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Patients with type 2 diabetes may soon receive artificial pancreas and a smartphone app assistance

Posted in Artificial Intelligence in Health Care - Tools & Innovations, Artificial Pancreas for Type 2 Diabetes, Artificial Pancreas for Type1 Diabetes, Diabetes Mellitus, HealthCare IT, Medical Devices R&D and Inventions, Mobile Healthcare, tagged artificial pancreas, Blood sugar, dialysis, Hypoglycemia, kidney disease, Medical device, type 2 diabetes on August 13, 2021| Leave a Comment »

Patients with type 2 diabetes may soon receive artificial pancreas and a smartphone app assistance

Curator and Reporter: Dr. Premalata Pati, Ph.D., Postdoc

In a brief, randomized crossover investigation, adults with type 2 diabetes and end-stage renal disease who needed dialysis benefited from an artificial pancreas. Tests conducted by the University of Cambridge and Inselspital, University Hospital of Bern, Switzerland, reveal that now the device can help patients safely and effectively monitor their blood sugar levels and reduce the risk of low blood sugar levels.

Diabetes is the most prevalent cause of kidney failure, accounting for just under one-third (30%) of all cases. As the number of people living with type 2 diabetes rises, so does the number of people who require dialysis or a kidney transplant. Kidney failure raises the risk of hypoglycemia and hyperglycemia, or unusually low or high blood sugar levels, which can lead to problems ranging from dizziness to falls and even coma.

Diabetes management in adults with renal failure is difficult for both the patients and the healthcare practitioners. Many components of their therapy, including blood sugar level targets and medications, are poorly understood. Because most oral diabetes drugs are not indicated for these patients, insulin injections are the most often utilized diabetic therapy-yet establishing optimum insulin dose regimes is difficult.

A team from the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust earlier developed an artificial pancreas with the goal of replacing insulin injections for type 1 diabetic patients. The team, collaborating with experts at Bern University Hospital and the University of Bern in Switzerland, demonstrated that the device may be used to help patients with type 2 diabetes and renal failure in a study published on 4 August 2021 in Nature Medicine.

The study’s lead author, Dr Charlotte Boughton of the Wellcome Trust-MRC Institute of Metabolic Science at the University of Cambridge, stated:

Patients living with type 2 diabetes and kidney failure are a particularly vulnerable group and managing their condition-trying to prevent potentially dangerous highs or lows of blood sugar levels – can be a challenge. There’s a real unmet need for new approaches to help them manage their condition safely and effectively.

The Device

The artificial pancreas is a compact, portable medical device that uses digital technology to automate insulin delivery to perform the role of a healthy pancreas in managing blood glucose levels. The system is worn on the outside of the body and consists of three functional components:

• a glucose sensor
• a computer algorithm for calculating the insulin dose
• an insulin pump

The artificial pancreas directed insulin delivery on a Dana Diabecare RS pump using a Dexcom G6 transmitter linked to the Cambridge adaptive model predictive control algorithm, automatically administering faster-acting insulin aspart (Fiasp). The CamDiab CamAPS HX closed-loop app on an unlocked Android phone was used to manage the closed loop system, with a goal glucose of 126 mg/dL. The program calculated an insulin infusion rate based on the data from the G6 sensor every 8 to 12 minutes, which was then wirelessly routed to the insulin pump, with data automatically uploaded to the Diasend/Glooko data management platform.

The Case Study

Between October 2019 and November 2020, the team recruited 26 dialysis patients. Thirteen patients were randomly assigned to get the artificial pancreas first, followed by 13 patients who received normal insulin therapy initially. The researchers compared how long patients spent as outpatients in the target blood sugar range (5.6 to 10.0mmol/L) throughout a 20-day period.

Patients who used the artificial pancreas spent 53 % in the target range on average, compared to 38% who utilized the control treatment. When compared to the control therapy, this translated to approximately 3.5 more hours per day spent in the target range.

The artificial pancreas resulted in reduced mean blood sugar levels (10.1 vs. 11.6 mmol/L). The artificial pancreas cut the amount of time patients spent with potentially dangerously low blood sugar levels, known as ‘hypos.’

The artificial pancreas’ efficacy improved significantly over the research period as the algorithm evolved, and the time spent in the target blood sugar range climbed from 36% on day one to over 60% by the twentieth day. This conclusion emphasizes the need of employing an adaptive algorithm that can adapt to an individual’s fluctuating insulin requirements over time.

When asked if they would recommend the artificial pancreas to others, everyone who responded indicated they would. Nine out of ten (92%) said they spent less time controlling their diabetes with the artificial pancreas than they did during the control period, and a comparable amount (87%) said they were less concerned about their blood sugar levels when using it.

Other advantages of the artificial pancreas mentioned by study participants included fewer finger-prick blood sugar tests, less time spent managing their diabetes, resulting in more personal time and independence, and increased peace of mind and reassurance. One disadvantage was the pain of wearing the insulin pump and carrying the smartphone.

Professor Roman Hovorka, a senior author from the Wellcome Trust-MRC Institute of Metabolic Science, mentioned:

Not only did the artificial pancreas increase the amount of time patients spent within the target range for the blood sugar levels, but it also gave the users peace of mind. They were able to spend less time having to focus on managing their condition and worrying about the blood sugar levels, and more time getting on with their lives.

The team is currently testing the artificial pancreas in outpatient settings in persons with type 2 diabetes who do not require dialysis, as well as in difficult medical scenarios such as perioperative care.

“The artificial pancreas has the potential to become a fundamental part of integrated personalized care for people with complicated medical needs,” said Dr Lia Bally, who co-led the study in Bern.

The authors stated that the study’s shortcomings included a small sample size due to “Brexit-related study funding concerns and the COVID-19 epidemic.”

Boughton concluded:

We would like other clinicians to be aware that automated insulin delivery systems may be a safe and effective treatment option for people with type 2 diabetes and kidney failure in the future.

Main Source:

Boughton, C. K., Tripyla, A., Hartnell, S., Daly, A., Herzig, D., Wilinska, M. E., & Hovorka, R. (2021). Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial. Nature Medicine, 1-6.

Other Related Articles published in this Open Access Online Scientific Journal include the following:

Developing Machine Learning Models for Prediction of Onset of Type-2 Diabetes

Reporter: Amandeep Kaur, B.Sc., M.Sc.

https://pharmaceuticalintelligence.com/2021/05/29/developing-machine-learning-models-for-prediction-of-onset-of-type-2-diabetes/

Artificial pancreas effectively controls type 1 diabetes in children age 6 and up

Reporter: Irina Robu, PhD

https://pharmaceuticalintelligence.com/2020/10/08/artificial-pancreas-effectively-controls-type-1-diabetes-in-children-age-6-and-up/

Google, Verily’s Uses AI to Screen for Diabetic Retinopathy

Reporter : Irina Robu, PhD

https://pharmaceuticalintelligence.com/2019/04/08/49900/

World’s first artificial pancreas

Reporter: Irina Robu, PhD

https://pharmaceuticalintelligence.com/2019/05/16/worlds-first-artificial-pancreas/

Artificial Pancreas – Medtronic Receives FDA Approval for World’s First Hybrid Closed Loop System for People with Type 1 Diabetes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/09/30/artificial-pancreas-medtronic-receives-fda-approval-for-worlds-first-hybrid-closed-loop-system-for-people-with-type-1-diabetes/

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The Way With Personalized Medicine: Reporters’ Voice at the 8th Annual Personalized Medicine Conference,11/28-29, 2012, Harvard Medical School, Boston, MA

Posted in Interviews with Scientific Leaders, Personalized and Precision Medicine & Genomic Research, tagged Blood sugar, Larry Smarr, Molecular phylogenetics, Personalized medicine, Snyder, Stanford University on November 28, 2012| 4 Comments »

The Way With Personalized Medicine: Reporters’ Voice at the 8th Annual Personalized Medicine Conference,11/28-29, 2012, Harvard Medical School, Boston, MA

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #8: The Way With Personalized Medicine: Reporters’ Voice at the 8th Annual Personalized Medicine Conference,11/28-29, 2012, Harvard Medical School, Boston, MA. Published on 11/28/2012

WordCloud Image Produced by Adam Tubman

 

Stanford’s Mike Snyder is Showing the Way With Personalized Medicine

Luke Timmerman 

11/19/12

Follow @ldtimmerman

Say the words “personalized medicine” to people from various walks of life, and you’re likely to get one of about four different reactions.

A. “Personalized medicine? What’s that?” (Usually spoken by 99 percent of patients.)

B. “Personalized medicine will bankrupt the country with expensive new diagnostic tests, and overrated targeted drugs.” (Usually spoken by health economists.)

C. “Personalized medicine is overhyped, a load of bunk.” (Usually spoken by grizzled pharma industry vets who remember the genomics crash of a decade ago, and have a financial interest in preserving the status quo.)

D. “Personalized medicine will revolutionize healthcare, moving us away from reactive sick-care and more toward predictive and preventive strategies focused on wellness.” (Usually spoken by the subset of true believers in science and the biotech industry.)

You can make arguments, buttressed with data, to support any of the last three positions. But none of these positions quite captures the truth. We are in the early days of the personalized medicine movement, and don’t know how the story will unfold. As a journalist who’s followed many different threads of this story for thelast decade, I keep getting the feeling that we’re moving further away from one-size-fits-all medicine, and more toward treatment based on extremely detailed molecular readouts on your state of health or disease. People may havesnickered at Internet pioneer Larry Smarr and his friends in the “Quantified Self” movement for being weird a couple years ago, but I can easily envision people jumping on this bandwagon sometime not too far out.

I was fascinated this past week when I had a chance to talk with Mike Snyder, a geneticist who has turned himself into a poster child for personalized medicine through his work at Stanford University. After talking with him for about a half hour last week, I hung up thinking his experience today could seem mainstream in another 10 or 20 years.

Stanford geneticist Mike Snyder

Snyder, for those who are unfamiliar, was the guy at the center of an important paper published in the journal Cell back in March. This paper described how researchers sequenced Snyder’s genome, and then really got rolling in their quest to understand his biochemical state of being at 20 different snapshots in time over a 14-month period. The scientists took blood samples from him when he was feeling fine, and a few times when he was sick with viral infections. They then ran the samples through instruments that captured an extremely detailed look at 40,000 molecular parameters in his blood. These were metabolites, proteins, RNA transcripts, self-directed antibodies. This hard-core genomic, transcriptomic, metabolomic and proteomic approach (which the scientists called an integrative personal ‘omics profile) could have been just a demonstration of technological overkill, offering very little information that could lead anyone to make better decisions about their health.

But that’s not what happened. It turned out that the results, surprisingly, showed this healthy white guy in his mid-50s was at high risk of getting Type 2 diabetes—which if it’s not controlled, it can lead down the path to blindness, amputations, stroke, or heart attack.

At the time the molecular analysis revealed this trend, it was hard to believe. Snyder had no family history of the disease, and most everybody in his family is thin. His genome said he was at low risk of obesity, and at a shade under 5-foot-10, and 160 pounds, Snyder’s general practitioner thought the idea of him becoming diabetic was far-fetched.

But just as the pan-‘omics tests had predicted, researchers saw over time that something was amiss with Snyder’s ability to control his blood sugar—especially, and oddly, when he had viral infections. When looking at two traditional blood measurements of diabetes—blood sugar concentration levels and hemoglobin A1C counts—both of those numbers progressively climbed into worrisome territory. As the sweeping ‘omics-driven analysis had predicted, Snyder was diagnosed with diabetes.

He remembers the day that word came, April 11, 2011. He decided it was time to change his health habits.

“Up until that point, I had been eating lots of sweets. I’d have ice cream all the time after dinner. It really was a pretty bad diet,” Snyder says. After the diagnosis, it took him six months to get his blood sugar levels back to normal. “I completely cut out all dessert, and have had one bite of wedding cake since,” he says. That one exception came when one of his postdocs got married, he says.

That might be how anybody in this situation would react to a diabetes diagnosis, with enough self-discipline. But what makes this story even more interesting is that when Snyder changed his diet, and ramped up his daily exercise routines, he could see how his biochemical profile changed when his behavior changed. The scientists have kept looking at measurements of 40,000 different molecules in Snyder’s blood, before, during, and after his diagnosis. Suddenly, you can see not only that bicycling 40-50 miles a week instead of 20-30 miles has helped him lose 15 pounds. You can also see the molecular warning signs of diabetes have returned roughly to normal, along with his blood sugar and hemoglobin A1c scores.

“This study is a landmark for personalized medicine,” Eric Topol, a professor of genomics at the Scripps Research Institute in San Diego, told the New York Times.

Months later, Snyder reports that even though he’s not technically cured of diabetes, he’s been able to keep it in remission through these behavior changes, without taking any drugs. That doesn’t mean he’s completely in the clear. He knows his risk will go up again as he gets older. He also knows from his genome that if he gets diabetes, and needs to take the generic drug metformin, he should take a lower-than-usual dose. But most importantly, because he’s a scientist willing to make himself a laboratory subject, he’s more likely to catch diabetes or some other ailment at an early and treatable stage.

After giving 50 samples to his research team over the past 34 months, Snyder says he expects much more interesting data to come. This wasn’t just a case of a single paper which generates some buzz, maybe a few new research ideas, and then fades into the ether. It’s really just the first step in a long-range study of Snyder at the molecular level, and what that means for his health. “I’m sure I’ll be doing this the rest of my life,” Snyder says.

No question, this is all still very much at a research stage. This kind of hard-core data-gathering approach is many years away from being reduced to practical use, or lending itself to new products for diagnosis or treatment. The Stanford team used a next-generation gene sequencing machine, and two different mass spectrometers, which are expensive pieces of equipment. The first study of Snyder’s ‘omics profile generated 50 terabytes of data, and he says the next phase of research will probably double the amount of data. It cost tens of thousands of dollars, and he doesn’t really have a full accounting that includes computer analysis and staff time. And the costs keep recurring. While the team only had to sequence his genome once—because his unique DNA signature doesn’t change over time—the battery of other ‘omic tests will probably cost at least $2,000 each time he gives blood, just for the chemical reagents required, not counting costs for analysis and staff time.

Still, every day as the costs come down, more research ideas become feasible. Snyder’s story, which got a fair bit of media attention in the spring, has inspired a number of volunteers who want to help. The Stanford team is broadening the scope of their personalized medicine vision by looking to analyze the microbes in Snyder’s gut—the microbiome—and his epigenome, which will show how his genes get expressed. Those extra analyses will add cost, but Snyder says he believes it will be soon be possible to capture a simple version of the molecular analysis for maybe $600 each time he gives blood. Once the costs get down into that range, it will be feasible to do one continuous study of 10 volunteers like Snyder, who are willing to subject themselves to all these regular blood draws, when they’re feeling well and when they’re not.

Beyond that study, Snyder says he and his team are exploring a 250-person study of people at high risk for diabetes, or who are pre-diabetic. The idea will be to take these regular personal ‘omic snapshots, connect it with a detailed picture of the person’s environmental stimuli (particularly their diet/exercise habits), and watch over a 5-year period to see whether certain biochemical pathways are truly predictive of whether a person will get diabetes. That kind of study would be clearly more informative to the practice of medicine than just one man’s experience, which could be a fluke.

Certainly, there are going to be experiments that fail, or just give us vague ideas of where an individual’s health is headed. People, being human, won’t always follow their doctor’s advice, even if they know they can stop themselves from getting diabetes. Insurance companies may use this data to their own advantage, and to the disadvantage of the individual. (In fact, Snyder says his life insurance premiums went up once he told his insurer about his diabetes diagnosis. That action is perfectly legal, he notes, because life insurance firms aren’t subject to theGenetic Information Non-Discrimination Act of 2008.)

The whole march of science, the business implications, and the ethics of this movement will surely lurch along in fits and starts over the coming decades. It will be messy. It won’t happen overnight.

But I do believe we’re going to learn amazing things that will change our behavior. And I think that within the next decade, a whole lot more people in the U.S. will have the same kind of visibility Snyder got into his individual health, because it really ought to save the whole system money if it scares people into leading healthier lives. The 99 percent of patients will no longer say “Personalized Medicine? What’s that?” People will want this information, they’ll demand it, and many will act on it. Some of today’s skeptics will turn into believers, and they’ll find ways to profit from this movement, by helping people prevent bad things from happening. As Snyder puts it, “This is what personalized medicine is all about. You can look at your altered biochemical state, and you can change things when you catch them early. It’s the name of the game.”

Luke Timmerman is the National Biotech Editor of Xconomy. E-mail him at

ltimmerman@xconomy.com Follow @ldtimmerman

SOURCE:

http://www.xconomy.com/national/2012/11/19/stanfords-mike-snyder-starts-living-the-personalized-medicine-story/2/

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Engineered Pancreatic Tissues Could Lead to Better Transplants for Diabetics

Posted in Bio Instrumentation in Experimental Life Sciences Research, Chemical Biology and its relations to Metabolic Disease, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Genomic Testing: Methodology for Diagnosis, Health Economics and Outcomes Research, Human Immune System in Health and in Disease, Infectious Disease & New Antibiotic Targets, Liver & Digestive Diseases Research, tagged Blood sugar, Blood vessel, Conditions and Diseases, health, Pancreas, University of Pennsylvania on August 20, 2012| 1 Comment »

Engineered Pancreatic Tissues Could Lead to Better Transplants for Diabetics

Reporter: Aviva Lev-Ari, PhD, RN

Wednesday, August 15, 2012
By: Kevin Hattori

Technion researchers have built pancreatic tissue with insulin-secreting cells, surrounded by a three-dimensional network of blood vessels. The engineered tissue could pave the way for improved tissue transplants to treat diabetes.

The tissue created by Professor Shulamit Levenberg of the Technion-Israel Institute of Technology and her colleagues has some significant advantages over traditional transplant material that has been harvested from healthy pancreatic tissue.

Prof. Shulamit Levenberg

 

The insulin-producing cells survive longer in the engineered tissue, and produce more insulin and other essential hormones, Levenberg and colleagues said. When they transplanted the tissue into diabetic mice, the cells began functioning well enough to lower blood sugar levels in the mice.

Transplantation of islets, the pancreatic tissue that contains hormone-producing cells, is one therapy considered for people with type 1 diabetes, who produce little or no insulin because their islets are destroyed by their own immune systems. But as with many tissue and organ transplants, donors are scarce, and there is a strong possibility that the transplantation will fail.

The well-developed blood vessel network built into the engineered tissue is key to its success, the researchers concluded. The blood vessels encourage cell-to-cell communication, by secreting growth hormones and other molecules, that significantly improve the odds that transplanted tissue will survive and function normally.

The findings confirm that the blood vessel network “provides key survival signals to pancreatic, hormone-producing cells even in the absence of blood flow,” Levenberg and colleagues concluded in their study published in the journal PLoS One.

One reason transplants fail, Levenberg said, “is that the islets are usually transplanted without any accompanying blood vessels.” Until the islets begin to connect with a person’s own vascular system, they are vulnerable to starvation.

The 3-D system developed by the Technion researchers tackled this challenge by bringing together several different cell types to form a new transplantable tissue. Using a porous plastic material as the scaffold for the new tissue, the scientists seeded the scaffold with mouse islets, tiny blood vessel cells taken from human umbilical veins, and human foreskin cells that encouraged the blood vessels to develop a tube-like structure.

“The advantages provided by this type of environment are really profound,” said Xunrong Luo, an islet transplantation specialist at the Northwestern University Feinberg School of Medicine. She noted that the number of islets used to lower blood sugar levels in the mice was nearly half the number used in a typical islet transplant.

Islets grown in these rich, multicellular environments lived three times as long on average as islets grown by themselves, Levenberg and colleagues found.

The technology “is still far from tests in humans,” Levenberg said, but she noted that she and her colleagues are beginning to test the 3-D tissue scaffolds using human instead of mouse islets.

According to Northwestern’s Luo, the 3-D model demonstrated in the study “will have important and rapid clinical implications” if the same results can be replicated with human cells. “This model system also provides a good platform to study the details and mechanisms that underlie successful transplantation.”

The Technion-Israel Institute of Technology is a major source of the innovation and brainpower that drives the Israeli economy, and a key to Israel’s renown as the world’s “Start-Up Nation.” Its three Nobel Prize winners exemplify academic excellence. Technion people, ideas and inventions make immeasurable contributions to the world including life-saving medicine, sustainable energy, computer science, water conservation and nanotechnology.

American Technion Society (ATS) donors provide critical support for the Technion—more than $1.7 billion since its inception in 1940. Based in New York City, the ATS and its network of chapters across the U.S. provide funds for scholarships, fellowships, faculty recruitment and chairs, research, buildings, laboratories, classrooms and dormitories, and more.

 

http://www.ats.org/site/News2?page=NewsArticle&id=7567&news_iv_ctrl=1161

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