Hypoglycemia is a daily concern for people with type 1 diabetes (T1D) and is one of the most feared complications of diabetes treatment. This condition happens when the body has too much insulin. Typically, one would take a simple carbohydrate—be it juice, candy, or a glucose tablet—to bring the blood sugar back to normal range. Severe hypoglycemia means that another person has to help administer treatment. One of the treatments for severe hypoglycemia is glucagon administration, which raises blood sugar.
The FDA approved Zegalogue® (dasiglucagon) injection, for the treatment of severe hypoglycemia in children and adults with diabetes aged 6 and above. Its approval was based on results from three clinical trials, showing an average time to blood sugar recovery of 10 minutes following injection. It will be available in June, in both an auto injector and a pre-filled syringe.
“The more options for emergency glucagon use is important as every person living with type 1 diabetes needs to have glucagon on hand and teach their family/friends how to use it,” says Jeremy Pettus, M.D., a Breakthrough T1D grantee and Assistant Professor of Medicine, University of California, San Diego.
Download our Hypoglycemia one-pager.
“There was a real clinical need for easier to use rescue glucagon,” says Jonathan Rosen, Ph.D., Associate Director, Research, at Breakthrough T1D. “The newest generation of glucagon rescue therapies are much easier to use than the older kits, which required numerous steps to administer the drug. Since disorientation is a feature of severe hypoglycemia, it’s so important to have rescue glucagon administration be simple. This is exciting news for the T1D community.”
This is the fourth FDA approval of a glucagon treatment for severe hypoglycemia, providing people with choice that Breakthrough T1D strongly advocates for. The first was GlucaGen® (glucagon injection), and, in recent years, the T1D community got more options: The approval of Baqsimi®, a nasal spray, was the first non-injectable treatment, and the GVOKE® line of products featured the first pre-mixed, pre-filled liquid glucagon formulation on the market.
Breakthrough T1D will continue to fight for better management tools and technologies, across the world, until cures are found. To find out more about how we’re turning type 1 into type none here.
This educational content is made possible with support from Abbott, the makers of the FreeStyle Libre 2. Editorial control rests solely with Breakthrough T1D.
Hannah M. was diagnosed with type 1 diabetes (T1D) at 3 years old in 2000 and remembers how afraid she was of having to prick her finger. She had the tale-tell signs, including extreme thirst and fatigue, and ending up going to the hospital where she was eventually diagnosed.
“My life changed within a day,” says Hannah, who remembers being so young at the time that the support of her parents was critical in helping her maintain control over her blood sugar levels. When she tried her first continuous glucose monitor (CGM) in elementary school, Hannah went along with her classmates’ observations that her new tech made her appear like a robot!
“I thought I was so cool that I got to be like a robot, and the new technology wasn’t scary at all. I was excited because it made taking care of myself a lot easier.”
The device that made Hannah’s classmates think she turned into a robot was a CGM, but for many CGMs are still a foreign term. So, what exactly are CGMs?
CGMs are FDA-approved devices that provide insight into glucose levels 24 hours a day. They display information about glucose direction and speed while providing additional information to help with a user’s diabetes management. One of the most crucial benefits of using a CGM is having the device actively monitor your blood-glucose levels at night and alerting you of an approaching high or low.
Fast forward to now, where Hannah is currently a graduate school student with an extremely busy schedule. Hannah wears the FreeStyle Libre 2, a CGM device manufactured by Abbott, and feels that 20 years later, although she still has T1D, she is thriving.
“These devices are life-changing because they affect the whole way you take care of yourself.”
Where Hannah may have skipped eating particular foods, wearing a CGM has given her more control to make the choices she wants without feeling restricted. She can also give her full attention to her studies without having to take breaks for manual finger pricks.
“As a doctoral student, my days are packed with clinical hours, research, classes, and studying, so being able to quickly scan my sensor with my phone and know immediately my glucose level is an amazing time-saver,” Hannah said. “It has also significantly improved my ability to keep my glucose in range. The ease of use with the FreeStyle Libre 2 app means I can instantly see what my glucose is and say ‘yes’ to snacks that are offered, a more strenuous workout, and/or a good night’s sleep based on the glucose level on my phone.”
“I love not having to constantly think about if my glucose is okay, because I’ll know automatically. I can just be a student, and not have to think about anything else,” she added.
As technology progresses so do the features of CGMs, making glucose monitoring even more seamless. One of Hannah’s favorite new features is the ability to control the alarms on her device where she can set her own range for high and low glucose levels.
“One of my favorite parts about the FreeStyle Libre 2 app is that I can set my own range for my high and low alarms,” Hannah said. “Since I always have my phone with me, it is so much easier to make sure I am in range because I can scan any time and respond quickly if I get an alarm that I am going out of range. I can catch my highs and give some insulin before I am too far out of range and eat a quick snack or put a temporary basal on my insulin pump to prevent a serious low.”
“I can also temporarily turn off the alarm function during class so that my CGM doesn’t go off while I’m giving a presentation,” she added.
One tip that Hannah has for other CGM users or those who are thinking about using a CGM: “I’ve learned how helpful it is to have a routine. It’s good for maintaining my glucose levels and I’m able to make better decisions.”
If you want to learn more about the variety of CGMs available and their features, visit our CGM fact-sheet. CGMs also require a prescription through your health care provider, so if you have any questions about coverage of your T1D supplies or devices like a CGM, visit our Health Insurance Guide.
Being diagnosed at the young age of 3, Hannah tells us that she doesn’t remember a life without T1D, but she’s grateful that technology is allowing her to live a life less burdened by the disease.
“It doesn’t define me, but just something I happen to live with. I can still do everything I want to do to the fullest.”
Insulin is the reason that Jeremy Pettus, M.D., an endocrinologist at the University of California San Diego, is alive. He’s had type 1 diabetes (T1D) since he was 15. But “we’ve been too focused on it,” he says. “There’s a need to develop other therapies to help people get their glucose under control.”
Insulin, for people without T1D, is secreted by beta cells in the pancreas. But there’s also glucagon, which is secreted by alpha cells. In people with T1D, the pancreas stops producing insulin, but glucagon dysregulation is a core defect, too. The glucagon hormone is not released when it is needed, and is released when it is not.
Dr. Pettus finds it fascinating, and conducts clinical trials of therapies that can restore the glucagon axis, in the hope of people using less insulin, improving their time-in-range (the amount of time that a person with diabetes spends with their blood-sugar levels in a target range—typically between 70-180 mg/dL), lowering their A1c, and avoiding complications.
Hear Dr. Pettus talk about his research—and get introduced to many more Breakthrough T1D-supported investigators—by watching the video below:
Breakthrough T1D’s funding enables promising scientists, like Jeremy, to focus their talent, ambition, and passion on improving life for those with T1D. Learn more about the researchers we fund, and learn how you can support their work to prevent, treat, and—one day—find cures for T1D.
Last month, SFC Fluidics received a breakthrough device designation for the company’s interoperable insulin delivery pod from the Food and Drug Administration (FDA). The product is in late-stage development and submission for clearance is expected in 2021. The development of SFC’s interoperable pump was partly funded by Breakthrough T1D.
How is the SFC interoperable pump different than other insulin pumps?
SFC Fluidics’ Chief Executive Officer, Anthony Cruz, tells us that the primary goal for SFC’s product development is to empower people with diabetes; to use their cutting-edge microfluidics technology to make things easier and better for the individual.
Two Simple Questions
The Company’s engineers and scientists were challenged with two simple questions, “How do we make the person forget about his/her diabetes?” and “How do we ease the burden of diabetes?”
Insulin pumps currently in use can fall short in dosing accuracy. SFC believes that insulin dose inaccuracy leads to inconsistent diabetes management. Furthermore, current pumps can also fall short in alerting the person of no or low insulin-flow errors—unnecessarily putting millions of people with insulin-dependent diabetes at risk.
SFC’s pump is designed to be safe and deliver highly precise insulin doses. Its pod technology can detect flow or no flow conditions of insulin in real-time, even in extremely small doses.
SFC believes its technology will effectively eliminate 95 percent of over and under dispenses of insulin. The end result promises to be a significant “step up” in peace of mind that the person is safe and can focus on living their lives.
The Breakthrough Device Program is an FDA platform for more effective treatments of serious diseases, like T1D, and enables timely access to these devices by speeding their development, assessment, and review. Other companies that have received the FDA Breakthrough Device designation for T1D technologies include Breakthrough T1D partners EOFlow, Medtronic, and Bigfoot.
Its safety and exceptional dose accuracy are promising features of SFC’s interoperable insulin delivery pod, and Breakthrough T1D applauds SFC on this special honor.
Learn more about how you can support Breakthrough T1D and our work to prevent, treat, and—one day—find cures for T1D.
Accurate control of blood sugar for people with type 1 diabetes (T1D) was not easy in the 1970s. At the time, the degree of diabetes control relied on patient history, urinary sugar and blood-sugar measurement at the time of the doctor’s visit. There was nothing that could tell you what your blood-sugar levels were for the past 2 to 3 months.
Enter Anthony Cerami, Ph.D. In 1976, he and his colleagues, knowing that sugar attaches to red blood cells (hemoglobin) in the body, demonstrated that it could be used to determine how well blood sugar had been controlled in the previous 2 or 3 months (because red blood cells have a life span of about 120 days). This discovery led to the creation of the hemoglobin A1c (HbA1c) test. (Although other researchers had already observed elevated HbA1c levels in people with diabetes, Cerami was the first to propose its use for monitoring blood-sugar control.)
Breakthrough T1D funded Dr. Cerami in 1976-1978, to study the role of HbA1c as a monitor of diabetes control. This led to it being used for the Diabetes Control and Complications Trial (DCCT), a comprehensive clinical study from 1983-1993, to find out if intensive insulin control warded off complications from the disease. The conclusion of the trial: people who were able to keep their blood-sugar levels as close to normal as possible, as assessed using HbA1c, had less chance of developing complications, such as eye, kidney, heart and nerve disease.
At the time, many doctors had not put much emphasis on tight control of blood-sugar levels. The common belief for decades was that diligent monitoring of blood sugars and intensive insulin therapy had little consequence for people with diabetes. Since the DCCT’s findings, statistics have proven that tight blood-sugar control can be extremely beneficial for people with diabetes.
Without HbA1c, this would have been nearly impossible to demonstrate.
During a recent Breakthrough T1D Facebook Live event, Tandem Diabetes Care Senior Director of Behavioral Sciences Stephanie Habif and Tandem Product Manager of Clinical Solutions Christina Pamelar discussed outcomes from real-world Tandem insulin pump users, the t:connect® Mobile App (launched July 7), the remote insulin pump training process and other practical insights about Tandem Diabetes Care product use.
Breakthrough T1D Vice President of Corporate Development Joe Watterson delivered introductory remarks.
Habif holds Doctor of Education (EdD) and Master of Science (MS) degrees; Pamelar holds a Master of Science degree in Nursing (MSN) and is a Registered Nurse (RN), Certified Pediatric Nurse Practitioner (CPNP) and Certified Diabetes Care and Education Specialist (CDCES).
During the event, Habif and Pamelar covered numerous topics, including:
- Features of the t:slim X2.
- The differences between the two predictive insulin delivery technologies that are available when the t:slim X2 is used with the Dexcom G6 continuous glucose monitor (CGM): Control-IQ Technology and Basal-IQ Technology.
- Real world examples of use of the t:slim X2 with each of the predictive technologies.
- The advantages of the recently-launched t:connect® Mobile App.
The event wrapped up with a Q&A session during which Habif and Pamelar answered questions submitted in the comments.
Watch the full, recorded livestream:
A New Breakthrough T1D-Tandem Partnership
Find out about how Breakthrough T1D and Tandem Diabetes Care are teaming up to help drive awareness and education on topics related to technology innovation, diabetes management and healthcare for people with diabetes.
Smart insulin; what is that? It’s the type of insulin that Chandra Bhattacharya, Ph.D., has spent her Breakthrough T1D-funded postdoctoral fellowship—the time right after you receive your doctoral degree, but are not ready for primetime as an assistant professor, yet—to pursue. And she has a lot of shoes to fill. At the Massachusetts Institute of Technology (MIT), she’s a postdoc in the laboratory of Bob Langer, Sc.D.—a scientist known for educating a generation of researchers and a prolific inventor and patent holder—and Dan Anderson, Ph.D.—himself once a postdoc of Dr. Langer and, today, a professor.
So, let’s get back to the topic. Smart insulin is a form of insulin that turns on when it’s needed to lower blood sugars, and turns off when blood sugars are at safe levels. It’s like a pancreas (well, a healthy one), but in drug-form. Some with type 1 diabetes (T1D) think that this will be a functional cure. Take it once a day, and you’re all set.
But making smart insulin is really hard. There are two proteins (for the most part) that regulate blood sugar: insulin, which makes blood sugar go down, and glucose, which makes blood sugar go up. A very small change in glucose levels, however, is very difficult to measure, so we need a very sensitive and very selective sensor to gauge it. And that’s where Chandra fits in. Find out from her video why making a good smart insulin is both difficult and, possibly in the end, rewarding.
Breakthrough T1D’s early-career funding enables promising scientists, like Chandra, to focus their talent, ambition and passion on improving life with T1D. Learn more about the researchers we fund, and learn how you can support their work to prevent, treat and—one day—find cures for T1D.
Thanks to a new, national partnership, Breakthrough T1D and Tandem Diabetes Care are teaming up to help drive awareness and education on topics related to technology innovation, diabetes management and healthcare for people with diabetes.
“Together, we will show how innovations in type 1 diabetes (T1D) management and care will continue to minimize the intrusions of T1D on day-to-day life and provide better health outcomes for people living with the disease,” said Joe Watterson, Breakthrough T1D Vice President of Corporate Development.
The partnership will utilize Breakthrough T1D’s community facing platforms—including local chapter events, digital channels and education programs—to highlight the benefits of devices such as insulin pumps, continuous glucose monitors, and novel treatment approaches like hybrid closed loop therapy.
People living with T1D have a variety of needs that span from reducing the daily burden of disease management to finding a trusted technology partner who can deliver solutions that work reliably, provide clinical benefits and improve their overall quality of life.
The Breakthrough T1D and Tandem partnership aims to actively support the growing needs of the T1D community and help address the gap in diabetes education on these topics through regional and local activities, including select Community Summits and Breakthrough T1D Walk events.
“Education is the foundation for improved quality of life and clinical outcomes for people with type 1 diabetes, and we are proud to partner with Breakthrough T1D in furthering our shared mission to support the diabetes community,” said Brian Hansen, Executive Vice President and Chief Commercial Officer at Tandem Diabetes Care.
Recently Expand Choice for Prospective Tandem Users
Thanks to a concerted effort that included mobilizing Breakthrough T1D’s grassroots network of T1D champions across the nation, UnitedHealthcare (UHC) recently announced it would cover the t:slim X2 insulin pump from Tandem Diabetes in network, starting July 1, 2020.
This came on the heels of FDA clearance of an expanded pediatric indication for the Tandem t:slim X2™ insulin pump with Control-IQ™ technology in children ages six and older. Initially, the device was only authorized for use in people 14 and older.
Thanks to a concerted effort that included mobilizing Breakthrough T1D’s grassroots network of T1D champions across the nation, UnitedHealthcare (UHC), the nation’s largest insurer, has increased choice and will begin to cover the t:slim X2 insulin pump from Tandem Diabetes in network on July 1st.
This gives people living with type 1 diabetes (T1D) more choice in deciding which technology they use to manage their T1D.
“UHC’s decision to cover Tandem Diabetes’ insulin pumps is a direct result of the T1D community’s advocacy,” said Aaron J. Kowalski, Ph.D., Breakthrough T1D President and CEO. “Our Coverage2Control campaign brought together thousands of T1D champions demanding UHC give people with T1D the freedom to choose the insulin pump that’s right for them.”
“Today’s decision reflects the power of the collective voice of our community,” Kowalski emphasized. “We thank UnitedHealthcare for ensuring that its members have access to the technology they need to stay as healthy as possible until we have cures for T1D.”
Another T1D Triumph
Through its Coverage2Control campaign, Breakthrough T1D rallies members of the T1D community to encourage health insurers to provide affordable options, give people more choices, and offer coverage for all therapies to help ensure that people with T1D have what they need to survive and lead healthy lives.
As a result, the 25 largest insurance companies in the United States covered the first artificial pancreas system, and many put into place options to lower out-of-pocket costs for insulin.
Unfortunately, UHC had a pre-existing policy that limited pump choice for adults. On February 1, 2019, UHC announced the policy would also apply to children.
Breakthrough T1D saw this as an unacceptable step backward and mobilized the community to respond.
Using Breakthrough T1D’s campaign tools, more than 27,000 supporters sent upwards of 145,000 messages to UHC leadership and shared their concerns on social media, urging them to change their decision.
In October 2019, Kowalski and other members of the Breakthrough T1D senior leadership team met with UHC’s Chief Medical Officer, Dr. Richard Migliori, to make the case directly.
Importance of Insulin Pump Choice
Finding the best insulin pump is a personal decision that affects how people manage their T1D. Pumps have different features and capabilities and different insulin pumps work best for different people.
A person living with T1D may choose to go without a pump if they are unable to find or afford one that works for them. This can lead to diabetes being managed less successfully and increase the cost of care as health outcomes are negatively affected. Providing people with diabetes the full range of pump options increases the likelihood that they will use insulin pumps, will better manage their T1D and achieve improved health outcomes.
While Breakthrough T1D works with its partners and researchers to unlock the science for cures, we are fighting for policies that increase access to life-saving T1D treatments—such as insulin, insulin pumps, artificial pancreas systems, and continuous glucose monitors—and are sharing the most up-to-date information on programs that help with costs.
“My son and I are thrilled to learn that UHC is opening the door to covering new technologies so those living with T1D can choose the management tools that are right for them,” said Jill Folsom. “As a young adult, my son was essentially forced off of his preferred pump, and—in using a pump that didn’t fit his needs as well—he’s seen poor outcomes as a result. I am so grateful for Breakthrough T1D’s continued advocacy efforts to ensure people with T1D are empowered to make these important, personal decisions, and that health plans follow suit by covering a wide range of tools to manage the disease.”
During a recent Breakthrough T1D Facebook Live event, elite T1D Athlete/Ultramarathoner and Dexcom Warrior Eric Tozer and Dexcom Certified Diabetes Educator (CDE) Cher Pastore, MS, RD, discussed Dexcom CLARITY technology.
Leaders from Breakthrough T1D and Dexcom delivered brief remarks before Tozer’s and Pastore’s discussion:
- Joe Watterson, Breakthrough T1D Vice President of Corporate Development
- Molly Donahue, Dexcom Associate Marketing Manager
- James McIntosh, Dexcom Senior Manager of Public Relations
During their discussion, Pastore and Tozer covered a variety of topics, including:
- How CLARITY can help people living with T1D focus conversations with their healthcare providers.
- Why telemedicine visits may be more convenient for people with T1D and how CLARITY can enhance that convenience.
- How CLARITY can help people living with T1D establish goals in between visits with their healthcare providers (either via telemedicine or in-office visits).
- Tozer’s experiences with CLARITY and telemedicine visits.
Watch the full, recorded livestream: