For some adults who use inhaled insulin at mealtimes, it provides another option to manage their diabetes and it is taken with the first bite of food. But it’s only available for people who are 18+ years old. Children and most teens do not currently have this option. The results of a clinical trial recruiting participants may change that.

Younger kids may be unable to understand diabetes and effectively manage their blood sugar. For tweens and teens, managing diabetes can add an extra layer of stress, particularly when it comes to meals and snacks. Hormonal changes during these years make glucose levels unpredictable, and adolescents tend to eat more meals away from home and are “likely to engage in eating as a major social event with peers.”1

Stopping for a snack after school, participating in a classroom party, eating a mid-morning snack; this could be managed by taking injected insulin about 15-20 minutes before eating or drinking. But children and teens don’t always plan ahead (their executive functioning skills are still developing). They can eat randomly, without time for preplanning insulin doses.

But what if it was safe and effective to take a rapid-acting inhaled insulin just as they start eating? The INHALE-1 clinical trial is finding out.

This study aims to evaluate the safety and effectiveness of a rapid-acting inhaled insulin product for use in children and teenagers with diabetes.

Who Can Join?

What’s Involved?

Where Is It Recruiting?

Recruitment is taking place, as of now, at 22 sites located in California, Florida, Georgia, Idaho, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Nevada, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Texas. Find the site location nearest you on the National Institutes of Health’s (NIH) ClinicalTrials.gov website.

If you and your child or teen are interested in becoming involved, contact 1-844-INHALE1 or visit INHALE-1.

Facebook Live Event

To learn more about the INHALE-1 clinical trial, you can also watch our Facebook Live event titled “Children are Not Little Adults: The Importance of Pediatric Research,” featuring:

This educational content is made possible with support from MannKind Corporation. Breakthrough T1D produces this content to provide information to our supporters about their potential options for managing their T1D and not as an endorsement of products. Editorial control rests solely with Breakthrough T1D.

1Borus JS, Laffel L. Adherence challenges in the management of type 1 diabetes in adolescents: prevention and intervention. Curr Opin Pediatr. 2010 Aug; 22 (4): 405-11. doi: 10.1097/MOP.0b013e32833a46a7.

Derek is an outdoor person. He spends much of his time in Macomb, MI, camping, hiking, fishing, and hunting, often with his sons, one of whom has type 1 diabetes (T1D)—just like Derek.

Derek, who lives with T1D, enjoys the outdoors

Derek fishing in Michigan

A few years ago, while his sons were visiting, Derek was treating a low blood sugar with a few chocolate chip cookies. The next thing he remembers is waking up next to a jar of honey, an empty bottle of apple juice, and two used glucagon kits. He was disoriented…and surprised.

“I’ve always been able to treat lows without any problems, but that one got away from me,” he said.

Fortunately, he had glucagon nearby and his wife knew how, and when, to administer it.

“She gave me one shot of glucagon but my son, a state police officer, still couldn’t get me to respond,” Derek said. “So, she gave me a second shot. A few minutes later, I came around, but I felt like I had gone a few rounds in the ring with Muhammad Ali.”

The episode left them both shaken.

“My wife said to never let that happen again and I understood her feelings completely,” he said.

Glucagon to the Rescue

Glucagon. It’s a word familiar to people with T1D, yet one most hope to avoid discussing. But what is glucagon and what is its role in the management of T1D?

Glucagon is a hormone released by the pancreas that works in tandem with insulin to keep blood sugar levels in healthy ranges. In people without T1D, the two hormones are being released all the time–insulin to prevent blood sugar levels from rising too high, and glucagon to prevent it from going too low.

But for people with type 1 diabetes, a drop in blood sugar often doesn’t trigger a normal glucagon response and blood sugar can continue to drop, occasionally resulting in severe hypoglycemia (less than 55 mg/dL or 3 mmol/L).

Signs that a person with T1D is experiencing a severe low blood sugar episode include:

Glucagon is used as a rescue medication, in injectable or nasal spray forms, to treat episodes of severe low blood sugar when someone is unable or unwilling to ingest carbohydrates safely, or if they are unresponsive. It typically helps bring blood glucose levels back up into a safe range (over 70mg/dL).

Download Breakthrough T1D’s hypoglycemia one-pager for parents and caregivers
(Sponsored by Lilly)
Watch our Hypoglycemia 101 video
(Sponsored by Lilly)

A Scary Teaching Moment

Coleen cares for her grandson with type 1 diabetes (T1D)

Coleen with her grandson around the time of his diagnosis at age 4

Coleen cares for her teenaged grandson with T1D in San Diego, CA. He recently went to a party with friends and came home sick, with vomiting and severe lows. She was monitoring his blood sugar on his continuous glucose monitor (CGM), watching his number dip into the 40s, and forcing him to drink soda with no improvement. “At some point, I decided to use Baqsimi nasal spray,” she said. “It took about 15-20 minutes to bring him up, but I knew he was going to be okay.”

That event, while frightening, was a “teaching moment” for Coleen and her grandson. Now, his best friends are all trained in how to use Baqsimi in case of emergency.

The Different Forms of Glucagon

We all know that T1D care is not “one size fits all.” Personal preference and insurance coverage (or lack thereof) all impact how people manage their disease. Glucagon comes in several forms, which gives people with T1D options to choose from based on those factors:

Baqsimi is a dry nasal spray administered in one nostril. Because there is no needle involved, it tends to be a bit less intimidating for caregivers to administer. The most common side effects after use are mild and include nausea, headache, and discomfort in your nose.

The Gvoke HypoPen is available as a pre-mixed autoinjector or a pre-filled syringe (PFS). It is injected into the upper arm, stomach, or thigh. Both come in a convenient two-pack and are available in two premeasured doses: one for kids (under 100 lbs.) and one for adolescents and adults. The most common side effects after administration are mild and include nausea, vomiting, swelling at the injection site, and headache.

Zegalogue comes in a pre-filled syringe (PFS) or an autoinjector pen—no mixing is necessary. It is injected into the upper arms, lower abdomen, front or back of thighs, or buttocks. The most common side effects after administration are mild and include nausea, vomiting, headache, diarrhea, and injection site pain.

In all cases, after Glucagon is administered the person must be turned on their side in case of vomiting and 911 (or emergency medical help) should be called immediately.

I Have a CGM, I Don’t Need Glucagon!

With the increase in use of CGMs and artificial pancreas (AP) systems, the risk of severe hypoglycemia is reduced for many people with T1D, so carrying glucagon may not be as much of a concern. For Coleen, while her grandson’s CGM has been “lifesaving” on many occasions, it doesn’t preclude the “what ifs” or the unpredictability of the disease.

“That night, if he had slept over at a friend’s house, he may not have woken up,” she says. “He carries Baqsimi with him all the time now.”

Availability and Affordability

Glucagon is considered an essential part of a T1D’s supply kit, yet a recent study shows that only 47% of T1D caregivers carry a form of glucagon with them at all times. For adults with T1D, that number is even lower, a troubling 29%. In contrast, almost 60% of people who need an epi-pen, another lifesaving rescue medication, always have it with them.

So why is glucagon an afterthought for so many people with T1D? The most common concern is cost.

The list price for the various forms of glucagon is around $300 per device, but insured patients can download savings cards that reduce the cost significantly.

Breakthrough T1D’s Insurance Guide is also a helpful resource for people with T1D to find ways to reduce the financial burden of the disease.

The Life Raft in Your Supply Bag

Having the right tools to manage T1D allows you to take charge of your well-being. Glucagon is like a life raft: you may not use it daily, or even ever, but if there comes a time when you do, you’ll never be without it again.

Despite being diagnosed over 50 years ago, Derek still recognizes the challenges of having T1D, but he doesn’t let bumps in the road stop him from living his life to the fullest. “I control my diabetes so I can do things I enjoy when I want to,” he said. “Sure, T1D gets in the way every once in a while, but it doesn’t control me.”

Editor’s Note: This educational content is made possible with support from Lilly. Breakthrough T1D produces this content to provide information to our supporters about their potential options for managing their T1D and not as an endorsement of products. Editorial control rests solely with Breakthrough T1D.

You’ve seen the ads: Victoza®. Ozempic®. Trulicity®.

They are for type 2 diabetes, and they lower your blood-sugar levels and cause the majority of people who use them to lose weight. And they can lower your risk of major cardiovascular events, such as heart attack and stroke.

But did you know that these drugs came about, in part, because of type 1 diabetes (T1D) research?

In honor of the 100th anniversary of the first administration of insulin, Breakthrough T1D launched “100 Years, 100 Breakthrough T1D Scientists,” to tell the story of scientists and their discoveries, which put together the vast knowledge that we have about diabetes today.

The next one: GLP-1 treatments.

Cloning the Hormone Glucagon

You read about the cloning and expression of insulin in our latest “100, 100,” but it does not stop with insulin. When she was a postdoctoral fellow working in the laboratory of Joel Habener, Ph.D., Pauline Kay Lund, Ph.D.—who would go on to receive a 1982-1985 Breakthrough T1D Career Development Award—was the first to clone the hormone glucagon and discover two new hormones: glucagon-like peptide 1 (GLP-1) and 2 (GLP-2).

Said Lund, in an interview published in the Autumn 1985 issue of Countdown: “By understanding the factors which regulate glucagon gene activity and the production of glucagon, GLP-1, and GLP-2, it should be possible to predict the dietary and hormonal influences which best produce normal regulation of plasma glucose. This will aid in development of preventive and therapeutic measures to produce normal glucose regulation in patients with diabetes.”

In other words, understanding the protein could lead to the development of drugs that can help you reach a better blood-sugar range for people with diabetes.

Subsequent work revealed that GLP-1 encourages the release of insulin from the pancreas and reduces the release of glucagon, and clinical trials demonstrated that it was effective in treating type 2 diabetes.

In 2005, the FDA approved Byetta (exenatide). There are now seven GLP-1 medicines on the market.

Breakthrough T1D Leadership

Breakthrough T1D funded copious research in the 1980s and 1990s to understand the role of glucagon and glucagon-like peptide 1 in type 1 diabetes, including:

And there are many more Breakthrough T1D investigators who had a hand in making this new class of agents a reality to the diabetes community.

Breakthrough T1D Clinical Trials

When GLP-1 treatments came out, everyone in the type 1 space wanted to know if it worked for type 1 diabetes. Breakthrough T1D and others funded a number of clinical trials testing it with insulin, to see if it improved outcomes. Unfortunately, although it reduced HbA1c and total insulin dose, it increased the rates of low blood sugar (called hypoglycemia) and high blood sugar (hyperglycemia) events, thereby limiting its clinical use.

In the past few years, however, we have started to wonder whether three drugs (insulin + 2 other drugs) might work, and are now funding a trial to see if a GLP-1 therapy (semaglutide, brand name Ozempic, Rybelsus) and an SGLT therapy (dapagliflozin, brand name Farxiga), taken with insulin, can reach better blood sugar levels, compared with a dual therapy or insulin only.

Results won’t be out for another year or two, but stay tuned.

[1] Lund PK, Goodman RH, Habener JF. Intestinal glucagon mRNA identified by hybridization to a cloned islet cDNA encoding a precursor. Biochem Biophys Res Commun 1981; 100: 1659-1666. PMID: 7028035.

[2] Lund PK, Goodman RH, Habener JF. Pancreatic pre-proglucagons are encoded by two separate mRNAs. J Biol Chem 1981; 256: 6515-6518. PMID: 6165720.

[3] Lund PK, Goodman RH, Dee PC, Habener JF. Pancreatic preproglucagon cDNA contains two glucagon-related coding sequences arranged in tandem. Proc Natl Acad Sci USA 1982; 79: 345-349. PMID: 7043459 PMCID: PMC345726.

[4] Lund PK, Goodman RH, Montminy MR, Dee PC, Habener JF. Anglerfish islet pre-proglucagon II. Nucleotide and corresponding amino acid sequence of the cDNA. J Biol Chem 1983; 258: 3280-3284. PMID: 6338015.

In honor of the 100th anniversary of the first administration of insulin, Breakthrough T1D launched “100 Years, 100 Breakthrough T1D Scientists,” to tell the story of scientists and their discoveries, putting together the vast knowledge that we have about diabetes today.

The next one: Genetically engineered human insulin.

Before the advent of human insulin, insulins were derived from animals, and safe dosing was wildly inconsistent. But in 1976, research teams set out to synthesize the human insulin gene and make human insulin, and Breakthrough T1D researchers had multiple hands in the biosynthesis of it.

It all began when Eli Lilly called a meeting on May 24-25, 1976. Presenting first was William L. Chick, M.D., a junior faculty member at Joslin Diabetes Center, who had recently developed a rat with a rare tumor in beta cells—called insulinoma—which could generate huge amounts of insulin [1]. He had a Breakthrough T1D grant beginning in 1976.

Several of the teams at the Lilly meeting were planning on isolating the human gene for insulin and cloning it, and Chick’s insulinoma model provided the raw material. From the insulin gene to the cloning of it; this is where it all began.

The City of Hope-Genentech team prevailed in the summer of 1978 [2]—for which we gave the David Rumbough Award in 1979 to Arthur Riggs, Ph.D., David Goeddel, Ph.D., Keiichi Itakura, Ph.D., Roberto Crea, Ph.D., and Dennis Kleid, Ph.D.—however, there were two more groups involved:

In October 1982, the FDA approved the first genetically engineered drug, Humulin®, and would go on to approve many more insulins—short- and rapid-acting, long-acting, and a nasal version of it.

There are now genetically engineered therapies not just for diabetes, but for cancer, hepatitis B, stroke, and others. Research is how genetic engineering made the first human insulin product, and Breakthrough T1D research is advancing us toward cures and the next generation of life-changing breakthroughs for type 1 diabetes.

Follow up each week to find out who we selected and their major discoveries, in honor of the 100th anniversary of the first administration of insulin.

*I thank—very much so—the book by Stephen S. Hall, Invisible Frontiers: The Race to Synthesize a Human Gene (1987), who captured the turns and tribulations of the race to clone the human insulin gene and, with it, the birth of biotechnology.

[1] Chick WL, Warren S, Chute RN, Like AA, Lauris V, Kitchen KC. A transplantable insulinoma in the rat. Proc Natl Acad Sci U S A. 1977 Feb; 74 (2): 628-32. doi: 10.1073/pnas.74.2.628.

[2] Goeddel DV, Kleid DG, Bolivar F, Heyneker HL, Yansura DG, Crea R, Hirose T, Kraszewski A, Itakura K, Riggs AD. Expression in Escherichia coli of chemically synthesized genes for human insulin. Proc Natl Acad Sci U S A. 1979 Jan; 76 (1): 106-10. doi: 10.1073/pnas.76.1.106.

In conjunction with leading partners in diabetes, advocacy, and healthcare, Breakthrough T1D lends its support to Civica, to help combat a nationwide insulin affordability crisis.

This project will manufacture and distribute low-cost biosimilar insulin options for three of the most-prescribed insulins: glargine (Lantus®), lispro (Humalog®), and aspart (Novolog®). It will enable anyone to purchase insulin at no more than $30/vial or $55/box of five pens, regardless of insurance status. Civica anticipates that the insulins will be available in 2024.

What is a Biosimilar? A biologic drug that is highly similar to the original drug. Biosimilars can be manufactured when the original drug patent expires. An interchangeable biosimilar may be substituted in place of the originally prescribed drug at the pharmacy counter.

Currently, insulin can cost between $175 and $300 a vial and up to $1,000 a month. Studies have shown that these inflated costs can cause up to one-quarter of people with diabetes to skip or ration their insulin [1], potentially leading to medical emergencies, severe complications, or death. Once brought to market, these biosimilars will save lives by significantly lowering the cost of insulin for millions of Americans.

Breakthrough T1D’s Leadership

Over a 10-year period, the cost of insulin increased threefold [2]. That’s why lowering the cost of insulin is such an important and necessary step, so that no one should have to choose between paying the rent or obtaining this life-saving medication.

Breakthrough T1D has been fighting the rising cost of insulin for years, advocating for both private sector solutions and action in Washington, D.C. Through our Coverage2Control campaign, we have rallied our community to call for insulin manufacturers, health plans, employers, and the government to take action to lower the cost of this life-saving medication. Breakthrough T1D executives have met repeatedly with the leadership of each of the three major insulin manufacturers and called on them to find new ways to lower the price.

While some progress has been made, there is more to be done. Breakthrough T1D will not rest until we have long-term solutions that make this life-saving insulin affordable for everyone, whether someone has private insurance, Medicare, or no insurance at all. Our support of the Civica project addresses a wide-spread issue plaguing far too many people who depend on this medication.

Furthermore, by making insulin more affordable, people will be more likely to follow the course of care prescribed by their healthcare providers, as opposed to thinking about the stress it will put on their wallets.

Hear more about this historic partnership by Aaron J. Kowalski, Ph.D., CEO of Breakthrough T1D:

1. Herkert D, Vijayakumar P, Luo J, Schwartz JI, Rabin TL, DeFilippo E, Lipska KJ. Cost-Related Insulin Underuse Among Patients With Diabetes. JAMA Intern Med. 2019 Jan 1; 179 (1): 112-114.

2. Hua X, Carvalho N, Tew M, Huang, E, Herman W, Clarke P.  Expenditures and Prices of Antihyperglycemic Medications in the United States: 2002-2013, JAMA, April 5, 2016; 315 (13): 1400-1402.

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:

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:

This educational content is made possible with support from Medtronic. Breakthrough T1D produces this content to provide information to our supporters about their potential options for managing their T1D and not as an endorsement of products. Editorial control rests solely with Breakthrough T1D.

*<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

Thanks to leadership of Breakthrough T1D and partners in the public and private sector, this new system is a win for the entire diabetes community, both type 1 and type 2. There has been tremendous innovation over the past 15 years in diabetes technology. Continuous glucose monitors provide real time trend information and alarms enabling people with T1D to achieve better control. CGMs are connected to insulin pumps in artificial pancreas or automated insulin delivery systems providing real time insulin dosing. However, the choice to use an insulin pump or MDI to manage T1D is extremely personal. Both MDI and pump therapy have their benefits and challenges, with the majority of people with T1D using MDI as of 2019. This clearance brings the benefits of automation and connected devices to more members of the diabetes community as the first MDI system to utilize continuous glucose data to provide low glucose alerts and personalized insulin dosing recommendations.

Read Breakthrough T1D’s statement celebrating the clearance of this new therapy here.

Breakthrough T1D and Bigfoot

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).