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

Oh. My. Gosh. I’m writing this blog, for Mathematics and Statistics Awareness Month, and I couldn’t believe what people with type 1 diabetes (T1D) have to do, in mathematics, to reach the right blood-sugar levels. It’s insane! It’s not an overstatement to say that, to effectively manage T1D, one needs to be a mathematician.

Keep in mind, this is all hypothetical. If you have T1D, talk to your doctor/endocrinologist if you have any questions about anything in this post.

​Total Daily Insulin Requirement

Let’s take a seemingly simple mathematical equation: Total daily insulin requirement (in units of insulin).

You take your weight and divide it by 4. If you weigh 160 pounds, then:

160 ÷ 4 = 40 units of insulin per day.

Easy, right? No.

Because it might be too much insulin if you are newly diagnosed and still making a lot of insulin on your own or you are sensitive to insulin; or it might be too little if you are very resistant to insulin; or, if you eat more, there’s more insulin; if you eat less, it’s less insulin. (This is a general formula, so, as always, talk to your doctor/endocrinologist about the best insulin dose for you.)

Basal Insulin Dose

Next, you need to establish the basal (also called background) insulin dose, which is generally constant from day to day. A couple of things to know about insulin:

Let’s say, again, you weigh 160, and your totally daily insulin dose is 40 units (160 ÷ 4 = 40 units).

Your basal dose is 40%-50% of your total daily insulin dose. Let’s say we make it 50%, so it’s:

50% of 40 units = 20 units (of either long acting insulin or intermediate insulin).

Bolus (Carbohydrate Coverage) Insulin Dose

Okay, you’ve gotten this far. But what about mealtimes? Now you have to remember—it can be calculated using the “Rule of 500.”

You take 500, and divide it by your total daily insulin dose (40 units) to get your carbohydrate coverage ratio:

500 ÷ 40 = 12 grams of carbohydrate per 1 unit of insulin.

Easy, right? Think again.

This assumes that you have a constant response to insulin throughout the day, but insulin-to-carbohydrate ratio varies. Someone who is resistant in the morning, but sensitive at mid-day, will need to adjust the insulin-to-carbohydrate ratio at different mealtimes. The insulin-to-carbohydrate ratio might be breakfast 1:8 grams, lunch 1:15 grams, and dinner 1:12 grams.

Carbohydrate Coverage at a Meal

1 unit of insulin = 12 grams of carbohydrate.

Let’s say you’re going to have a turkey sandwich for lunch. That’s 36 grams of carbohydrate.

36 grams ÷ 12 grams = 3 units of insulin.

You’ll need 3 units of short or rapid acting insulin to cover the carbohydrate.

But…

High Blood Sugar Correction Dose (Correction Factor)

High blood sugar correction is defined as how much 1 unit of rapid acting insulin will reduce the blood sugar so many mg/dL. This time, you have to remember the number 1800.

1800 ÷ Total Daily Insulin Dose (40 units) = 1 unit of insulin will reduce the blood-sugar level by 45 mg/dL.

Next, you have to calculate the high blood sugar correction dose.

(Actual blood sugar – target blood sugar) ÷ correction factor = high blood sugar correction dose.

Let’s say your actual blood sugar, before lunch, is 235 mg/dL, and your target is 100 mg/dL.

So 235 mg/dL – 100 mg/dL = 135 mg/dL, then we divide it by the correction factor (45), and we get 3 units of rapid acting insulin, to “correct” the blood sugar down to a target of 100 mg/dL.

 So…

 Total Mealtime Dose

 To get the total mealtime insulin dose, add the carbohydrate coverage dose together with the high blood sugar correction dose, so:

3 units of insulin + 3 units of insulin = 6 units of rapid acting insulin for your lunch.

And this was just lunch!

There’s nothing bad you can say about John J. McDonough. He was a self-made man. He served on Breakthrough T1D’s International Board of Directors and was Chairman in 1999 to 2000. He and his wife, Marilyn, founded the BETA Society, for people who name Breakthrough T1D in their estate plans. He was a poet. Well, no, he wasn’t…but that didn’t stop him from trying. And, he had “the ability to laugh in the face of some pretty awful things.”

This was “one of his best qualities,” said Allison, his eldest daughter.

He passed away on February 16 at the age of 84, from complications of type 1 diabetes (T1D).

He was a champion. A philanthropist. And, above all, a friend. He will be sorely missed.

Early YearsA young John McDonough on a sailboat cruising around

John was age 6 when he was diagnosed with T1D, in 1943. This was well before insulin pumps, continuous glucose monitors, and engineered insulin were around. John was told he would likely die by age 15. But, against all odds, John thrived.

He met Marilyn when he was 16, she 15. He graduated high school and attended the University of Notre Dame. John loved working as a campus photographer. His favorite gigs were photographing Louis Armstrong and his band, and President Eisenhower. John and Marilyn married before he graduated with honors and entered the business world as an accountant.

They began having children right away, and would go on to raise 5 McDonoughs (and 1 son-in-law, 2 daughters-in-law, 8 grandchildren, 3 granddaughters-in-law, and 3 great-grandchildren!).

Successful and Significant Life

Young John and Marilyn McDonough

John’s determination to control the disease is what helped him defy the odds. He had a successful career in business and finance spanning more than 50 years and several industries: manufacturing, marketing, medical and dental products, and telecommunications.

But John wanted significance, too. When he received Notre Dame’s Sorin Award, which is presented to a graduate who has rendered distinguished service to the university and community, he said: “Success is important because it makes education, care of family, and a reasonable lifestyle possible. Significance is about making your life count. They can be simultaneous or sequential, but without significance, one’s life cannot be a success.”

John and Marilyn McDonoughIt was the diagnosis of his daughter, Allison, with type 1 in 1983 that led John to take a driving interest in moving T1D research forward.

In addition to being a member of Breakthrough T1D’s Board and founding chairman of the BETA Society, he served on many special committees for both Breakthrough T1D International and Breakthrough T1D’s Illinois Chapter. John and Allison testified before Congress at Breakthrough T1D’s Children’s Congress in Washington, D.C. He received the Person of the Year Award from both the Breakthrough T1D Southern Florida Chapter and the Breakthrough T1D Illinois Chapter. He’s made significant gifts to help fund research for the past 25 years.

John McDonough and Family“We are much farther down the path of curing type 1 diabetes because of John’s efforts,” said Joe Lacher, now chairman of the Breakthrough T1D International Board of Directors. “He was incredibly proud of the innovations—like continuous glucose monitors and the artificial pancreas—that benefited John, Allison, and the type 1 diabetes community. It is because of his efforts that people with the disease are living longer and healthier lives and curing type 1 is within reach.”

Love of Life, and Silly Jokes

You know how I said that the remarkable thing about John was his humor? Even in the face of diabetes complications, even in the face of losing his leg, he always had that.

John McDonough and Ron Santo comparing leg prosthetics

John and Ron Santo, comparing leg prosthetics

“After Dad lost his leg, we went together to get his first prosthetic leg,” recalled Allison. “Sitting in the waiting room, I was very surprised when all this grief welled up inside of me and I just started to weep. There I was, wailing away, and I could tell Dad was very upset because I was so upset. He said, ‘Hon, this amputation is really the best thing that could have happened.’ I just wasn’t in the mood to be spiritually advanced and was about to tell him that I loved his attitude, but I just couldn’t be positive right then. Then he continued, ‘I only worry about athlete’s foot half as much as I used to.’”

“I wasn’t expecting a joke,” said Allison. “I was stunned for a moment, but then we both started laughing through our tears. If others in the waiting room thought we were loons, I didn’t care. Once again, Dad showed his amazing ability to not let his diabetes dampen his spirit.”

Let’s hope that, someday, T1D won’t let anyone dampen one’s spirit again—because we have found cures for the disease. Until that day comes, we will fund research that will get us there.

We also wanted to share a recent video, featuring John, and his amazing spirit. John, you will be missed.

Accommodations. You might not know that it’s an important word, for anyone who has a disability. And, if you’re a person with type 1 diabetes (T1D), you have a qualified disability, and can request reasonable accommodations to help you go to school or work.

But what about COVID-19 and T1D? To help you traverse the school and employment rights, Breakthrough T1D had a Facebook Live event with Daniel Phelan, Esq., an attorney who’s an associate at Duval and Stachenfeld LLP and chairman and CEO of the Type 1 Action Foundation. He was diagnosed with T1D when he was in seventh grade, just a few weeks after his 13th birthday.

You’ll learn:

General
  • What are the basic legal protections for T1D?

Children

 
  • Are there any legal protections for students who chose distance learning due to T1D, and now would like to re-enroll with in-person learning?
  • What legal requests can be made for transportation to and from school? How would I make the request?
  • How about after school extra-curricular activities like athletics, band, or theater. Can special accommodations for in-person practices or transportation be requested?
  • Are there any legal protections that staff be trained to assist the child with T1D management, and that a nurse must be present?
  • What accommodations are a reasonable expectation when it comes to college and wanting virtual classes? Could a T1D student request a dorm room with single occupancy?

Employment Rights for Adults with T1D who Work in Schools

 
  • The school district has moved to a hybrid learning model. Do I have any rights, as a teacher, to keep doing virtual learning only?
  • What about physical education teachers and providing lunch supervision—times when students are not required to wear masks. What accommodations can they seek while still continuing to work?

Workplace Employment Rights for Adults with T1D

 
  • Hospitals are facing staffing shortages and I may have to begin working with COVID patients. Do I have any legal rights, as a nurse, to take sick leave and/or collect disability?
  • Are there protections that could help someone working at a warehouse? What about retail?

Check out the full, recorded Facebook Live event below. 

In type 1 diabetes (T1D), receiving transplanted donor beta cells restores blood-sugar control and significantly improves people’s quality of life. The current approach, however, is available to a limited number of people and these individuals need to take immunosuppressive drugs for the rest of their lives.

Our ambition at Breakthrough T1D is to bring beta cell replacement therapies to the broader T1D community with renewable cell sources and without the need for chronic immune suppressing drugs.

We’ve already solved a key challenge: After more than a decade of research, steered by Breakthrough T1D, Douglas A. Melton, Ph.D., and colleagues have solved the major obstacle of generating unlimited numbers of beta cells using stem cells, in 2014. Now, Dr. Melton, the principal investigator on the new New England Center of Excellence, will focus on the challenge of protecting these cells from rejection by the immune system that occur following transplantation.

Dr. Melton, in partnership with Breakthrough T1D research leadership, has assembled a multidisciplinary team that includes key diabetes investigators involved in cellular biology and immunology research, from five institutions: Harvard University, University of Massachusetts Medical School, Joslin Diabetes Center, The Jackson Laboratory, and Dana-Farber Cancer Institute.

They are applying their talents toward one of the most exciting, emerging fields: Gene modification, or gene editing. They are using gene modification technology to create beta cells that can withstand immune attacks and utilizing these engineered cells in the development of T1D therapies.

“I am truly blown away by the research at the Breakthrough T1D Center of Excellence in New England,” says John Cammett, co-founder of Realterm Global, president/CEO and co-founding partner of Aeroterm, and a seed funder of the Breakthrough T1D Center of Excellence in New England. “My own desire to find a cure is inspired by my mom living with type 1 diabetes for almost 60 years.

“We have supported several of the researchers at this Breakthrough T1D Center of Excellence individually before,” he describes. “But the Breakthrough T1D Center of Excellence in New England excites me and gives me tremendous optimism because it brings together the brightest minds, along with the entire Breakthrough T1D ecosystem, with a laser-sharp focus on developing cures. I encourage others to provide financial support, because it’s collectively between these researchers’ intellect and our financial resources that we will cure type 1 diabetes.”

“The Breakthrough T1D Center of Excellence in New England excites me and gives me tremendous optimism because it brings together the brightest minds, along with the entire Breakthrough T1D ecosystem, with a laser-sharp focus on developing cures.”

—John Cammett
Seed Funder, Breakthrough T1D Center of Excellence in New England

This is the third Center of Excellence launched by Breakthrough T1D, the first one in Northern California with Stanford University and the University of California, San Francisco, and the second at the University of Michigan.

The Northern California Center will focus on the interaction of immune cells with insulin-producing beta cells; generating islets and immune cells from stem cells for next-generation therapies; and developing ways to transplant insulin-producing cells into people with T1D without requiring immunosuppression.

The Michigan site will focus on undertaking a comprehensive definition of T1D metabolism, with the goal of preventing or treating short- and long-term complications—like low or high blood-sugar levels; eye, kidney, heart, and nerve diseases; and brain impairment and psychosocial stress—that arise from the disease, and aiming to identify drug targets that can be used in beta cell replacement therapy.

To learn more, read our press release.

The researchers involved in the Breakthrough T1D Center of Excellence in New England:

Harvard University
Douglas A. Melton, Ph.D. (principal investigator)

University of Massachusetts Medical School
Michael A. Brehm, Ph.D. (co-principal investigator)
Dale L. Greiner, Ph.D.
David M. Harlan, M.D.
Sally C. Kent, Ph.D.
René Maehr, Ph.D.

Joslin Diabetes Center
Jason Gaglia, M.D. (co-principal investigator)
Stephan Kissler, Ph.D. (co-principal investigator)
Peng Yi, Ph.D.

The Jackson Laboratory
Lenny Shultz, Ph.D.

Dana-Farber Cancer Institute
Judith Agudo, Ph.D.

After a thorough national search, we are pleased to announce that Timothy Doyle will join Breakthrough T1D as President and Chief Operating Officer (COO), effective February 1, 2021.Timothy Doyle

Tim will report to Aaron Kowalski, Ph.D., who will continue to serve as Breakthrough T1D’s Chief Executive Officer.  

He will serve as a critical strategic partner to Aaron, leading organizational operations to broaden Breakthrough T1D’s reach and impact, working with Breakthrough T1D’s executive team and International Board of Directors.

Tim’s appointment will enable Aaron to focus on overall strategy and take a more active, external-facing role driving growth and accelerating mission as the face and voice of Breakthrough T1D.

Tim is a highly experienced and well-regarded leader with a track record of success developing and implementing strategic plans and management strategies in higher education and research institutions. He comes to Breakthrough T1D from the Carnegie Institution for Science, where he served as COO.

Prior to that, he was Associate Dean for Finance and Chief Financial Officer (CFO) for Harvard’s School of Engineering & Applied Sciences. Tim earned a Master of Business Administration degree from Suffolk University and served 13 years in the United States Army. His ability to build high-performing teams and collaborate across complex organizations will be a tremendous asset to Breakthrough T1D.

“As we begin to see light at the end of the COVD-19 tunnel and come into 2021 prepared to propel Breakthrough T1D to an even higher level of impact, we look forward to the value Tim brings to Breakthrough T1D,” Kowalski said. “I am confident that Breakthrough T1D will greatly benefit from Tim’s expertise as we focus on accelerating our mission through significant growth in the years to come and meaningfully improving lives during every stage of the T1D journey.”

Tim’s passion for Breakthrough T1D’s mission is fueled by family members, colleagues, and friends who live with T1D.

Please join us in welcoming Tim as he joins Breakthrough T1D and works to advance the mission we all share.

It’s been a tough year, to say the least. In the beginning of the year, the Center for Disease Control and Prevention (CDC) gave out the stark news that type 1 diabetes (T1D) has gone up, to nearly 1.6 million Americans, from 1.25 million people; that’s a nearly 30% increase.

And then Breakthrough T1D and The Leona M. and Harry B. Helmsley Charitable Trust published a study that found that those people living with T1D now will pay a total of approximately $813 billion over their lifetimes in medical and in lost income and productivity costs. For an individual, that works out to nearly $500,000 per person over the course of a lifetime.

Then came COVID-19.

Without a doubt, the uncertainty and unprecedented challenges of the last year have left many of us feeling anxious, stressed, and overwhelmed.

But there’s news, as well, that we can be proud of. Really proud of. Take a look below.

1. Young Adult Reversed T1D + Clinical Trial of Baricitinib

If you haven’t already heard, T1D was reversed in a young man. I’ll say it again: T1D was reversed in a young man. This was a precision medicine treatment that corrects the effect of a genetic mutation, and the young man has been off insulin treatment for more than 2 years.

The treatment is a JAK inhibitor. JAK inhibitors are a type of therapeutic that do what the name says—stop or inhibit the activity of a JAK protein in your body.

JAK inhibitors are also being researched by Breakthrough T1D-funded scientists, Thomas Kay, M.B.B.S., and Helen Thomas, Ph.D., who found that blocking the protein may work in slowing down or preventing beta cell loss. They now have a clinical trial, funded by Breakthrough T1D, to find out if a JAK inhibitor, called baricitinib, will preserve beta cell function in children and young adults with recently diagnosed T1D.

This is the first time that a JAK inhibitor is being tested in type 1.

It is a bench-to-bedside research project—that has gone from basic research at the laboratory through a clinical trial in people with T1D—that Breakthrough T1D has had a hand in for more than a decade.

2. Drug Delays T1D Onset by Nearly 3 Years

A follow-up on the clinical trial testing the drug teplizumab—a therapy that blocks the blood marker CD3, which activates immune cells—demonstrated that it could delay the onset of T1D for nearly three years in people almost certain to develop the disease—adding a year to the previous results. This was the first ever study in humans to show a delay in the onset of type 1.

A submission to the U.S. Food and Drug Administration (FDA) is complete, and we’ll know if teplizumab is approved for the delay of clinical T1D in at-risk individuals in a year. If successful, we will be moving ever closer to a world without this disease. Teplizumab is also being tested in a phase III clinical trial in people who have been recently diagnosed, headed by Provention Bio, a company with an investment from the Breakthrough T1D Fund.

Teplizumab could become the first disease-modifying therapy approved for T1D.

Breakthrough T1D had a hand in the development of teplizumab from nearly the beginning, from the Career Development Award given to Kevan Herold, M.D., in 1988-1990, who showed that he could prevent autoimmune diabetes with an anti-CD3 non-activating antibody (which, later, became a humanized version, teplizumab), to clinical trials in recent-onset disease published in 2002, 2005, and 2013 and a phase III trial run by MacroGenics (it was called MGA031 at the time), who received a Breakthrough T1D Industry Discovery and Development Program grant from 2006-2011, to identifying who is likely to respond to teplizumab.

3. Special Diabetes Program

The Special Diabetes Program (SDP) has received several patches of funding this year while Congress has been working on a longer-term renewal of the program. Recently, the Breakthrough T1D Advocacy team had WONDERFUL news to share! Congress passed a 3-year, $150 million per year, renewal of the SDP—committing a total of $450 million for T1D research! This is a big, big win!

The T1D community has benefited immensely from the SDP since it was first enacted in 1997, and the program complements many of Breakthrough T1D’s research priorities. The SDP has helped scientists make significant advances, including artificial pancreas technology, beta cell replacement techniques, improvements to continuous glucose monitors (CGMs), and treatments for T1D complications like kidney and eye disease. These advancements bring us closer to cures and, in the meantime, make it easier to lead healthy lives with T1D.

We are grateful to our countless volunteers for helping us achieve this monumental accomplishment. Join us now in saying ‘Thank You’ to Congress today! And stay tuned for next steps!

4. Screening for T1D-Related Antibodies

Breakthrough T1D has launched a brand-new screening initiative for T1D, called T1Detect, designed to make early detection of T1D easier and more accessible to a broad population.

BreakthroughT1D-funded scientists have discovered that having 2 or more specific autoantibodies—antibodies that are directed toward your own body—means that you have an almost 100% chance of developing T1D. We can screen for these autoantibodies, and Breakthrough T1D-funded studies have shown that screening followed by close monitoring can help decrease diabetic ketoacidosis (DKA), which can be life threatening, and expands the pool of qualified participants for future trials of disease-modifying therapies. Early detection also enables families to prepare for the onset of clinical disease.

For more information about T1Detect and how to obtain an at-home testing kit, visit www.breakthrought1d.org/t1detect.

5. Insulin Activity

In December 2017, the T1D community got a jolt after a publication that tested the insulin concentrations in 18 vials, said that “brand-new screening initiative for T1D.” In other words, insulin was not at the recommended dose; in fact, the percentage of insulin was around 40% (as opposed to a minimum required dose of 95%). So Breakthrough T1D, the American Diabetes Association (ADA), and The Leona M. and Harry B. Helmsley Charitable Trust issued a request for proposals (RFP) to verify the findings.

BreakthroughT1D-funded researchers tested 9 insulin formulations, purchased at 4 pharmacies within 5 geographic locations in the U.S., and the results are out: All of the insulins purchased contained the expected quantity of active insulin. (Can we all say, “Phew!”) This study brings welcomed news to the T1D community and should ease any remaining doubt about the quality of our insulin supply.

6. Regulatory Approval of Several T1D Therapies and Technologies

We fund research to enable the development of new therapies and technologies to make day-to-day life with T1D easier, safer, and healthier, until we can find cures or prevent this disease. In 2020, we got a lot to be thankful for.

Artificial Pancreas Systems

CGM

Insulin

7. Predicting Which Children Will Develop T1D

What if there were a way to more precisely estimate future T1D risk? Breakthrough T1D-funded scientists in The Environmental Determinants of Diabetes in the Young (TEDDY) study developed a model that can help predict which children will develop T1D during the first 10 years of life.

This can guide families regarding the risk of impending onset of T1D in their child, which can, among other things, prevent diabetic ketoacidosis (DKA)—averting the treatment costs and distress that it brings. It can also greatly improve the costs of early clinical trials, such as those testing expensive vaccines, by reducing the number of participants needed.

8. A Potential First-in-Class Adjunct Therapy

A BreakthroughT1D-funded clinical trial by vTv Therapeutics provided evidence that treatment with TTP399—an oral therapy to be used in conjunction with insulin—resulted in significant improvements in HbA1c with reduction in insulin dose and, importantly, without increasing the risk of life-threatening events associated with T1D: diabetic ketoacidosis (DKA) and severe low blood sugar.

TTP399 is a glucokinase (or GK) activator. GK acts as a key regulator of sugar levels in the body. If blood-sugar levels are deemed too high, activation of GK has been shown to increase glucose utilization, which in turn lowers glucose levels in the blood.

The next step: A phase III clinical trial.

9. England to Provide Pregnant Women with CGM Technology

It’s a milestone for pregnant women with T1D and Breakthrough T1D: the National Health Service (NHS) England and the National Institute Health and Care Excellence (NICE) will provide CGM devices to pregnant women with T1D.

This is something that Breakthrough T1D can be proud of—evidence for it came from the BreakthroughT1D-funded CONCEPTT study, which proved that CGM use during pregnancy improves the health outcomes for both mothers and babies and reduces the cost for neonatal hospitalization, an otherwise frequent occurrence.

10. Europe Supports Autoantibodies

It was 2015—five years ago—that three organizations (BreakthroughT1D, the Endocrine Society, and the American Diabetes Association) published a statement urging the adoption of a staging system of T1D that uses islet autoantibodies as biomarkers. (Biomarkers, in this sense, are indicators that a person is developing T1D but is still without symptoms.)

In the spring of 2020, the European Medicines Agency (EMA) presented a letter of support to the Critical Path Institute’s T1D Consortium—who Breakthrough T1D and like-minded organizations have partnered with—to facilitate the development and validation of autoantibodies for T1D for regulatory use. This regulatory endorsement will help provide sponsors with the confidence to use autoantibodies in clinical trials evaluating novel therapies focused on the delay and/or prevention of T1D.

One Additional Accomplishment: Breakthrough T1D Turned 50!

It was 1970 and Lee Ducat’s son had just been diagnosed with a disease she had never heard of: juvenile diabetes (now known as type 1 diabetes or T1D; it was called “juvenile diabetes” because it was believed it only affected children).

After a doctor told her that with enough money, scientists could cure the disease impacting her son. So, starting with one cocktail party on May 21, 1970, she aimed to raise enough money to support T1D research—to help her son and every child affected.

“It was on that evening that the Juvenile Diabetes Foundation was born,” says Lee.

At the same time, in New York, another family was following a parallel course. Carol Lurie was seeking out families who also were struggling with a diagnosis they were told would last a lifetime. Her son was 10.

Together, the two became an unstoppable force. They were two moms who stood up, joined forces, and brought others together into what is now a growing, supporting community. They wanted to make the world see how T1D affects those impacted by the disease. They wanted to form a community that would improve diabetes management and support research that could cure T1D.

And Breakthrough T1D was born.

Breakthrough T1D, the leading nonprofit organization dedicated to curing, preventing and treating type 1 diabetes (T1D), was recently selected as a winner of the 2020 Amazon Web Services (AWS) Imagine Grant, a public grant opportunity open to registered 501(c) nonprofit organizations in the United States.

The award goes to nonprofit organizations that are using technology to solve the world’s most pressing challenges.

“We received an inspiring set of applications for this year’s AWS Imagine Grant, representing a diverse set of projects across the nonprofit sector,” said Vice President of Nonprofits and U.S. Government at AWS Dave Levy. “We congratulate our winners, who are doing fantastic work to address important societal challenges. AWS looks forward to collaborating with these amazing organizations and to building, inventing, and reimagining solutions that drive meaningful change.”

Breakthrough T1D will receive up to $100,000 in unrestricted funding and up to $50,000 in AWS Promotional Credits. This will be in addition to other capacity-building resources, such as training and implementation support.

Breakthrough T1D will use the grant to help advance its mission to cure and treat T1D and its complications, as well as improve the lives of those living with the disease.

Proposals for the AWS Imagine Grant were judged on several factors, including the innovative and unique nature of the project, impact on mission-critical goals, and clearly-defined outcomes and milestones.

T1D Diagnoses Increasing

According to a 2020 CDC report, the number of people living with T1D in the United States has grown from 1.25 to 1.6 million. Health care costs  and access to and affordability of insulin—as well as advanced technologies that help manage T1D, such as continuous glucose monitors (CGM)—can  present major impediments to improved health outcomes.

This project, in collaboration with AWS and Breakthrough T1D’s other industry partners, will help Breakthrough T1D to harness the power of data and technology in its mission to discover and get cures into the hands of people with T1D faster.

Three key goals of this initiative are:

“This award is a testament to how we’re driving progress during this challenging time,” said Breakthrough T1D President and CEO Aaron Kowalski, Ph.D. “In recognizing the advances Breakthrough T1D is making in leveraging data and technology, the AWS Imagine Grant will help us accelerate novel therapies and cures and get them into the hands of people living with T1D as soon as possible.”

Tackling Critical Challenges

Now in its third year, the AWS Imagine Grant program provides vital resources to nonprofit organizations looking to deploy cloud technology as a central tool to achieve mission goals. As part of the program, AWS seeks proposals for big ideas on how to leverage technology in new and innovative ways to accelerate impact in local and global communities.

Previous winners are currently using AWS services to tackle critical challenges such as finding cures for childhood cancer, stopping illegal fuel dumping in oceans, giving unbanked populations a financial voice, and helping veterans access critical support.

Since the launch of the Imagine Grant program, AWS has awarded over $2.5M in funding, AWS Promotional Credits and AWS training support to 26 nonprofit organizations.

“We at Breakthrough T1D and our T1D community are excited to receive the AWS Imagine Grant,” said Breakthrough T1D Chief Data and Technology Officer Sri Mishra. “Collaboration between technology leader AWS and Breakthrough T1D will open-up tremendous opportunities to help accelerate the discovery and adoption of cures and disease-modifying therapies for T1D.”

Learn more about the AWS Imagine Grant and how previous winning nonprofit organizations are using the award to advance their missions.

Read the Amazon Web Services announcement about the 2020-2021 recipients of the AWS Imagine Grant.

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.

Breakthrough T1D recently became the first nonprofit organization whose Chief Data and Technology Officer, Sri Mishra, has received one of three, highly-coveted annual awards from the International Society of Chief Data Officers (isCDO).

JDRF's CDO, Sri Mishra, holds the isCDO award.Inaugurated in 2017, the awards recognize the achievements of Chief Data Officers (CDOs) who led organizations in developing and implementing analytics capabilities with outstanding transformational results.

Mishra received the award at the 2020 Annual MIT Chief Data Officer and Information Quality Symposium hosted by MIT’s Sloan School of Management on Wednesday, August 19.

In recognition of the development and implementation of a data-driven technology architecture and infrastructure to centralize all of Breakthrough T1D’s digital systems and data, Mishra accepted the award titled “Transformation of Collaboration from Inwards to Outwards.”

According to the isCDO, the category acknowledges work that has demonstrably “impacted business mission outcomes, improved trustworthiness and timeliness of data, improved data governance” and provides a unified, secure and user-friendly data experience to internal and external stakeholders.

A Bold Vision For the Future

Breakthrough T1D’s technology transformation is a critical linchpin of its bold vision for the future: to accelerate mission and become more volunteer-powered than ever before.

The vision outlines Breakthrough T1D’s strategies to drive greater impact to unlock cures and drive research that improves the lives of people with type one diabetes (T1D) today.

As part of that vision, Breakthrough T1D will use its technology transformation to advance research collaborations, increase fundraising, and engage more supporters.

Improved technology has already helped with the disruption brought on by the coronavirus pandemic: in a timely manner, Breakthrough T1D was able to pivot from in-person to virtual community-building and fundraising events.

“We were thrilled our efforts helped the T1D community continue to move our mission forward in this challenging time,” Mishra said.