Rush for COVID Vaccine Hinders Diabetes Tech Advancements

Modern science is amazing. The COVID-19 pandemic, which is still shaking the world as we know it, is quickly getting controlled due to fast scientific progress and the vaccine rollout (in the United States, at least).

Having an effective vaccine come to market within a year of the appearance of a novel disease is unheard of; most medicines take decades for adequate approval processes within the Food and Drug Administration (FDA) to be completed. This feat is incredible.

That being said, with all of the rush to get a vaccine to the masses, the FDA pushed the Pfizer, Moderna, and Johnson & Johnson vaccines literally to the front of the approval line, delaying other important medical and technological advancements, including those related to diabetes.

While the vaccine did (and should!) take precedent here, the delays have been tough for people with diabetes in many ways. 

The head of the FDA’s device center, Jeff Shuren, described a “tsunami” of product applications from companies hoping to join the fight against the COVID-19 pandemic.

Those applications include over 1,200 submissions for products like diagnostic tests, ventilators, and digital technology, all of which have slowed their work in other diseases, including diabetes.

Shuren went on to say that review times had begun to increase amid growing backlogs due to the high volume. 

The agency is trying to make as much space as possible to approve COVID-19 related vaccines, medicine, and technology quickly to end the pandemic, which has taken precedence over almost everything else. Experts suspect that the FDA may not be able to meet its own timelines going forward.

In addition, lockdowns and social distancing regulations halted clinical trials and product releases. It’s been a tough year for diabetes tech firms to get much done.

The following products, and their release dates, have been most affected by the pandemic:

Senseonics’ 180-Day Eversense Glucose Monitor

The Eversense continuous glucose monitor (CGM) is a device implanted under the skin that lasts for 90 days. The newest version of their CGM system aims to double its lifespan to 180 days without changing a sensor.

What was supposed to be released in early 2021 now faces delays of up to two months for its application to the FDA while the agency tasks its staff with emergency reviews of coronavirus tests and other medical devices. The new release date of the model is scheduled for mid-2021.

The Omnipod 5 (Originally “Horizon”)

Insulet’s Omnipod 5 system, which utilizes CGM data to make automated adjustments to basal insulin throughout the day, will be the company’s first hybrid-closed loop system.

Similar to the T-slim Control IQ system, this insulin pump will provide mobile app control and insulin dosing from a smartphone, eliminating the need to carry their hallmark Personal Diabetes Manager (PDM) around to control the release of insulin.

While significantly delayed due to the COVID-19 pandemic, Insulet said during its Nov. 4, 2020 investor update call that it had recently finished its clinical trial and was finalizing its FDA submission.

They hope to launch their product by June of 2021.

Medtronic 780G

Also known as the Advanced Hybrid-Closed Loop (AHCL) system, this system will improve upon its first iterations of the hybrid-closed loop system, the 670g and 770g. Hoping to seek approval for adults and children as young as two, this system includes:

  • A CGM sensor that will require just one calibration on the first day of wear and no further calibrations after that
  • Automatic correction bolus delivery every 5 minutes, in conjunction with CGM readings, that can automatically bolus for missed meal doses.
  • A lower glucose target range, adjustable between 100-120 mg/dL
  • Different insulin duration times, to adjust for the “tail” of your insulin (eg, Fiasp vs. Humalog)
  • Built-in Bluetooth to share data and provide remote software updates

Due to the pandemic, the approval for this device has been delayed, but Medtronic confirmed that it had submitted its application for review to the FDA in February, 2021.

They hope to have a commercial launch sometime in 2021.

Dexcom G7

The much-anticipated Dexcom G7 continuous glucose monitor (CGM) was also delayed due to the pandemic, but it should be worth the wait. You’ll no longer need to buy separate transmitters; each sensor is a complete and disposable transmitter/sensor integrated system. Some other great features include:

  • No calibrations, much like the G6
  • At the start, wear time will be 10 days, but eventual use will include a 14-15 day feature, also without any calibrations
  • Smaller and thinner: the newest CGM will be 60% smaller than the G6
  • One hour warm-up period

Dexcom CEO Kevin Sayer said that the company eventually plans to have different versions of the G7 for different people.

For example, people with type 2 diabetes who don’t use insulin (or even the general public) might opt for a much simpler interface than people with type 1 diabetes, who will want all of the alarms and settings.

Abbott Freestyle Libre 3

For years, the FreeStyle Libre from Abbott Diabetes was a considered Flash Glucose Monitor (FGM), because it only reported blood sugar levels whenever a user scanned their sensor with a receiver or smartphone.

That will change with the new edition: The Freestyle Libre 3 will function as a real-time CGM, because it won’t require sensor scanning to get a “flash” of blood glucose data. It will instead provide trends and graphs to track blood sugars throughout the day.

The Libre 3 generates real-time blood sugar readings every minute (as opposed to Dexcom’s every 5 minutes), displaying the result on a mobile app on your smartphone. This version also has optional high and low blood sugar alarms, a feature introduced with the Libre 2 in 2020.

Additionally, the sensor is much smaller and thinner (a 70% size reduction), and is kinder to the earth, using 41% less plastic overall.

The Libre 3 received global approval in September 2020. The timeline in the US has been pushed backwards, but with clinical trials now complete, we’ll likely see the Libre 3 applications submitted to the FDA mid-2021.

While the hustle for an effective COVID-19 vaccine has been nothing short of miraculous, people with diabetes don’t want to wait any longer!

Hopefully, with the hastened release of the vaccine, we can see more diabetes technology hit the market in 2021. 

Source: diabetesdaily.com

So You Got a CGM – Now What?

This content originally appeared on diaTribe. Republished with permission.

By Katie Mahoney, Hanna Gutow, and Diana Isaacs

If you just got a continuous glucose monitoring system, you may be wondering how to use it most effectively and how to understand your glucose data. Read our tips, tricks, and things to consider.

Congratulations – you got a continuous glucose monitor (CGM), an excellent tool to support diabetes management. Hopefully you’re feeling optimistic and excited that you have the opportunity to use this technology.

It’s most likely that you and your healthcare team decided that using a CGM is the optimal way for you to manage your diabetes. Perhaps you were given a prescription for a personal CGM. Or maybe you’re trying CGM as part of Dexcom’s Hello Dexcom program (a free ten-day trial), through Abbott’s MyFreestyle program (a free 14-day trial), or as part of Medtronic’s CGM Discount Access program. You might also be trying professional CGM, which is owned by your healthcare clinic and worn on a short-term basis.

If you haven’t yet been able to get CGM, ask your healthcare team if you can get a trial device or get a prescription. CGM is recommended for anyone with diabetes who takes mealtime insulin. While many people with diabetes currently don’t have access to CGM, we’re hopeful that more and more individuals will be able to use this technology in the future. Regardless of what brings you to using a CGM, we’ve created a three-part guide to help you get started, including tips, tricks, and considerations.

Click to jump down to a section:

Part 1: Before you apply your CGM

Learn the basics.

Before you start using your CGM, it can be helpful to understand its basic features. Continuous glucose monitors (CGM) measure the body’s glucose (or sugar) levels by sensing the glucose present in tissue fluid (also called interstitial fluid). While a blood glucose meter (BGM) provides a measurement of the blood glucose level at a specific moment in time (when you prick your finger), CGMs provide a new glucose level every one to five minutes – depending on the device, that’s 288 to 1,440 times per day. A CGM provides a constant stream of information on glucose levels, trends, and patterns.

A CGM can either be transcutaneous (it goes through your skin) or implanted (it lies under your skin). CGMs require three basic parts:

  1. A sensor that monitors real-time glucose levels under your skin.
  2. A transmitter that sits on top of the sensor and sends glucose information to a smartphone app, reader, or receiver. In transcutaneous systems, the sensor and transmitter are connected as one small on-body device. Some transmitters are disposable with the sensor while others require an additional step to attach. In implanted systems, the transmitter is attached to the skin and can be removed without harming the sensor below the skin.
  3. A smartphone app, reader, or receiver to collect and display your data.

CGMs have a variety of features that differ by brand and model, including the amount of time the CGM needs to “warm up” before glucose readings are available, how long you can wear a CGM sensor before needing to replace it, and alarms that alert you to highs and lows. You can learn more about CGM devices here. For brand-specific resources and information, click here to jump down.

Personal CGM vs. Professional CGM

The CGMs that we just described are called personal CGMs – they are owned by the person with diabetes and used for a long period of time. They are available as real-time CGMs, where the data can be continuously viewed, or as intermittently-scanned CGMs, where information is recorded all of the time, but you need to scan the sensor to view the data.

Another type of CGM is called “professional CGM.” Professional CGMs are given to someone with diabetes for a short session (usually one to two weeks) to better understand that person’s glucose levels. After the wear period, the person will review the data with their healthcare professional. This can provide insights that inform the person’s diabetes treatment, and it can help healthcare professionals recommend therapy and lifestyle recommendations that lead to better glucose management.

Some professional CGMs have a real-time mode, meaning that the user can see their glucose levels while wearing the device. Other professional CGMs have a “blinded” mode. Blinded CGM means that you cannot look at their glucose values on-demand; instead, all of your glucose data is stored and shared with your healthcare professional. This can help your healthcare team identify hypoglycemia (or low blood sugar levels). If you get a blinded professional CGM, your healthcare team will analyze the data and discuss it with you once your wear period is complete.

While long-term, real-time CGM is most effective for day-to-day diabetes management, especially for insulin users, professional CGM can be an important tool for people who are not using personal CGM. Periodic use of CGM can help people learn the effects of food and physical activity on glucose levels, even for those not taking any diabetes medications.

Reflect on your goals, know your targets, and make a plan to respond to highs and lows.

It can be helpful to reflect on your CGM goals, set your glucose targets, make plans for responding to your glucose readings, and decide with whom you want to share your data:

  • Reflect on your CGM goals. Perhaps you want to use CGM to prevent hypoglycemia using its alert system, or to prevent hyperglycemia and increase your Time in Range, or to manage glucose during exercise. Or, maybe you and your healthcare team are going to use professional CGM for two weeks to explore how your lifestyle habits affects your glucose levels. Regardless, the ultimate goal of CGM is to improve your diabetes management.
  • Know your personal glucose targets and make a plan with your healthcare team for how you’ll respond to hyperglycemia and hypoglycemia. Knowing your target glucose range is important for responding to your real-time glucose values. For most people with diabetes the target range is 70-180mg/dl – learn more about Time in Range goals here. Make a plan that incorporates glucose trend arrows from your CGM to help you prevent big spikes out of range. Here are some prompts for you to discuss with your healthcare team:
    • What is my glucose target when I wake up and before meals?
    • What should my glucose level be two hours after a meal? If it is above that value, what actions should I take to bring my glucose levels down?
    • What is my glucose target before bed?
    • What high glucose level should I try to avoid? What should I do if my glucose gets that high?
    • What low glucose level should I try to avoid? What should I do if my glucose gets that low? What should I do if my glucose levels are trending down?

Part 2: Applying your CGM

Connect the CGM to the app and set the system up.

Download the mobile app associated with your CGM system if available. If you’re using a receiver (Dexcom device) or reader (Libre device), make sure it’s charged daily. The CGM should come with instructions for applying the sensor (every seven, ten, or 14 days) and pairing the app, reader, or receiver with your sensor and transmitter. If you have an implanted CGM, it will be applied by a healthcare professional and can last up to 90 days. To jump to brand-specific instructions and tutorials, click here. To learn about CGM adhesives and tips for keeping your CGM on, check out Adam Brown’s suggestions on the topic.

Once your system is set up, your CGM will need to “warm up” before you can see your data. Different models have different warm-up periods, but this will generally take one to two hours, after which your data will be accessible either directly (Dexcom, Guardian, Eversense) or by scanning your sensor (FreeStyle Libre). The warm up period for the implantable Eversense system is 24 hours.

For many people starting to use a CGM, video tutorials can be quite helpful. If you have the opportunity, it’s good to meet with a diabetes care and education specialist or your local pharmacist (if picking up your CGM from a pharmacy). Here are set-up and application tips and tutorials for your CGM:

Part 3: Understanding your CGM data

Once you’re set up with your CGM and the warm up period is complete, you can access your data. There are two types of data you’ll want to pay attention to: real-time data and past data.

Interpret your real-time data.

Depending on the CGM brand you’re using, you can either access your glucose data at any time by looking at an app on your phone, your smart watch, or your receiver. For those using an intermittently-scanned CGM, you can view your glucose levels by scanning your sensor with your smart phone or reader. Looking at your data can feel overwhelming at first, so we recommend focusing on two aspects of your real-time data:

  • First, look at your CGM glucose value. Is it in your target range? If your glucose level is out of range, which steps of your plan should you follow?

If you’re experiencing hypoglycemia in particular, make sure you act right away to increase your glucose levels.

  • Second, look at the trend arrow. Your CGM provides a “trend arrow,” to tell you the direction and speed with which your glucose values are changing. The trend arrow is helpful for understanding what’s going on and how you can respond. For example, if your glucose value is 90 mg/dl and your trend arrow shows that your glucose levels are going down, you may need to take action to prevent hypoglycemia; if your glucose value is 90 mg/dl and your trend arrow shows your glucose levels are increasing, you are likely not going to develop hypoglycemia.

Trend arrows can help with premeal insulin dosing, before and after exercise, before bed, and to understand where your glucose will be trending in the next 30 minutes. Trend arrows are particularly beneficial when used with insulin on board (short-acting insulin that was recently taken for food or to correct a high glucose level and is still working in the body). For example, if your trend arrows are going down and you have insulin on board from an insulin dose given two hours previously, your risk of hypoglycemia is even greater.

For those not using insulin, trend arrows can help understand how different foods and activities affect glucose levels. For example, if a person sees that the arrow is rising rapidly after a certain meal or snack, they can go for a walk to try to bring it down. It may also signal that next time you should consider a smaller portion size or try to add protein or fat to prevent glucose levels from rising as quickly.

Each CGM has a slightly different interpretation of the arrows, but here’s a general idea of what the trend arrows can tell you.

data

Image source: diaTribe

We recommend working with your healthcare team to decide how often to check your glucose levels. Many people benefit from checking glucose when waking up, before meals, before physical activity, and at bedtime. Some people benefit from checking one to two hours after meals. A person should also check their CGM any time they feel symptoms of high or low glucose. CGM alarms are especially helpful for monitoring glucose levels as they change – more on this below.

Interpret your past data.

Once you’ve used your CGM for a few days, you can see your recent daily trends and the amount of time you’re spending in the target range (70-180 mg/dl). This is also called retrospective data. It is beneficial to review your glucose data regularly to understand how your lifestyle – like the food you eat, your exercise habits, your stress levels, and medications you use – affects your glucose levels. Look at your glucose levels over the past two weeks, one month, and three months; talk with your healthcare team about trends that you are noticing and how they might be addressed. Learn about the many factors that affect glucose here.

During diabetes care appointments, your healthcare team can view this data in an Ambulatory Glucose Profile (AGP) report and use it to talk with you about how your diabetes management is going and any potential adjustments to your care plan. This should be a collaborative discussion between you and your healthcare team about how your diabetes data compares to your management goals and what changes could be made.

Each CGM system offers a standardized one-page report, called an ambulatory glucose profile (AGP). The AGP includes three important components:

  1. CGM key metrics
  2. 24-hour profile
  3. Daily glucose patterns

Although there are many ways to view your glucose data, the AGP report often has all of the information that you need. We’ll explain the three main pieces below. To learn more, read our in-depth piece on understanding your AGP report: “Making the Most of CGM: Uncover the Magic of Your Ambulatory Glucose Profile.”

CGM key metrics

More green, less red.

The time in range bar shows the percentage of time you spend in five glycemic ranges:

  • data

    Image source: diaTribe

    Time in Range: glucose levels between 70-180 mg/dl

  • Time Below Range: glucose levels below 70 mg/dl
  • Time in severe hypoglycemia: glucose levels below 54 mg/dl
  • Time Above Range: glucose levels above 180 mg/dl
  • Time in severe hyperglycemia: glucose levels above 250 mg/dl

Your goal is to grow the green bar and shrink the red bars – in other words, increase Time in Range and decrease time Below Range and time in severe hypoglycemia. See more on Time in Range goals and standard targets.

24-hour profile, also known as Ambulatory Glucose Profile (AGP).

chart

Image source: diaTribe

How do you figure out how to change your diabetes management to increase your Time in Range and decrease your Time Below and Above Range? That’s where the 24-hour profile is helpful, which shows your daily glucose trends across the full 24-hour day.

  • Understanding what the 24-hour profile shows: The black line represents your median glucose level throughout the day based on data from a set period of your CGM use (e.g., the last two weeks). The blue shaded areas help show how much your glucose levels vary at different points in the day.
  • Using the data: Compare different times of day to see what might be influencing your glucose numbers. For example, while the person shown above has glucose readings that vary greatly at 3pm (indicated by a very wide shaded area), their 8am glucose numbers are much more consistent (the shaded area at 8am is narrower), despite being higher. This person also regularly sees a spike in sensor glucose readings at around 9am. What’s causing that increase? Maybe it’s a higher carbohydrate breakfast choice, forgetting to bolus, not bolusing early enough, or not accounting for all the carbs in breakfast. Reflecting on what is causing a spike or valley can help you make behavior changes to reduce fluctuations and increase your Time in Range.
  • chart

    Image source: diaTribe

    The goal: The overall goal is to keep your glucose levels in your target range without big spikes or valleys, sometimes called “flat, narrow, in range” (FNIR). In the AGP above, the green box represents the user’s target sensor glucose range (70-180 mg/dl). While the user stays in range overnight and in the afternoon, they tend to see spikes in the morning and evening. With the goal of FNIR in mind, you can look at your long-term data and ask, what’s making it possible for me to stay in range? What is making my glucose spike or fall?

  • The good news is the goal for most people is to spend 70% or more Time in Range. However, increasing your Time in Range by even 5% (an extra hour per day in range!) can be helpful. You don’t have to reach perfection to improve clinical outcomes.

Daily glucose profiles.

With your trend data, you also can see your daily 24-hour glucose profiles from the last two weeks. The figures show the target range (70-180 mg/dl) in gray, spikes above 180 mg/dl (hyperglycemia) in yellow, and valleys below 70 mg/dl (hypoglycemia) in red. Viewing the data day by day can help you evaluate how specific factors and behaviors impacted your glucose values on a certain day.

data

Image source: diaTribe

To make the most out of your daily glucose profiles, it can be helpful to log your daily food and exercise to compare with your glucose profile and see which behaviors help you stay in range and which ones tend to make you go out of range.

A helpful tool when reviewing your data with your healthcare team is called DATAA. Which stands for:

  • Data – look at your diabetes data together
  • Assess Safety – Look for and try to solve Time Below Range (hypoglycemia) first
  • Time in Range – Discuss what’s working and how to replicate that by looking for the times of day or the days of the week when Time in Range was the highest
  • Areas to Improve – Note when you spent more Time Above Range (hyperglycemia) and discuss ways to reduce this
  • Action Plan – Develop an action plan together

Other Tips, Tricks, and Considerations

1. Exercise & your CGM

To learn about how to use your CGM before, during, and after exercise, check out our article “Exercise Well with Your CGM – Recommendations, Glucose Trends, and Strategies.”

An important note about exercising with a CGM: There can be a difference between CGM glucose measurements and BGM glucose measurements due to what we call a “lag.” Changes in glucose levels in interstitial fluid are not seen as quickly as they are in the blood. At rest, the interstitial glucose lags about five minutes behind the blood glucose; in situations when glucose changes rapidly, such as during exercise, lag time can increase up to 24 minutes. This means that your CGM readings aren’t always going to be accurate during exercise. This lag can also occur outside of exercise, any time your glucose levels are rising or falling quickly.

2. How to make CGM alarms your friend

Adam Brown has written about how it can be helpful to think about your CGM as a partner in your diabetes management, rather than a nag that points out when you’re not in range. Alarms can be useful tools. By alerting you to current or predicted highs and lows, as well as rate of change, you can increase your Time in Range and see your 24-hour glucose profile become flatter, narrower, and more in range. You can personalize your CGM alarm settings to your preferred thresholds or turn them off completely (though some devices won’t let you turn off an urgent low alarm at 55 mg/dl). It’s helpful to work with your diabetes care team to determine your individualized alarm settings.

3. Sharing data with friends, family, and care-partners

The ability to share your real-time glucose data with your care-partners and loved ones is a huge plus of using CGM – your support network can help you track your glucose levels and keep them in range. At the same time, sharing your data with others makes some people nervous and self-conscious. Decide who you want to share your data with and talk with that person about boundaries and how you want to communicate about your data. For more on how to approach these conversations, check out Kerri Sparling’s “To Share or Not to Share: My Approach to Diabetes Data,” and “How to Coach Your Care-Partner on CGM Data.”

4. How to talk to your healthcare team about your CGM

Now that you’re using a CGM, talking with your healthcare team about your CGM data should become a key part of every visit.

Ahead of the visit: To help visits go smoothly, many healthcare professionals will ask you to upload your CGM data before you come into the office (or before your telehealth appointment) so they can review the data and be prepared to talk with you. Learn about uploading your data here. Note: some CGM systems upload automatically once connected to the clinic’s data portal. It’s also helpful to look over your data – like your AGP report – and come up with questions to ask your healthcare professional ahead of the visit. You may have questions about parts of your daily glucose profile that you don’t understand, areas where you’re having a hard time staying in range, or just general questions to help you navigate your data.

During the visit: To make sure that you and your healthcare professional are on the same page, it can be helpful to take a few minutes at the beginning of your appointment to explain your interpretation of your data in your own words. This may be a good time to start a conversation on any questions you may have prepared ahead of your visit. It is also important to take time with your care team to develop an action plan based on your CGM data with a few straightforward priorities for you to focus on before your next visit.

Brand-Specific Resources

While any CGM can help improve your diabetes management, there are some differences between the currently available systems that you may want to consider or talk about with your healthcare team – see our chart comparing different CGMs here. Specifically, we recommend asking your healthcare professional about how alarms may be able to alert you to times of hyperglycemia or hypoglycemia, what it means if you have to calibrate your CGM, and how to use your CGM with smart insulin pens, mobile apps, or even insulin pumps in an automated insulin delivery (AID) system.

To reach out to CGM companies for product support, contact their customer service departments:

  • Abbott: +1-855-632-8658
  • Dexcom: +1-888-738-3646
  • Medtronic: +1-800-646-4633
  • Senseonics: +1-844-736-7348

This article is part of a series on Time in Range.

The diaTribe Foundation, in concert with the Time in Range Coalition, is committed to helping people with diabetes and their caregivers understand Time in Range to maximize patients’ health. Learn more about the Time in Range Coalition here.

Source: diabetesdaily.com

Breakthroughs in Pancreatic Cell Replacement: The ViaCyte Interview

I recently had the opportunity to sit down with Manasi Sinha Jaiman, M.D., M.P.H., Vice President of Clinical Development, and Mark Daniels, Senior Director of Clinical Development, of ViaCyte, “a regenerative medicine company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for all type 1 diabetes and a next-generation treatment for insulin-requiring type 2 diabetes.”

They have amazing things coming down the pike, so I was super excited to speak with them:

Tell our readers about ViaCyte. What’s the company’s mission and story?

Dr. Jaiman: ViaCyte is at the forefront of regenerative medicine approaches to develop a functional cure for type 1 diabetes (T1D). We have cell replacement therapies for pancreatic islet cells contained in a small retrievable pouch implanted under a patient’s skin.

The therapy is designed to enable insulin and glucagon (the counter-regulatory hormone that treats low blood glucose) production with the implanted cells to effectively control blood glucose levels, decrease the risk of hypoglycemia, and mitigate short-term and long-term diabetes-related complications for patients.

What is exciting is that ViaCyte is the first company to advance human stem cell-derived islet cell replacement therapy capable of producing insulin in the clinic, backed by two decades of research and expertise.

We are further augmenting our therapies by optimizing both the delivery device and the cells through collaborations with industry leaders, including W. L. Gore & Associates (the makers of GORE-TEX) and CRISPR Therapeutics.

Our mission is to develop cell replacement therapies offering long-term treatment to decrease the burden of the constant management needed with T1D.

What led you to your work at ViaCyte?

Dr. Jaiman: A significant focus of my medical career has been the integration of technology and medicine to advance treatments that can change the paradigm of diabetes disease management.

My experiences both in research and actively seeing patients with T1D have given me first-hand experience in seeing the daily work required to achieve any form of glycemic control as well as the burden patients and families face from complications from hypoglycemia or DKA.

I have also been able to see the importance of innovative approaches in addressing their needs. When I looked at the ViaCyte technology, I immediately saw great potential in their regenerative medicine approach to lessen the burden of disease and improve quality of life.

Mr. Daniels: Throughout my time in the industry I have been extremely fortunate to be able to work with innovative companies advancing potential, game-changing therapies for difficult-to-treat diseases. I was attracted to ViaCyte because the bar is set high; ViaCyte is looking to develop functional cures for diseases and is not just treating symptoms.

I also believe in the potential of cell replacement therapies and that these will be a meaningful new chapter in the advancement of medical treatments.

In ViaCyte, I have also found a team of extremely gifted and dedicated scientist-coworkers who are all generous with their knowledge and completely aligned in the mission to deliver a functional cure to the type 1 diabetes community.

It is exciting to be the first company to evaluate human stem cell-derived islet cell replacement therapy for its potential to functionally cure type 1 diabetes in the clinic.

Manasi Sinha Jaiman, M.D., M.P.H., Vice President of Clinical Development and Mark Daniels, Senior Director of Clinical Development

Manasi Sinha Jaiman, M.D., M.P.H., Vice President of Clinical Development and Mark Daniels, Senior Director of Clinical Development

What exciting new developments is ViaCyte currently working on?

Dr. Jaiman: Currently, ViaCyte has two clinical cell replacement therapy candidates. First, VC‑02 PEC-Direct is a treatment comprised of pancreatic islet cells in a pouch designed to allow blood vessels to enter the device and directly interact with the implanted cells to produce insulin and glucagon.

This treatment candidate is targeted for those with high-risk type 1 diabetes (hypoglycemia unawareness) able to tolerate immunosuppression.

In contrast, our groundbreaking VC‑01 PEC-Encap device is an advanced treatment comprised of pancreatic islet cells in a pouch that fully encapsulates the cells preventing immune cells from interacting with the implanted cells, which eliminates the requirement for immunosuppressants.

We are collaborating with W. L. Gore & Associates to optimize their innovative membranes which encapsulate the cells in our implanted devices. We expect to share clinical data in the second half of 2021.

Anything new in the pipeline that people with diabetes should be especially excited about?

Dr. Jaiman: One of the challenges with cell replacement therapies is to protect against adverse reactions and rejection of implants by the body’s immune system, which serves as a defense mechanism against foreign bodies.

In collaboration with CRISPR Therapeutics, we are employing gene-editing technology to engineer cells to avoid recognition by the immune system. Our partnership is focused on advancing gene-edited allogeneic stem cell-derived therapies from discovery through commercialization with the goal of developing a potential next-generation functional cure for all insulin-requiring type 1 and type 2 diabetes.

Mr. Daniels: With our preclinical candidate, VCTX210 PEC-QT, pancreatic islet cells would be in the same pouch as PEC-Direct, allowing the implanted cells to interact directly with blood vessels, an approach intended to enable robust and consistent engraftment.

Yet by designing the cells to be immune-evasive through CRISPR Therapeutics’ gene editing we would expect to eliminate the need for immunosuppressants as are required with PEC-Direct. We look forward to sharing more about this unique program in the future.

Photo credit: ViaCyte

Where do you envision ViaCyte and people’s lives affected by diabetes in five years? Ten years?

Mr. Daniels: This year marks the 100th anniversary of the development of therapeutic insulin to regulate blood glucose, yet dependency on tedious insulin injections are still a common course of treatment for many living with type 1 diabetes.

Within the next five years, we envision delivering significant progress in later clinical-stage studies with increased time in range, reduction in hypoglycemic events, and reduction in (or elimination of) the need for insulin injections in patients following our cell replacement treatments as we move toward making these therapies more widely available.

Dr. Jaiman: Within five years, we expect to be moving through the final phases of our regulatory process for our human stem cell-derived islet cell replacement therapy enabling availability more broadly for patients with type 1 diabetes.

It is our hope that within a decade, cell replacement therapy will offer longer-term treatment, easing the burden of constantly monitoring blood glucose. A functional cure will no longer be a dream, rather, a reality.

Is the ever-elusive cure on the horizon? A functional cure?

Dr. Jaiman: Yes, we believe a functional cure is on the horizon!

ViaCyte is focused on advancing cell replacement therapies toward a functional cure with a combination of implanted cells and device engineering.

This cell replacement therapy could represent insulin production protected from the immune system in a way that totally mitigates the underlying disease. Our technology is designed to safely implant the missing cells that make insulin and glucagon – that’s the breakthrough that gets us to the functional cure.

How can people with diabetes get involved or learn more?

Mr. Daniels: As ViaCyte is advancing novel treatments for type 1 diabetes, our team has been very fortunate to collaborate with multiple incredible research and advocacy organizations, including the Juvenile Diabetes Research Foundation (JDRF), Beyond Type 1, and California Institute for Regenerative Medicine (CIRM).

These organizations are focused on education and support for finding a cure for diabetes with resources for both patients and researchers on their websites. A great resource is the website www.clinicaltrials.gov – by typing “ViaCyte” into the search window, you can find more details regarding our ongoing clinical trials.

This includes details about the entry criteria to participate as well as the geographical locations of the sites (to find the one closest to you) and contact details necessary to reach out and connect with the study site team to learn more about what is involved in the study participation.

Photo credit: ViaCyte

Anything else you’d like to share?

Dr. Jaiman: Insulin treatment has largely transformed type 1 diabetes from a fatal illness to a chronic one, yet it is not a cure. At ViaCyte we recognize the long journey in the evolution of diabetes management, and we are keen to deliver a solution that offers real hope for a functional cure for type 1 diabetes.

Every single member of our team is passionate and dedicated to this endeavor. Managing diabetes can be difficult at any time, however, this past year has highlighted the need for accelerating therapeutic advancements to help reduce COVID-associated morbidity and mortality in the vulnerable population with diabetes.

With the pandemic still ever-present, we believe our mission of realizing a functional cure is even more critical for patients as they navigate living with a chronic disease during this very trying time. Our leadership team is wholly focused on improving patient care with an eye to the future.

Mr. Daniels: I am very appreciative of the Diabetes Daily team for providing this forum to connect to their community. The stories of family member’s and loved one’s experiences (including those of some of our own coworkers) with T1D resonate clearly within us and fuel our motivation behind the work we do.

It is only through the support of the T1D community and especially the valued study participants that we are able to advance this important research.

We are proud to be part of the biotech and biopharma community advancing some of the world’s most promising medical devices and therapeutic treatments. We look forward to sharing more details regarding the value of these treatments in the clinic.

Source: diabetesdaily.com

Keto Instant Pot White Chicken Chili

This content originally appeared on Sugar-Free Mom. Republished with permission.

This keto one-pot white chicken chili takes just 10 minutes to prep and only 20 minutes to cook in the Instant Pot and is the perfect bowl of comfort on any night of the week! This stores well in the fridge for up to 3 days or freezer for 2 months so you can make a big batch, put it in Tupperware and freeze for when you don’t have time to cook.

Serve with cauliflower rice or low-carb vegetables, like broccoli, cauliflower, or spinach. Add right to the Instant pot and make it more into a chicken chili soup. Feel free to customize it and make it your own. This is a meal everyone in the family will enjoy, especially when they can add all their favorite toppings, like avocado, cheese, sour cream, or fresh cilantro!

white chicken chili

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Keto Instant Pot White Chicken Chili

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This Keto Instant Pot White Chicken Chili has maximum taste with just 10 minutes of prep time. You can dial up the heat to your liking and there is a dairy-free option as well. You don’t have to slave away at the stove all day to get a really comforting homemade keto dinner on the table quickly.
Course Dinner
Cuisine American
Keyword Avocado, Chicken
Prep Time 10 minutes
Cook Time 40 minutes
Total Time 50 minutes
Servings 4 servings

Equipment

  • Instant Pot
  • Slow Cooker

Ingredients

  • 2 tbsp butter or ghee (or olive oil for dairy-free)
  • 24 ounces chicken breasts boneless and skinless, or 670g
  • 2 ounces yellow onion or 60g
  • 1.5 tsp ground cumin
  • 1 tsp ground coriander
  • 2 tsp dried oregano
  • 1/2 tsp paprika
  • 1/4 tsp cayenne pepper optional
  • 1 tsp sea salt flaked or to taste
  • 1/2 tsp black pepper or to taste
  • 4 oz green chiles 1 – 4oz can chopped, mild
  • 1 jalapeno small
  • 2 cloves garlic minced
  • 2.5 cups chicken broth
  • 1/4 cup heavy cream
  • 2.5 ounces cream cheese or 80g (for dairy-free use 2/3 cup coconut milk to replace heavy cream and cream cheese)

Optional Toppings

  • 3/4 cup Monterey jack cheese or Mexican or cheddar cheese (or 85g), shredded
  • 1 avocado cubed
  • 3 tbsp fresh cilantro chopped
  • 1/3 cup sour cream
  • sliced jalapenos

Instructions

Instant Pot Instructions

  • Place the instant pot on sauté mode (medium). Add the butter, ghee, or olive oil. Once hot add the chicken breasts and sear for 2 – 3 minutes per side. Turn off sauté. Add the onion, cumin, coriander, oregano, paprika, optional cayenne, salt, pepper, green chiles, jalapeño, garlic, and broth. Stir to combine.
  • Secure the lid on the instant pot and close the pressure valve. Press the “pressure cook” button and set the time to cook for 20 minutes at high pressure. Once the time is up, quick release the pressure.
  • When the pressure has released, remove the lid and chicken breasts. Place chicken on a chopping board and shred the chicken with two forks.
  • Switch the Instant Pot back to sauté mode, medium, and set the timer for 15 minutes allowing the broth to concentrate and reduce. Add the heavy cheese and cream cheese (or coconut milk for dairy-free) for the last 3 minutes, whisking it with a hand balloon whisk until combined. Taste and adjust the seasoning. Add the chicken back in and allow it to warm through.
  • Ladle into bowls and serve with desired toppings and cauli rice or veggies.

Slow Cooker Instructions

  • Add the butter, ghee, or oil to a non-stick frying pan. Sauté the chicken breasts (2 – 3 minutes per side) on medium heat.
  • Transfer (along with the pan juices) to a slow cooker. Add the onion, cumin, coriander, oregano, paprika, optional cayenne, salt, pepper, green chiles, jalapeño, garlic, and broth. Stir to combine.
  • Cover and cook on LOW for 8 hours or on HIGH for 3.5 hours.
  • Remove the chicken and place it on a chopping board. Shred between two forks. Add the heavy cream and cream cheese (or coconut milk for dairy-free) to the slow cooker, whisking to combine to the juices. Taste and season to your likeness. Add the chicken back to the slow cooker and cook for a further 20 – 30 minutes on low (or 10 minutes on high) until warmed through.
  • Stir well. Ladle into bowls and serve with desired toppings and cauli rice or veggies.

Notes

Storage: Store in the fridge for up to 3 days or freezer for 2 months

Net Carbs: 5g

Nutrition

Carbohydrates: 7g | Protein: 39g | Fat: 22g | Saturated Fat: 12g | Trans Fat: 1g | Cholesterol: 143mg | Sodium: 1520mg | Potassium: 852mg | Fiber: 2g | Sugar: 2g | Vitamin A: 708IU | Vitamin C: 22mg | Calcium: 71mg | Iron: 2mg


Please note that the nutritional information may vary depending
on the specific brands of products used. We encourage everyone to check specific
product labels in calculating the exact nutritional information.

Keto Instant Pot White Chicken Chili Recipe

Source: diabetesdaily.com

Study Compares MiniMed 780G and MiniMed 670G Algorithms

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

A new study in adolescents and young adults with type 1 diabetes directly compared two automated insulin delivery algorithms. Medtronic’s newer Advanced Hybrid Closed Loop (built into the MiniMed 780G system) improved glucose management more than the MiniMed 670G, though both systems showed impressive increases in Time in Range for this population. Ultimately, the 670G gave users over an hour and a half more time in range each day, while the 780G gave wearers over two hours every day in range!

Two Medtronic automated insulin delivery algorithms, the Advanced Hybrid Closed Loop and the MiniMed 670G, were recently compared in a cross-over study, allowing 113 participants to use both algorithms. Results from the study were published in the medical journal The Lancet. Notably, the study tested this technology in adolescents and young adults with type 1 diabetes ­– a group for which diabetes management is notoriously challenging. View our resources for adolescents with diabetes here.

For an introduction to automated insulin delivery (AID), check out our piece on current and coming-soon AID systems in 2021.

What is the MiniMed 670G?

The MiniMed 670G is an AID system that has been available since spring 2017 – it was the first system ever to “close the loop.” The system includes the MiniMed 670G pump, the Guardian Sensor 3 continuous glucose monitor (CGM), and an automated insulin adjustment algorithm. The algorithm adjusts basal insulin delivery every five minutes based on CGM readings, and a target of 120 mg/dl.

What is Advanced Hybrid Closed Loop?

Advanced Hybrid Closed Loop (AHCL) is Medtronic’s next-generation AID algorithm. The AHCL algorithm is used in Medtronic’s MiniMed 780G system, which is currently available in at least twelve countries in Europe. While it is not yet available in the US, Medtronic hopes to launch the 780G in the US this spring. In addition to automatic basal rate adjustments, the AHCL algorithm can also deliver automatic correction boluses and has an adjustable glucose target that goes down to 100 mg/dl. This is big news because many people using closed loop do not want to target the higher 120 mg/dl, even as a safety measure. The 780G algorithm is designed to have fewer alarms and even simpler operation than the MiniMed 670G system.

What was the study?

The newly published FLAIR (Fuzzy Logic Automated Insulin Regulation) study was conducted over six months across seven diabetes centers (four in the US, two in Europe, and one in Israel). The study enrolled 113 adolescents and young adults (ages 14-29) with type 1 diabetes. The study sample is notable, because teens and young adults with type 1 diabetes have the highest average A1C levels of any age group.

At the beginning of the study, participants performed their usual diabetes management routine for two weeks to establish their baseline glucose levels. Half of the group was then randomly assigned to use the MiniMed 670G system, while the other half of the group used the same pump and CGM, but with the new AHCL algorithm. After three months – the halfway point of the study – the two groups “crossed over,” switching to the opposite technology.

What were the results?

Nearly every measure of glucose management favored the AHCL period over the MiniMed 670G:

  • Compared to baseline, participants reduced time spent above 180 mg/dl by 1.2 hours per day when using MiniMed 670G and 1.9 hours per day when using AHCL.
  • Time in Range (TIR, time between 70-180 mg/dl) improved from a baseline of 57% to 63% using Minimed 670G and to 67% using AHCL.
  • Time spent below 70 mg/dl fell 0.2% of the time. While those 28 minutes a day may not be statistically significant – and time in severe hypoglycemia, or below 54 mg/dl, did not increase from baseline when using either algorithm – many people with diabetes would benefit from that additional half hour in range.

The graph below shows the time spent in glucose ranges during baseline, MiniMed 670G, and AHCL periods. For both algorithms, the Time in Range increase from baseline was significant – use of either AID system led to at least 14 hours more each week spent in range. Nevertheless, we also point out, of course, that the group (again, the group that has the most challenges of any age group managing diabetes) still experienced a fair amount of time above 250 mg/dl. This is  another reason for healthcare professionals and people with diabetes to think about the “whole person” when considering diabetes management, and another reason why we always recommend Adam Brown’s Bright Spots and Landmines for ways to improve diabetes management in terms of food, exercise, mindset, and sleep – it includes many strategies for people, especially teens and young adults, to use each day.

AID comparison

Image source: diaTribe

  • The biggest Time in Range improvement came overnight (between midnight to 6am). During this six-hour overnight period, AHCL users spent an average of 4.4 hours in range (74% TIR), compared to 4.2 hours (70% TIR) for 670G, and 3.5 hours (58% TIR) during baseline. While the overnight Time in Range difference between AHCL and 670G may not seem large, it added up to nearly a 22-hour difference over the three-month the AHCL period.
  • With daytime numbers, the average AHCL user spent 63 more hours (about 2.6 days) in range than the average 670G user in each three-month study period.

The graph below shows daytime and nighttime differences in time spent in range (70-180 mg/dl), and the data is included in a table at the end of this article. Better sleep the night before can also make diabetes management more effective during the day.

Comparison

Image source: diaTribe

  • Using MiniMed 670G drove an average A1C improvement from 7.9% to 7.6%, while AHCL use improved A1C from 7.9% to 7.4%.

Both systems showed extremely positive results and were found to be safe for use in young people with type 1 diabetes. The AID algorithms led to dramatic increases in Time in Range in a population that stands to benefit – over the course of a year, adolescents and young adults could spend more than ten additional days in range. The direct comparison between these two AID algorithms is highly informative – we hope to see similar trials in the future.

Comparison

Image source: diaTribe

Source: diabetesdaily.com

Tech on the Horizon: Where Will Automated Insulin Delivery (AID) be in 2021?

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

What AID systems are currently available, what can we expect in the next year, and where is AID technology headed?

Want more information just like this?

As we enter 2021, we’re taking a look at what’s ahead for automated insulin delivery (AID) systems. Because the COVID-19 pandemic delayed many clinical trials and FDA reviews in 2020, several companies are expecting to launch new AID systems in 2021. This list covers many of the most notable upcoming products, but there are likely others on the horizon – if you know of a system you think we should track, please let us know.

Click to jump to a product, organized by expected launch date. You’ll find detailed descriptions and possible launch timelines for each, reflecting US availability.

What is automated insulin delivery (AID)?

Automated insulin delivery has many names – artificial pancreas, hybrid closed loop, bionic pancreas, predictive low-glucose suspend – but all share the same goal: combining continuous glucose monitors (CGMs) with smart algorithms to automatically adjust insulin delivery via an insulin pump. AID systems aim to reduce or eliminate hypoglycemia, improve Time in Range, and reduce hyperglycemia – especially postmeal and overnight.

When thinking about the development of AID technology, it’s often helpful to think in stages.

  • Stage 1: The most basic AID system might shut off the insulin pump whenever the user’s CGM readings drop below a certain number, such as 70 mg/dl, to reduce time spent in hypoglycemia and help prevent severe hypoglycemia.
  • Stage 2: The AID system could predict when glucose is going to go low and automatically reduce or stop insulin delivery to further help prevent hypoglycemia.
  • Stage 3: The AID system may be able to automatically adjust basal insulin delivery depending on whether the user’s glucose is trending up or down, and taking into account other factors, such as insulin on board. This adjustment of basal insulin would aim to increase Time in Range (TIR), and help prevent both high and low glucose levels. At this stage, the user would still have to manually give meal boluses and correction boluses.
  • Stage 4: The AID system will be able to deliver correction boluses when glucose values are high. These small adjustment boluses would be a further step in improving TIR, with less time with hyperglycemia.
  • Stage 5: The systems will be able to detect meals and automatically deliver a system-calculated meal bolus to reduce postmeal high blood glucose levels. With the elimination of manual meal bolusing, the system is considered to be a “fully closed loop” System.

Currently available products are in stages 3-4. By the end of 2021, we may have multiple stage 4 systems available.

Medtronic MiniMed 670G and 770G – already available 

AID

Image source: diaTribe

Now available for people over the age of two.

What is it? Medtronic’s MiniMed 670G has been available since spring 2017 and was the first stage 3 AID system to be cleared by the FDA. Prior to the 670G, Medtronic released stage 1 and stage 2 systems (Medtronic MiniMed 530Gand 630G, respectively). More recently, the MiniMed 770G system was cleared in the US in September 2020. Both the MiniMed 670G and 770G systems use the same insulin adjustment algorithm, which adjusts basal insulin delivery every five minutes based on CGM readings, targeting 120 mg/dl. The target glucose level can be temporarily raised to 150 mg/dl when low blood sugar (is a concern, such as during exercise or sleepovers for children. Both systems come with Medtronic’s Guardian Sensor 3 CGM, which has seven-day wear and requires two fingerstick calibrations per day (although four are recommended). See our article from 2016 for a full breakdown on the MiniMed 670G and from September for more on the 770G.

What’s the difference between the MiniMed 670G and 770G? As mentioned, both the MiniMed 670G and 770G systems use the same insulin adjustment algorithm and the same CGM. However, the newer MiniMed 770G has an improved pump: the 770G pump includes Bluetooth connectivity and can be paired to the MiniMed Mobile smartphone app (available for the iOS and Android) for users to view their CGM and pump information without pulling out their pumps. The app also allows users to share their data with others in real-time. Note: users can only view information but cannot control the pump (e.g., deliver a bolus, adjust basal rates) from the app. Bluetooth connectivity also means the system’s insulin adjustment algorithm can be updated. Medtronic has promised current MiniMed 770G users a free upgrade to the MiniMed 780G when that system becomes available (more below). Finally, the MiniMed 670G is only cleared in the US for people over the age of seven, while the MiniMed 770G is cleared for people over the age of two.

Medtronic management recently shared that algorithms will become an increasingly important part of the diabetes ecosystem, and presumably, a key differentiator for companies – lots of exciting times ahead with AID, that is for certain.

Tandem Control-IQ – already available in US

AID

Image source: diaTribe

Now available for people six years and older.

What is it? The Control-IQ system from Tandem was cleared by the FDA at the end of 2019 and launched to customers in January 2020. It’s precursor – Basal-IQ – was cleared in 2018. The Control-IQ system uses Tandem’s t:slim X2 pump, Dexcom’s G6 CGM which requires no fingerstick calibrations, and the Control-IQ insulin adjustment algorithm. In addition to automatic basal rate adjustments and predictive insulin suspension, the Control-IQ system is the only AID system with automatic correction boluses: when it predicts glucose to be above 180 mg/dL in 30 minutes, the system will deliver 60% of the correction bolus needed to reach a target of 110 mg/dL. Control-IQ targets glucose values between 112.5 and 160 mg/dL, though users can turn on or schedule “Sleep Activity” mode to achieve 112.5-120 mg/dL by the morning. This past summer, Tandem launched the t:connect smartphone app (for iOS and Android), which allows users to check their pump and CGM data on their phones.

What’s next? With the current t:connect smartphone app, users can view information but cannot control the pump (e.g., deliver a bolus, adjust basal rates). Tandem has already submitted an updated app with pump control to the FDA and expects to launch that functionality in 2021. Tandem has also mentioned enhancements to the Control-IQ algorithm that are expected in 2021. While we haven’t heard many specifics, we believe it’s likely that these enhancements will focus on improving glycemic outcomes, personalization, and usability of the system.

Insulet Omnipod 5 – expected early-to-mid-2021 

AID

Image source: diaTribe

FDA submission is likely coming soon (if it hasn’t occurred already), and Insulet aims for a “limited” launch in early-to-mid 2021. Insulet has completed the clinical trial for Omnipod 5 but has not shared the results.

What’s new? Omnipod 5 is Insulet’s AID for its popular Omnipod disposable pumps, also called patch pumps. If you’ve been following the field, you’ll know that Insulet previously called the new system Horizon – same system, new name. Omnipod 5 uses Dexcom’s G6 CGM, and Insulet expects to launch the system with smartphone control capability; users can still opt for a dedicated controller device, since smartphone control will be available for Android users first. Insulet is working on an iPhone version for Omnipod 5, though that will not be available at launch. Insulet is also working with Tidepool (more below) on an iPhone-based AID system. Omnipod 5 will have adjustable targets between 100 to 150 mg/dl. Because the Omnipod pump will store the algorithm and communicate directly with Dexcom G6, the system will work even without the smartphone or pump controller nearby.

Medtronic MiniMed 780G – expected mid-2021

AID

Image source: diaTribe

Pivotal trial completed for 780G and presented at ADA 2020. Medtronic aims to submit the system to the FDA by January 2021 with launch coming around mid-2021 for adults (either ages 14+ or 18+).

What’s new? The MiniMed 780G will be Medtronic’s second AID algorithm and a significant upgrade over the MiniMed 670G and 770G systems. In addition to automatic basal rate adjustments, the MiniMed 780G will include automatic correction boluses and an adjustable glucose target down to 100 mg/dl. The system will also have fewer alarms and simpler operation with the goal of further increasing Time in Range. The MiniMed 770G and MiniMed 780G pumps are identical, meaning MiniMed 780G users will also be able to use the MiniMed Mobile smartphone app for viewing pump data, uploading pump data wirelessly, and updating their pump wirelessly. As the pumps are identical, Medtronic has promised that those who purchase the MiniMed 770G now will be able to wirelessly upgrade to the MiniMed 780G for free when 780G does become available. Finally, the MiniMed 780G will use the same Guardian Sensor 3 CGM as the 670G and 770G, which requires two fingerstick calibrations per day and has a seven-day wear time. As a sidenote, an improved CGM sensor is in development by Medtronic, but isn’t expected to be available when MiniMed 780G launches.

The MiniMed 780G is already available in many countries in Europe, and data from a clinical trial was presented at the ADA 2020 conference. On average, the 157 participants in the study (ages 14-75) saw their Time in Range improve by 1.4 hours per day (69% to 75%) while using the system – that’s particularly notable given the low baseline of the A1C. Speaking of A1C, the A1C improved by 0.5% (7.5% to 7%) after using the system.

Beta Bionics insulin-only iLet – expected mid-to-late-2021

AID

Image source: diaTribe

Pivotal trial underway with completion expected in the first half of 2021. Launch expected mid-to-late-2021, though this is subject to change.

What’s new? Beta Bionics is a Massachusetts-based startup developing an AID pump and algorithm called iLet. iLet will work with Dexcom and Senseonics’ CGMs (and possibly others in the future) and is designed to be especially user-friendly. diaTribe founder Kelly Close participated in an early Beta Bionics trial (2013!) and raved about the system and how easy the pump seems. At set up, users only need to enter body weight (no insulin-to-carb ratio, sensitivity factor, basal rates, etc.), and the system will learn more over time. To bolus, users will use icons to describe meals as containing more, less, or the same amount of carbs as usual (no carb counting). The insulin-only clinical trial for iLet began in the summer of 2020 and is expected to wrap up in the first half of 2021. Beta Bionics aims to launch iLet mid-to-late-2021, though this could be delayed as the FDA continues to prioritize COVID-19-related devices.

What’s next? Beta Bionics’ iLet is unique from the other pumps on this list, because it is designed to work in either insulin-only or insulin-and-glucagon configurations. With glucagon, Beta Bionics believes the system can reduce hypoglycemia while maintaining stable glucose levels and potentially even better-than-average, lower glucose levels due to availability of glucagon. Currently, there are different views on using glucagon in an AID system – in addition to the potential for improved glycemic management, there are uncertainties around glucagon pricing and availability. Regardless, the insulin-and-glucagon version of iLet is still a few years away.

Tidepool Loop – launch timing unclear

AID

Image source: diaTribe

Online observational study completed, and launch timeline depends on FDA progress.

What’s new? Unlike the others in this list, Tidepool is a non-profit and is working on the AID algorithm only; Tidepool does not have its own insulin pump or its own pump and CGM combination (like Medtronic). About two years ago, Tidepool announced plans to submit the do-it-yourself (DIY) Loop app to the FDA to become an officially supported app available on the Apple App Store, compatible with in-warranty, commercially available pumps and CGMs. For now, DIY Loop is a free, publicly available, open-source, non-FDA-approved AID system that works with Dexcom and Medtronic CGMs and old Medtronic and Insulet pumps. Read about Adam Brown’s experience using DIY Loop here. For those who are very interested in the project, there is a great deal to learn from notes that Tidepool shares about its communications with FDA – the latest notes are from a mid-2020 meeting.

Initially, Tidepool plans to launch with Insulet Omnipod and Dexcom G6 compatibility. To set it apart from the DIY-version, Tidepool Loop will have different colors, guardrails around certain settings, and a built-in tutorial for new users. A 12-month, completely virtual study was performed with Loop users and will support Tidepool’s submission of Loop to the FDA. The six-month data was presented at ATTD 2020 showing a Time in Range increase of about 1.4 hours per day (67% to 73%) with Loop. Tidepool also announced in November, 2020 that its human factors study had also been completed – this is another required step of the FDA submission. Much of what Tidepool is doing is unprecedented, so the launch timing is unclear.  In an update on January 8th, Tidepool shared that it has now completed FDA submission of Loop.

Source: diabetesdaily.com

Want to Donate Your Unused Diabetes Supplies?

This content originally appeared on diaTribe. Republished with permission.

By Eliza Skoler

If you’ve got unused diabetes supplies that you no longer need, don’t throw them away! Here are several easy ways that you can donate your supplies to others.

If you’ve recently switched to a new diabetes medication or device, you may have leftover diabetes supplies that you won’t need. It might feel like such a waste to throw away things like insulin vials, needles, and test strips, especially when there are many people in the world who cannot afford the diabetes devices and medication that they need to live healthy lives. The good news is that there are several ways to donate your supplies so that people who do need these items can receive them.

It’s important to know that your supplies should be unused and unopened – most donations will not be accepted if the supplies are no longer sealed, or if they have already expired.

Option 1: Contact your healthcare office

There is a chance that your care team collects unused diabetes supplies to provide to other people with diabetes. You can call and ask them about whether they are interested in your donation

Option 2: Contact local diabetes advocacy organizations

Diabetes education centers or local branches of advocacy organizations (like ADA or JDRF) may collect diabetes supplies themselves or be able to refer you to other donation sites.

Option 3: Mail your supplies to a national organization

We know of four national organizations currently accepting diabetes supplies donations: Insulin for Life, SafeNetRx, Integrated Diabetes Services, and CR3 Diabetes. The most well-known and widest-reaching of the three is Insulin for Life. Learn more about each organization below.

Insulin for Life is a non-profit organization that collects diabetes supplies from people in the US for redistribution all over the world to people who otherwise cannot access the life-saving treatments that they need. You can read our 2015 profile on Insulin for Life here.

Insulin for Life accepts the following supplies donations (with specific details and requirements for each found on their site). The organization does not accept pump supplies.

  • Insulin Vials
  • Insulin Pens
  • Insulin Cartridges
  • A1C Test Kits
  • KetoStix
  • Glucagon
  • Glucose Meters
  • Glucose Strips
  • Lancing Devices
  • Syringes
  • Pen Needles
  • Lancets

To donate, click here. You’ll be able to download and print a shipping label to mail your supplies to Insulin for Life. You can find instructions on how to pack insulin (with refrigeration) here.

SafeNetRx collects medical supplies and redistributes them to people in need living in Iowa. To donate diabetes supplies, call 1-866-282-5817.

Integrated Diabetes Services collects many types of diabetes equipment and supplies (almost anything but lancets) to distribute by request to people with diabetes in the US and around the world. To donate or request supplies, call 1-877-735-3648.

CR3 Diabetes Association provides affordable diabetes devices and supplies (glucose meters, test strips, insulin pumps, and pump supplies) to people with diabetes across the world. CR3 Diabetes currently accepts:

  • Medtronic insulin pumps – 630G, 670G, and 530G (models 551 and 751)
  • Unexpired pump supplies
  • Guardian3 sensors
  • Glucose test strips

Read the specifics for donating and find mailing instructions here. If you or someone you know need help paying for diabetes supplies, you can apply for assistance through CR3 Diabetes.

Thank you for taking the time to donate your old diabetes supplies to those who need it. At diaTribe we are grateful each day for the strength and generosity of the diabetes community. Given the immense need, we’re hopeful that someday soon there may be easier and more effective ways to also donate unused diabetes medications.

Source: diabetesdaily.com

From Coping to Healing (and Everything in Between): An Interview With Michelle Bauer

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

By Makaila Heifner

If you ask us, Michelle Bauer is about as badass as you can get. An Iron Man competitor, a newly published author, and one of the biggest hearts in the diabetes community, she’s the definition of a game-changer. Michelle recently sat down with Beyond Type 1 to talk more about her journey through grief after losing her son, Jesse, her work thereafter to create the support hub for T1D loss, Jesse Was Here, and what’s on the horizon now that she’s published her book.

Beyond Type 1: What were you doing before you got into diabetes professionally + how did you come to get so involved in the community?

Michelle Bauer: I started my own at-home business, doing medical billing for mental health clinics. I had no interest in diabetes, even though I grew up with five aunts and uncles that grew up with type 1 diabetes. It didn’t really resonate with me until Jesse, my son, was diagnosed when he was three years old on March 3rd, 2000.

I pretty much dropped everything to volunteer for JDRF. Doing the JDRF Ride to Cure became something I was really interested in, and I became an Executive Director for them. From there, I did Ironman Wisconsin and got interested in trying to find people with type 1 diabetes who wanted to do Ironman. I filmed and produced a documentary in 2008 about 12 people with diabetes doing Ironman, called “Triabetes.” Back then, nobody was doing that.

From there, I was doing the Riding On Insulin snowboard camp for kids with type 1 diabetes. And once Jesse passed away, I dropped everything even more, and then became a director for Riding On Insulin and helped develop camps all over the world for kids to snowboard and mountain bike.

Today, I work full-time at Diabetes Daily, as their Sales Director.

BT1: What was it like when Jesse was diagnosed? Did you have any prior knowledge about type 1?

MB: I had a knowledge of it, but my knowledge was basically based in the 1970s and ’80s. I’m kind of wowed by it and I look back at my grandmother, who had multiple kids with diabetes so long ago when there wasn’t even blood glucose testing. They were peeing in vials that would change color and they had one kind of insulin.

I was very familiar with it, but they were all so independent. Everybody ran high because you didn’t know what your blood sugar was at any given point in the day, so there weren’t a lot of low blood sugars. It was a lot of high blood sugar and complications. When Jesse was diagnosed, I didn’t know as much as I should have, but it was different. The insulin pump was a new thing, and it was hard to get him on it when he was five. I had to fight to get him on a Medtronic pump. Continuous Glucose Monitors (CGM) just weren’t a thing yet; it was just a lot of finger pokes, and regular and NPH insulin back then.

Can you talk about what losing Jesse was like?

Take it back to 2010: I was very active in the diabetes community, and back then, nobody talked about people passing away from type 1 diabetes. Our diabetes educators never really talked about it being a possibility. All I ever heard was, “Oh, they’re fine. They’re going to live a healthy life. Don’t even worry about it.”

When he passed away, it was very sudden and unexpected. I was known enough in the diabetes community, from the documentary, that people knew who I was, so it put everyone in kind of a panic. That if this could happen to my family, it could happen to theirs. In the early days, the panic went the wrong way. People didn’t want me talking about it, they thought I was scaring the newly diagnosed families, and it wasn’t a very well-received conversation.

When I lost him, there was this feeling of dread – I thought I was going to lose my community. I’d spent so much time working in diabetes and all my friends either had type 1 diabetes or their kids had type 1 diabetes. I was thinking, “Well, who’s going to want to hang out with a mom who lost their kid to a disease their kids have?”

What happened was actually the exact opposite. My friends really rallied around me. They wanted me at events. They wanted me to talk about Jesse. I felt that the piece that was missing for me was wanting to know other people who were going through what I was going through. I started reaching out to other people and talked more and more about my loss, and slowly but surely, started the Jesse Was Here network. I just found it was really cathartic to talk to these other people who understood, who’d been in my shoes, and could relate to my pain.

Is it hard to be constantly reminded of Jesse through the work you do + how you cope when those feelings come up?

What I’ve learned over the ten years is that everybody grieves differently. My way of coping was to talk about him constantly. I found the more I talked about him and being involved with other people, I felt like he was living on in my life. People just want to feel like their loved one is still part of their lives and people don’t forget them.

It was very cathartic. When I look back, I went from coping to healing without even realizing it. Because I was coping every time a new mom called me that had lost their child and I would sob. I would stand in their shoes, I would feel the pain all over again. Now, it’s more of helping and healing. I don’t have to go back to that day every time I talk to somebody who’s lost, because now part of my healing is helping other people. But there are always days where I see a little boy who looks like Jesse or the smell of insulin sometimes gets me.

What are other ways you’ve commemorated Jesse’s memory?

Just weeks after he passed, I got an essay by him in the mail from a teacher. I was feeling really distraught, feeling sorry for myself, and trying to figure out what my path was going to be outside of diabetes because diabetes was no longer in my life. The essay could have been about anything he wanted, and it was just called, “My Mom is Courageous.” He had detailed everything that I had ever done for him in diabetes. He had detailed all of these things that he was proud of, like Ride to Cure Diabetes and Ironman. I knew, right then and there, I would continue on the Ironman route. I created the Riding On Insulin Endurance Team, where there were 63 of us who did Ironman Wisconsin. 36 of our teammates had type 1, which was probably one of my coolest moments.

Every year since he’s been gone, we have a rock concert called Jessepalooza, where we get local bands together and do auctions. It’s really an excuse to get together, to celebrate him. He played guitar and he played drums. We do that every summer, and we’ve had ten of those.

I was very involved in the JDRF Ride to Cure Diabetes when Jesse was alive. The year he passed away, I decided to go back to Death Valley, California and ride in his memory. The JDRF Ride Director, Allie, and the coaches at the time knew me very well, and they advised me that mile 23 was going to be a mile of silence from then on, in memory of Jesse; they came up with 23 because he died on February 3rd. And so Mile 23 has morphed into this amazing thing, where at the beginning of the weekend they talk about how there are 99 miles, to celebrate all that we’ve done towards a cure for type 1 diabetes, but there’s one mile to remember those we’ve lost. It’s meaningful to way more people than just my family; it’s in memory of everyone.

Talk to me about the book…

I have to pinch myself that it’s a real, tangible thing. About a month after Jesse passed away, I started writing. I felt like, “Well, maybe I’ll write down how I feel, for the first six months and maybe my writing will help somebody else not feel alone.” The book was supposed to just chronicle the first six months, but I kept writing. At the five year mark, it was ironic, because I was looking back, saying, “Wow. How I feel changed. I need to write about that.” At the ten-year mark, I thought, “Even more so.” I started to find joy in my life.

There’s a lot of satisfaction knowing that people have gotten their hands on my book and it’s helped them. There was a point where I was wondering if it would ever get published. But I was giving this draft copy to people as they were losing children and I knew it was helping them.

Then, a friend of mine who I kind of lost contact with saw me post on Facebook, and, when he realized who I was, told me he’d started a publishing company and that we should talk. That was in February, and by April 23rd, he had launched it. Since then, it’s been number one on Amazon in a couple of categories. We’ve sold a lot of copies, and what I love most about it is not only are people who have type 1 reading it, but a lot of first responders in the country are reading it. In Wisconsin, it kind of went out to all of the Wisconsin police as a resource for them. That’s one of the most rewarding parts, that it’s helping those beyond the diabetes community.

What are you hoping that people get out of your book + what have you learned about yourself through the grieving process?

I hope that it helps people who are grieving a recent loss to have hope that they can find joy again; that they’ll be allowed to push a little bit of the guilt aside, and that they feel their loss, but allow themselves to find happiness again, because that is what the people who are gone would want.

I’ve learned you’re not the only person going through something. You can’t just walk through Target and think that the grandma ahead of you is just living life with a grandchild on her hip. A lot of people have lost something big in their life. I’ve become a little bit more compassionate with other people, their losses, and their grief.

What’s next for you + Jesse was here?

We’re really hoping, through the Jesse Was Here program, to reach more siblings, and get them talking to one another. We do a really good job with parents, but we haven’t really done a great job with siblings. I’m also hopeful to re-engage public speaking in the T1D community and beyond.  I’ve been a keynote speaker on many occasions and hope to inspire others with a “Don’t Waste Your Pain” message of why it’s important to get involved.

Source: diabetesdaily.com

Injection Device Helping a Family Manage New Diabetes Diagnosis During COVID

Injection Port Device Help Family Whose Son Lives with Diabetes

Jennifer, like many others, has worried about her family’s health during the coronavirus pandemic.

In June, she was diagnosed with COVID-19. Shortly after, her 13-year old son Mason started feeling ill. Unsure if he too had contracted the virus, they visited their local emergency room. Soon after, the family was informed that Mason was living with type 1 diabetes. In this post, Jennifer discusses her family’s experience and the ways they are managing Mason’s diabetes during the global pandemic.

Mason came to me and said he didn’t feel right. Upset tummy, sinus issues, and a small headache. We took him to a local emergency room, and sure enough his rapid test was positive for COVID-19. The doctors also said that his sugar was pretty high. They asked if I could watch his levels at home over the next couple of days and if his sugars remained high, then I should call our family doctor. We left the ER on Tuesday evening. By Thursday, I called our doctor because his sugars never went below 200 mg/dL. We were put in touch with an endocrinologist, who advised us to take him to the hospital where he was diagnosed with diabetes. 

As a parent, all fears set in. I was worried that I didn’t know enough about diet and medication. I worried about if my son would ever feel normal again.

I was surprised that Mason was able to start giving his own insulin almost immediately, and he preferred it that way. In the three months since he was diagnosed, I have probably only given 10 shots! 

I was introduced to the i-Port Advance™ injection port through a Facebook page. I posted that we were having issues with him taking too much insulin before meals, and then he was too full to finish what he had dosed for. Several parents came back and suggested we try an injection port! I called my doctor’s office the next day and they were super excited to let him try it.

Almost immediately, Medtronic sent us a box of the i-Port Advance™ injection port to try at no-cost. I could not express my happiness! I was thankful the company was willing to let us try the port before we purchased. As a parent, this was such an amazing feeling and it was one of the first easy experiences we had since Mason was diagnosed! 

Mason fell in love with the injection port, and so did I! When he used the port, it was the first time since he was diagnosed that he didn’t feel like an outcast. Although he is incredibly diligent with what he eats and doesn’t take advantage of his insulin, he is a kid! He wants little treats, he wants to hang out with friends his age, and eat cupcake or have snow cones from time to time. All of which he had stopped because he hated sticking himself all the time and taking shots in front of people. Now, he can take a little extra insulin if he needs to. He can hang out with friends and not feel like an outsider because he can’t eat what they do! I’m also happy because he is building up less scar tissue with 1 stick every 3 days compared to 12-15 injections.

As a parent, I’ve been so happy to watch his outlook change. He knows that he can manage this disease and he isn’t constantly worried with taking another shot! 

Mason’s family enrolled in the 12-day evaluation program offered by Medtronic. To learn more, click below.

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The testimonial above relates an account of an individual’s experience using a Medtronic device. The account is genuine, typical and documented. However, this individual’s experience does not provide any indication, guide, warranty or guarantee as to the response or experience other people may have using the device. The experience other individuals have with the device could be different. Experiences can and do vary. Please talk to your doctor about your condition and the risks and benefits of Medtronic devices.

Safety Information: i-Port Advance injection port

i-Port Advance injection port is indicated for patients who administer or receive multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple injections without the discomfort of additional needle sticks. i-Port Advance injection port may be used on a wide range of patients, including adults and children. For more, please see http://www.medtronicdiabetes.com/important-safety-information.

Source: diabetesdaily.com

Tackling Carbs with Tech

Many people who live with diabetes avidly avoid eating carbohydrates, as historically speaking, it has been notoriously difficult to cover carbohydrates appropriately with exogenous insulins. But with access to better, faster insulins and the uptick in the use of patient-friendly technology, things are changing, and people’s diets (and their feelings of freedom) have expanded more than ever. Here are the best tech-friendly hacks to tackle the carbohydrate conundrum.

MyNetDiary

This popular app has a searchable database with nearly a million food entries for people to access and look up carbohydrate counts on the go. The company also has a separate Diabetes app that allows users to track blood glucose levels, HbA1c results, and insulin doses, to track their progress over time. If you’re looking to lose weight, MyNetDiary can create a diet plan to meet your needs. You never have to feel restricted when eating meals with family or friends, having all your carbohydrate counting needs right at your fingertips.

Photo credit: GreaterGoods

GreaterGoods Nourish Digital Scale

This food scale is a game changer for those who cook with lots of fresh produce, where carbohydrate counts can vary quite a bit. This scale lets the user view nutrition facts for over 2,000 foods in the scale’s built-in database, and create up to 99 more custom entries. Measure individual ingredients, track full meals, and calculate daily carbohydrate intake much easier with this digital scale.

InPen

This revolutionary device is the only FDA-approved smart pen insulin system that helps prevent users from “stacking” their insulin doses and take the right amount of insulin at the right time. This device works in tandem with a phone app, where users can track insulin on board/active insulin, personalize your doses, sync with continuous glucose monitor (CGM) or glucometer data, and share reports with others. The pen itself is compatible with Humalog, Novolog, and Fiasp, and will even dose in half units. Eating carbohydrates has traditionally been much harder on multiple daily injections, but advancements such as the InPen are making strides to make life much easier for people with diabetes.

Use Alternative Pump Boluses

If you are an insulin pump user, dosing for a high carbohydrate meal can also be difficult, especially if the meal also has a moderate amount of protein and fat (which can delay the absorption of the glucose in the meal). To handle that, try opting for a combination bolus (a.k.a. Combo Bolus or Dual Wave Bolus,  for Animas or Medtronic users, respectively; Omnipod, Tandem t:slim users will use “Extended Bolus”). This is a hybrid delivery mode: a specified portion of the total insulin bolus is delivered upfront, as a normal bolus, while the rest is delivered over a specified period of time as an extended/square wave bolus.

For example, given a 12U dose delivered as a 60/40 combination/square wave bolus over 3 hours: 60% of the total dose (7.2U) will be delivered within seconds of pressing the “deliver” button; the remaining 40% (4.8U) will be delivered equally every few minutes over the next three hours. The result is an initial dose to cover faster-digesting foods, plus an extended amount of insulin action to deal with the slower-digesting foods (which tend to be fattier or have more protein), and to prevent postprandial spikes in blood glucose. Utilizing these settings can be extremely helpful when you’re eating foods like pizza, pasta, Chinese food, Mexican food, or ice cream. Always consult with your diabetes healthcare provider before making any changes to your dosing routine.

Dexcom CLARITY Diabetes Management Software

Photo credit: Dexcom

Dexcom Clarity App

This software can be helpful for patients already using the Dexcom continuous glucose monitoring system, but are wanting to track and change problematic patterns in their blood glucose. This app lets you set target goals for your blood sugars, will track time-in-range, detects patterns of highs and lows and will alert you to them, and will even give the user a predicted HbA1c result. You can also choose to share your data with your health clinic to make changes to your insulin routine or insulin to carbohydrate ratio in real time, and to really find what will work best for you for optimal management.

Living with diabetes is never easy, but thankfully technology has made counting carbohydrates and eating easier than ever before. What apps or tech has helped you to navigate food, eating, and counting carbohydrates? What’s worked best and what hasn’t? Share this post and comment below; we love hearing from our readers!

Source: diabetesdaily.com

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