The FDA just authorized the Insulet Omnipod 5 tubeless insulin delivery system for pediatrics with type 1 diabetes starting as young as age 2. This remarkable moment marks the availability of the world’s first tubeless, wearable insulin delivery system for toddlers.
The Omnipod 5 received FDA approval earlier this year for integration with the Dexcom G6 continuous glucose monitor for adults and kids with type 1, but Insulet also petitioned the FDA to approve this technology for toddlers.
This first tubeless hybrid closed loop system to receive FDA authorization includes the Omnipod 5, Dexcom G6 CGM and a phone app or controller to manage insulin delivery and monitor glucose levels. The Omnipod holds three days worth of insulin in a pod delivery device without the need for tubing, which can be helpful for active toddlers. No calibration or fingersticks are required.
As a hybrid loop system, the Omnipod and Dexcom are continuously data sharing, so most of the insulin delivery is automated. However, users can make needed adjustments, deliver bolus insulin and easily share data with the smartphone app or Ominpod 5 Controller.
Based on a study presented at the annual ADA Scientific Session, children with type 1 diabetes experienced a drop in A1C levels from a baseline of 7.4% to 6.9% and they remained at this improved A1C level for one year into the study. Time in range also increased from 57% at baseline to 68% after using the Omnipod 5 for three months. In addition, there were no reported cases of DKA or severe hypoglycemia. For more information on the latest in insulin pumps and CGMs, please join our Virtual Conference with technology expert Diana Issacs. In addition to explaining the technology, she provides an awesome “show and tell”.
On a related note, I would like to give recognition to the courageous Lila Grace Moss, who lives with type 1 diabetes. On a recent runway show, she did not shy away from wearing her Omnipod as she modeled the latest fashion styles with camera’s clicking and hundreds of audience members.
Social media took note and many instagram followers thanked Lila for her bold and brave statement.
Thanks Lila!
Whether you are new to diabetes or a seasoned expert, you’ll benefit from this virtual conference with the latest research plus critical content that you can immediately apply to your clinical practice.
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An implantable Continuous Glucose Monitor about the size of a matchstick, that only needs to be changed every 180 days, received approved by the FDA this February.
Eversense E3 will be available later this year, for people 18 and over. This implanted sensor determines interstitial glucose readings for 180 days. Sensor data is captured by a small transmitter patch that adheres to the skin, near the implanted device. The transmitter is rechargeable and sends glucose readings data via bluetooth connection to a mobile device. Users can download the mobile app on both iOS and Android devices to monitor glucose trends every 5 minutes and set custom alarms for highs and lows.
The transmitter patch is changed daily and can be set to vibrate as an alarm to alert the user of hypo and hyperglycemia.
To assure accuracy, sensor calibration is required twice per day for the first 21 days of wear. After day 21, once a day calibration a day is required.
In the PROMISE study, researchers analyzed the safety and accuracy of the Eversense E3 in 181 adults age 18 and up. Results showed that the Eversense E3 was very accurate, with a MARD of 8.5%. The accuracy of the Eversense E3 was also better than any currently available CGM on the market – though it does require daily meter calibrations.
According to Senseonics, the medical technology company that created the implantable device, the out-of-pocket cost will be the same as their original 90-day sensor. Most insurance companies should cover the cost of the device and for insertion and removal.
Senseonics has partnered with Ascencia Diabetes Care (the maker of the Contour blood glucose meters). Ascencia will handle the marketing and distribution of the Eversense products. Plus, Ascencia will offer a Patient Assistance Program that can save users up to $1,200 a year. To learn more, you can contact Ascencia here.
To read more about the Eversense E3, click here.
Whether you are new to diabetes or a seasoned expert, you’ll benefit from this virtual conference with the latest research plus critical content that you can immediately apply to your clinical practice.
Download Course Schedule | Download Course Flyer
If you are seeking a state-of-the-art review of current diabetes care, this course is for you. Our team has been fine-tuning this course for over fifteen years, and we know what you need. This program can also be a great addition to your CDCES or BC-ADM exam study plan.
Join us LIVE for this Virtual Course and enjoy a sense of community!
Team of expert faculty includes:
Deluxe Option for $499: Virtual Program includes:
Deluxe Version includes Syllabus, Standards and Swag*:
Deluxe Option for $499: Virtual Program includes:
Don’t worry if you can’t make it live. Your registration guarantees access to the recorded version in the Online University.
All hours earned count toward your CDCES Accreditation Information
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The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.
The first tubeless Automated Insulin Delivery (AID) System, was just approved by the Food and Drug Administration (FDA).
The Omnipod 5 hybrid closed-loop system (Insulet Corporation) links with Dexcom’s G6 Continuous Glucose Monitor and is now FDA approved for people with type 1 diabetes age six and older.
This anxiously awaited approval now means that there are 3 semi-automated closed-loop insulin delivery systems in the United States.
A unique feature of the Omnipod 5 system, is that it includes the first approved tubing free insulin delivery device that is paired with the Dexcom G6 continuous glucose monitor (CGM). The Omnipod holds up to 3 days of insulin and is worn directly on the body.
Omnipod 5 Users can monitor glucose trends and deliver insulin using a smartphone app or a separate controller device. Plus, this SmartAdjust technology automatically adjusts insulin to keep glucose on target and minimize hypo and hyperglycemic events.
Included in the app is a SmartBolus calculator that receives Dexcom CGM values every 5 minutes and automatically adjusts insulin based on predicted values for 60 minutes into the future and the individual’s customized glucose targets.
Insulet said it will begin selling the prescription Omnipod 5 device through U.S. pharmacies, starting with an initially limited release before expanding its commercial reach. The company is also offering users of its current Omnipod DASH system—a more manual tubeless pump—an upgrade to the Omnipod 5 at no additional cost once insurance coverage becomes available.
Read more here Omniopod approved by FDA.
Whether you are new to diabetes or a seasoned expert, you’ll benefit from this virtual conference with the latest research plus critical content that you can immediately apply to your clinical practice.
If you are seeking a state-of-the-art review of current diabetes care, this course is for you. Our team has been fine-tuning this course for over fifteen years, and we know what you need. This program can also be a great addition to your CDCES or BC-ADM exam study plan.
Download Course Schedule | Download Course Flyer
Join us LIVE for this Virtual Course and enjoy a sense of community!
Team of expert faculty includes:
Deluxe Option for $499: Virtual Program includes:
Deluxe Version includes Syllabus, Standards and Swag*:
Deluxe Option for $499: Virtual Program includes:
Don’t worry if you can’t make it live. Your registration guarantees access to the recorded version in the Online University.
All hours earned count toward your CDCES Accreditation Information
Sign up for Diabetes Blog Bytes – we post one daily Blog Byte from Monday to Friday. And of course, Tuesday is our Question of the Week. It’s Informative and FREE! Sign up below!
[yikes-mailchimp form=”1″]The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.
Vertex Pharmaceuticals just announced preliminary results from a trial that explores a new intervention to treat type 1 diabetes. The early results are very promising.
The first person with type 1 diabetes to receive this new stem-cell derived experimental therapy, had an 91% drop in their insulin needs. The person has lived with type 1 for over 40 years. After the intervention, they not only experienced a reduction in their insulin needs, their fasting C-peptide levels went from undetectable to 280. This dramatic C-peptide increase is a clinical indicator of stem-cell therapy success and endogenous insulin secretion.
These results are exciting and offer hope for a potential new treatment approach for type 1 diabetes.
VX-880 is a stem cell derived therapy that replaces damaged beta cells with healthy transplanted insulin producing cells in clinical trials. However, these new cells are at risk for attack by the body’s immune system, so immunosuppression therapy is currently required for stem-cell transplant success.
The future goal is to create a version of this treatment that doesn’t require immunosuppressive therapy. And Vertex, the makers of VX-880 are working on creating an encapsulated islet cell program that doesn’t initiate an autoimmune attack.
For more information and clinical trials, click this link.
Below is a list of helpful online resources for Type 1 Diabetes. They include sites for national organizations like the American Diabetes Association (ADA), sites for diabetes interest groups, and other participant organizations that provide helpful diabetes tips and opportunities to join online groups. Click here for a Type 1 Resource Handout to share with colleagues and people living with type 1 diabetes.
Click the links below to visit the website:
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[yikes-mailchimp form=”1″]Our new Diabetes Cheat Sheets are available on our CDCES Coach app!
We know how helpful these resources are for busy diabetes educations specialists so we wanted to make accessing them even easier!
If you don’t have it already, you can download our free CDCES Coach app and view or print the Cheat Sheets directly from the app.
These sheets and cards include information to study for certification exams and to use in your clinical setting. Plus, we have included teaching sheets for people with diabetes.
Studying for the CDCES Exam?
Join us for our free Preparing for the CDCES Exam Webinar on October 1st at 11:30 am
Unsure about updates for the 2020 exam?
Coach Beverly offers this FREE webinar to help get you to prepare for the CDCES Exam. All her tips and tricks are meant to ease your mind and reflect the updates to the CDCES content outline.
Instructor: Beverly Thomassian RN, MPH, CDCES, BC-ADM is a working educator who has passed her CDCES Exam 6 times. She is a nationally recognized diabetes expert for over 25 years.
See our Preparing for CDCES Resource Page >>
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[yikes-mailchimp form=”1″]Accreditation: Diabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*
The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.
For people with type 1 diabetes, access to Continuous Glucose Monitoring (CGM) technology, is considered a standard of care by most experts.
There is plenty of research that demonstrates CGM use is associated with not only improved A1c but significantly decreases time in hypoglycemic range and ketoacidosis rates.
YES.
According to a study presented at the Heart in Diabetes virtual meeting.
After three years of follow-up, the savings were substantial.
“In this study, we showed that it didn’t make any difference how you deliver insulin,” Grunberger said. “This difference is in how you monitor glucose.”
George Grunberger, MD, FACP, MACE, Chairman Grunberger Diabetes Institute and more
Glucose Crises are Expensive
According to Grunberger, the cost of diabetes ketoacidosis (DKA) in the U.S. is over 5 billion dollars a year.
Having a CGM reduces DKA rates, hospitalization, and leads to cost savings.
A study in the United Kingdom showed that for 900 people using the Freestyle Libre (Abbott), DKA episodes were reduced by 80% within six months of using this device.
A study in Belgium followed 1,913 people with type 1 diabetes using the Freestyle Libre CGM.
Not only did they see a dramatic reduction in hospitalizations from DKA and hypoglycemia, but the researchers also observed a fifty percent drop in work absenteeism.
Full Story: Healio (free registration)/Endocrine Today (8/31)
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[yikes-mailchimp form=”1″]Accreditation: Diabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*
The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.
[yikes-mailchimp form=”1″]The provision of Diabetes Self Management and Training (DSMT) has drastically changed since the COVID-19 pandemic.
In most health settings, in-person visits have been dramatically reduced. This is particularly difficult during a time of crisis when people with diabetes most need to connect with health care professionals for sound advice and coaching.
In addition, there has been confusion about which professionals are eligible to offer and bill for DSMT via telehealth.
Good News!
CMS has updated guidance to clarify that all accredited diabetes self-management training providers may furnish and bill for telehealth services during the COVID-19 public health emergency.
ADCES Advocacy Group
In early August the Centers for Medicare and Medicaid Services (CMS) released updated Guidelines that expand and clarify who is eligible to provide DSMT in a variety of health care settings. Now, there is more clarity about eligible telehealth providers and billing
By adding DSMT programs to the list of eligible providers of telehealth services, the final regulatory barriers preventing registered nurses and pharmacists from furnishing DSMT services via telehealth has been removed.
This means, that no matter the health care setting, recognized DSMT programs that are eligible to bill Medicare Part B directly for DSMT services, can be provided and bill for self-management training by accredited providers. In addition, the telehealth approval includes audio (if that is all that is available) as well as video platforms.
This clarification and expansion is in part due to the excellent work by the Association of Diabetes Care & Education Specialists (ADCES) Advocacy Team. Thank you for your excellent work.
The hope is that the ability to provide telehealth services to people living with diabetes will extend past the COVID pandemic since it is offering many participants an alternate way to receive valuable care and education.
For some very helpful information on eligible staff and telehealth billing, click here to review ADCES’ updated FAQ page.
These tools can be implemented with individuals before and after DSMES engagement to assess the effectiveness of telehealth services.
TUQ: Telehealth Usability Questionnaire:
DES: Diabetes Empowerment Scale Short Form:
SDCA: Summary of Diabetes Self Care Activities Measure:
Join live August 26th from 11:30 am to 1:00 pm (PST)
This program provides you with a succinct overview of the latest standards for Diabetes Self-Management Education (DSME) and Support Programs. It also provides insights into the exam philosophy and also highlights critical content areas.
Topics include:
Perfect for those planning to take the CDCES or BC-ADM or for those seeking a Standards update.
We are now offering the option to join the Level 2 Webinars live stream for free!
“Excellent as usual! Love Bev’s passion and energy. Thank you for all you do, I appreciate you plenty!! You guys are the absolute best as offering individuals that are not in need of CEs the opportunity to benefit by listening to the content without financial strain is huge, especially during these unprecedented times of furlough/layoff. Thank you and stay well”
Free viewing without CEs – This option is available for those who want to join the live stream of the Level 2 webinars(s), but don’t need CEs. More info here.
Need CEs? You can purchase the course, which includes the live stream webinar, recorded on-demand videos, podcast, handouts, and additional resources. Register here.
Watch for FREE recorded webinar (no CEs).
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[yikes-mailchimp form=”1″]Accreditation: Diabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*
The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.
The InPen smartpen, by Companian Medical, is now FDA approved for all ages!
The Inpen is a reusable battery-powered insulin pen that uses insulin cartridges. It is approved for use with three different insulins; Novolog, Humalog, and Fiasp. It can deliver insulin in half-unit doses plus it monitors insulin temperature. The battery lasts for a year and requires no charging.
“We are excited that we can help younger children and even more parents navigate the challenges associated with Type 1 diabetes. Now anyone can safely use InPen to help make decisions around insulin dosing, no matter what their age,”
Sean Saint, CEO and co-founder of Companion Medical.
In addition to all these features, the InPen Bluetooth enabled software allows users to connect to a FREE app on their Apple iOS or Android mobile device to track and share insulin dosing and glucose levels.
New users enter their insulin to carb ratios and insulin sensitivity along with target glucose into the app settings. Based on that data, the software helps to calculate the insulin dose needed and alerts users to insulin on board to prevent stacking (which can help reduce hypoglycemia.)
People can use Inpen in combination with CGM or traditional glucose monitoring and reports can be shared with providers and caretakers
Here is what InPen users can track on the app dashboard:
The InPen requires a prescription and is covered by many insurance companies in the United States. Most InPen users pay a $35 copay. Companion Medical has a co-pay assistance program for people without insurance coverage – more info here.
As a Diabetes Specialist, I am excited to share information on these new and emerging options to deliver insulin therapy that reduce the burden of diabetes self-management and improve connections to caregivers and providers.
Thanks for reading our Tech Thursday Blog! More info on InPen Here .
Perfect for those planning to take the CDCES or BC-ADM or for those seeking an update.
Diabetes Specialists have a critical role in advocating for CV reduction. Coach Beverly is extending a special invitation to join this webinar on the latest standards for CV reduction.
This webinar addresses:
Watch for FREE recorded webinar (no CEs).
Sign up for Diabetes Blog Bytes – we post one daily Blog Byte from Monday to Friday. And of course, Tuesday is our Question of the Week. It’s Informative and FREE! Sign up below!
[yikes-mailchimp form=”1″]Accreditation: Diabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*
The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.