Senseonics, a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, announced the approval of the next-generation Eversense® E3 CGM System by the Food and Drug Administration (FDA), for people ages 18+. The Eversense is the first and only long-term implantable CGM system, and the E3 includes technology that extends the use for up to 6 months.

Breakthrough T1D funded Senseonics in 2000-2003, for a “Minimally Invasive Long-Term Implantable Flourescence Based Sensor for Continuous Monitoring of Glucose,” which later advanced into the Eversense technology. Breakthrough T1D has spent years collaborating with the FDA to improve regulatory pathways for advanced diabetes technologies—and working closely with the Centers for Medicare and Medicaid Services (CMS) and commercial health plans to ensure this technology is covered and available to people with T1D.

Do you want to know what it’s like to use the Eversense?

Megan Casey, who has been working at Breakthrough T1D for more than 15 years and using the Eversense since 2018, says: “I have tried several CGMs, and I feel like I have finally found the CGM that has been just perfect for me and my lifestyle.” She concluded: “I love my Eversense.”

You can also read about Kelli Raleigh, who was a former Breakthrough T1D Outreach Manager, who shares her first-hand account of her experience on the Senseonics Promise Study. She says: “I think I’m most impressed with the idea that you never have to worry about your sensor ripping out or coming off like you do with other CGMs. Each day you change out the adhesive patch that the transmitter is stuck to and voila—that’s it! No pokes, needles, or anything needed.”

“The PROMISE study demonstrated safety and accuracy for the Eversense system for up to 180 days. Breakthrough T1D believes strongly in user choice for type 1 diabetes treatments, and the FDA approval of this long-lasting implantable CGM, the first of its kind, is a great option for the T1D community,” says Jonathan Rosen, Ph.D., Associate Director, Research, Breakthrough T1D. We congratulate the Senseonics team and thank the PROMISE study participants for contributing to this advance and the FDA for their diligence.”

The Eversense E3 is planned to be available to people in the United States beginning in the second quarter of 2022. You can contact 844-SENSE4U (844-736-7348) to learn more about the first and only long-term implantable CGM system.

People living with type 1 diabetes (T1D) have numerous advanced technologies to choose from to better manage their T1D: Continuous glucose monitors (CGMs), insulin pumps, and artificial pancreas systems, which combine the two.

These technologies can make managing T1D easier and help facilitate better outcomes: Fewer experiences of low blood sugar (called hypoglycemia) or high blood sugars (called hyperglycemia), better sleep, and more time-in-range.

There is no such thing as too many options to choose from for T1D management—what works for one person may not be the best fit for another.

Now, people living with T1D who prefer multiple daily injections (MDI) of insulin have two high-tech T1D management options: An insulin smart pen or an insulin smart pen cap.

What are Insulin Smart Pens/Smart Pen Caps? How Do They Work?

These are innovative devices used for MDI insulin administration.

Medtronic’s InPen™ (a Bluetooth-enabled insulin pen) was first cleared by the FDA in 2016, but received FDA clearance for all ages* in 2020. Bigfoot Biomedical’s Bigfoot Unity™ (a Bluetooth-enabled insulin pen cap) received regulatory clearance for ages 12 and up this past year.

Like conventional insulin pens, insulin smart pens can be used to administer certain long- or rapid-acting insulin as needed while basal insulin pen caps can track long-acting insulin.

Unlike conventional insulin pens and insulin pen caps, InPen and Bigfoot Unity do a lot more than physically deliver insulin into the body—they are part of an intuitive diabetes management system.

InPen and Bigfoot Unity pair with corresponding smartphone apps through which a person with diabetes can keep track of insulin doses, blood-glucose levels (via data from a compatible CGM or blood-glucose meter), as well as receive reminders, alerts, and reports.

More specifically, insulin smart pens/caps can:

• Calculate insulin dosage based on current blood-glucose level, carbohydrate reading, meals, active insulin or insulin on board, and settings prescribed by a physician
• Deliver correct half-unit doses that are ½ units**
• Issue alerts to help prevent skipped or missed doses
• Crunch the numbers when you’re trying to calculate how to dose for a meal or correct high blood glucose
• Track the time and amount of every dose, and issue reminders for the next insulin dose   
• Indicate whether insulin has expired or has been subjected to high temperatures so the cartridge can be replaced
• Provide diabetes data to your health care team at any time
• Sync with smart phones or watches, as well as popular diabetes data tracking platforms

Both InPen and Bigfoot Unity sync with CGMs that provide blood-glucose level data in real time; InPen with Medtronic’s Guardian™ Connect System or Dexcom and Bigfoot Unity with Abbott’s Freestyle Libre 2.  

Both can also be used by people using blood-glucose meters. Automatic transmission of blood glucose data may require the meter to meet technological requirements.  

This is crucial in that for the first time, people with T1D who do not wish to use any kind of wearable device, can finally reap some of the benefits of using more advanced T1D management technologies—and they have more than one choice. A huge step in bridging the T1D technology gap.

“One of Breakthrough T1D’s goals is to make sure that everyone has the diabetes management tools that work best for them,” said Associate Director of Research at Breakthrough T1D, Jonathan Rosen, Ph.D. “While we have driven forward the development of AP systems, which consist of a pump, CGM, and controller, and have demonstrated benefits in improving outcomes and reducing disease burden, we appreciate that not everyone wants to wear a pump and are thrilled to see the progress in smart pens like Medtronic’s InPen and Bigfoot Biomedical’s Unity. Smart pens can aid with many aspects of T1D care, including helping users determine when to take insulin and what the dose should be, which helps relieve the daily burden of T1D.”

“I am OBSESSED with My InPen”

Mattie Fisher is a wife and mother of two from Titusville, Florida. This marketing manager for a transportation firm is a plant-based lifestyle devotee who loves to spend time with her family outdoors—mostly engaging in water sports.

Diagnosed at age 12, Mattie has been living with T1D for 20 years. She can’t say enough good things about her InPen.

“I like to say I am OBSESSED—in a healthy way—with my InPen,” she said. 

When she was first diagnosed, Mattie used vials of long-lasting and rapid-acting insulin, along with syringes and lots of finger sticks. When she was ready to enter high school, she decided to try an insulin pump.

Turns out, it wasn’t the right fit for her.

“I did not like being connected to something all the time. Sleeping was uncomfortable, it would snag on different things,” she said.

She, her parents, and her heath care team decided to switch to insulin pens. 

“I have been on Humalog®¹ pens and my long-lasting pens since age 16,” Mattie said. “The pens really seemed to suit my lifestyle better, but I did not get any of the perks that the insulin pump offered—having to manually do all the adding and subtracting for all meal boluses and corrections for any high blood sugars was not my strong suit.”

Related content: “You’re a Mathematician! No, I just have type 1 diabetes”

She said this often led to her simply using a number she was comfortable with for meals or corrections.

“And that led to guessing, which is not a good idea,” she said.

Insta Attraction

All of that changed in March 2021.

“I came across another person on Instagram who is living with type 1 who was using the InPen,” Mattie said. “I had no clue what the InPen was and messaged her with a few questions. After a couple messages back and forth, I knew I had to find out more.”

She called Medtronic for more information and was immediately taken with InPen.

“I love that it does much of the work for me, as far as calculating how many units [of insulin] I need for the meal I am about to eat,” Mattie said. “I also enter my blood glucose and the amount of carbs into the InPen App—and BAM!—it does the rest. Lastly, it also calculates my correction dosage, if needed. And it automatically adjusts if I still have insulin on board [active in my body].”

Mattie uses the InPen with Medtronic’s Guardian Connect CGM. And while she raves about how much easier her T1D management is now, that is not the only big benefit.

“The InPen tells me how much insulin I have used and keeps track of how much insulin I still have in my system,” she said. “I am having fewer instances of low blood sugars now and my confidence in how I am managing my diabetes has improved greatly—almost immediately from using the InPen. I am happy with how my diabetes is being managed and I know my doctor is as well.”

Soon to Come: Even More Choices

Reportedly, other companies are working on products similar to InPen and Bigfoot Unity.

These will provide more people who choose MDI even more new technology choices to help ease the burden of managing their T1D, as well as potentially improve how they manage their T1D.

Mattie is living proof that finding the “just right” technology can make all the difference, and she’s far from the only person singing the praises of the InPen.

Editor’s note:

*<7 requires adult supervision

**InPen only

1. Humalog ® is a registered trademark of Eli Lilly and Company

Breakthrough T1D is excited to announce today that Breakthrough T1D T1D Fund portfolio company Protomer Technologies has been acquired by Eli Lilly and Company. Protomer is developing glucose-sensing, or “smart,” insulin, which is designed to sense sugar levels in the blood and automatically activate as needed throughout the day. This approach, using technology that began with Breakthrough T1D funding, has the potential to revolutionize the treatment and quality of life of people with diabetes by improving both the efficacy and safety of insulin therapy.

Breakthrough T1D and T1D Fund Connection

 Breakthrough T1D has been an early supporter of “smart” insulin (also called glucose-responsive insulin, or GRI), and Breakthrough T1D and the T1D Fund have supported Protomer from before the company’s inception through its sale to Lilly. In 2013, Alborz Mahdavi, Ph.D., was a winner of the Breakthrough T1D Agnes Varis GRI Grand Challenge Prize. Subsequently, he founded Protomer, which was initially funded by Breakthrough T1D’s Industry Discovery and Development Program.

Following these successful grants from Breakthrough T1D, the T1D Fund made a minority equity investment in Protomer’s Seed round, alongside Eli Lilly, to advance the company’s highly promising glucose-sensing insulin program.

The successful sale of Protomer to Eli Lilly is a great example of how Breakthrough T1D research, the T1D Fund, and key diabetes industry players collaborate as a part of a larger ecosystem to help advance meaningful therapies for the T1D community.

The T1D Fund’s investment in Protomer represents clear mission impact—moving treatments for type 1 diabetes closer to people. As one of the leaders in the field of diabetes, Lilly brings substantial resources that will be needed to move Protomer’s technology towards the clinic. The Fund’s share of any future returns from its minority investment in Protomer will be realized over the course of several years, if and when agreed-upon development and commercial milestones are achieved.

 For more information on the acquisition, please see Lilly’s press release.

Go here for more information about the Breakthrough T1D T1D Fund.

On Monday, the Bigfoot Unity™ Diabetes Management by Bigfoot Biomedical received U.S. Food and Drug Administration clearance for individuals 12 and older. For the first time, people who use multiple daily injections (MDI) to manage their diabetes will be able to integrate with a continuous glucose monitor and get personalized insulin dosing recommendations, lessening the burden of T1D.

How It Works

Bigfoot Unity™ Diabetes Management contains three parts: the Freestyle^® Libre 2 CGM sensor, the Bigfoot Unity™ proprietary pen caps and a mobile app. The user scans the Freestyle^® Libre 2 CGM sensor with the Bigfoot Unity™ pen cap for rapid-acting insulin, which fits onto the end of an insulin pen. The cap then displays the user’s blood glucose level along with trend lines and recommended insulin doses. The smart pen cap also provides a suggested mealtime bolus based on parameters programmed by the user’s physician.

It is compatible with pens manufactured by Eli Lilly and Company, Novo Nordisk, and Sanofi.

Bigfoot Unity™ System also provides alerts for very low glucose, which activates when the user’s blood glucose falls below 55 mg/dL, and an optional alert for low glucose, which activates when the user’s blood glucose falls below 70 mg/dl.

The Bigfoot Unity™ pen cap for long-acting insulin provides alerts for potentially missed doses of once-a-day “basal insulin” and displays the recommended dose determined by the user’s physician. Data is uploaded automatically to the cloud over WiFi, where the user’s physician can access it.

A Big Step Forward in T1D Management

The connection between Breakthrough T1D and Bigfoot Biomedical goes back over a decade. The Breakthrough T1D T1D Fund made its first equity investment in Bigfoot Biomedical in 2017, as one of the Fund’s first investments. Bigfoot is led by former Breakthrough T1D CEO and International Board member Jeffrey Brewer. Under Brewer’s leadership, Breakthrough T1D invested in artificial pancreas technology. This includes funding research demonstrating the benefits of utilizing CGM data to make insulin dosing recommendations, supporting the development of multiple diabetes management device systems to improve diabetes management now available to the T1D community and working with the Food and Drug Administration to ensure pathways for systems such as Unity which use interoperable devices.

To learn more about  Bigfoot Unity™ Diabetes Management’s availability visit  https://www.bigfootbiomedical.com/.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for vTv Therapeutics’ TTP399 as an adjunct therapy to insulin for type 1 diabetes (T1D). Once granted, Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious and life-threatening conditions.

In a BreakthroughT1D-funded phase II clinical trial called Simplici-T1, TTP399 significantly improved HbA1c in people with T1D. Additionally, trial participants who received TTP399 showed a reduction in insulin dose, reduced hypoglycemia (low blood sugar), and no increase in diabetic ketoacidosis (DKA).

TTP399 is a liver-selective glucokinase (or GK) activator. GK acts as a key regulator of sugar levels in the body. When blood-sugar levels rise, activation of GK in the liver stimulates glucose utilization, which in turn lowers glucose levels in the blood.

After several human studies in type 2 diabetes, vTv Therapeutics joined forces with Breakthrough T1D in 2017, to test TTP399 in people with T1D. The positive topline results from this phase II clinical trial follow the positive results obtained in the previous smaller clinical study reported by Breakthrough T1D in June 2019.

The next step: Upcoming pivotal trials and a mechanistic study to test the effects of TTP399 on diabetic ketoacidosis (DKA).

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.