ XX Another study that says people with type 1 who use a GLP-1 medication get better outcomes. In this study, those who use GLP-1 with insulin are 55% less likely to have a hyperglycemia-related ED visit, 26% less likely to have an amputation-related visit, and 29% less likely to have a diabetic ketoacidosis (DKA)-related ED visit in the following year compared to those on insulin alone. Although they are not approved for T1D, some patients may receive them off-label or for weight control. Pretty big study for an off label drug: compared 7,010 adult patients with T1D who were prescribed GLP-1s and insulin to 304,422 adult patients with T1D who were on insulin alone.  It is important to note that the rates of new diabetic complications in one year for both groups were around 1%, indicating that these are uncommon outcomes regardless of medication use. https://www.epicresearch.org/articles/some-diabetic-complications-less-likely-among-type-1-diabetics-on-glp-1s   XX Early research here but exposure to antibiotics during a key developmental window in infancy may stunt the growth of insulin-producing cells in the pancreas and boost risk of diabetes later in life The study, is published this month in the journal Science, it's a study in mice. These researchers are working off the idea that when while identical twins share DNA that predisposes them to Type 1 diabetes, only one twin usually gets the disease. She explained that human babies are born with a small amount of pancreatic “beta cells,” the only cells in the body that produce insulin.   But some time in a baby's first year, a once-in-a-lifetime surge in beta cell growth occurs.   “If, for whatever reason, we don't undergo this event of expansion and proliferation, that can be a cause of diabetes,” Hill said.   They found that when they gave broad-spectrum antibiotics to mice during a specific window (the human equivalent of about 7 to 12 months of life), the mice developed fewer insulin producing cells, higher blood sugar levels, lower insulin levels and generally worse metabolic function in adulthood.   in other experiments, the scientists gave specific microbes to mice, and found that several they increased their production of beta cells and boosted insulin levels in the blood. When male mice that were genetically predisposed to Type 1 diabetes were colonized with the fungus in infancy, they developed diabetes less than 15% of the time. Males that didn't receive the fungus got diabetes 90% of the time. Even more promising, when researchers gave the fungus to adult mice whose insulin-producing cells had been killed off, those cells regenerated. Hill stresses that she is not “anti-antibiotics.” But she does imagine a day when doctors could give microbe-based drugs or supplements alongside antibiotics to replace the metabolism-supporting bugs they inadvertently kill.   .   “Historically we have interpreted germs as something we want to avoid, but we probably have way more beneficial microbes than pathogens,” she said. “By harnessing their power, we can do a lot to benefit human health.”     https://www.eurekalert.org/news-releases/1078112 XX Future watch for something called BeaGL - created by researchers at the University of California Davis and UC Davis Health who were inspired by their own personal experiences with managing T1D.   BeaGL is designed to work with CGMs and has security-focused machine learning algorithms to make predictive alerts about anticipated glucose changes, which are sent to a device. In this case, a smartwatch. The end goal is for BeaGL to be completely automated to reduce the cognitive load on the patient, particularly for teens. It's still in research phase but six student with T1D have been using it for almost a year.     https://health.ucdavis.edu/news/headlines/with-ai-a-new-metabolic-watchdog-takes-diabetes-care-from-burden-to-balance/2025/02 XX Investigators are searching for a way forward after two long-term diabetes programs were terminated following the cancellation of their National Institutes of Health (NIH) funding, the result of federal allegations that study coordinator Columbia University had inappropriately handled antisemitism on campus. The programs include the three-decades-old Diabetes Prevention Program (DPP) and its offshoot, the Diabetes Prevention Program Outcomes Study (DPPOS). “We are reeling,” said David Nathan, MD, a previous chair of both the DPP and the DPPOS and an original leader of the landmark Diabetes Control and Complications Trial. Nathan is also founder of the Massachusetts General Hospital Diabetes Center in Boston, one of the 30 DPPOS sites in 21 states. On March 7, the Trump administration cancelled $400 million in awards to Columbia University from various federal agencies. While Columbia University agreed on March 21 to changes in policies and procedures to respond to the Trump administration's charges, in the hopes that the funding would be restored, DPPOS Principal Investigator Jose Luchsinger, MD, told Medscape Medical News that as of press time, the study was still cancelled. https://www.medscape.com/viewarticle/diabetes-prevention-program-cancellation-colossal-waste-2025a100076h XX XX Type 2 diabetes may quietly alter the brain in ways that mimic early Alzheimer's. This was only an animal study – but researchers say the high comorbidity of type 2 diabetes (T2D) with psychiatric or neurodegenerative disorders points to a need for understanding what links these diseases.   https://scitechdaily.com/how-diabetes-quietly-rewires-the-brains-reward-and-memory-system/ XX Eating chili once a month when you're pregnant seems to lower the risk of developing gestational diabetes. This is a real study! While chili showed a link to lower gestational diabetes risk, dried beans and bean soup had no significant effect, even among women who ate them more frequently. Some studies suggest that diets high in beans and legumes, including the Mediterranean diet, reduce GDM risk. While studies link beans to lower diabetes risk, their specific impact on GDM remains unclear. This study analyzed data from 1,397 U.S. pregnant women who participated in the Infant Feeding Practices Study II, conducted between 2005 and 2007. Chili consumption varied significantly by race, education, household size, income, supplemental nutrition status, and region. Non-Hispanic Black mothers consumed the most (0.33 cups/week), while those with higher income and education levels consumed less. Regional differences also influenced chili intake. One possible mechanism for chili's effect is capsaicin, a bioactive compound found in chili peppers, which has been linked to metabolic benefits in other studies. However, further research is needed to confirm this potential role in GDM prevention. Dried bean and bean soup consumption had no clear association with GDM. The study highlights limitations due to self-reported dietary data and the need for more detailed dietary measures. https://www.news-medical.net/news/20250317/Could-a-little-spice-in-your-diet-prevent-gestational-diabetes.aspx XX

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. Tandem's Mobi approved, T1D and aging study, kayaker with diabetes sets record, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jul 14, 2023 8:11


It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: a new insulin pump gets FDA approval, once-weekly basal insulin for type 2 gets through another trial, New Jersey caps insulin prices for some, possible link between ability to chew and glucose control, a landmark diabetes study moves on to aging and T1D, JDRF Children's Congress and more! Learn about Moms' Night Out - a new event for moms of children with diabetes Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by AG1. AG1 helps you build your health, foundation first. XX Our top story, Tandem's Mobi Pump is approved. The FDA cleared the tiny pump for people with diabetes ages six and up. Tandem says mobie is fully controllable from a mobile app and is the world's smallest durable AID system. It still has a button on the pump to dose and holds 200 units. You use the same infusion set as the current Tandem pumps and Mobi uses Control IQ. Limited release planned for late this year and fully available early 2024. https://www.drugdeliverybusiness.com/fda-clears-tandem-mobi-automated-insulin-pump/ XX Learning more about a newly approved therapy for type 1 diabetes called Lantidra. Two safety and efficacy studies found that 21 participants who took Lantidra did not need to administer themselves insulin for a year or more. Twelve of those participants did not need to take insulin for up to 5 years, and 9 did not need insulin for over 5 years. Lantidra is an allogeneic (donor) pancreatic islet cellular therapy. In other words, Lantidra uses cells taken — or isolated — from human organ donor pancreases. “In [a] subsequent process, the insulin-producing islets are purified from the rest of the pancreatic tissue using a density gradient. Once the islets are isolated, purified, and put for a short time in cell culture, the cell preparation is infused into the liver of the recipient,” he explained. https://www.medicalnewstoday.com/articles/fda-approves-first-cellular-therapy-for-type-1-diabetes-what-does-it-do#How-does-islet-cellular-therapy-work? XX Once weekly basal insulin for type 2 gets through another trial. After 26 weeks of treatment and five weeks of follow-up, patients on weekly insulin icodec had significantly larger improvements in their HbA1C than those using daily insulin. Both groups had an extremely low rate of adverse events. These researches say next step is FDA evaluation. https://www.utsouthwestern.edu/newsroom/articles/year-2023/july-weekly-insulin-found-safe.html XX That's the idea behind Fractyl Health's treatment for type 2 diabetes—which could also be used for weight control. The Lexington, Massachusetts-based biotech company is in the early stages of developing a one-time gene therapy intended to lower blood sugar and body weight using the same mechanism as semaglutide. “You have this problem where you need to stay on therapy for efficacy,” says Harith Rajagopalan, a cardiologist by training and CEO and cofounder of Fractyl Health. “That's the Achilles heel.” The company wants to deliver an artificial gene to the pancreas that continuously produces the GLP-1 hormone so there's no need for weekly injections. The approach, called gene therapy, uses inactivated viruses to carry a therapeutic gene to pancreatic cells. (Viruses are used because of their natural ability to deliver genetic material to cells.) The company is aiming to begin an initial human trial by the end of 2024 https://www.wired.com/story/a-one-time-shot-for-type-2-diabetes-a-biotech-company-is-on-it/ XX Gov. Phil Murphy signed three bills into law Monday aimed at cutting the high cost of prescription drugs in New Jersey. The new laws will cap how much residents will pay for some popular medications such as insulin, prevent pharmacy benefit managers from engaging in practices that make drugs more expensive, and create a panel that will monitor prices set by pharmaceutical companies. One measure (S1614) would cap the cost of insulin, epinephrine auto-injector devices and asthma inhalers for state and local public workers enrolled in the State Health Benefits Program, the School Employees' Health Benefits Program and other state-regulated plans. For a 30-day supply, insulin will cost $35, EpiPens $25 and asthma inhalers would be capped at $50, according to the bill. The law takes effect next year. https://www.nj.com/politics/2023/07/new-laws-to-stem-high-cost-of-prescription-drugs-in-nj-were-just-signed-by-gov-murphy.html XX The European Medicines Agency (EMA) said on Tuesday it has extended its probe into Novo Nordisk's (NOVOb.CO) diabetes drugs Ozempic and weight-loss treatment Saxenda, following two reports of suicidal thoughts, to include other drugs in the same class. The agency began its review on July 3 after Iceland's health regulator flagged the reports of patients thinking about suicide and one case of thoughts of self harm after use of Novo's drugs. https://www.reuters.com/business/healthcare-pharmaceuticals/eu-extends-ozempic-probe-include-other-drugs-2023-07-11/ XX We often hear that diabetes can lead to problems with your teeth.. but one researcher says it might be the other way around. A University at Buffalo researchers says there is a notable correlation between chewing functionality and blood glucose levels in people with type 2. Specifically, he found that patients with T2D who maintain a full chewing ability exhibit significantly lower blood glucose levels compared to those with compromised chewing function. The thinking here is that chewing stimulates the body in all sorts of ways, including releasing hormones that help you feel fuller and help in digestion. More studies are expected. DOI: 10.1371/journal.pone.0284319 https://scitechdaily.com/the-surprising-connection-between-chewing-and-type-2-diabetes/ XX The next step of the landmark Diabetes Control and Complications Trial will focus on aging with type 1 diabetes. The original randomized DCCT clinical trial results, published September 30, 1993, in the New England Journal of Medicine, proved that early intensive glycemic control was the key to preventing or slowing the progression of long-term eye, kidney, and nerve complications of type 1 diabetes. Subsequently, EDIC has yielded many more major findings including that early tight glycemic control also reduces cardiovascular risk and prolongs survival in type 1 diabetes. subsequent EDIC data also have suggested that it is never too late to initiate intensive glycemic control Together, DCCT and EDIC — both funded by the National Institutes of Health at 27 sites in the United States and Canada — have changed the standard of care for people with type 1 diabetes Prior to the DCCT, between 1930 and 1970, about a third of people with type 1 diabetes developed vision loss and one in five experienced kidney failure and/or myocardial infarction. Stroke and amputation were also common, DCCT/EDIC chair David M. Nathan, MD, said while introducing the symposium. "All of the advances in care of type 1 diabetes have developed because this study demonstrated that it was important — continuous glucose monitoring (CGM), new insulins, better [insulin] pumps…I think the most profound finding is that mortality in our intensively treated cohort is the same as in the general population. That says it all," Nathan told Medscape Medical News. https://www.medscape.com/viewarticle/994221 XX Commercial – AG1 XX Today, JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, urged members of the Senate Appropriations Committee to renew the Special Diabetes Program (SDP) and support policies to ensure insulin is available at an affordable and predictable price. Opened by U.S. Senator Patty Murray (D-WA) and led by U.S. Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), the hearing took place during the 2023 JDRF Children's Congress, a biennial event that brings over 160 kids and teens living with T1D face-to-face with lawmakers and top decision-makers. The youth delegates traveled to Washington, D.C. from across the country and JDRF's international affiliates in the United Kingdom, Australia, the Netherlands, and Canada. The SDP has accelerated the pace of T1D research through a long-term investment of funding at the National Institutes of Health. The program has led to significant scientific breakthroughs, including Tzield, the first disease-modifying treatment for T1D, which can delay the onset of the disease by over two years. Without Congressional action, the SDP will expire at the end of September. "The Special Diabetes Program has fundamentally changed what it means to live with diabetes, put new life-changing therapies in our hands, and brought us closer to cures," said Aaron Kowalski, Ph.D., JDRF CEO. "We must keep this momentum going so we can capitalize on the progress to date and realize cures. However, until we have cures, people need access to affordable insulin. JDRF urges Congress to pass the bipartisan INSULIN Act of 2023, which will establish a $35 per month insulin copay cap for people with commercial insurance and includes other provisions that would make insulin more affordable for everyone, regardless of insurance status." Dr. Kowalski was joined at the hearing by Dr. Griffin Rodgers, Director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, who provided testimony on the scientific value of the SDP, and Jimmy Jam, award-winning producer, songwriter, musician, member of the Rock & Roll Hall of Fame, and T1D parent. "My son Max, who is now in his twenties, was just two years old when he was first diagnosed with type 1 diabetes. Late nights working on music became late nights working on music and waking up my son to test and manage his blood sugar levels," said Jimmy Jam. "Type 1 diabetes should be one of those things we can all agree on. Diabetes doesn't care if you're a Democrat or a Republican. We can all agree that there should be research to improve the lives of those with diabetes. We can all agree that insulin should be affordable for all who need it." Two 2023 JDRF Children's Congress delegates shared their T1D experience with the committee: Maria Muayad: 10-year-old Maria is from Maine and is a member of her school's civil rights club and math challenge group. Every November, Maria, and her mother, Golsin, give blue ribbons to the staff at her school in honor of National Diabetes Awareness Month. Elise Cataldo: 15-year-old Elise lives in New Hampshire and is passionate about educating those around her about life with T1D and tries to use things like pump site changes and blood sugar checks as opportunities to help others learn. Following the hearing, the 2023 JDRF Children's Congress delegates continued their advocacy by meeting with lawmakers in their Capitol Hill offices. https://www.prnewswire.com/news-releases/2023-jdrf-childrens-congress-delegates-urge-lawmakers-to-support-type-1-diabetes-research-and-access-to-affordable-insulin-301874927.htmlXX XX A 23-year-old with type 1 diabetes has broken the record for circumnavigating Britain in a kayak after paddling 2,000 miles in 40 days. Dougal Glaisher beat the previous record by 27 days. Glaisher was diagnosed with type 1 diabetes at the age of 19 shortly after winning the Oban Sea Kayak race in Scotland, when he had blurred vision and struggled to recover his energy. The expedition was to raise money for the UK-based charity Action4Diabetes and Glaisher livestreamed his blood sugar On Tuesday he was well stocked with a bunch of bananas and a stash of cereal bars lashed to his boat. But in remote areas it was more challenging. Around the islands off Scotland he ran out of freeze-dried meals and survived on porridge for several days. He also sourced drinking water from streams. . It is the first time anyone has used a surfski – a kayak that you sit on top of – to paddle around the country. XX On the podcast next week.. I sat down with Dexcom's new Chief Commercial officer to talk about their announcements from this week about the type 2 market and other features important to people with type 1. Our last epoisde is all about Kickass Healthy LADA That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Rio Bravo qWeek
Episode 54 - A1C

Rio Bravo qWeek

Play Episode Listen Later Jun 2, 2021 24:56


A1C is an easy way to diagnose and monitor diabetes, use and limitations of A1C are discussed with Dr Rodriguez. Vaginal metformin is mentioned as an anecdote which has not been proven to work we remembered Memorial Day. Introduction: Vaginal Metformin.  By Hasaney Sin, MD, and Hector Arreaza, MD.Today is May 31, 2021.  There’s a saying that I came across on social media that has always spoken to me which I find relevant to our vocation. “The more I learn, the more I find out I don’t know”. So comes the joys (and challenges) of our chosen career. Case in point, have you ever heard of vaginal metformin? Neither have I, until today. There was a randomized clinical trial plan in 2013 at Assuit University in Egypt studying the effectiveness of vaginal metformin for the treatment of polycystic ovarian syndrome (PCOS). As primary care providers, we are very aware of the gastrointestinal side effects of metformin when taken PO. This sometimes prevents compliance with metformin. The study at Assuit University was to study the effectiveness of metformin when given vaginally in the effectiveness of treating PCOS, while also decreasing the undesirable side effects of metformin when given PO in hopes of also ultimately improving adherence. Unfortunately, the study was planned to be finished in 2014, but no results have been published thus far[1]. Stay tuned in case there is any update.Arreaza: I had to do a search because I was very curious too. There is at least one occurrence when vaginal metformin was mentioned, at least in English. It was in an online forum where a doctor recommended vaginal metformin for PCOS to a patient. This has not been evaluated or approved by any organization, so I would not recommend it. You know what would be great? Metformin patches! There you have a business idea guys: The Metfo-patch®. This is Rio Bravo qWeek, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California. Our program is affiliated with UCLA, and it’s sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home. Introduction: Memorial Day. Written by Valerie Civelli, MD, read by Steven Saito, MD, and Hector Arreaza, MDWhat is Memorial Day? Memorial Day is an American holiday at the end of May to honor the men and women who died while serving in the US military. It has great historical meaning to Americans. It originated from the Civil War which claimed more lives than any other conflict in US history. Civil war ended in 1865.   A fun fact to know, is that Memorial Day, was originally called “Decoration Day”.  It was 3-years after the Civil war ended, May 5, 1868, that “Decoration Day” was declared as a time for the nation to decorate the graves of those lost in war.  Graves were adorned with flowers and their lives celebrated.  Maj. Gen. John A. Logan then declared that “Decoration Day” should be observed on May 30th. It is believed that this date was chosen because flowers would be in full bloom across the country. The “birthplace” of “Memorial Day” was recognized as coming from Waterloo, New York, because Waterloo was the first to use this term to expand honor and recognition of all US fallen soldiers of war from the Civil War and from World War I. In 1971, “Memorial Day” was officially declared a national federal holiday: The National Moment of Remembrance encourages all Americans to pause wherever they are at 3:00 p.m. local time on Memorial Day for a minute of silence, to remember and honor those who have died in service to the nation. If you value your freedom wherever you are, this Memorial Day at 3:00 p.m., pause for a minute to recognize all of our military men and women, both past and present who served and continue to serve our country. We honor every soldier who lost his or her life in any war against America. You are the reason for our freedoms.  You gave the ultimate sacrifice, and we do not take this for granted. To all military members who have died at war, we appreciate the privileges we have today because of you. We honor the costly price at which it came.  We remember you. We honor you. We sincerely thank you. Happy Memorial Day everyone! ___________________________A1C.By Hector Arreaza, MD, and Yodaisy Rodriguez, MD.   Definition. Glycated hemoglobin (glycohemoglobin, hemoglobin A1c, or just A1c) is a form of hemoglobin that is chemically linked to a sugar. Glucose spontaneously bind with hemoglobin, when present in the bloodstream of humans.A1C refers to the percentage of glycosylation of the hemoglobin A1C chain and correlates with the average blood glucose levels over the previous 2-3 months from the slow turnover of red blood cells in the body. A RBC lives 120 days.History of A1C. Huisman and Meyering separated glycohemglobin for the first time in 1958. A1c for monitoring the degree of control of glucose metabolism in diabetic patients was proposed in 1976 by Anthony Cerami, Ronald Koenig and coworkers.A1C was first included in the ADA guidelines as a diagnostic test for diabetes in 2010. Prior to that random glucose or fasting plasma glucose were used for diagnosis.For diagnosis of diabetes, A1C testing should be done by a technique certified by the National Glycohemoglobin Standardization Program and consistent with the Diabetes Control and Complications Trial reference assay.A1C levels. A1C 6.5% is diabetes.Of note, other criteria for diagnosing diabetes: Fasting plasma glucose >126 mg/dL, 2-hour plasma glucose > 200, random glucose >200 plus classic symptoms.In patients with prediabetes, A1C should be tested yearly.The American Diabetes Association (ADA) has recommended glycated hemoglobin testing (HbA1c) twice a year for patients with stable glycemia, and quarterly for patients with poor glucose control. Use ADA guidelines to assess targets.Point-of-care A1C (POC A1C): POC is not recommended for screening or diagnosis but it is good for monitoring.A1C limitations.There are some limitations to A1C testing, and an incomplete correlation between A1C level and average glucose level in certain individuals.Nonglycemic Factors That May Interfere with A1C MeasurementFalsely lower A1C: Acute blood loss, Chronic liver disease, Hemolytic anemias, Patients receiving antiretroviral treatment for human immunodeficiency virus, Pregnancy, Vitamins E and C. Patients being treated for iron, B12 or folate deficiency, EPO, chronic hemolysis (thalassemia). Lower or elevate A1C: Hemoglobinopathies or hemoglobin variants, Malnutrition Falsely elevate A1C: Aplastic anemias, Hyperbilirubinemia, Hypertriglyceridemia, Iron deficiency anemias, Renal failure, Splenectomy.For example, when RBCs have a short life, like in acute bleeding, the A1C is falsely low. On the other hand, when RBCs live longer (history of splenectomy and aplastic anemias) the A1C is falsely elevated. It’s a good idea to do CBC with A1C.Ethnic groups: Hemoglobinopathies or hemoglobin variants can change A1C levels and may be more prevalent among certain racial and ethnic groups. A1C tends to be higher in some races/ethnic groups: AA, Hispanic-Americans, Asian-Americans.Other A1C limitations: It gives you an average, patient may be experiencing hypoglycemia alternated with hyperglycemia and result in normal A1C. Screening for diabetes.ADA: Screen for diabetes or prediabetes all asymptomatic adults, according to the ADA, who have overweight or obesity with one or more risk factor (first degree relative with diabetes, high risk race or ethnic group, history of CVD, hypertension, dyslipidemia, PCOS, physical inactivity, severe obesity, acanthosis nigricans), patients with prediabetes (every year), women with GDM (every 3 years), all other patients after 45 years of age. If results are normal, test every 3 years, patients with HIV.USPSTF: Adults aged 40 to 70 years who are overweight or obese. The USPSTF recommends screening for abnormal blood glucose as part of cardiovascular risk assessment in adults aged 40 to 70 years who are overweight or obese. (Draft: Asymptomatic adults ages 35 to 70 years who are overweight or obese) This is a Grade B recommendation. Clinicians should offer or refer patients with abnormal blood glucose to intensive behavioral counseling interventions to promote a healthful diet and physical activity. The USPSTF recommends screening for gestational diabetes mellitus (GDM) in asymptomatic pregnant women after 24 weeks of gestation. This is a Grade B recommendation.Grade I recommendation (insufficient evidence): Asymptomatic pregnant women, Before 24 Weeks of Gestation. The USPSTF concludes that the current evidence is insufficient to screen for GDM in asymptomatic pregnant women before 24 weeks of gestation.A1C Targets.A1C goals can range from 6.5% to 8%. Target is individualized based on life expectancy, disease duration, presence of complications, CVD risk factors, comorbid conditions and risks for severe hypoglycemia. Sometimes your goal can be independent of A1C, for example, your goal can be to avoid complications. As a fun fact, A1C is not used in veterinary medicine.Conclusion.By Hector Arreaza, MD. Now we conclude our episode number 54 “A1C”, three characters that may not mean much for most people but for patients with diabetes, it is a very important number to remember. Remember to check the A1C in all your patients with poor control of diabetes every 3 months, or every 6 months in patients with good control. A1C has its limitations but it certainly is the best way to assess your patients’ glycemic control. We started this episode by giving you a random report about vaginal metformin, the study was unfinished, and we also reminded you of the importance of remembering our heroes during Memorial Day. Even without trying, every night you go to bed being a little wiser.Thanks for listening to Rio Bravo qWeek. If you have any feedback about this podcast, contact us by email RBresidency@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. This podcast was created with educational purposes only. Visit your primary care physician for additional medical advice. This week we thank Hector Arreaza, Hasaney Sin, Valerie Civelli, Yodaisy Rodriguez, and Steven Saito. Audio edition: Suraj Amrutia. See you next week!References:Vaginal Administration of Metformin in PCOS Patients, U.S. National Library of Medicine, Clinical Trials.Gov, https://clinicaltrials.gov/ct2/show/study/NCT02026869. Office of Public and Intergovernmental Affairs, U.S. Department of Veteran Affairs,  https://www.va.gov/opa/speceven/memday/history.asp, accessed on May 26, 2021.  Pippitt K, Li M, Gurgle HE. Diabetes Mellitus: Screening and Diagnosis. Am Fam Physician. 2016 Jan 15;93(2):103-9. Erratum in: Am Fam Physician. 2016 Oct 1;94(7):533. PMID: 26926406. https://www.aafp.org/afp/2016/0115/p103.html. Standards of Medical Care in Diabetes – 2021, Diabetes Care, January 1, 2021, vol 44 issue supplement 1, https://care.diabetesjournals.org/content/diacare/suppl/2020/12/09/44.Supplement_1.DC1/DC_44_S1_final_copyright_stamped.pdf.

ACCEL Lite: Featured ACCEL Interviews on Exciting CV Research
ACCEL Lite: Featured ACCEL Interview With Peter McCullough and Matthew Budoff

ACCEL Lite: Featured ACCEL Interviews on Exciting CV Research

Play Episode Listen Later May 21, 2019 9:43


In this interview, Peter McCullough and Matthew Budoff discuss the association of coronary artery calcification with subsequent cardiovascular disease in DCCT (Diabetes Control and Complications Trial) and the EDIC (Epidemiology of Diabetes Interventions and Complications) study.

BetaCell Podcast
The Diabetes Control and Complications Trial: Weight Effects

BetaCell Podcast

Play Episode Listen Later Jun 3, 2014


 Dr. Doron Schneider and Dr. Jack Leahy discuss what The Diabetes Control and Complications discovered about weight issues and the Diabetic patient.

BetaCell Podcast
EDIC: Follow-Up Findings To The Diabetes Control and Complications Trial

BetaCell Podcast

Play Episode Listen Later Jun 3, 2014


 Dr. Schneider and Dr. Leahy discuss EDIC, the follow up study to The Diabetes Control and Complications trial.

BetaCell Podcast
History of The Diabetes Control and Complications Trial (DCCT)

BetaCell Podcast

Play Episode Listen Later Jun 3, 2014


Dr. Doron Schneider and Dr. Jack Leahy discuss The Diabetes and Complications Trial, a landmark study that still influences the standard of diabetes patient care. 

history diabetes diabetes control dcct complications trial
BetaCell Podcast
DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study

BetaCell Podcast

Play Episode Listen Later Jun 3, 2014


Dr. Doron Schneider and Dr. Jack Leahy discuss the Diabetes Control and Complications Trial and the follow up study, EDIC. These landmark, studies performed 30 years ago, have stood the test of time and still influences the standard of care today.

study edic diabetes control dcct complications trial
Diabetes Discourse
The Importance of Diabetes Education for Patients and Providers

Diabetes Discourse

Play Episode Listen Later Sep 28, 2009


Guest: Sandra Bourdette Host: Steven Edelman, MD The results of the landmark Diabetes Control and Complications Trial proved that intensive management of diabetes can significantly improve diabetes outcomes. The education of both the healthcare professional and patient is a key component in the successful management of diabetes. Join host Dr. Steven Edelman and his guest, executive director of Taking Control of Your Diabetes (TCOYD), Sandra Bourdette, as they discuss the mission and results of their novel approach to diabetes education.