Tidepool Loop receives FDA clearance
The future of diabetes management has arrived! Tidepool Loop, the first fully interoperable automated insulin dosing app, has recently received FDA clearance. This groundbreaking development marks a major milestone in diabetes care, giving people with diabetes more control over their health and wellness.
Tidepool Loop is an innovative, patient-led initiative that provides users with an automated insulin dosing system, allowing them to manage their diabetes without having to manually adjust insulin doses. The app allows users to monitor their glucose levels in real-time and adjust insulin levels accordingly. It also gives users access to a library of personalized settings, which they can use to customize their insulin dosing to suit their individual needs.
The app is designed to be user-friendly, with a simple, intuitive interface that makes it easy to track data, view insights, and adjust settings. It also has built-in safety features like low-glucose suspend, which automatically suspends insulin delivery when a user’s glucose levels reach a certain threshold. This ensures that users are always getting the right amount of insulin, while also providing peace of mind.
Tidepool Loop is an invaluable tool for people with diabetes, providing them with greater access to health care and more control over their health and wellness. The app is also a great resource for healthcare professionals, giving them access to real-time patient data and allowing them to make more informed decisions when it comes to diabetes management.
The FDA clearance of Tidepool Loop is a groundbreaking development for diabetes care, and it will undoubtedly have a profound impact on the lives of people with diabetes. This app is a major step forward in diabetes management, providing users with greater freedom and control over their health and wellness. We’re excited to see how this innovative technology will continue to shape the future of diabetes management in the years to come.
To learn much more listen to this Juicebox Podcast interview with President, CEO and Founder of Tidepool, Howard Look.
Dexcom G7 Receives FDA Approval!
Today is the day and the Juicebox Podcast has all the info you want about the Dexcom G7.
Episode 676 - Jake Leach Executive Vice President and Chief Technology Officer at Dexcom is back to talk G7.
https://www.juiceboxpodcast.com/episodes/jbp676
Episode 782 - Emily's son has type 1 diabetes and he uses the Dexcom G7.
https://www.juiceboxpodcast.com/episodes/jbp782
Episode 768 - Dexcom Senior Director of Global Product Design, Alex Diener has type 1 diabetes and he's here to talk about designing the Dexcom G7.
https://www.juiceboxpodcast.com/episodes/jbp768
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Dexcom G6 App Available In Spanish
From Dexcom Press Release
Diabetes disproportionately impacts Latinos, and as of 2022, it is estimated that 11.8% of U.S. Latino adults have diagnosed diabetes. Furthermore, the CDC estimates that U.S. Latino adults have more than a 50% chance of developing Type 2 diabetes, with a greater risk of complication.
“With a myriad of studies that point to language barriers in healthcare leading to miscommunication between patients and healthcare providers and a decrease in quality of care and patient safety, it’s important to provide access to diabetes information in a patient’s preferred language to improve health outcomes,” said Ana-Mari Calleja Carr, district business manager at Dexcom representing the South Florida region. “Launching the Dexcom G6 app in Spanish is a positive step toward improving health equity for individuals with diabetes who primarily speak Spanish.”
To access the Dexcom G6 mobile app in Spanish, users need to install the latest version of the app and set their compatible iOS (v1.10.1) or Android (v1.10.0) smartphone* language to Spanish (any dialect/region). The app will automatically display in Spanish as long as the phone language is set to Spanish.
“Being able to offer this powerful CGM technology to my Spanish-speaking patients in their preferred language can help them better understand their diabetes and be more proactive about managing their health,” said Dr. Rocio Harbison, MD, FACE, an endocrinologist who treats a large Spanish-speaking population. “CGM technology is one of the most powerful tools available for managing diabetes and this new development from Dexcom will help improve access for Spanish-speaking people who often have to navigate their health with limited Spanish-language tools.”
Dexcom G6 uses a small, wearable sensor and transmitter to continuously measure and send glucose levels wirelessly to a compatible smart device* or receiver, giving patients real-time glucose data without the need to prick their finger.† The system also offers customizable alerts and alarms to help avoid potentially dangerous low and high blood sugar events.
“It’s great to see that Dexcom invested in developing a Spanish-language app for patients,” said Siena Ruelas, a professional soccer player and Dexcom Warrior who has Type 1 diabetes. “This offering will help remove a significant barrier to accessing important glucose information and improve one’s ability to make critical health decisions.”
The Dexcom Follow app is not immediately available in Spanish but the functionality will be added in a future product update. For more information in Spanish on Dexcom G6, please visit Dexcom.com/ayuda.
La diabetes afecta desproporcionadamente a los latinos, y desde el 2022, se estima que el 11.8% de los adultos latinos en los Estados Unidos han sido diagnosticados con diabetes.1 Además, los Centros para el Control y la Prevención de Enfermedades estiman que los adultos latinos en EE.UU. tienen más de un 50% de probabilidad de desarrollar diabetes tipo 2 con un mayor riesgo de complicaciones.2
"Debido a que un gran número de estudios indican que las barreras del idioma llevan a la falta de comunicación entre los pacientes y los profesionales de la salud3 - y disminuyen la calidad de la atención media y la seguridad del paciente - es importante proporcionar acceso a información sobre la diabetes en el idioma preferido del paciente para mejorar los resultados de salud," dijo Ana-Mari Calleja Carr, gerente de negocios del distrito en Dexcom que representa a la región del sur de la Florida. "El lanzamiento de la aplicación Dexcom G6 en español es un gran paso hacia la mejora de la equidad en salud para las personas con diabetes que hablan español."
Para acceder la aplicación móvil Dexcom G6 en español, los usuarios deben instalar la última versión de la aplicación y establecer el idioma de su teléfono inteligente iOS (v1.10.1) o Android (v1.10.1) a español (cualquier dialecto/región). La aplicación se mostrará automáticamente en español siempre que el idioma del teléfono esté configurado a español.
"Ofrecer esta poderosa tecnología de monitoreo continuo de glucosa a mis pacientes de habla hispana les ayudará a entender su diabetes un poco mejor, ayudándoles a ser más proactivos en el manejo de su salud," dijo la Dra. Rocío Harbison, MD, FACE, endocrinóloga que trata a pacientes de habla hispana. "La tecnología MCG es una de las herramientas más poderosas disponibles para controlar la diabetes y este nuevo desarrollo de Dexcom ayudará a mejorar el acceso para las personas de habla hispana que a menudo tienen que navegar productos de salud con herramientas limitadas en español."
Dexcom G6 utiliza un pequeño sensor y transmisor portátil para medir y enviar continuamente los niveles de glucosa de forma inalámbrica a un dispositivo inteligente* o receptor compatible, proporcionando a los pacientes datos de glucosa en tiempo real sin la necesidad de pincharse el dedo.† El sistema también ofrece alertas y alarmas personalizables para ayudar a evitar eventos potencialmente peligrosos de bajo y alto nivel de azúcar en la sangre.
"Es genial ver que Dexcom invirtió en el desarrollo de una aplicación en español," dijo Siena Ruelas, jugadora de fútbol profesional y Dexcom Warrior con diabetes tipo 1. "Esta opción ayudará a eliminar una barrera significativa cuando se trata de acceder información importante sobre la glucosa, y mejorará la capacidad de tomar decisiones críticas sobre nuestra salud."
La aplicación Dexcom Follow no está disponible en español, pero la funcionalidad se agregará en una futura actualización del producto. Para obtener más información sobre Dexcom G6 en español, visite Dexcom.com/ayuda.
Divorce: Companion to Episode 708
Co-parenting through divorce presents a multitude of challenges. When your child has special needs, those issues are only amplified. As a family law attorney and mom to a T1D child, I see the intersection of these two worlds resulting in conflict which negatively impacts the child and the parent’s ability to effectively co-parent.
Through my interview on the Juicebox Podcast and the information provided in this post, I hope to provide some general information and tools that you can use to improve your co-parenting relationship and protect your child’s best interests in navigating some common issues.
The two critical components of a parenting agreement relate to decision making and parenting time.
Parenting Schedule.
If you are contemplating divorce, or in the process of divorce, it is crucial to include terms to your parenting agreement to provide for a parenting schedule in your child’s best interests. If the other parent does not wake to alarms, has not managed care, and your child is not old enough to take on that responsibility, it may not be appropriate for your co-parent to have overnight parenting time until he or she can demonstrate that they are up to the task. Some potential protections and obstacles to consider:
Supervised parenting time with a trusted care provider. Is it appropriate to require supervision by a third party who understands your child’s care until your co-parent can demonstrate a working knowledge?
Step ups to allow for increased time when the parent reaches certain milestones/demonstrates ability to provide care. If you are MDI, do they know your child’s ISF and your insulin to carb ratio? If using a pump, do they know how to change the pump, what to look for to determine whether a site is bad? Perhaps you want to consider re-education with a CDE?
Physical distance and managing supplies. Are you transporting everything for each exchange or will each parent have sufficient supplies at their respective home?
What communication tools will you use? Are you comfortable texting your co-parent or do you want something more formal like a co-parenting communication app, to not only communicate but log issues, have a shared calendar, etc.
Medical Decision Making.
If you have a child with T1D, you absolutely should have an entire section of your parenting plan which addresses this specifically. It should be treated differently than other medical decisions because it is both an extraordinary health condition, but an every day one as well.
Unless what you are agreeing to is unconscionable or otherwise not in your child’s best interests, Judges typically will not interfere and do not have strong preferences what the parties agree to in their parenting plans. Parents can include language about their respective goals and expectations related to your child’s care. You may want to consider the appointment of a Parenting Coordinator to act as an intermediary in disputes relative to your child’s care to avoid going to Court.
How to handle a parent who is not taking your child’s health seriously.
Co-parenting with any special medical need is difficult. However, other conditions may have periods of flare ups and remission, good days and bad days. Diabetes is constant and parents of T1D children don’t get a break. A common theme where issues surface involves one parent who has been the point person primarily responsible for the child’s care, and in the event of a divorce, the other parent is ill equipped to properly manage the child’s care.
First, this is why it is so crucial to set up safeguards in your parenting plan. However, if you are past this point (you were divorced prior to diagnosis or your parenting plan is not specific enough), a few things to consider:
One of the hardest realities to face is that there is nothing you can do to make the other parent care. You can force changes in behavior through court intervention, you can seek that they have less time with your child, but ultimately, they have to understand that their lack of care has a negative impact on their child’s health.
Mandatory Diabetes education? If you are seeing consistent issues with your co-parent, this is potential relief that you can seek from the Court.
Consult with a lawyer. If your child’s parent is not taking their condition seriously, this may provide the Court with a basis to modify the parenting schedule. Documenting issues in writing is crucial. Educating the Court is also essential. Most Judges do not have an understanding of the complexities of diabetes. Your lawyer should be prepared to cite medical journals about long terms impacts of diabetes, importance of maintaining a low A1C, etc.
Example of how to communicate and document:
Child is at Parent 1’s house and his BG levels are high, he is coming back to Parent 2’s house and you see that he was consistently running high, not bolusing appropriately, etc. If your co-parent brushes off your concerns, the next time it happens, carefully document the issues and put them in writing. Child was only in range X% of the time while in your care, his average BG was YYY, and we need to get on the same page regarding his care until such time as he can independently manage it.
After you have continued to address these issues in writing, document them for your lawyer and consult with him or her to determine next steps in seeking to modify your Agreement.
If your co-parent is not taking your child’s health seriously, it is both infuriating and heartbreaking. Try to keep your emotions in check and address the issue factually. When you are involved in an acrimonious divorce, tensions are high and both parents are on edge when communicating with the other. If you are able to keep your tone balance and remove accusations in favor of facts, it will help you communicate more effectively to achieve better results for your child.
Disclaimer. Nothing in article should be construed as legal advice; consult your attorney in your jurisdiction for any questions about your case.
Omnipod® 5 has been cleared by the FDA!
Insulet, makers of the Omnipod tubeless insulin pump, just announced that they have received clearance from the FDA for their Omnipod® 5 Automated Insulin Delivery System. The first tubeless system with compatible smartphone control. Press release below.
Later today the Juicebox Podcast will have an exclusive interview with two surprise guests about the announcement that will be full of juicy product details! There will be a special link in the episode to a website all about the Omnipod® 5.
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PRESS RELEASE:
Insulet Announces FDA Clearance of its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control
ACTON, Mass.--(BUSINESS WIRE)— Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged six years and older with type 1 diabetes. Omnipod 5 is the first tubeless automated insulin delivery (AID) system that integrates
with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.
Omnipod 5 is designed to make it easier than ever to manage glucose with no multiple daily injections,
no tubes, and zero fingersticks1 to help simplify life with diabetes.
“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, President and Chief Executive Officer of Insulet. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”
The Omnipod 5 System2 consists of the tubeless Pod enhanced with SmartAdjustTM technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with its integrated SmartBolus Calculator. The user has the option to download this app onto a compatible personal smartphone or to use the Omnipod 5 Controller, which is provided free with the first prescription.
Every five minutes, SmartAdjust receives a Dexcom CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery using the user’s desired and customized glucose target, helping to protect against highs and lows.
“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system,” said Kevin Sayer, Chairman, President and CEO of Dexcom. “Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”
Omnipod 5 will launch through the pharmacy channel, providing customer benefits of no contract, no
commitment, and no obligation. In the coming days, Insulet will offer Omnipod 5 in a limited market
release so that the Company can incorporate learnings to deliver a best-in-class product experience.
Omnipod 5 is expected to be broadly available shortly after the limited market release.
Omnipod 5 was recently selected as a CES® 2022 Innovation Award honoree in two categories: Health
and Wellness and Wearable Technologies. The CES Innovation Awards is an annual competition
honoring outstanding design and engineering in consumer technology products.
People with diabetes can enjoy the benefits of Pod Therapy today through OmnipodPromiseTM, which
allows new and existing users to start on Omnipod DASH® and upgrade to Omnipod 5 at no additional
cost when coverage is available.
To learn more, visit the Omnipod website.
Insulet will provide additional details about today’s announcement on the Company’s fourth quarter 2021 earnings conference call on February 23, 2022 at 4:30 p.m. (Eastern Time). The link to the live call will be available here and will be archived for future replay. To participate in the live call via phone, please pre-register online here to receive a telephone number, passcode, and a unique registrant ID required to enter the call.
About Insulet Corporation:
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device
company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod
product platform. The Omnipod Insulin Management System provides a unique alternative to traditional
insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days
of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique
design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin
subcutaneous drugs across other therapeutic areas. For more information, please visit
insulet.com and omnipod.com. Forward-Looking Statement:
This press release may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 24, 2021 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.
1 If a user’s glucose alerts and readings from the G6 do not match symptoms or expectations or a user is taking over the recommended maximum dosage amount of 1000mg of acetaminophen every six hours, one should use a blood glucose meter to make diabetes treatment decisions.
2 The Omnipod 5 Automated Insulin Delivery System is comprised of SmartAdjustTM technology (cleared in K203774), the Omnipod 5 Pod and Omnipod 5 App (cleared in K203768) and the Omnipod 5 SmartBolus Calculator (cleared in K203772). Integration with the Dexcom G6 CGM is required for automated insulin delivery.
©2021 Insulet Corporation. Omnipod, Omnipod DASH, Omnipod 5, SmartAdjust, and OmnipodPromise are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved. Dexcom G6 is a registered trademark of Dexcom and used with permission. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.
Contacts:
Investor Relations:
Deborah R. Gordon
Vice President, Investor Relations (978) 600-7717 dgordon@insulet.com
Media:
Angela Geryak Wiczek
Senior Director, Corporate Communications (978) 932-0611
awiczek@insulet.com
Source: Insulet Corporation