FDA Approves New Glucagon Option From Zealand Pharma

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

By Lala Jackson

On March 22, 2021, Zealand Pharma announced the FDA approval of Zegalogue in an autoinjector and prefilled syringe. The approval will add two more easy-to-use glucagon options, joining Eli Lilly’s nasal glucagon Baqsimi and Xeris Pharmaceuticals’ GVOKE HypoPen and prefilled syringe.

Slated to be commercially available in the US in June 2021 for ages six and older, Zegalogue’s approval follows three clinical trials in adults and children with insulin-dependent diabetes. Following use of Zegalogue in response to severe hypoglycemia, patients showed recovery (an increase in blood glucose of ≥ 20 mg/dL) within 10-15 minutes.

Dasiglucagon is a peptide analog (i.e. a human-created drug designed to mimic the actual hormone) version of glucagon, a naturally occurring hormone that triggers the body to release glucose reserves from the liver to raise blood sugar. In the body of a person with diabetes, this process has to be manually managed. However, partly because easy-to-use glucagon options are fairly new to the market, many people with insulin-dependent diabetes don’t typically carry or know when to use glucagon.

FDA guidance for Zegalogue and other forms of glucagon indicate usage in response to any severe hypoglycemic event, defined as a severe low blood sugar during which the person experiencing the low becomes unable to easily help themselves. A person with diabetes does not need to be experiencing seizures or unconsciousness before dosing glucagon, and it is safer to dose glucagon before either occurs.

For all forms of glucagon, possible side effects after dosing are nausea, vomiting, and headache, with a small number of people also experiencing diarrhea or injection site pain.

Source: diabetesdaily.com

What if a Pump Could Deliver Both Insulin and Glucagon?

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

By Lala Jackson

Diabetes technology like insulin pumps and continuous glucose monitors (CGMs) have created less burdensome care routines for people living with diabetes who are able to get them. For some, this tech has also led to lower A1c, more time in range, and fewer hypoglycemic events. As we work to get better access to diabetes technology and medications for all who need them, we’re also looking forward to what’s next in diabetes tech – dual hormone artificial pancreas systems that keep blood sugar levels in a healthy range using both insulin and glucagon delivery.

Existing artificial pancreas (AP) systems, also known as hybrid closed loop systems, integrate insulin-only pumps and CGMs using a programmed algorithm that allows the insulin pump to “make decisions” in insulin dosing based on the blood sugar number provided by the CGM. In the current systems, the insulin pump can dose insulin in response to high blood sugars, but has no way to directly address a predicted low blood sugar other than lowering or stopping insulin delivery, or suggesting external actions (such as eating carbs) be taken. Even with this limitation, current AP systems are shown to significantly improve daily time in range, a key measure for safety and quality of life in those living with diabetes. But what if we could more closely mimic a fully functioning pancreas?

Enter, the Dual Hormone Artificial Pancreas

Also known as the bihormonal artificial pancreas (BHAP), several companies have been working on these systems over the last decade, but the last few years show promise toward a streamlined, effective, easy-to-use BHAP.

In late 2019, the FDA granted breakthrough device designation to the iLet™ pump system, made by Beta Bionics. Breakthrough device designations create an accelerated regulatory review process for a product or therapy that “has potential to address unmet medical needs.” Essentially, it shows priority for a solution that is believed able to create a large impact on people’s lives, beyond anything currently available.

Beta Bionics’ intentions for their iLet systems are ambitious – they aim to provide their system in insulin-only, glucagon-only, or bihormonal with both insulin and glucagon. Additionally, their algorithm is unique, in that the wearer must only enter their body weight, “with no need to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.

The iLet system was granted breakthrough designation with the use of insulin analogs that are currently approved for usage in an insulin pump, alongside Zealand Pharma’s dasiglucagon, recently approved by the FDA for use in an autoinjector and prefilled syringe. Dasiglucagon, a glucagon analog (i.e. a synthetic lab made version of the naturally occurring hormone), is stable as a liquid, versus old formats of glucagon in which a powder and liquid had to be mixed immediately before use.

Beta Bionics’ insulin-only AP system is currently in Phase 3 clinical trials, with its BHAP system slated to be one to two years behind, having completed a Phase 2 at-home use trial in 2019. Phase 3 trials of the BHAP system are expected in 2021.

Other insulin and glucagon BHAP systems are also in development, with additional companies looking into a dual-hormone format pump using insulin and pramlintide (commercial brand name Symlin), aimed at better mimicking natural absorption rates of food, leading to better time in range.

The Bottom Line

As we get closer to diabetes technology that more closely mimics a fully functioning pancreas, affordable access to both life-improving diabetes technologies and life-sustaining insulin remains key. Robust diabetes technology has the power to greatly improve quality of life, particularly when coupled with affordable, equitable healthcare.

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

Debate: Should the Artificial Pancreas Include Glucagon? (ADA 2020)

For the millions of people living with type 1 diabetes worldwide, the development of an effective system to automatically regulate blood sugar levels is of paramount significance. Artificial pancreas systems (APS) are being developed with the goals of automatically adjusting the delivery of insulin (and potentially, glucagon) based on glucose readings from a continuous glucose monitor (CGM), taking a lot of burden off patients, improving glycemic management, and enhancing safety.

What is the best way to approach the design of an artificial pancreas system? What are the pros and cons of including glucagon in the system alongside insulin?

Two experts debated this important issue at the American Diabetes Association (ADA) 80th Scientific Sessions last month.

Dr. Roman Hovorka, PhD, FMedSci from the University of Cambridge, argued against the inclusion of glucagon in the system, while Dr. Steven J. Russell, MD, PhD from the Massachusetts General Hospital, presented his case to support the use of a dual-hormone system. Both speakers disclosed several relationships with diabetes technology companies (including those working to develop APS).

Here is the summary of this interesting debate.

The Case for Single Hormone

Dr. Roman Hovorka highlighted some research outcomes of artificial pancreas systems that utilize insulin alone.  He presented data from several studies showing that these devices “improve time in target and time below target” as well as reduce A1c. However, the time in target range was only increased by ~11%, and the A1c improvements were modest, with the average A1c still above the ADA recommendations.

Dr. Hovorka explained that the vast majority of companies are currently moving forward with single-hormone systems. He also focused on a system developed by Cambridge that he’s very familiar with, showing data where ~95% time-in-range (TIR) was achieved. Notably, he remarked that a low-carb diet was also an important factor in this success case. Overall, however, only 7% of users were shown to achieve a time-in-range metric of >90%, although 28% achieved a TIR of >80%, 69% achieved a TRI >70%, and 86% achieved a TIR of >60%.

The presenter noted that one of the main issues currently hindering the efficacy of the APS is the delayed insulin absorption and action after subcutaneous insulin delivery. Adding glucagon into the system will not fix the issue, he noted, as “dual hormone delivery DOES NOT accelerate insulin absorption.”

While he acknowledged that glucagon could be useful in reducing low blood sugar risk in such systems, he also highlighted the complexity and high cost of such a system as barriers. In addition, he noted that the use of two separate cannulas could be burdensome, and for children, in particular. He also noted that the chronic delivery of glucagon subcutaneously requires more research to identify any risks.

In comparing the outcomes between single-hormone vs. dual-hormone systems, Dr. Hovorka noted that there was a slight increase in the TIR for the dual system (~78% vs. 71% in the longest studies), and the mean glucose (156 mg/dL vs. 140 mg/dL) was lower for those using the dual system. He also presented data to indicate that daytime hypoglycemia (in particular during exercise) could be reduced using a glucagon-insulin system, while a single insulin system was enough to eliminate hypoglycemia overnight. Furthermore, “comparative benefits of the single- and dual-hormone systems for improving HbA1c and preventing severe hypoglycemia remain unknown,” he underscored.

The Case for Dual Hormone

Dr. Steven Russell noted first that he believes “insulin-only hybrid artificial pancreas systems are the state-of-the-art in diabetes care” and that he is involved with projects that utilize both single- and dual-hormone approaches. Next, he went on to explain why he thinks a dual-hormone system would be more appropriate.

After pointing out that there are actually two hormones that are missing in type 1 diabetes – insulin AND glucagon, he suggested that in addition to further preventing hypoglycemia, a dual-hormone system can also help achieve lower average glucose and higher TIR than an insulin-only system. He presented several studies to support this point, including recent data from his project.

Importantly, Dr. Russell pointed out that by using micro-doses of glucagon to prevent or treat hypoglycemia could “oppose weight gain or encourage loss”. This is because using glucagon instead of carbohydrates to prevent or treat low blood glucose “promotes satiety and increases energy expenditure”.

While the speaker acknowledged the challenges associated with developing a dual-hormone system, he also noted that recent work has been bringing us closer to achieving this feat effectively. For instance, a number of stable glucagon formulations are now available (although not yet FDA approved for use in such a system). The safety studies that have been conducted have been reassuring.

Moreover, Dr. Russell addressed a common concern of glycogen store depletion, citing a 2015 study that indicated “no significant decrement in liver glycogen after repeated glucagon doses”. Importantly, he also presented some research showing that “users prefer the bi-hormonal system”, especially among those who aim for lower targets.

When addressing the potential increase in cost for a dual-hormone system, Dr. Russell had this to say:

“[The] significant increase in beneficial outcomes will justify the increase in cost… The difference in having no automation to single-hormone artificial pancreas is the same increment as you get going from a single-hormone artificial pancreas to dual-hormone… If one can justify adding automation, one could justify some additional expense to add the cost of the glucagon…”

Conclusions

Numerous artificial pancreas systems are currently being developed, with the vast majority opting for the insulin-only version. No doubt, the specific algorithms and insulin types used also play a paramount role in their efficacy and patient satisfaction. The use of glucagon remains a point of contention.

What are your thoughts on the subject?

Source: diabetesdaily.com

Why Glucagon Is a Must for Sick Days

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

By Jordan Dakin

Common Knowledge

Becoming sick when you have type 1 diabetes can easily complicate things. When you have the flu or a serious bacterial infection, your blood sugar levels can quickly become harder to manage, as they typically trend higher because of your body’s automatic, hormonal response to being sick. Because of this, you might find yourself needing more insulin than usual and needing to check for ketones more often to prevent diabetic ketoacidosis (DKA). Having a plan for sick day management when you have type 1 diabetes is crucial.

It’s important to be mindful of the possibility of high blood sugar when you’re sick. But it is also important to realize that sick day lows are a definite possibility as well! Especially if you’re taking more insulin than normal to combat highs when sick, you have to be mindful of resulting lows. You also run the risk of encountering a severe low if you are either unable to keep food down or lack an appetite when you’re sick, which are common realities when you have a cold or flu.

Enter Glucagon

Whatever the reason for a low, keeping glucagon handy to combat severe bouts of hypoglycemia on a sick day is definitely a must. Severe hypoglycemia is a dangerous complication of type 1 that can result in seizure, loss of consciousness, or death, and there is peace of mind in having a safety net to prevent any one of those outcomes. Glucagon is the first line treatment for severe hypoglycemia because it is the main counter-regulatory hormone to insulin. Parents and caretakers of those with type 1 can especially benefit by having an immediate safeguard against the dangers realities of a severe low.

The standard of care has been to keep a glucagon emergency kit handy. Historically, these emergency kits came equipped with an injectable form of glucagon, that requires mixing powder and liquid with a syringe by whoever is administering the shot. While this can definitely be an effective form of glucagon, having to mix the shot prior has made the procedure complicated and intimidating for some.

Next Level Options

Luckily for those of us affected by type 1 diabetes (T1D), glucagon has been approved in two new forms over the last year: nasal glucagon and pre-mixed steady state.

Baqsimi is the first and only nasal, non-injectable form of glucagon, offering a slight variation on what most people with diabetes are used to. It is administered like a nasal spray, but does not require inhalation, so even if a patient is unconscious (a frequent cause of severe hypoglycemia), anyone can administer Baqsimi and it will work.

Gvoke is the first liquid stable form of glucagon, meaning though it is an injection, it comes ready to use and requires no mixing on the part of whoever is administering the shot. Gvoke also comes in two forms: a pre-filled syringe (called Gvoke PFS) that is available to patients now and an auto-injector pen (the Gvoke HypoPen) that has yet to become officially available.

Neither Gvoke nor Baqsimi require refrigeration, and both have an impressive shelf life of up to two years if kept at room temperature. Another added benefit of these next generation iterations of glucagon is that these tools can likely prevent an ambulance trip to the hospital, saving time and resources. (Editor’s Note: This is especially important during the current COVID-19 pandemic, as it is not advised to visit hospitals unless absolutely necessary.)

How to Get Glucagon

Lilly currently offers a Baqsimi coupon patients can use to get up to two devices for as little as $25.

Through the end of April 2020, Xeris is offering a Gvoke co-pay card with which some patients can pay as little as $0 with eligible insurance to get their Gvoke PFS. Patients can also opt to request their prescription through the website and have Gvoke PFS delivered by PillPack at no additional cost.

Keeping glucagon handy is the best defense against unexpected lows when you’re not feeling well. Being sick might come with some uncertainties and cause some worry, but you can rest easier knowing you’re prepared and equipped with the necessary tools to take on whatever comes your way.

For step by step instructions on how to use each type of emergency glucagon, click here.

Source: diabetesdaily.com

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