USFDA just approved the world’s first ‘artificial pancreas’

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The FDA just approved a device that’s often referred to as an ‘artificial pancreas’. The device, made by Medtronic, is called the MiniMed 670G.

It’s been approved for people with type 1 diabetes over the age of 14. It works by automatically monitoring a person’s blood sugar levels and administering insulin as needed – no constant checking and injecting required.

Diabetes is a condition in which people have a hard time processing sugar. Type 1, in particular, is an autoimmune disease in which the body mistakenly kills cells that are supposed to make insulin, a hormone that helps people absorb and process the sugar in food.

Insulin is produced and released through the pancreas – that’s where the term ‘artificial pancreas’ comes in.

Roughly 1.25 million people in the US have type 1 diabetes. These patients often opt to have an insulin pump that can administer insulin as needed throughout the day.

Some also buy a glucose monitor, which is used to continuously monitor blood sugar levels; that way a diabetic can know if their levels are going too low or too high and find a way to correct it.

In contrast, the MiniMed 670G, referred to as a ‘hybrid closed loop’ system, is what Jeffrey Shoorin of the FDA said in a statement is a “first-of-its-kind technology”: the first approved system that combines both the glucose monitor and the insulin pump in one device.

According to the FDA, the device measures blood sugar every five minutes, then responds by sending insulin into the body, or holding steady. Diabetics can also manually request insulin around mealtimes.

A clinical trial of the MiniMed 670G involving 123 people with type 1 diabetes had no serious adverse events, though the FDA notes that “risks may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch.”

While the device is approved as of today, Medtronic will do additional testing to see how well it works in real-life situations. The company is also conducting additional trials to see if it can be used in children 7 to 14 years old.

“We are committed to preparing for commercial launch as quickly as possible,” Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic, said in a statement.

Here’s what the device looks like:

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Researchers created a new contact lens to test glucose levels in tears

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Researchers have developed a new technology that could allow non-invasive testing of glucose levels, via a contact lens that samples glucose levels in tears.

Current method to monitor glucose levels involve a medication process along with a painful fingerpick blood test.

Glucose is a good target for optical sensing, and can be used as an alternative approach, the study said.

“It should be noted that glucose is present not only in the blood but also in tears, and thus accurate monitoring of the glucose level in human tears by employing a contact-lens-type sensor can be an alternative approach for non-invasive glucose monitoring,” said Wei-Chuan Shih, Associate Professor at University of Houston in Texas, US.

The researchers developed a tiny device built with multiple layers of gold nanowires and gold film that was produced, using solvent assisted nanotransfer printing.

This component strengthens a technique called surface-enhanced Raman scattering — named after Indian physicist C.V. Raman, who discovered the effect first in 1928 — which gauges how light interacts with a material to determine its molecular composition, the researchers stated.

Further, the device enhances the sensing properties of the technique by creating “hot spots” or narrow gaps within the nanostructure which intensified the Raman signal.

Traditional nanofabrication techniques rely on a hard substrate — usually glass or a silicon wafer — but researchers wanted a flexible nanostructure which would be more suited to wearable electronics, Shih said.

The layered nanoarray was produced on a hard substrate but lifted off and printed onto a soft contact, Shih said in the paper published in the journal Advanced Materials.

Although non-invasive glucose sensing is just one potential application of the technology, it provided a good way to prove the technology, he said.

Moreover, the device is also an effective mechanism for using surface-enhanced Raman scattering spectroscopy.

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A single injection can eliminate type 2 diabetes in mice for months

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Scientists have made a discovery that could lead to better treatments for diabetes in the future, with a protein injection administered directly into the brains of rodents with type 2 diabetes putting the animals into remission for several months.

Both mice and rats were injected with a low dose of synthesised Fibroblast Growth Factor 1 (FGF1), a growth-promoting protein known to lower blood glucose levels in diabetic mice. But while FGF1 had previously been shown to restore healthy blood sugar levels in mice for up to two days after injection, the same hormones injected directly into the animals’ brains provided a dramatically extended effect: up to 17 weeks of what the researchers call a “sustained remission

While it might not be quite a cure, it’s still a big improvement on previous research with FGF1, and the findings could lead to a new potential target for diabetic treatments – focusing on the brain’s role in regulating blood glucose levels, rather than other organs and organ systems in the body.

“We thought that FGF1 could be acting in the brain, because the receptors for FGF1 are highly prevalent there,” gastroenterologist Jarrad Scarlett from the University of Washington told Laurie Tarkan at EndocrineWeb. “We think that diabetes represents a dysfunction of neural circuits within the brain. What FGF1 is doing is acting upon these circuits to ameliorate the dysfunction.”

And the level of that effect surprised even the researchers, who thought they might see similar results to what had previously been shown when diabetic mice bodies were injected with the protein.

“We were expecting the results to last 48 to 72 hours, not several months,” Scarlett told EndocrineWeb. “We think it’s stimulating synaptic remodelling within these circuits.”

When the first diabetic mice had the peptide injected just once into their brains, the researchers observed increased production of the brain’s neuroprotective proteins, and strengthened connections in the hypothalamus, which helps to regulate appetite and metabolism. The animals’ systems improved their clearance of glucose after meals, leading to normalised blood sugar levels.

To confirm the results, the team repeated the experiment on two more sets of animals, administering the single injection of FGF1 to rats, and to a second group of mice, which had been bred to develop type 2 diabetes in a different manner. Once again, the one-off approach produced long-lasting remission from diabetic symptoms.

While the study’s impressive results are clearly limited to animals – and it’s unlikely we’ll see brain injections offered as a treatment for type 2 diabetic humans any time soon – the findings, reported in Nature Medicine, could indicate a new path for future diabetes research.

“We are entering an era where, really, when it comes to treating diabetes using insulin or insulin-related treatments – which they all are – we’ve gotten as far as we’re going to get,” lead researcher and endocrinologist Michael W. Schwartz told Melissa Healy at the Los Angeles Times. “[T]here probably are not going to be breakthroughs by hammering away at the same drug targets… So if there’s going to be a paradigm shift in finding treatments that might complement or make other drugs more effective, then targeting the brain might be the way to do this.”

Although any human treatments stemming from this research would be several years away, the researchers suggest people wouldn’t need to suffer a needle to the head to see the benefits of any future brain-targeted remedies. They say it’s more likely that some form of nasal ingestion could confer the same effects.

For the hundreds of millions of type 2 diabetics around the world forced to deal with daily injections to manage their blood sugar levels, this kind of innovation can’t come soon enough.

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Artificial Pancreas in 2 years?

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Not only does this allow those with type 1 diabetes to live fuller lives, it also negates the amount of human error, ensuring that the user doesn’t accidentally inject too much or too little insulin.

Researchers from the UK say that the world’s first artificial pancreas could hit the market as early as 2018, offering a better way for those with type 1 diabetes to monitor and control their glucose levels without daily injections.

This is huge news, because until now, type 1 diabetes sufferers have had to use two devices to stay healthy: one to test for glucose levels and the other to inject the correct dose of insulin. This new pancreas device combines them into one closed system.

“In trials to date, users have been positive about how use of an artificial pancreas gave them ‘time off’ or a ‘holiday’  from their diabetes management, since the system is managing their blood sugar effectively without the need for constant monitoring by the user,” said team members Roman Hovorka and Hood Thabit from the University of Cambridge.

The device — which the team doesn’t describe on a physical level, but most likely looks like a small box —would monitor and adjust a user’s blood sugar levels without them needing a bunch of different equipment to do so.

 Not only does this allow those with type 1 diabetes to live fuller lives, it also negates the amount of human error, ensuring that the user doesn’t accidentally inject too much or too little insulin.

The device also offers an alternative to transplant new beta cells — the cells in the pancreas that produce insulin — into diabetics. This is another new treatment option that researchers are looking into, but results have been mixed, and the surgery places a heavy burden on patients’ immune system.

When it comes to the artificial pancreas, it’s important to note that researchers aren’t talking about one specific artificial pancreas that they developed themselves. Instead, they reviewed the landscape surrounding the device as a whole to see when one — from any company or institution — might hit the market.

They found that despite how promising the invention sounds, there are still many hurdles for research to overcome.

For example, insulin — even fast-acting types — take up to two hours to reach peak levels in the bloodstream, making it hard for a single device to constantly monitor and keep on track autonomously, especially when a user is exercising or doing other activities that may affect blood sugar levels.

There’s also a problem of security, because an artificial pancreas would basically be a very simple computer, leaving it open for hackers to take advantage of.

“As closed loop devices may be vulnerable to cybersecurity threats such as interference with wireless protocols and unauthorised data retrieval, implementation of secure communications protocols is a must,” the team notes.

Besides these practical hurdles that stand in the way of the device’s launch, there are also a tonne of regulatory boards that need to sign off on them before they hit the market.

But, after assessing the progress so far and these challenges, the researchers remain hopeful that some type of artificial pancreas will hit the market in 2018.

Sourced from Deccan Chronicle

Merck, Samsung Bioepis ink pact to develop & commercialize insulin glargine candidate for diabetes

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Merck, known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd., have expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. Phase III clinical studies in type 1 and type 2 diabetes will begin soon.

“We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company,” said Matt Strasburger, senior vice president, diabetes, global human health, Merck. “Merck is strengthening its leadership in diabetes through our own work and in collaboration with others, and this agreement will help build our portfolio across the spectrum of the disease.”

“Samsung Bioepis is very pleased to extend the partnership with Merck to the field of diabetes,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “This collaboration will bring better access to patients with diabetes worldwide.”

Under the terms of the agreement, the companies will collaborate on clinical development, regulatory filings and manufacturing. If approved, Merck will commercialize this candidate. This collaboration builds on the agreement made by the two companies in February 2013 to develop and commercialize multiple biosimilar candidates.

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, aims to develop affordable and high-quality biopharmaceutical and biosimilar products.

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions.

Source: PharmaBiz