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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.
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insulin

“Artificial Pancreas” Is Approved

Original article published by The JAMA Network on October 4, 2016. Click here to read the original article.

A new device that automatically monitors blood glucose levels and adjusts insulin levels has received FDA approval. The device, manufactured by Dublin-based Medtronic PLC, is the first such system to gain the agency’s blessing.

The new MiniMed 670G hybrid closed-loop system is intended for people aged 14 years or older who have type 1 diabetes. Because it operates with a smart algorithm that learns an individual’s insulin needs and delivers appropriate basal doses 24 hours a day, little user input is required. Patients who use the system will only have to enter their mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor.

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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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DRC

U.S. FDA approves Medtronic’s ‘artificial pancreas’ for diabetes

Original article published by Yahoo! Finance. Click here to read the original article.

Medtronic Plc won U.S. approval on Wednesday for an “artificial pancreas” that is the first device to automatically deliver the right dose of insulin to patients with type 1 diabetes, freeing them from continually monitoring insulin levels throughout each day.

The U.S. Food and Drug Administration, in its approval of the device, the MiniMed 670G, hailed it as a breakthrough.

The device offers type 1 diabetics “greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” Dr. Jeffrey Shuren, director of the FDA’s medical device division, said in a statement.

Analysts said the FDA approved the device six months sooner than expected. However, it will not be available until the spring of 2017.

The MiniMed 670G is the first device that allows a glucose sensor to communicate with an insulin pump and automatically regulate the insulin flow. The device is approved for those aged 14 and older.

The device measures glucose levels every five minutes and automatically administers insulin as needed. Patients will still need to instruct the device to deliver extra insulin for meals and notify the device when they exercise – which lowers glucose levels.

About 1.25 million American children and adults have type 1 diabetes, a condition in which the pancreas produces little or no insulin – a hormone needed to obtain energy from food.

Patients take insulin injections at various times of the day. But blood sugar can drop to dangerously low levels if too much insulin circulates in the bloodstream, requiring patients to frequently or continually monitor their insulin levels throughout the entire day.

“This device will mean peace of mind, in knowing a person will be in normal blood sugar range a great majority of the time,” said Derek Rapp, chief executive officer of the Juvenile Diabetes Research Foundation, which has spent $116 million on research in the artificial pancreas field.

Rapp, who has a college-age son with type 1 diabetes, said his son as a child had to be awakened many times each evening so his finger could be pricked for a blood sample, to ensure his blood sugar level was in an acceptable range. If too low, his son would be given fruit juice or a snack. If too high, he would be given insulin.

“It is a major news event that a system of this kind has been approved – the first time a pump will administer insulin as a result of information it receives from a sensor,” Rapp said.

The Medtronic device includes a coin-size sensor with a protruding needle that is slipped under the skin and continually monitors glucose levels. It is held in place with a sticky backing. The other main component is an insulin pump, often worn on the side of the abdomen, which has tubes that lead to a catheter that delivers the insulin.

Insulin pumps are currently used by more than a third of U.S. patients with type 1 diabetes, but they require manual adjustment to administer the needed insulin dose. Many patients also wear sensors that continually monitor their glucose levels.

Several insulin pump makers, including Johnson & Johnson , Tandem Diabetes Care Inc and Insulet Corp , are teaming up with sensor maker Dexcom Inc to develop devices like Medtronic’s but are several years behind, according to Jefferies analyst Raj Denhoy.

He said the Medtronic system is a big step for patients, but the Holy Grail would be a completely automatic artificial pancreas that does not need any intervention, including for meals or exercise. Such a product is probably at least five years away from development, he said.

Although Medtronic has not announced a price for the MiniMed 670G, Denhoy estimated it may cost $5,000 to $8,000, with the annual cost of disposable sensors another few thousand dollars.

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t1d research

Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes

Original article published by The Journal of the American Medical Association. Click here to read the original article.

Closed-loop artificial pancreas technology uses a control algorithm to automatically adjust insulin delivery based on subcutaneous sensor data to improve diabetes management. Currently available systems stop insulin in response to existing or predicted low sensor glucose values, whereas hybrid closed-loop systems combine user-delivered premeal boluses with automatic interprandial insulin delivery. This study investigated the safety of a hybrid closed-loop system in patients with type 1 diabetes.

Methods

Patients aged 14 to 75 years with type 1 diabetes for at least 2 years, glycated hemoglobin (HbA1c) less than 10%, and more than 6 months of insulin pump use were recruited from 10 centers (9 in the United States, 1 in Israel) between June 2, 2015, and November 11, 2015. This before and after study had a 2-week run-in period (baseline) for patients to learn the devices without the automated features followed by a 3-month study period with the initial 6 days used to collect insulin and sensor glucose data for the hybrid closed-loop algorithm. In the study period, there was a 6-day hotel stay during which 1 day was used for frequent sampling of venous blood glucose to verify the accuracy of the system. The last patient visit was March 7, 2016. Two central and 4 local institutional review boards approved the study. Written informed consent was obtained from adults and parents, and written assent from minors.

The system included investigational continuous glucose monitoring sensors with transmitters, insulin pumps displaying real-time glucose data, a proprietary algorithm, and blood glucose meters. Patients were required to periodically calibrate sensors and enter carbohydrate estimates for meal boluses. Every midnight, multiple parameters were automatically adjusted by the algorithm.

Safety end points obtained during the run-in and study periods (including the hotel stay) were the incidence of severe hypoglycemia and diabetic ketoacidosis, serious adverse events, and device-related serious and unanticipated adverse events. Prespecified descriptive end points included time in open vs closed-loop systems; the percentage of sensor glucose values below, within, and above target range (71-180 mg/dL), including at night time; changes in HbA1c, insulin requirements and body weight; and measures of glycemic variability. End points were collected during both periods and analyzed with SAS(SAS Institute), version 9.4.

Results

Of the 124 participants (mean age, 37.8 years [SD, 16.5]; men, 44.4%), mean diabetes duration was 21.7 years, mean total daily insulin dose was 47.5 U/d (SD, 22.7), and mean HbA1c was 7.4% (SD, 0.9). Over 12 389 patient-days, no episodes of severe hypoglycemia or ketoacidosis were observed. There were 28 device-related adverse events that were resolved at home. There were 4 serious adverse events (appendicitis, bacterial arthritis, worsening rheumatoid arthritis, Clostridium difficile diarrhea) and 117 adverse events not related to the system, including 7 episodes of severe hyperglycemia due to intercurrent illness or other nonsystem causes.

The system was in closed-loop mode for a median of 87.2% of the study period (interquartile range, 75.0%-91.7%). Glycated hemoglobin levels changed from 7.4% (SD, 0.9) at baseline to 6.9% (SD, 0.6) at study end . From baseline to the end of the study, daily dose of insulin changed from 47.5 U/d to 50.9 U/d, and weight changed from 76.9 kg to 77.6 kg. The percentage of sensor glucose values within the target range changed from 66.7% at baseline to 72.2% at study end. Sensor and reference glucose values collected during the hotel stays were in good agreement, with an overall mean absolute relative difference of 10.3% (SD, 9.0).

Discussion

To our knowledge, this is the largest outpatient study to date and it demonstrated that hybrid closed-loop automated insulin delivery was associated with few serious or device-related adverse events in patients with type 1 diabetes. Limitations include lack of a control group, restriction to relatively healthy and well-controlled patients, the relatively short duration, and an imbalance between the length of the study periods. Differences in HbA1c levels may be attributable to participation in the study. A similar study in children is under way. Longer-term registry data and randomized studies are needed to further characterize the safety and efficacy of the hybrid closed-loop system.

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continuous glucose monitoring

Does CGM Benefit Injection Users? Yes! Results from Dexcom’s DIaMonD Study

Original article published by diaTribe. Click here to read the original article.

Continuous glucose monitoring (CGM) is often considered a technology for insulin pump users – not those on injections. New results from Dexcom’s DIaMonD study, presented at the ADA Scientific Sessions, will hopefully change that.

DIaMonD examined if the addition of CGM in those on multiple daily injections (MDI) could help improve blood sugar control. In this six-month study, participants with an average starting A1c of 8.6% were given either “usual care” (fingersticks alone) or the use of CGM for 24 weeks, measuring changes in A1c, time-in-range, and other outcomes. MDI users that added CGM saw a meaningful reduction in A1c of 0.9%, compared to a 0.4% improvement in the fingersticks (control) group. CGM also cut hypoglycemia by 30% (23 fewer minutes per day) and reduced time spent over 180 mg/dl by 83 minutes per day, far exceeding results in the control group.

Dr. Howard Wolpert (Joslin Diabetes Center) summarized the implications of the DIaMonD study, asserting that healthcare providers should consider recommending CGM to ALL patients with type 1 diabetes who have not attained their glucose goals – not just those on insulin pumps. This would be a major change from current trends, where only ~7% of MDI users with type 1 diabetes use CGM in the T1D Exchange registry.

DIaMonD adds to the evidence that CGM improves time-in-range, reduces highs and lows, and improves A1c. This does not come as a surprise since glucose value and trend can be observed every five minutes and alarms sound for lows and highs, allowing people to recognize patterns, tighten the feedback loop, and take action to improve. We expect this technology to only improve as apps and software make CGM data more useful – particularly for those not on pumps.

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diabetes infographic preview

What Are The Types of Diabetes? [INFOGRAPHIC]

The term “diabetes” refers to a group of diseases that result in problems with blood sugar levels. Each type of diabetes has a different root cause.

View the infographic below to learn more about the different types of diabetes, including who they affect, their cause and typical treatment.

For more information about type 1 diabetes, check out our resource center.

DRC-Infographic

Note: T1D is diagnosed in children, young adults and adults.

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type 1 diabetes resource center

Introducing Our New Type 1 Diabetes Resource Center

As an organization devoted to making a difference in the lives of those with type 1 diabetes and their caretakers by funding innovative scientific researching into ways to treat, cure and prevent T1D, it’s important to us that we’re supporting those with T1D in any way we can.

In a recent survey sent to our donors, we learned that 89% felt that there is a lack of education about living with the disease, and another 89% felt that there is a lack of education about current type 1 diabetes research. 55% of those we surveyed said they felt a lack of emotional support, and 77% said they felt that the people they interact with on a daily basis don’t understand what type 1 diabetes is. Perhaps most astounding, 100% of those we surveyed agreed that there is a lack of type 1 diabetes awareness among those not living with the disease.

Additionally, we found that our donors would like to learn more about living with type 1 diabetes, and that they especially wanted to learn more about current research being done into preventing, treating and curing type 1 diabetes.

To help meet this need for diabetes awareness and education, we’re proud to present our new type 1 diabetes resources center. We’ve scoured the internet and curated the best resources we can find for those with T1D, parents and family of those diagnosed with T1D and anyone else interested in learning more about the disease.

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Find the Type 1 Diabetes Information and Resources You Need

In our type 1 diabetes resource center, you’ll find links to all the information you need, including:

  • A basic overview of type 1 diabetes
  • Information about the true cost of type 1 diabetes
  • Tips for managing type 1 diabetes or supporting a loved who with diabetes
  • Where to find support online
  • Food and fitness tips, including delicious diabetic-friendly recipes and great workouts
  • Information about what puts people at risk for developing type 1 diabetes
  • An overview of current type 1 diabetes research
  • Ways to get involved in diabetes research

Looking for even more tips, information and resources about type 1 diabetes? Sign up to receive our monthly newsletter!

For more information about the type 1 diabetes research we’re helping to fund, check out our active projects.

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type 1 diabetes type 2 diabetes differences

Differences Between Type 1 and Type 2 Diabetes

Despite sharing a name, type 1 and type 2 diabetes are quite different. Understanding the key differences in type 1 diabetes and type 2 diabetes is critical for research into finding a way to cure, treat and prevent diabetes, but also for caring for someone with diabetes and managing your own diabetes. How these diseases begin, how they affect the body and how they are treated are all quite different.

What is Type 1 Diabetes?

Type 1 diabetes is the result of the human immune system mistaking the body’s beta cells, which produce insulin, for foreign cells and causing their destruction. Insulin is a protein that allows the transport of sugar into cells to provide energy. When sugar can’t get from the blood into the cells, the cells have no access to the glucose they need and cannot function correctly. The composition of our blood also gets off balance, with high blood sugar levels leading to detrimental effects on other organs of the body.

Injecting synthetic insulin solves this problem because it keeps blood glucose levels in the right range and helps glucose reach our cells.

What is Type 2 Diabetes?

Although type 2 diabetes is much more common than type 1, the causes for it aren’t fully understood. What doctors and scientists do know is that excess weight, inactivity, age and genetic makeup contribute to development of the disease.

Patients with type 2 diabetes make insulin, but the cells in the body cannot respond to it adequately so they cannot take up glucose. Later on, especially when treatment fails, type 2 diabetes is aggravated by exhausted beta cells, decreasing their insulin production resulting in further increases in blood sugar levels. Since beta cells aren’t killed off in type 2 diabetes, at least initially, blood sugar levels often become elevated at a slower rate than with type 1 diabetes. This means that someone can have high blood sugar for quite sometime without realizing it, and may only find out they have type 2 diabetes when complications of diabetes appear, such as damage to eyes, the kidney and nerves. Additionally, this means that treatment for type 2 diabetes varies from case to case. While insulin therapy is needed for some people with type 2 diabetes, others are able to use alternative medications. Lifestyle changes such as diet and exercise have also been known to help type 2 diabetes and are always recommended for those with the disease.

Chart: What are the Differences Between Type 1 and Type 2 Diabetes?

Type 1 Diabetes

Type 2 Diabetes

Often diagnosed in children and young adults Usually diagnosed in adults
Caused by an autoimmune response against insulin-producing beta cells Cause is unknown, but related to weight, age, inactivity and genetics
Treatment must include insulin, as the body no longer produces it Treatment usually includes some combination of medications, diet, exercise and insulin

Similarities Between Type 1 and Type 2 Diabetes

Both the cause and treatment for type 1 diabetes and type 2 diabetes are clearly very different. However, there are some similarities between the two. For example, even though diet and exercise are key parts to managing type 2 diabetes, good diet and adequate exercise are also important for those with type 1 diabetes because lower weight and increased activity can help increase insulin sensitivity, which helps control blood sugar. Long-term complications arising from increased blood sugar levels are common to both forms of disease and include neuropathy (nerve damage), retinopathy (eye damage) and nephropathy (kidney damage). Cardiovascular complications lead to heart attacks while insufficient delivery to blood in the extremities combined with nerve damage and impaired wound healing capacity leads to lower extremity amputations.

Above all, it’s important to keep in mind just how different these two diseases are, and how much we still have to learn about them. To stay up-to- date on type 1 diabetes research and learn more about managing and living with diabetes, sign up for our newsletter.

If you are looking for information regarding Type 2 Diabetes, we highly recommend looking at Type 2 Digest.

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