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Research and Innovation

Smart Insulin Patch Could Replace Painful Injections for Diabetes

For Immediate Release

Painful insulin injections could become a thing of the past for the millions of Americans who suffer from diabetes, thanks to a new invention from researchers at North Carolina State University and the University of North Carolina at Chapel Hill, who have created the first “smart insulin patch.” Though it has thus far only been tested in an animal model, the patch has been shown to detect increases in blood sugar levels and secrete doses of insulin into the bloodstream whenever needed.

The patch – a thin square no bigger than a penny – is covered with more than one hundred tiny needles, each about the size of an eyelash. These “microneedles” are packed with microscopic storage units for insulin and glucose-sensing enzymes that rapidly release their cargo when blood sugar levels get too high.

The study found that the new, painless patch could lower blood glucose in a mouse model of type 1 diabetes for up to nine hours. More pre-clinical tests and subsequent clinical trials in humans will be required before the patch can be administered to patients, but the approach shows great promise. A paper describing the work, “Microneedle-array patches loaded with hypoxia-sensitive vesicles provide fast glucose-responsive insulin delivery,” is published in the Proceedings of the National Academy of Sciences.

“We have designed a patch for diabetes that works fast, is easy to use, and is made from nontoxic, biocompatible materials,” said co-senior author Zhen Gu, PhD, a professor in the Joint Department of Biomedical Engineering at NC State and UNC-Chapel Hill. Gu also holds appointments in the UNC School of Medicine, the UNC Eshelman School of Pharmacy, and the UNC Diabetes Care Center. “The whole system can be personalized to account for a diabetic’s weight and sensitivity to insulin,” he added, “so we could make the smart patch even smarter.”

Diabetes affects more than 387 million people worldwide, and that number is expected to grow to 592 million by the year 2035. Patients with type 1 and advanced type 2 diabetes try to keep their blood sugar levels under control with regular finger pricks and repeated insulin shots, a process that is painful and imprecise. John Buse, MD, PhD, co-senior author of the PNAS paper and the director of the UNC Diabetes Care Center, said, “Injecting the wrong amount of medication can lead to significant complications like blindness and limb amputations, or even more disastrous consequences such as diabetic comas and death.”

Researchers have tried to remove the potential for human error by creating “closed-loop systems” that directly connect the devices that track blood sugar and administer insulin. However, these approaches involve mechanical sensors and pumps, with needle-tipped catheters that have to be stuck under the skin and replaced every few days.

Instead of inventing another completely manmade system, Gu and his colleagues chose to emulate the body’s natural insulin generators known as beta cells. These versatile cells act both as factories and warehouses, making and storing insulin in tiny sacs called vesicles. They also behave like alarm call centers, sensing increases in blood sugar levels and signaling the release of insulin into the bloodstream.

“We constructed artificial vesicles to perform these same functions by using two materials that could easily be found in nature,” said PNAS first author Jiching Yu, a Ph.D. student in Gu’s lab.

The first material was hyaluronic acid or HA, a natural substance that is an ingredient of many cosmetics. The second was 2-nitroimidazole or NI, an organic compound commonly used in diagnostics. The researchers connected the two to create a new molecule, with one end that was water-loving or hydrophilic and one that was water-fearing or hydrophobic. A mixture of these molecules self-assembled into a vesicle, much like the coalescing of oil droplets in water, with the hydrophobic ends pointing inward and the hydrophilic ends pointing outward.

The result was millions of bubble-like structures, each 100 times smaller than the width of a human hair. Into each of these vesicles, the researchers inserted a core of solid insulin and enzymes specially designed to sense glucose.

In lab experiments, when blood sugar levels increased, the excess glucose crowded into the artificial vesicles. The enzymes then converted the glucose into gluconic acid, consuming oxygen all the while. The resulting lack of oxygen or “hypoxia” made the hydrophobic NI molecules turn hydrophilic, causing the vesicles to rapidly fall apart and send insulin into the bloodstream.

Once the researchers designed these “intelligent insulin nanoparticles,” they had to figure out a way to administer them to patients with diabetes. Rather than rely on the large needles or catheters that had beleaguered previous approaches, they decided to incorporate these balls of sugar-sensing, insulin-releasing material into an array of tiny needles.

Gu created these “microneedles” using the same hyaluronic acid that was a chief ingredient of the nanoparticles, only in a more rigid form so the tiny needles were stiff enough to pierce the skin. They arranged more than one hundred of these microneedles on a thin silicon strip to create what looks like a tiny, painless version of a bed of nails. When this patch was placed onto the skin, the microneedles penetrated the surface, tapping into the blood flowing through the capillaries just below.

The researchers tested the ability of this approach to control blood sugar levels in a mouse model of type 1 diabetes. They gave one set of mice a standard injection of insulin and measured the blood glucose levels, which dropped down to normal but then they quickly climbed back into the hyperglycemic range. In contrast, when the researchers treated another set of mice with the microneedle patch, they saw that blood glucose levels were brought under control within thirty minutes and stayed that way for several hours.

In addition, the researchers found that they could tune the patch to alter blood glucose levels only within a certain range by varying the dose of enzyme contained within each of the microneedles. They also found that the patch did not pose the hazards that insulin injections do. Injections can send blood sugar plummeting to dangerously low levels when administered too frequently.

“The hard part of diabetes care is not the insulin shots, or the blood sugar checks, or the diet but the fact that you have to do them all several times a day every day for the rest of your life, said Buse, the director of the North Carolina Translational and Clinical Sciences (NC TraCS) Institute and past president of the American Diabetes Association. “If we can get these patches to work in people, it will be a game changer.”

Because mice are less sensitive to insulin than humans, the researchers think that the blood sugar-stabilizing effects of the patch could last even longer when given to actual patients. Their eventual goal, Gu said, is to develop a smart insulin patch that patients would only have to change every few days.

The research was funded by a pilot grant from the NC TraCS Institute and a “Pathway to Stop Diabetes” Research Award from the American Diabetes Association.

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  1. where can i get the smart patch can my doctor prescribe it for me is it covered by my insurance medicare and atena does it make you gain weight

  2. I and my daughter have diabetes I have had it for 19 yrs never been on insulin but my daughter takes insulin and pills and she hates to take the pills she prefer to take the insulin so this would be very good for her she is 17 yrs old been a diabiatic for 4 yrs now so I really that this research would be good for all that’s is fighting diabetes

  3. I hope they won’t sell it to pharma like Tod Zion @ MIT did with his Smart Insulin. it disappeared on a shelf at Merck never to be brought to market.

  4. Sounds genious new delivery system maybe wont take as long for approval through FDA when human trials?Not a ten year time line I hope go overseas if u must if you can get human trials expedited. My daughter 19 year old type 1 x 11 years . Love to be ur human mouse.

  5. I have type 2 diabetes my husband has Type 2 diabetes we both would love to be in the study how can we find out information on it?

  6. I have been a type 1 diabetic for 20 years with no complications as of yet and would love to take part in research for this patch.

  7. The trick will be to not need a replacement at 3 am or out somewhere, not expecting it to run out or come off. Companies like Dexcom have had to deal with the adhesive aspects/difficulties (i.e., allergies, ability to remain on in heat, sweat, etc). You might benefit from consulting with experts in that area as it will be an important as far as this solution working in the real world.

    Do you see this being something made more readily accessible than existing products at a lower cost than pumps, insulin, etc.? If it is, that would open it up to people who do not presently have insurance or who live in 3rd world countries where it is often difficult or impossible to live with diabetes.

    –Diabetic more than 40 years and with 5.8 A1C

  8. What pharma companies are you working with to market and distribute the product, if proven successful?
    I’m an investor.

  9. I would love to take part in your research study. 40 year T1 diabetic. It would not be a hardship to get to Chapel Hill. I’m in Florida.

  10. I am concerned about this breakthrough reserch
    Getting enough funding, and approval, and then being able to put it in the markets. In a perfect world these should be supported by the industry and medicin.
    Consider that insulin manufacturers are going to
    Loose a lot of money, a good chance this Research will be shelved for quite sometime. Otherwise, it sounds to me there is not that much to the technology, it should be out for all suffers do diabetes by 2017 at most 2018. My intuition, it is going to be way longer, 2025 -2030 earliest. Most of us will not live to take Adavanatge of it, and live a better life. Thanks to the pharmecuticles. This in fact is the case with many break through medical technologies that can better people,s lifes.

  11. I’m completely in LOVE with this idea! Count me in on the trials to come!! Diagnosed with type 2 and re-diagnosed 8 months later with type 1.5 LADA and now I’m totally insulin dependent. Keep up the GREAT work and thank you!

  12. I am K.Buchaiah,my son was 13 yrs old,suffering with type 1 diabetic since 2 months,we are ready to sign up for trial,thanks for your successful innovation in smart insullin patch, please release immediately in world wide,so your LIVE GOD,to rescue patients from type 1.

  13. dear sirs.,
    i am completely ready to participate in this research .,
    instead of mouse please do the test of patch on me.,
    i appreciate for your kind attention .,
    sincerely yours.,
    saeed behrouzfar.,

    meanwhile i am 58 years old and have diabetic no2

  14. My 16 year old grandson was diagnosed type 1 at 18 months old. He is also borderline Aspergers. Already suffering with diabeic related issues, i.e. thyroid. The whole family would be behind him participating in a trial. He doesn’t manage his insulin regime well, please help and advise.

  15. Wow, exactly what I need right now, I’m sick of constant blood sugar level monitoring and self injecting insulin daily. living in Alice Springs, AU we are a long away away from the current research Laboratories, but I’d willingly sign up as a “Lab rat” right now,

  16. I was diagnosed 51 years ago at 18 months of age. I was accepted into the NIH-funded islet cell transplant trial in Charlotte, but very unfortunately did not receive a transplant. I would love another chance at being a part of research. Thank you, thank you for all of your work. May it impact many lives!

  17. My sister and I are both type 1’s for 30 years, now. We have both been on injection and pump therapy. We differ in our response to insulin. I tend to run hypoglycemic and have had many interventions through the years to bring me back to a normal range. My sister tends to run higher glucose levels and has had in the last year heart complications with one stent to unblock fully blocked main artery. I have been more fortunate thus far except for the extremely low blood sugars on a regular basis. My sugars can run in the 50’s most of a day and not till it drops into the low 30’s do I really feel the need to remedy the low by drinking juice or eating. This full service system would be a God send for so many of us and I do appreciate all the incredible research your team has done. I hope human trials are soon underway. If you need 2 more type 1’s, I’m sure my sister and I would be willing to help.

  18. Where do I sign up for test of the Smartpatch ? I have had type1 diabetes since 1979 ,was diagnosed in Atlanta. My a1c runs 8 or 9, my kidneys function at 37ish percent, and I have some other problems. Please save me, diabetes is killing me!

  19. Type 1 IDDM x 50yrs & on insulin pump x 20 yrs. Brittle diabetic , severely hypoglycemic unaware. Hx of retinopathy, now have worsening glaucoma. Please let me get in on the trials for this…need serious med help.

  20. I’m diabetic type 2 since 12 yrs with angioplasty and having insulin shot 4-5 times a day. I would be interested to be part of this research trial.

  21. Wow!!!

    Dear Dr. Zhen Gu, I cant find any word to experess my
    fealings on this exciting treatment, specially regarding my weak English!
    Just let me say , you and your team of scientists, bring me and each of those 400000000 diabetics , great hopes of keeping our eyes to see the face of our beloved children when they are grown, and more hopes of keeping our feet and legs to stand by them when they need us , and to keep our hearts beating for you forever……
    I am ready to be one of your rats in Iran!

  22. Would love to be in trials. This is the first promising treatment I’ve been excited in. My daughter, age 33 and I are both Type 1 (diagnosed approximately 21 and 19 years ago, respectively). My daughter was 11 and diagnosed 2 years before I was. We are in Texas, but we would do what it takes to be in the trials!!!

  23. I have a niece with diabetes type I since she has 7 years old. In mexico the social security doesent cover anymore the insuline shots, and she need more than 8 daily…pump is not an alternative because the cost. Please if you make a protocol with humans consider her. She is now 15 years old and she has not a good life quality despite of all the efforts we made to help her…this notice of the patches is a light for us.

  24. I have been a Type I Diabetic 56 years. I have worked hard over the years to maintain good sugar levels. I developed SLE Lupus about 20 years ago and for the last few yearsI am having problems keeping my sugars under control at times when I am sick and have pain from the lupus attacks. This invention looks very promising and I would appreciate your consideration in allowing me to try this. I am currently on a Medtronic Insulin Pump. Thank you for sharing this article.

  25. This sounds like a wonderful possibility. I was diagnosed with type 1 diabetes 32 years ago at the age of 27. I am extremely insulin sensitive. 1 unit of fast acting insulin takes care of 24 grams of carb for me. I use 3 units of lantus in the morning and at night. I am very active physically and have been able to keep my weight under control through exercise and diet, but I still have issues with blood sugars, especially too many lows. I started out with injections and then moved on to an insulin pump after control became more difficult through the years. I was on a couple of different types of pumps for about 12 years, but ended up going back to injections a couple of years ago. My A1c has edged up to 7.2. I used to be able to keep it around 6.5, but that has become harder as time has progressed. I would also consider signing up for a trial! This sounds like a much better answer to type 1 diabetes than the insulin pump. I live in Florida.

  26. I have been a type 1 diabetic for 31 yrs. I’m on a pump now. My A1C was 7.8 in May 2015. I try to keep my blood sugar’s under control, but life gets in the way. Not an easy job. I have always said “that I have 2 full time jobs, never have vacations or time to relax.” I would like to be apart of any trials that will be available to participate in.

  27. Sign me up. I have been on pumps and glucose monitoring systems for years. So bulky and expensive. I am back on injections. I would love to be a part of your trial. Thanks for all of the research.

  28. I too would happily sign up for trials for the patch. Approaching 40 years with type 1 and been hearing for too long that a cure is around the corner.

  29. My husband has been a type 1 diabetic for 50 years now. We have tried many things except the pump. He dosen’t have many highs but does experience several lows some of which have required visits to the emergency room. I know this would be a God send for him. Can’t wait!

  30. Dealing with Type I diabetes (or Type II for that matter) is a constant pain in the you know what. I am very interested in becoming a research subject. My son attends NC State and I live in Charlotte, so travel to the campus would not be a problem. How do I sign up?

  31. I live in Raleigh, NC and as a Type 1 Diabetic for coming up on 30 years I would gladly volunteer for the human trials to rid the struggles we all go through on a daily basis.

  32. I gladly volunteer myself for the sake of a technological breakthrough like this. I’ve been a type 1 diabetic for 10 years now, and this would make life much easier, but I will say, I have looked at diabetes as a blessing. It’s strengthened my ability to crunch numbers in my head in a split second. This is encouraging news. Think and Do. Go pack!

  33. Seeing my mother being a victim of high blood sugar levels and currently my grandfather fighting his life with insulin and other medications back home makes me always realize how much it is important for such translational research to become a part of our society.

  34. I am an unaware diabetic when my sugar is low and go into hypoglycemia. I have no warning. I wear an insulin pump now for 12 years. My wife watches me closely and I check myself 7 times per day. The patch sounds good to me!

  35. I have been a type 1 diabetic for 47 years, diagnosed as a juvenile type, therefore very brittle. Unfortunately this has not changed. How does the patch work for low blood sugars? I seem to fluctuate a lot, but quite often too low. I am a very active 68 year old – running regularly, playing table tennis twice a week and walking and cycling a lot. If you need a British participant, please count me in! Sounds great – good luck with producing it.

  36. this is very exciting. I am on a pump, but would love to take part in this study. Hopefully, after it is approved, Medicare will help cover the cost to patient.

  37. This sounds wonderful. Would it be a possibility for a Type 2 diabetic? I cannot get mine under control on a sliding scale–last A1C was 10.4.

  38. I have had type 1 for 37 years. So far no permanent complications but the constant monitoring and needle sticks gets so depressing. Would love to help anyway I could to develop the patch.

  39. My husband has no pancreas. Due to this he gets 5-7 insulin shots daily & has to test 4- 6 times a day. Something like this could be great if it works. He’s not eligible for a insulin pump because of the quantities of insulin he has to take.

  40. I am fairly new at the injection process and I hate it. I would love to give it a try. Is there anyway I could help out with the research trials?

    Thanks..

  41. I have been a type 1 diabetic for over 43 years. I am so far in good health due to tight control. I do have lots of up and downs, especially downs due to the tight control. This sounds promising, diabetes is something that is always there, you can’t ever let your guard down. I cannot wait to see what happens This article got my attention more than anything else has. Over the years I have seen many test to help us but nothing like this.

    1. SOME OF THESE MESSAGES ARE DATED 2015 IT IS NOW 2018 SO WHERE IS THE PRODUCT IS IT IN CLINICAL TRIALS OR WHAT

  42. This sounds like an amazing break through! I would be happy to be a lab rat. I have been type 1 since 1997 when I had my daughter at age 40. My A1c runs in the high 7s to low 8s. I would love to have better control, and not have to figure carbs,etc! I am very involved with the ADA chapter in Santa Clarita, CA. My sister lives in Raleigh, so I can come to you for any research studies. 🙂

  43. I love this! When and where do we sign up for research trials!

    My diabetes has caused liver failure, kidney failure and almost caused heart failure a few years ago, (all recovered from, in some unexplainable way actually) so I’d love to be able to try something that will actually help me control my levels!

    1. I have type II diabetes just diagnosed over the past recent years. I would like to be contacted for clinical trial purposes. Please this new Smart Patch sounds so wonderful and my Father has Type II Diabetes and something he didn’t have until approximately 15 years ago. We would love to see \something as painless as possible. Insulin injections are painful and since I’ve had to inject Levemier I will need to ask my doctor about soreness in the area I have been using. God Bless You and NC State University for developing research for treatment of Diabetes. I retired from a Federal Government Research Agency in Rockville, Maryland U.S. DHHS/PHS/AHRQ – Charlene Renee Joy

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