What’s Coming and What’s Delayed in Continuous Glucose Monitoring?

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

Updates and delays from Abbott, Dexcom, Medtronic, and Senseonics

With several clinical trials on hold due to the COVID-19 pandemic, we’re bringing you a roundup of the latest updates on future continuous glucose monitors (CGM). Understandably, the FDA also announced a few months ago that it would focus its efforts on devices related to COVID-19. With the disclaimer that it’s impossible to know exactly when the pandemic will subside, when trials might resume, and how FDA reviews might be affected, here is the latest news we’ve heard from companies.

Click to jump to a product, which are organized alphabetically.

Abbott FreeStyle Libre 2

CGM

Image source: Abbott FreeStyle

What’s new? FreeStyle Libre 2 keeps the same “scanning” feature as the original FreeStyle Libre, but adds Bluetooth connectivity. This is important because it enables optional high and low glucose alerts. Users who enable these alerts will be able to get a notification on their reader or phone whenever their glucose reading goes above or below their specified ranges. Looking ahead, the Bluetooth feature will also allow FreeStyle Libre 2 to be part of automated insulin delivery systems (AID), like Insulet’s Omnipod Horizon.

Like the original FreeStyle Libre, FreeStyle Libre 2 has 14-day wear, is factory-calibrated (no fingerstick calibrations required), and can be scanned with either a phone or a reader device (the reader for FreeStyle Libre 2 is blue, instead of black). Importantly, FreeStyle Libre 2 will be offered at the same price as the original FreeStyle Libre.

When’s it coming? The FreeStyle Libre 2 has already launched in a few European countries (we know of Germany and Norway) and will launch in others soon. In the US, FreeStyle Libre 2 has been under FDA review for over a year. In March, Abbott said that it was working through “some finishing items” and was “very confident” the device would be cleared soon.

Dexcom G7

Dexcom

Image source: Dexcom

What’s new? Dexcom’s G7 will be fully disposable (the transmitter and sensor are combined and thrown away together) and have longer wear (we believe somewhere around 14-16 days). Remember that the Dexcom G6 sensor lasts for 10 days but has a transmitter that is re-used for 90 days. The G7 will be considerably slimmer than G6 and will have a lower cost of manufacturing in bulk, though consumer pricing is not yet determined – we imagine it will be similar. The G7 will keep the same accuracy, no fingerstick calibrations, and Bluetooth connectivity as the G6.

Dexcom has been developing G7 in partnership with Verily, the division of Alphabet formerly known as Google Life Sciences. There has been mention from Verily that an accelerometer may also be built-in to the G7 device, but we aren’t sure if that feature made it into the final version of G7. Having a built-in accelerometer could allow the G7 to also track physical activity, like a Fitbit or other fitness tracker.

When’s it coming? Dexcom planned on launching G7 in “early 2021,” but with most clinics placing new trials on hold, Dexcom is expecting a “minimum delay of approximately six months.” It’s difficult to know when clinics will be able to conduct trials (and when people will feel comfortable enrolling in trials), but assuming a six-month delay, G7 could be on the US market sometime in the second half of 2021.

Medtronic “Project Zeus” CGM

Abbott FreeStyle

Image source: Medtronic

What’s new? Medtronic’s next CGM, referred to as “Project Zeus,” will reduce the number of required fingerstick calibrations and have improved accuracy (compared to its current offering, Guardian Sensor 3). The new CGM will require day-one calibration (unclear on the number of fingersticks that will be required on day one), compared to Guardian Sensor 3, which requires at least two fingerstick calibrations every day. Medtronic expects Project Zeus to launch with a “non-adjunctive” indication, meaning users will be able to bolus insulin based on CGM reading alone, and not have to perform a confirmatory fingerstick. the new CGM will keep the same seven-day wear, size and shape, and reusable transmitter component as the Guardian Sensor 3 (pictured above).

When’s it coming? The trial for Project Zeus began in June 2019 and is expected to wrap up within the next month. Medtronic expects to submit the CGM to the FDA by the “end of the summer.”

Senseonics Eversense XL (180-day)

Eversense XL

Image source: Eversense XL

What’s new? The “XL” extended life-version of Senseonics’ Eversense in the U.S. will have the same size and features as the original Eversense, but the Eversense XL is implanted for 180 days, rather than the 90-day Eversense. As a reminder, the Eversense sensor is implanted in the users’ upper arm in a clinic and remains there for the sensor duration; a silver-dollar sized on-body transmitter is worn on the outside of the arm to deliver readings to a smartphone. Senseonics is targeting reducing calibrations from 2 per day to 1 per day with same non-adjunctive indication.

When’s it coming? Eversense XL is already available in Senseonics’ European markets. The trial for Eversense XL in the US wrapped up in late March, and Senseonics has previously aimed for FDA clearance in “late” 2020. We aren’t sure whether that timeline has been pushed back due to COVID-19, but the fact that the trial has already completed is encouraging.

Source: diabetesdaily.com

Pump Peelz Does Their Part and Creates Intubation Boxes

We spoke to the founders of Pump Peelz, about the COVID-19 pandemic and important work they’re doing to help.

Hi Scott, thank you so much for taking the time to talk to me. The COVID-19 pandemic has left us all in fear, especially for those who are elderly or have pre-existing conditions. Knowing that we, or someone we love, fits this demographic adds an extra layer to this difficult time.  It is more important than ever to come together and help each other through these uncertain times.

I know you and your wife Emily started Pump Peelz in 2011 with the goal of creating adhesives to help empower people living with diabetes to express themselves and to feel confident in their ability to manage their disease. I know the diabetes community thanks you, and I now wear my Dexcom loud and proud!

How long has your wife Emily been living with type 1 diabetes?

She just celebrated her 10th diaversary in January!

What prompted you to start on this venture of creating adhesives for our community?

Emily was diagnosed while we were both in college. We were taking a few graphic design courses and noticed that at that time there were no graphics, skins, or adhesives for insulin pumps or CGM’s. We took it on as a class project really… and slowly built the business at night for the first few years before taking on Peelz full time and purchasing our own equipment at a specialized facility.

When you heard the virus was picking up speed, what were your first thoughts? Fears? How did you prepare for staying at home?

Emily read to our son, Oliver’s, preschool class for their “Reading Month’ on March 12 and almost immediately after class, the virus started making headlines in our area. We actually had discussed possibly keeping him home for a little while and talking to the teachers to keep us healthy at home. But later that day, his school became canceled indefinitely anyway. I think we have the same fears and concerns as everyone… Our initial fear was for Emily being immunocompromised but we decided to self-quarantine for the past month to keep her and our family safe. We have groceries delivered, we have only one person at the office at a time, and are really keeping busy at home with our 3 year old.

Being that Emily falls under high risk, what extra precautions have you taken? 

She really hasn’t gone anywhere since March 12. We take drives and will go for walks in the park and our neighborhood. We mostly have groceries delivered or I will go by myself with my facemask and gloves… I also keep sanitizer in the car. Our office is stocked with Lysol and cleaning supplies to keep all surfaces clean.

Being that you are a small business, how has COVID-19 affected your business so far?

We’ve tried to find different uses for our machinery to try and help a local medical facility. It has given us an opportunity to be more creative and experiment for the better good. Our main business struggle at the moment is simply keeping up while maintaining social distancing and keep our priority on everyone staying healthy. We’re being open and upfront on our website to let people know that during this time, it’s taking us a little longer to produce products.

An intubation box allows doctors and nurses to safely intubate COVID-19 patients | Photo credit: Pump Peelz

How did your local hospital find you? Did they know that you would have the equipment necessary to create intubation boxes?

I knew right away that our facility has capabilities beyond what we normally manufacture. I started early on reaching out to our friends in the medical field to let them know that we have the capability of making masks, cutting materials for face shields, or anything else that might come up. It just so happened that our local hospital system heard this and asked us to make an intubation box for their ICU which they currently have in place.

I am sure you have been extremely stressed about the pandemic, what were your initial thoughts about taking on this task?

I try not to stress too much about things I can’t control. This was one thing that was asked of us that I knew we had the capability to produce and something that we could control to help.

It is so amazing that you quickly learned how to create such a necessary and urgently needed product. How exactly were you able to design and produce it?

We launched our Patch+ product late last year which was the most challenging product for us to produce. We had to purchase new equipment, have software designed, and create processes to rapidly prototype and get products out quickly and efficiently. Because we just made it through this project I felt that I understood our machinery enough to know that this task was possible. I quickly found a website called intubationbox.com that had the assembly instructions… I simply modified their steps so that our laser cutter could easily cut out the pieces like a puzzle. Once I figured it out, I saved those files because I thought someone else could also use them.

It looks like you have been sharing this information on social media and hoping that others follow suit and do their part. Where can people find information on how to create intubation boxes?

Go to intubationbox.com and there is a material list sheet of things you can pick up at Home Depot or Lowe’s. You can email me directly at scott@pumppeelz.com and I can send our vector files to anyone that wants them. They can also follow the instructions and use normal hand tools to produce these. I also recommend talking to your local print shop or sign show to see if they could use our files to cut the acrylic sheets.

Ear relief straps for healthcare workers. These go behind your head and hook onto the straps of a mask rather than the straps rubbing the back of your ears. | Photo credit: Pump Peelz

I must say seeing your post about how you are helping out during this time of need was such a ray of sunshine on what seems to be the longest gloomiest day in a long time. How does it feel knowing that you are helping save lives?

That was really nice of you to say that. We can all pitch in just a little to do something bigger than ourselves. That can be simply staying at home to ‘slow the spread’ or it can be offering your sewing services to make masks, offering a 3D printer at a school to make face shields, or building a box. We all have little talents or things that we can do to help each other… this just happened to be ours.

Going forward we are taking the remaining materials from our boxes to make Mask Relief Straps to take the pressure off of the ears of nurses and doctors who are wearing them all day long. You can look up photos on Google to see what I’m talking about!

Thank you so much for taking the time to talk to me. I know personally, I thank you guys every time I can get more life out of my Dexcom thanks to your adhesives, but now you are truly heroes!

Source: diabetesdaily.com

Supporting Older Adults with Diabetes During COVID-19

This content originally appeared on Beyond Type 1. Republished with permission.

By T’ara Smith

With COVID-19 spreading around the world, it’s important to be prepared, not panic, and practice social distancing, especially for people with underlying conditions such as asthma, diabetes, and heart disease. Though people of all ages are susceptible to contracting COVID-19, older adults appear to be more vulnerable. The Centers for Disease Control and Prevention has labeled adults aged 65 and older as a high-risk group for severe illness from COVID-19. It’s also important to note diabetes impacts many older adults — an estimated 33 percent aged 65 and over have diabetes and are at risk of complications like low blood sugar, kidney failure, and heart disease.

At a time like this, it’s important to think about how the COVID-19 public health crisis impacts our elders with diabetes, whether they be our grandparents, friends, or neighbors. Here are some tips on supporting older adults with diabetes during COVID-19:

Help Ensure Medications and Food Are Stocked

Help older adults obtain at least a month’s supply or more of diabetes medications and supplies. If available, have them delivered by the pharmacy. Note that insulin can’t be delivered, so consider picking it up from the pharmacy for them. Health plans are also waiving early refill restrictions and allowing 90-day supplies. America’s Health Insurance Plans has a list of health insurance companies and the steps they’re taking to address the pandemic.

In regards to food, insist on helping older adults set up a grocery delivery service. If those services are unavailable, offer to pick up groceries for them. If your loved one is insisting they shop on their own, many grocery stores have set up a system where the first hour the store is open is reserved for older and immuno-compromised shoppers only. Everything is freshly cleaned and the crowds are smaller.

Stay Informed About COVID-19

We’re learning new information about the coronavirus, which leads to the viral disease COVID-19, every day. Keep up-to-date with changing guidelines and new research by the WHO and CDC. As we learn more about the coronavirus, we’ll be updating the information here. In the meantime, continue to follow WHO and CDC guidelines such as hand-washing, disinfecting high-touch surfaces, avoiding touching your face, coughing into your elbow, and more.

Implement Household Changes

If you live in a multi-generational household, there are varying levels of COVID-19 risks. In this case, it’s important to consider how likely each member is to be carrying the virus, especially if some members are essential workers. Consider implementing household rules such as not sharing personal items like cups, utensils, food, and water. If you have space, designate a bedroom and bathroom for potentially exposed or sick family members. Also, consider limiting or forbidding visitors. People may be carrying the disease without displaying symptoms.

Communicate With Their Healthcare Team

You can support older adults with diabetes during COVID-19 by helping them communicate with their healthcare team. Non-essential doctor’s visits can be held online and these services are offered by health plans. Assist older adults who may not be technologically savvy by setting up virtual doctor’s appointments.

If your loved one is in a nursing or retirement home, contact the facility to learn what measures are in place to handle the public health crisis. Ask what adjustments are going to be made to your loved one’s routine, particularly with blood glucose management.

Know that visitation may not be recommended at this time, as assisted-living and long-term care facilities have to consider that visitors may be carrying the disease. Advocates are also urging family members to not panic and do not recommend bringing home loved ones to avoid infection. However, if you’re interested in becoming a caregiver, learn what the caregiver laws are in your state and what health decisions you can legally make on their behalf.

Stay Connected to Prevent Isolation

In the midst of social distancing, feeling isolated can become a real problem. Older adults may be feeling more anxious and overwhelmed than usual. Use things like FaceTime, Google Hangouts, Facebook Messenger, and more to stay connected. Talk about things that aren’t related to COVID-19. However, if they want to discuss the virus and simply need someone to listen, be that person. If you notice COVID-19 is taking a deeper toll than you can handle, recommend professional online therapy services. Some are covered by insurance or have a co-pay. There are other online therapy services like Talkspace and BetterHealth where you can be connected to a counselor.

Source: diabetesdaily.com

Prior Authorization: Getting Diabetes Supplies and Medications Covered by Insurance

This content originally appeared on diaTribe. Republished with permission.

By Divya Gopisetty

What is a prior authorization? Read on to learn more about why diabetes supplies or medications might require a prior authorization and how to go through the process

It can be frustrating to learn that you need a prior authorization when you already have a prescription. Insurance plans sometimes require a prior authorization to cover a diabetes supply, device, or medication, even if your doctor prescribed it to you.

Read on to learn about what a prior authorization is, and how you can make the submission process as smooth as possible.

In this article:

Click to jump to a specific section!

What is a prior authorization?

My pharmacist told me I need a prior authorization. What happens next?

How can I check if I need a prior authorization?

How long do prior authorizations last?

What happens if the prior authorization is denied?

What is a prior authorization?

A prior authorization, also known as a pre-authorization or pre-certification, means that your healthcare provider or device company has to get specific approval from your health insurance company (so that it will pay for it).  The requirements for prior authorization differ between and within insurance plans.

If you need a prior authorization, the pharmacist cannot process your prescription until your healthcare professional has contacted the insurance company. Similarly, a device company may not ship your diabetes device to you until it has prior authorization from the insurance company.

A prior authorization is designed to make sure certain prescription drugs or devices are used correctly and only when medically necessary. Before your insurance plan will cover a certain device or drug, you must show that you meet a set of criteria.

Prior authorizations are most often handled by your healthcare professional’s office, but sometimes are handled by the device company itself (e.g., for CGM).

If you want to see what a prior authorization request form looks like, check out this one for OptumRx.

My pharmacist told me I need a prior authorization. What happens next? 

  1. If your insurance company requires (and has not received prior authorization), your pharmacy will contact your healthcare professional.
  2. The healthcare professional will contact your insurance company and submit a formal authorization request.
  3. Your insurance plan may have you fill out and sign some forms.
  4. Your insurance plan will contact the pharmacy once it has approved or denied the request.

During this process, be sure to communicate with both your healthcare provider and your insurance company to see if they need any additional information. Prior authorizations usually take about a week to process – after that, check with your pharmacy to see if the request was approved. If the request was approved, you should be able to pick up your prescription from the pharmacy.

If it wasn’t approved, your pharmacy should be able to tell you why, and then you can decide to request an appeal.

As someone living with diabetes, you are your best advocate. Be prepared to track down the paperwork to make sure you receive the requested device or medication.

How can I check if I need a prior authorization?

Check your health plan’s policy and formulary (you can normally access these on the insurance company’s website) to see if any of your treatments require a prior authorization. Or, you can call the member services number found on the back of your insurance ID card to speak with someone directly.

How long do prior authorizations last?

Most approved prior authorizations last for a set period of time (usually one year). Once it expires, you’ll have to go through the prior authorization process again.

What happens if the prior authorization is denied?

  • You can request an appeal (which is often successful!)
  • You can pay the full cost for the medication or healthcare supply, without insurance coverage.

Want to learn more?

Check out this easy-to-read resource created by DiabetesSisters on prior authorizations, step therapy, and appeals.

What’s Worked for Other People with Diabetes? Hear from Them!

  • I was denied my first CGM in 2008 by a Blue plan and fought and won by knowing how to Google my payer’s medical policy and prove that I met coverage criteria. It helped that I was given the HCP line phone number by a nurse sympathetic to my cause, but I ended the call with an authorization code. – Melissa
  • My strategy has always been persistence pays (eventually the insurance company will give in, although they may have peculiarities to navigate. The doctor’s office is really key and many have specialists who only deal with insurance company issues [mine does]). I’ve been covered by 4 insurance companies over the past decade while at the same employer if that tells you anything about the evolving insurance market. My experience with Anthem was a hassle but predictable, United Healthcare was easiest to navigate, Aetna was straightforward but a pain and had some weird rules (Why does a precertification inexplicably expire at the end of a calendar year? My chronic illness did not expire at the end of the year.). – Scott
  • Do you have experiences with prior authorizations? Let us know!
diaTribe Series

Image source: diaTribe

This article is part of a series on access that was made possible by support from AstraZeneca. The diaTribe Foundation retains strict editorial independence for all content. 

Source: diabetesdaily.com

Diabetes Care from Parent to Child: Passing the Torch of Care

This content originally appeared on diaTribe. Republished with permission.By Kerri Sparling Transitioning care from parent to child can be a stressful time for families with diabetes – six strategies on how to reduce the burden  Transitioning from my parents being in charge of my diabetes to assuming full care myself didn’t happen overnight. It was a […]
Source: diabetesdaily.com

Waking up with My Sleep Cycle

This content originally appeared on Type 1 Writes. Republished with permission.The one problem that I have been trying to solve for the better part of last year is why I often find myself feeling so tired. Despite getting a solid 7-9 hours of sleep each night, I was waking up most mornings feeling like I had gotten […]
Source: diabetesdaily.com

Dexcom G6: Giving it a Whirl

This content originally appeared on There’s More to the Story. Republished with permission.My delay in this post? I haven’t been in a blog writing or social media mood (more on that to come!) Well. I did it–I did in fact switch to the Dexcom G6! I can just hear the gasps and see the shocked faces. […]
Source: diabetesdaily.com

Search

+