DRC & Research News

This page shares the latest news in T1D research and DRC’s community.

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Brain Differences May Impact Ability to Recognize Low Blood Sugar

Healthy adults can typically recognize when their blood sugar may be becoming too low. It triggers physical symptoms such as dizziness, sweating, weakness, and rapid heartbeat, just to name a few. Plus, their body responds by producing glucose and initiating the brain to signal for food. However, in individuals with type 1 diabetes, the brain does not always respond in this way.

A recent study found that the areas of the brain activated by low blood sugar in adults without diabetes are not the same as those in adults with type 1 diabetes. In brain scans of non-diabetic adults, areas associated with reward, motivation, and decision making showed changes during brain scans. However, only half of the individuals with T1D experienced similar changes, and only in one area of the brain – the area associated with attention – and the other half experienced no changes. Their brain showed no noticeable response to having low blood sugar, which is why individuals may miss cues that others would typically pick up on.

According to Janice Hwang, M.D., assistant professor of medicine and first author on the study, “There is a progressive loss of coordinated brain response to low blood sugar as you go from healthy adult to aware to unaware. The first areas of the brain to go are associated with feeding behavior.” The researchers are hoping that these findings will lead to more effective ways of restoring low blood sugar awareness in individuals with T1D who have lost this awareness.

It is these types of discoveries that help to improve understanding of how T1D affects the brain and body and allows researchers to develop more effective ways of treating and managing the condition. The Diabetes Research Connection supports early career scientists striving to advance research regarding the treatment, prevention, diagnosis, and management of T1D. Researchers can receive up to $50,000 in funding to apply toward their project. To learn more or support these efforts, visit http://diabetesresearchconnection.org.

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DRC-Funded Scientist Creates New Insulin-Producing Cells to Fight Type 1 Diabetes

Thanks in part to funding from the Diabetes Research Connection (DRC), Dr. Kristin Mussar was able to conduct an in-depth study regarding how to stimulate the body’s own cells to create new insulin-producing cells that may help treat type 1 diabetes (T1D). In individuals with T1D, the immune system attacks insulin-producing cells, destroying them and leaving the body unable to effectively regulate blood sugar.

The human body is filled with myeloid cells that all differentiate to help grow, maintain, and repair various organs. When these cells are depleted, it impacts organ health. For instance, lack of insulin-producing cells results in diabetes. However, Dr. Mussar and her team discovered that there is a population of macrophages – white blood cells that recirculate throughout the body constantly monitoring the health status of all tissues – that instruct insulin-producing cells to grow in the perinatal stage of pancreas development. During this period of prolific growth, enough insulin-producing cells are created to support glucose homeostasis throughout one’s life.

Dr. Mussar found that there is a special population of these cells that act as cargos of potent growth factors for the insulin-producing cells in the pancreas. If these cells are prevented from entering the pancreas, the growth of insulin-producing cells is arrested and diabetes ensues. This lack of cell growth, as well as cell destruction, are issues that researchers have been trying to remedy through various strategies for treating T1D.

One avenue of treatment that is being explored is finding ways to use the body’s own cells and processes to support insulin production. Current challenges in treatment include the constant monitoring and accurate dosing of insulin, as well as the use of immunosuppressants or other medications to prevent the body from destroying modified cells or specialized therapies. Using the body’s own cells can help reduce risk of immune attack or rejection.

To this effect, Dr. Mussar’s research revealed that there are precursors to these special macrophages that exist within the bone marrow of adults. When these precursors are injected into the blood stream, they are able to signal growth of insulin-producing cells. This discovery raises hopes that, by dispatching these pro-regenerative cells from the bone marrow to injured pancreatic islets, it may be possible to enhance regeneration of insulin-producing cells in individuals with type 1 diabetes. This may in turn help to stabilize blood sugar naturally using the body’s own cells.

The Diabetes Research Connection is proud to have played a role in making Dr. Mussar’s research possible by providing funding that enabled her to continue moving forward with her project and eventually get the results published in the Journal of Clinical Investigation.

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Could Reprogramming Cells Help Treat Type 1 Diabetes?

More than 300 million people around the world are living with diabetes. Currently, there is no cure, but scientists are continually researching and testing different methods for treating and managing this disease. One of the major obstacles faced in treating type 1 diabetes is that the body’s immune system attacks and destroys insulin-producing beta cells, whether these cells are naturally occurring or introduced through medical treatment.

Some researchers are looking at ways to reprogram the body’s own cells to function as insulin-producing cells to help better control blood sugar. The human pancreas contains small niches where hormone-making cells reside. Within these niches, two different cells predominate: alpha cells, which make glucagon, and beta cells, which make insulin. In individuals with type 1 diabetes, insulin-producing cells are destroyed, but glucagon cells are not.

Scientists developed a method using viruses as carriers to deliver two genes that are present in insulin but glucagon cells to the glucagon cells allowing the cells to be able to produce insulin. Glucagon cells are a good option for this process because they are similar to insulin cells and appear in abundance in islets within the pancreas already. A decrease in these cells as they were reprogrammed did not appear to affect glucose metabolism.

These experiments have been performed in NOD mice, which are mice that develop diabetes very close to human diabetes. Following the experiment, the diabetes disease appeared to have resolved in the diabetic NOD mice thanks to the new source of cells making insulin in their pancreas. However, human application of this technique will take time since targeting specific cells is complicated, and the use of viral elements creates side effects that need to be resolved.

It is this type of research and these experiments that lead to breakthroughs in the treatment, management, prevention, and improvement in the quality of life for individuals living with type 1 diabetes. Though not involved in this particular study, the Diabetes Research Connection supports early-career scientists through funding for novel research on type 1 diabetes. Learn more about current projects and support their advancement by visiting http://diabetesresearchconnection.org.

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Diabetes Research Connection 2016 Year in Review

This past year has been a big one for us at Diabetes Research Connection. Our donors have stepped up to the plate and helped us fund research towards treating, curing and preventing type 1 diabetes. In fact, in 2016 we were able to raise more than $490,000 thanks to the support of our donors.

We’re committed to keeping our backers updated on all projects and DRC happenings, so we wanted to take time at the beginning of 2017 to remind ourselves and our donors of all the amazing things that happened in 2016.

In January, Sangeeta Dhawan, Ph.D. at UCLA School of Medicine started off the year with her project, Making More and Better Insulin Producing Cells with Cell Regeneration. We were able to help her raise more than $30,000.

Dr. Sangeeta Dhawan

 

In February, we launched another project, Replacement Beta-Cells From An Unexpected Source, a research study conducted by Joseph Lancman, Ph.D. — Sanford Burnham Prebys Medical Discovery Institute. We were able to raise more than $45,000 in support of this project.

Dr.Lancman in Lab

In April, we celebrated World Health Day. This year’s theme was Beat Diabetes, and we encouraged our donors and supporters to get involved in the global fight against diabetes.

In May, another project launched, and we were able to help Peter Thompson, Ph.D. at University of California San Francisco raise more than $30,000 for his project, Regrowth of Beta Cells with Small Molecule Therapy.

Peter Thompson - Regrowth of beta cells with small molecule therapy

Another new project came online in July; Agata Jurcyzk, Ph.D. of the University of Massachusetts Medical School, What is the Connection Between T1D and Depression?

Agata-Headshot

August was a busy month for us at DRC. In mid-August, we partnered with the diaTribe Foundation for Brews & Blood Sugar. More than 100 people joined us to samples beer from one of San Diego’s premier breweries, to learn how different varieties of beer affect blood sugar and support efforts to find solutions for those with diabetes. We also launched our T1D resource center in August, where we’ve curated the best information out there pertaining to T1D. Lastly, we launched a project to raise funds for Gene-Specific Models and Therapies for Type 1 Diabetes, research being conducted by Jeremy Racine, Ph.D. of The Jackson Laboratory.

jeremy_racine_lab

In September, we were honored to be featured by The Huffington Post. We also launched our campaign on Gladitood, which helped us raise money and support for our General Fund as we began to close out the year.

In November, we celebrated National Diabetes Month. As a part of these celebrations, we launched our Double Your Dollars campaign, where every dollar donated to the General Fund was matched 100%. We upped the ante on Cyber Monday, doubling each match, making donations go even further. All told, we raised more than $80,000 in November. Additionally, we hosted a Crowdfunding Science event on Cyber Monday, where attendees joined three Rancho Santa Fe Foundation Donor Advised Fund families to learn about an exciting, successful and innovative crowdfunding platform for scientific research.

doubledollarsplaceholder

In December, we started a new blog series to help our donors meet the board, and we began by introducing you to Alberto Hayek, M.D., President of DRC.

This past year was monumental for DRC, and 2017 is already off to a great start with the launch of a new research project, Determining How Other Cells (Non-Beta) In The Pancreas Affect Diabetes by Jeffrey D. Serrill, Ph.D. of City of Hope, Los Angeles, California. We’re looking forward to seeing what the year holds as we fund research projects that will bring us closer to preventing, treating and curing T1D.

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ETH Researchers T1D

New Weapon Against Diabetes

Original article published by ETH Zurich on December 1, 2016. Click here to read the original article.

Researchers have used the simplest approach yet to produce artificial beta cells from human kidney cells. Like their natural model, the artificial cells act as both sugar sensors and insulin producers.

Researchers led by ETH Professor Martin Fussenegger at the Department of Biosystems Science and Engineering (D-BSSE) in Basel have produced artificial beta cells using a straightforward engineering approach. These pancreatic cells can do everything that natural ones do: they measure the glucose concentration in the blood and produce enough insulin to effectively lower the blood sugar level. The ETH researchers presented their development in the latest edition of the journal Science.

Previous approaches were based on stem cells, which the scientists allowed to mature into beta cells either by adding growth factors or by incorporating complex genetic networks.

For their new approach, the ETH researchers used a cell line based on human kidney cells, HEK cells. The researchers used the natural glucose transport proteins and potassium channels in the membrane of the HEK cells. They enhanced these with a voltage-dependent calcium channel and a gene for the production of insulin and GLP-1, a hormone involved in the regulation of the blood sugar level.

Voltage switch causes insulin production

In the artificial beta cells, the HEK cells’ natural glucose transport protein carries glucose from the bloodstream into the cell’s interior. When the blood sugar level exceeds a certain threshold, the potassium channels close. This flips the voltage distribution at the membrane, causing the calcium channels to open. As calcium flows in, it triggers the HEK cells’ built-in signalling cascade, leading to the production and secretion of insulin or GLP-1.

The initial tests of the artificial beta cells in diabetic mice revealed the cells to be extremely effective: “They worked better and for longer than any solution achieved anywhere in the world so far,” says Fussenegger. When implanted into diabetic mice, the modified HEK cells worked reliably for three weeks, producing sufficient quantities of the messengers that regulate blood sugar level.

Helpful modelling

In developing the artificial cells, the researchers had the help of a computer model created by researchers working under Jörg Stelling, another professor in ETH Zurich’s Department of Biosystems Science and Engineering (D-BSSE). The model allows predictions to be made of cell behaviour, which can be verified experimentally. “The data from the experiments and the values calculated using the models were almost identical,” says Fussenegger.

He and his group have been working on biotechnology-based solutions for diabetes therapy for a long time. Several months ago, they unveiled beta cells that had been grown from stem cells from a person’s fatty tissue. This technique is expensive, however, since the beta cells have to be produced individually for each patient. The new solution would be cheaper, as the system is suitable for all diabetics.

Market-readiness is a long way off

It remains uncertain, though, when these artificial beta cells will reach the market. They first have to undergo various clinical trials before they can be used in humans. Trials of this kind are expensive and often last several years. “If our cells clear all the hurdles, they could reach the market in 10 years,” the ETH professor estimates.

Diabetes is becoming the modern-day scourge of humanity. The International Diabetes Federation estimates that more than 640 million people worldwide will suffer from diabetes by 2040. Half a million people are affected in Switzerland today, with 40,000 of them suffering from type 1 diabetes, the form in which the body’s immune system completely destroys the insulin-producing beta cells.
[su_button url=”https://www.ethz.ch/en/news-and-events/eth-news/news/2016/12/artificial-beta-cells.html?elqTrackId=3118751de0d340b8bf7c42cba3a3a7d2&elq=3ba510d3772545b28e0cfdf8c559795e&elqaid=17762&elqat=1&elqCampaignId=10602″ target=”blank” style=”flat” background=”#64b243″ size=”6″ center=”yes” radius=”5″ icon=”icon: angle-right”]Continue Reading[/su_button]

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diabetes research

Economic 3D-Printing Approach for Transplantation of Human Stem Cell-Derived β-Like Cells

Original article published by IOP Science on December 1, 2016. Click here to read the original article.

Abstract

Transplantation of human pluripotent stem cells (hPSC) differentiated into insulin-producing βcells is a regenerative medicine approach being investigated for diabetes cell replacement therapy. This report presents a multifaceted transplantation strategy that combines differentiation into stem cell-derived β (SC-β) cells with 3D printing. By modulating the parameters of a low-cost 3D printer, we created a macroporous device composed of polylactic acid (PLA) that houses SC-β cell clusters within a degradable fibrin gel. Using finite element modeling of cellular oxygen diffusion-consumption and an in vitro culture system that allows for culture of devices at physiological oxygen levels, we identified cluster sizes that avoid severe hypoxia within 3D-printed devices and developed a microwell-based technique for resizing clusters within this range. Upon transplantation into mice, SC-β cell-embedded 3D-printed devices function for 12 weeks, are retrievable, and maintain structural integrity. Here, we demonstrate a novel 3D-printing approach that advances the use of differentiated hPSC for regenerative medicine applications and serves as a platform for future transplantation strategies.

[su_button url=”http://iopscience.iop.org/article/10.1088/1758-5090/9/1/015002/meta?elqTrackId=96062d779f46499eb7cc18d9ab30d665&elq=3d599e01edda49df92afa531a8a717ae&elqaid=17717&elqat=1&elqCampaignId=10609″ target=”blank” style=”flat” background=”#64b243″ size=”6″ center=”yes” radius=”5″ icon=”icon: angle-right”]Continue Reading[/su_button]

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How to Honor National Diabetes Month

Diabetes affects more than 29 million Americans and is the 7th leading cause of death in the US today. While Diabetes Research Connection fights to find a cure for type 1 diabetes every month, we give an extra push during the month of November for National Diabetes Month. There are many ways you can contribute during National Diabetes Month, including our Double Your Dollars campaign, shopping with AmazonSmile, volunteering at a hospital or research center or participating in a walk/run benefiting diabetes. Read below for more details on how you can get involved.

Make Your Donation Count Twice As Much With Double Your Dollars

In honor of National Diabetes Month, DRC is matching every dollar donated to the General Fund (up to $50,000) between now and November 30 through our Double Your Dollars campaign. It is the perfect time to make a difference in the T1D community by donating to our campaign and making your charitable act go twice as far.

Every donation helps early-career scientists launch their ideas and allows 100% of funds directed for T1D research to go directly to the researcher’s laboratory. Donations are critical for us to operate our innovative platform, even though DRC’s operating costs are kept less than 10% of gross revenue.

Make a Difference While Shopping on Amazon

November is the month where most of us start our holiday shopping- the excitement of the good deals of Black Friday and Cyber Monday are almost too much to bear. If the crowds and late hours of Black Friday intimidate and overwhelm you and Cyber Monday is more your speed, try using AmazonSmile to accommodate all your holiday shopping needs. AmazonSmile is Amazon’s nonprofit charitable support arm and allows the shopper to choose from a variety of charities who will benefit monetarily from their purchases, without any additional cost to the shopper.

To honor National Diabetes Month, you can do your holiday shopping through AmazonSmile and select Diabetes Research Connection as your charity of choice so that a portion of your purchase goes to finding a cure for those with T1D. Visit smile.amazon.com to get started.

Participate in a Walk or Run

A great way to get involved with the fight to find a cure for T1D and honor National Diabetes Month is to participate in a walk/run benefiting diabetes. Not only would it be benefitting a great cause, but doing a walk/run is a great way to be active with a big group of people. There are many options available depending on what area you live, so it helps to do some research to find one that suits your fitness level needs.

Volunteer at a Hospital or Research Center

It’s very easy to find places that need volunteers, such as hospitals or research centers. Not only is it a good time of year to donate your time because of the holiday giving season, but also because of National Diabetes Month- you can opt for a research center or a hospital that specializes in T1D. This is the perfect way to give back for those who can’t donate money.

For more information on how you can get involved in the fight to find a cure for T1D, and to receive frequent updates about DRC, sign up for our newsletter!

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t1d research

Antibiotic-Mediated Gut Microbiome Perturbation Accelerates Development of Type 1 Diabetes in Mice

Original article published by PubMed on August 22, 2016. Click here to read the original article.

The early life microbiome plays important roles in host immunological and metabolic development. Because the incidence of type 1 diabetes (T1D) has been increasing substantially in recent decades, we hypothesized that early-life antibiotic use alters gut microbiota, which predisposes to disease. Using non-obese diabetic mice that are genetically susceptible to T1D, we examined the effects of exposure to either continuous low-dose antibiotics or pulsed therapeutic antibiotics (PAT) early in life, mimicking childhood exposures. We found that in mice receiving PAT, T1D incidence was significantly higher, and microbial community composition and structure differed compared with controls. In pre-diabetic male PAT mice, the intestinal lamina propria had lower Th17 and Treg proportions and intestinal SAA expression than in controls, suggesting key roles in transducing the altered microbiota signals. PAT affected microbial lipid metabolism and host cholesterol biosynthetic gene expression. These findings show that early-life antibiotic treatments alter the gut microbiota and its metabolic capacities, intestinal gene expression and T-cell populations, accelerating T1D onset in non-obese diabetic mice.

[su_button url=”https://www.ncbi.nlm.nih.gov/pubmed/27782139?dopt=Abstract&utm_source=twitterfeed&utm_medium=twitter#” target=”blank” style=”flat” background=”#64b243″ size=”6″ center=”yes” radius=”5″ icon=”icon: angle-right”]Continue Reading[/su_button]

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insulin pen

In-Depth: Five innovators who see the future of connected insulin delivery in pens, not pumps

Original article published by Mobi Health News on October 21, 2016. Click here to read the original article.

Medtronic. Dexcom. Abbott. Sanofi. Google. A lot of very large, well-known companies are investing heavily into innovating the diabetes space, and that innovation is exciting. But a disproportionate amount of the innovation around insulin delivery focuses on the insulin pump, a delivery device that’s only used by a small percentage of insulin users. Most insulin users — between 70 and 93 percent, depending on whose figures you use and what part of the world you’re looking at — use an insulin pen, a device developed by Novo Nordisk in the eighties and relatively unchanged since then.

A small crop of startups has decided that it’s high time connected health innovation came to the insulin pen. One of the leaders of the pack — a San Diego startup called Companion Medical — is led by a veteran of those big company efforts. CEO Sean Saint previously worked at Medtronic, Dexcom, and Tandem Diabetes.

“Here I am at Tandem asking this question ‘How do we get more people to use the insulin pump?’” he told MobiHealthNews. “And that’s the right question for Tandem. So we’re asking questions like ‘Why will you or won’t you use an insulin pump?’ and we’re getting answers like tubing, cost, complexity that sort of thing. To be frank I was getting a little frustrated with the patient, and asking ‘Why won’t you use this great technology we’re developing?’”

That’s when Saint found himself on the other side of the pump: He was diagnosed with Type 1 diabetes.

“For me it caused me to look in the mirror and say ‘Stop being frustrated with people who won’t use your great technology. They have their reasons.’ Instead, let’s ask a different question. Let’s ask ‘How do we bring the benefits of insulin pumps to the 93 percent of people who use insulin who are pen and syringe users?’”

Companion Medical, with backing from Eli Lilly and Company, announced this past summer that it had FDA clearance to do just that. And in the months that followed, three other companies came out of stealth announcing that they were working on similar offerings. A fifth, Emperra, has been quietly developing its own smart insulin pen in Germany and will soon be ready to take it to other parts of the world.

First Patients Pending, a London company that had already innovated the insulin pen space with a non-connected cap called Timesulin, announced that it was working on a smartphone-connected product. Then an Irish group called Innovation Zed, which also had a pre-existing nonconnected insulin pen accessory, announced its plans to enter the space. And finally a second US company, Cambridge, Massachusetts-based Common Sensing, announced a trial funded by Sanofi and led by the Joslin Diabetes Center.

What all these companies have in common is they recognize that, though it might be the focus of big companies, the insulin pump is not the preferred device of the masses.

“We’ve talked to a lot of people in the space and what we’ve learned is that, first of all, not everyone prefers pumps,” James White, president of Common Sensing, told MobiHealthNews. “There’s people that have access to them and a lot of them choose not to use pumps. There’s people who want access and can’t get them. But we’re pretty sure for the next five to 10 years there is not a pump both for the market and everyone’s preferences, so there won’t be that ‘coming together’ to take any kind of authority in the market. We talk with pharma companies and we hear a fair amount of their predictions. And as nice as the pump is for some people, for a lot of people it just doesn’t make sense.”

Creating a connected insulin pen is a leap of several steps at a time. Unlike, say, fingerstick glucometers, which have always collected data but didn’t always store or transmit it, the traditional insulin pen doesn’t collect data at all. If patients want a record of how much insulin they used, they have to eyeball it and write it down. A connected pen is first and foremost an adherence play, but it can go much further — by interfacing with glucometer or CGM data or self-reported food data, a connected insulin pen could allow pen users to live some variant of the artificial pancreas dream, which up until now has only been a possibility for pump users.

“I believe that the insulin data is the most important data that we have,” Patients Pending CEO and cofounder John Sjölund told MobiHealthNews. “Currently, every time you turn the dial and inject yourself, it just disappears. All of the blood sugar and especially the CGMs, they exist, they’re good enough and the apps exist and they’re getting better. But the insulin information is just missing. And that’s the piece of the pie we bring out, and what’s important is the accuracy we bring to the table.”

From insulin adherence to insulin management

One way in which the various companies in this space differ is exactly what problem they’re using connectivity to solve. For most of the startups right now, the objective is simply to collect the data of how a often a patient uses an insulin pen and how much insulin they inject, and to use that data to drive adherence.

“The [device] we announced this week is the first step, we’re tackling that 60 to 70 percent adherence rate of insulin users,” John Hughes, CEO of Innovation Zed, told MobiHealthNews. “The insulin user audience are at a very low level of compliance. You show up at the doctor and inevitably when you get there, you don’t have your records. They’re working on anecdotal data. We have focus groups [of doctors] that we work with and they tell us, they cannot trust the data that they’re getting.”

The most basic advantage of tracking pen usage doesn’t require connectivity at all. Patients Pending’s original product, Timesulin, is a cap for insulin pens that starts a timer when it’s removed and replaced, so that patients can always look at it and see when their most recent dose was. Even this is useful information that can help prevent double dosing.

Adding connectivity also allows a device to send alerts about a missed dose to the patient’s smartphone, or to alert a patient’s physician, caregiver, or coach when they miss a dose. That’s where James White, president of Common Sensing, sees the initial value of the technology.

“Right now, people go home from the doctor after being given insulin for the first time and they don’t have another touchpoint for three months with anything,” he told MobiHealthNews. “Their data is theirs, they’re looking at it, they often don’t know how to interpret it because they weren’t taught at the doctor, and more than half of those people, in those first three months, drop off. They come back and they’re not using it. They haven’t filled all their prescriptions, things like that. The reasons vary a ton. Sometimes people aren’t prescribed needles to use with their insulin pen. Some people don’t know how to use it, they’re afraid to inject something new, or they don’t remember the instructions.”

Common Sensing’s Gocap is focused on collecting the data and sending it to a smartphone app, from whence it can also be sent to a data aggregator or a caregiver. The company is looking into developing its device for different levels of tech savvy: some use cases might allow for more patient engagement while others are designed to be more passive.

“We’ve sent this home now with a fair number of people and we’ve seen a wide spectrum. Some people don’t have a smartphone, they want to keep a very cheap mobile data device plugged into the wall and never look at it and use this hardware device. They know the data’s going somewhere, to their doctor, and that’s all they care about,” he said. “And then some people are the power users, just like any product. They want to get into the data, enable that exact setting, see every new dose they’ve done, understand the accuracy and the glucose readings.”

As an adherence play, the space is very reminiscent of another medication delivery device that’s recently blossomed into a burgeoning industry in digital health: the connected, sensor-laden inhaler. After some early success by companies like Propeller Health, the connected inhaler space rapidly became a hot acquisition target for the pharmaceutical industry. The comparison isn’t lost on insulin pen innovators.

“What I like about insulin and why we made it a first target for the company is that right now, you know, inhalers can be expensive when they’re taken incorrectly, but the cost burden on the healthcare system right now of incorrect insulin use is far greater than any other medication,” White said. “Pharma right now loses on the order of a third of revenue they could be getting just because a third of prescriptions are never picked up. And not only that but among people who are using it it’s not being used very effectively. So a company that can differentiate in making their insulin more effective stands to benefit, and that’s why companies like Sanofi are interested.”

So far at least two major pharma companies have invested in this space: Sanofi has invested in Common Sensing and Lilly has invested in Companion Medical. Neither of those investments has “strings attached” according to the two companies, but the interest is certainly notable.

But Sean Saint, of Companion, sees the insulin pen space as being much deeper than the inhaler space.

“The connected inhaler market is a compliance tool,” he said. “And that’s wonderful, because we all know about compliance problems. And we have 100 percent of that benefit. Same exact thing. But one of the biggest problems in diabetes is not that I don’t remember to take my dose, but how much do I take? I know my blood sugar, I know what I have recently eaten and my recent insulin doses, so how much insulin do I take right now? That’s what a dose calculator provides and we are the only company I am aware of in the connected pen/cap space that has a dose calculator and certainly the only one cleared by FDA.”

That’s why Companion Medical has FDA 510(k) clearance while some of the other companies are holding off. (Common Sensing is registered with the FDA but White doesn’t believe it’s current adherence-focused offering requires premarket approval). By taking the next step and offering a dose calculator, and starting to offer advice on how much insulin a patient could take, the company enters a new risk category, but also potentially offers even more benefits to people with diabetes.

Saint’s company’s goal is to create a learning dose calculator, which will use the same kind of algorithms closed-loop “artificial pancreas” systems use, but with a connected pen rather than a pump as the delivery method.

“You can call it a poor man’s artificial pancreas or artificial pancreas light or whatever you want to call it, but it’s basically using the same algorithms and applying them to mobile injection therapy,” he said. “Nobody’s ever done that, so nobody knows what the ultimate clinical benefit of that will be, but we know that there will be one.”

For Patients Pending and Common Sensing, that functionality could be in the cards eventually, but they don’t see a reason to reinvent the wheel. Once the data is accurately collected and sent to a smartphone, third party apps can focus on making it actionable for the user.

“We’ve had a lot of experience developing software, but we’ve also learned how tricky healthcare and medical apps is,” Patients Pending’s Sjölund said. “And there are a lot of apps in the space already.”

Pens, caps, and wraps

Another differentiating factor between the various companies is the form factor. Only two of the five companies make a full-on insulin pen, two make smart pen caps, and one, Innovation Zed, makes a unique wraparound device that fits on the back part of the pen.

There are different facets to the decision. One is that, most companies agree, creating an entire insulin pen is a more daunting endeavor than creating an add-on.

“At first we thought, hey let’s build a digital pen,” Innovation Zed’s John Hughes told MobiHealthNews. “Not being very experienced in medical device market we were quickly put off by the regulatory implications of such a device. We thought, it will take us seven years to do that. So we came up with the concept of an add-on technology.”

Saint, at Companion, echoed these sentiments, though his company did decide to go down the full pen road (as did Emperra in Germany).

“One thing I can absolutely assure you: we did not design a full insulin pen instead of a cap because we thought it would be fun,” he said. “We considered the different solutions and we decided that the only way we could provide a solution to the patient that was going to be truly transparent to their current therapy was to control the whole experience. And that’s why we went with the pen.”

Controlling the whole device simplifies the design of the sensors and allows Companion Medical to include a larger battery — their device will last a year with no need to plug in or replace batteries, compared to Common Sensing’s cap, which will have to be plugged in once a week (though White says they’re also working on a version with a longer-term battery). It also allows for some complex features, like compensating for inaccuracies that can be caused by priming the pen (activating it without dosing to eliminate air bubbles).

On the other hand, add-on solutions have some added convenience in the market. While Companion’s device will replace a durable pen, other devices can work with disposable insulin pens, which are currently more popular.

“We diabetics are a pretty conservative lot and we don’t like changing our habits,” Innovation Zed’s Hughes said. “So when we get used to insulin pens we want to keep them. So we offer them a sleeve that wraps around the pen and a timer devices that clips on to the sleeve and is triggered only when the injection is completed.”

Saint thinks the additional value will be enough to persuade patients to change their habits. Caps are also likely cheaper to produce, but that could be a moot point if health insurers start routinely reimbursing for the devices.

The path to market and reimbursement

Although the space is just starting to emerge into public consciousness, the players have been working quietly on it for years, and now the race to market is on.

One company, Emperra, has a big lead, but it has only focused on its native Germany. It’s CE-marked Esysta pen is already on the market in Germany and reimbursable by German payers.

“We are on the market,” Emperra CEO Christian Krey told MobiHealthNews in an email. “It is working and has proved success. We are reimbursed by all health insurers in Germany. We have a unique software, that connects patients, relatives, nurses and physicians with high secured servers. We have unique contracts with health insurers that pay not only for the hardware, but also for data sharing between patient and the physician as well as for coaching the patients, depending on their needs.”

He also said the company has “proven success in a field trial together with a health insurer, that the use of the ESYSTA system leads to significant lowering of HbA1c without more usage of insulin.”

Emperra is already making inroads in the rest of the EU and in the US. The company has filed for FDA approval and hopes to enter the US market next year.

Innovation Zed also has trial data showing its product improves HbA1c, thanks to a partnership with the UK’s NHS. The Irish company also has a joint venture with Swedish injectables manufacturer SHL Group that could help them bring their new solution to market quickly once it’s fully developed. They’re targeting a 2017 European launch for the connected product and eyeing the US shortly thereafter. They are hoping for reimbursement from national systems like the NHS and from private payers in the US.

Common Sensing recently announced a clinical trial with Joslin Diabetes Center. Their product is ready to go, White says.

“The device is ready now, so what we’re looking for is the most efficient way to commercialize it with those services to insurers, self-insured employers, etc.,” he said.

Similarly, Companion Medical’s Sean Saint says his company is planning for commercialization in 2017, having been focused up until now on the FDA clearance.

“Smart pens are not a category yet,” he said. “We have the first cleared smart pen, and we’re going to be in the unenviable position of starting to figure out pricing on that. Pricing what amounts to a new category of devices can be very challenging. On the one hand, we have the negative that we look a lot like a traditional insulin pen. On the other hand we have the positive that we believe we offer a very significant clinical benefit over and above traditional insulin pens and potentially as much as a pump. So certainly the pricing will be in between traditional insulin pens and pumps. But I can’t tell you exactly where at this point.”

He says there will be some work to do for reimbursement, but he’s confident that the device will eventually be covered via the pharmacy benefit of a prescription drug plan. White agrees that reimbursement is inevitable.

“The general idea is we don’t want people to have to pay for this out of pocket,” he said. “The idea that patients are causing the problem right now is one that shouldn’t really exist in any modern society. And that means that patients shouldn’t be responsible for fixing this problem in terms of paying for their own medicine. So in our minds, the people who stand to gain the most from this are insurance companies and pharma companies. If someone switches from taking their insulin to not taking their insulin, in the next year they will probably cost on the order of $2,500 more per year and the insurer’s paying for all of that.”

Innovation in the diabetes space is coming in a lot of forms from a lot of places, from the artificial pancreas, to AI coaching, to glucose-sensing contact lenses. But when it comes to making a big difference right now in the lives of many insulin-using type 1 diabetics, smart pens might just be the next big thing. As Saint pointed out, the market is so much larger for pens that even a modest improvement in diabetes management could help a lot of people.

“The health economics of smart pens are phenomenal when you start to think about them,” he said.

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Gladitood

Support a Cure for Type 1 Diabetes on Gladitood

Millions of children and adults struggle with type 1 diabetes (T1D). Throughout the month of October, we’ll be raising money to help find a cure on Gladitood, a crowdfunding platform that helps nonprofits raise funds for important causes. This is an exciting opportunity but we need your help

Consider Autumn, a woman in her mid-20s who was diagnosed at the age of nine. Every day she is carefully balancing her blood sugar through painfully pricking her fingers to manage her blood sugar. She’s been hospitalized for diabetic ketoacidosis, a condition where they body produces excess blood acid, which can quickly become fatal if not treated. Diabetes doesn’t just affect her, it affects her family, friends and co-workers too.

We need to raise $5,000 by the end of October.

How Can You Help?

Donate to Diabetes Research Connection on Gladitood. Donating to DRC through Gladitood is easy. Simply visit our campaign page, choose a donation level to the right that you’d like to contribute to, then follow the prompts to donate through Gladitood’s secure platform. In exchange for donating, you’ll be able to choose from a variety of “rewards,” ranging from a Facebook shout-out, to tickets to our Brews and Blood Sugar event, to a Q&A session with a T1D researcher. There is no minimum or maximum donation; donors can contribute as little or as much as they want, and all donations are tax-deductible as DRC is a 501(c)(3) nonprofit organization.

Spread the word about our Gladitood campaign! Whether you post about it on Facebook, email it to your contacts or share the link with your co-workers, we’re grateful for everyone who shares our project and helps us raise $5,000 through Gladitood. For those that want to be more involved, Gladitood allows volunteers to create a fundraising page, set a personal fundraising goal, and share their unique URL link with their network in order to raise money on behalf of DRC.

Why Is DRC Raising Money on Gladitood?

Gladitood offers the ability for donors to fundraise on DRC’s behalf by creating and sharing a custom fundraising page with your network of family and friends. Running a project on Gladitood helps spread the word about our mission, just by taking our organization to donors looking for a place to give. The more visibility, the more likely we are to meet our goal and continue to fund innovative, peer-reviewed T1D research.

How Will the Money Raised Through Gladitood be Used?

Donations to the General Fund collected through Gladitood will help early-career scientists get their ideas off the ground by providing funds to conduct peer-reviewed research designed to prevent, cure and treat T1D. The General Fund, after reasonable reserves, may be used to complete funding for research projects that are short of their goal. DRC’s operating costs are kept as low as possible and are targeted to be less than 10% of gross revenue.

Unfortunately, scientific research is expensive. Just consumable supplies needed for a research project can cost $20,000 or more. By raising money that goes directly to the scientists researching T1D, we’re able to ease the financial burden of research and fight for a cure for T1D.

Visit our Gladitood campaign page today to support our T1D research and help us reach our $5,000 goal by the end of October.

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