Insulet takes another step closer to introduce artificial pancreas

By ARUNDHATI PARMAR

Another established device maker is throwing its hat in the ring of artificial pancreas development.

diabetes-glucose-testInsulet, the maker of the tubeless insulin pump, announced Tuesday that the first patient has completed the feasibility study to test its OmniPod Horizon Automated Glucose Control System, a hybrid closed loop system intended for patients that depend on insulin or type 1 diabetes patients.

The full study will enroll 20 such adults to see how they respond to a personal Model Predictive Control algorithm — Insulet acquired the algorithm, originally developed at the University of California Santa Barbara from a company in February — along with the Omnipod platform. The data gathered through this study will help to perfect the algorithm in future studies  that the company will need to conduct to get the product through the Food and Drug Administration.

The agency, meanwhile, is already reviewing the premarket approval submission for another hybrid closed loop system — this one from Medtronic. If approved, Medtronic will have the distinction of introducing the first hybrid loop system, which is different from a fully closed loop artificial pancreas. The latter technology doesn’t require any patient input in the delivery of insulin.

A variety of startups including Bigfoot Medical and Beta Bionics are also on the path to automate insulin delivery.

While Insulet, based in Billerica, Massachusetts, may not be first in the marketplace with an approved device, executives believe that it’s system will be distinct from competing products.

“Our personalized Model Predictive Control (MPC) algorithm is intended to be integrated inside the Pod — a true differentiator among the artificial pancreas technologies on the horizon,” said Patrick Sullivan, president and CEO of Insulet, in an email forwarded by a representative. “This feature is intended to allow for uninterrupted insulin control for up to 72 hours, a similar, small footprint to the current Pod and a fully functioning on-body artificial pancreas system.”

Sullivan declined to say how much has been invested so far in the development of the OmniPod Horizon and what will be needed to commercialize the device.

Whatever the investment level turns out to be, the market opportunity is attractive. Sullivan pointed to the fact that only 30% of patients with type 1 diabetes currently meet ADA guidelines for glucose control. And a widely-held belief is that an artificial pancreas will be able to more tightly control a patient’s glucose levels, a big headache in the day-to-day diabetes management.

While Insulet and Medtronic are developing hybrid loop systems, the Holy Grail of diabetes management is the closed-loop system where the device is fully automated and doesn’t depend on the user at all. However, it appears that a system like that needs advances in other key areas as well.

“We do not believe that a full closed-loop is practical with current insulin formulations,” Sullivan said.

Insulet takes another step closer to introduce artificial pancreas

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Managing your diabetes in hot weather

The summer heat can negatively impact your diabetes if you don’t take precautions.

Depending on the type of food you’ve eaten, how hydrated you are and your activity level, heat can effect your blood glucose (sugar) levels. If you’re very active but not well-hydrated, the excessive heat can cause you to sweat leading to dehydration. Your blood glucose level may rise if you’re too dehydrated, and that can lead to frequent urination. That cycle can continue if you do not prevent it. It is also important to know that if you take insulin but you’re not well hydrated, the supply of blood to the skin is reduced; therefore, the injected insulin is not absorbed efficiently.

High temperatures can affect your medication and testing equipment as well by damaging them. Most types of insulin can tolerate heat up to 95 degrees Fahrenheit. Any tempreture higher than that can cause insulin to degrade. Testing supplies like test strips and glucose monitoring devices also can become ineffective if exposed to high temperatures.

Keep these tips in mind during hot summer days:

  • Stay hydrated by drinking plenty of water. Always carry enough water with you.
  • Seek your healthcare provider’s advice on adjusting your insulin dosage as needed prior to exercising in hot weather.
  • Be aware of your blood glucose levels by monitoring regularly and frequently since sweating in hot weather can cause your blood glucose levels to fluctuate. This will allow you to take quick actions to stabilize your levels and bring them back to normal.
  • Always have available foods that treat low blood sugar like glucose tablets, small tubes of cake icing, a small piece of fruit, or any other foods you have used before to treat low blood sugar. Eating regular meals or snacks can prevent blood sugar fluctuation so always carry healthy snacks with you.
  • Protect your medication and testing supplies from high heat by storing them at the right temperature. You can do that by taking a cooler with you or taking your supplies with you if you’ll be gone for a longer period of time.
  • Protect yourself from sunburn. Sunburn can raise your blood sugar levels by stressing your body. Use sunscreen and protective clothing if you’ll be spending any time outdoor as sunburn can occur quickly.

Always remember to consult with your health care provider if you have any concerns and use common sense when weather temperatures are too extreme. To find a Diabetes PATH, a Dining with Diabetes or a Diabetes Prevention program near you visit, the Michigan State University Extension events page.

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Peer support, connectivity empower college students with diabetes

SAN DIEGO — Young adults with type 1 diabetes often struggle with the new and added burden of managing a complicated disease on their own as they head off to college, yet many clinical providers and diabetes educators fail to discuss the topics that students have questions about, according to a speaker here.

“We realized that the right information wasn’t available,” said Christina Roth, chief executive officer and founder of the nonprofit advocacy group College Diabetes Network, said during the presentation at the American Association of Diabetes Educators annual meeting. “It wasn’t necessarily available in all the right topics, written in the right way, and in a way that was accessible when [young adults] actually needed it. So, our website has become a hub of information specific to young adults with diabetes.”

College Diabetes Network, or CDN, founded in 2009, has evolved to become a network of more than 85 chapters with another 30 in development, Roth said. The organization serves as a platform for collaboration with other partner efforts to identify gaps in the system related to young adults with diabetes and address them to better manage transition risk with resources like the “Off to College” program.

“We want to make this time in life, this transitional period, safer, we want to make it easier and just a little more endurable,” Roth said. “Our job is to create the platform that brings [young adults] together. With their local communities that they work to create so passionately, we’re then able to connect all of them and create this larger community of adults with diabetes that hadn’t existed before.”

To help foster a safer transition, the CDN Off to College Program provides printed booklets for students and their families and informational toolkits for health clinics and diabetes organizations to host local Off to College events.

The tools stress that topics including drinking, managing relationships and mental health need to be discussed in an open and honest way, Roth said.

“It is also important to recognize that the source of the information, and the way in which it is delivered plays a critical role,” Roth told Endocrine Today before the presentation. “Often at this time in life, getting information from a peer will be far more impactful and effective and is more likely to lead to behavior changes.”

Peer support can be critical during this time and foster important connections between young adults with diabetes, Roth said; however, forcing such relationships on a young adult, either by the parent or provider, can have the opposite effect of driving a person away from resources.

“One of the key reasons CDN offers our free student membership is to incentivize students and young adults with diabetes to stay in contact, even passively,” Roth said. “This then creates a continuous line of communication, which, when they are ready, they can use to connect further.”

Parents and providers can start the conversation with college-age young adults by introducing the idea of connecting with peers not as a “support group,” but simply as a way to trade tips and tricks and to talk to someone else who “gets it when they are high in class” Roth said.

Currently, there are no clinical care recommendations related to young adults that mention the role of peer support, Roth said, and she would like to see that change.

“There should be more encouragement for providers to be more proactive in embracing support systems and tools outside of the clinic,” Roth said. “Focusing more on helping their patient put systems in place to support them for all the time in between visits, instead of simply relying on that individual’s motivation being enough, but looking at it as failure when it is not.” – by Regina Schaffer

Reference: Roth C. S21. Off to College and Beyond: Resources and Programs to Launch Young Adults with Diabetes. Presented at: AADE 2016; Aug. 12-15, 2016; San Diego.

http://www.healio.com/endocrinology/diabetes-education/news/online/%7B654a0719-e076-47e3-bfba-ca71d79b3a4c%7D/peer-support-connectivity-empower-college-students-with-diabetes

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Even Small Bursts of Exercise Can Make Kids Healthier

As little as 20 minutes of activity three times a week could go a long way.
Getting kids to exercise is hard. Getting kids to exercise a lot is harder. That’s always been a problem, but it’s even more so now, as a combination of cheap junk food, scaled back gym class time, extreme portions and online living have led to obesity epidemics in developed countries around the world—including among children.

Now there may be a simple way to mitigate the problem, if not solve it entirely: according to a new study published in the journal PLOS One, very short intervals of high-intensity physical activity could have a range of health benefits for kids, including lowering triglycerides and reducing body fat. Known by the kid-friendly acronym FFAB, for Fun Fast Activity Blasts, the exercises can yield benefits with as little as 20 minutes of alternating activity and rest, three times per week.

The study, led by Kathryn Weston, a senior lecturer in applied biosciences at Teesside University in the United Kingdom, was conducted in eight secondary schools in the Tees Valley region in northeast England. Weston and her colleagues recruited 101 students and divided them into two groups: one would receive the FFAB training in ten sessions over 13 weeks; the other would receive no intervention and simply be monitored. All of the students would go through physical exams beforehand which measured not just blood fat and body fat, but weight, blood pressure, glucose levels and more.

For the intervention group, each of the three weekly sessions began with five minutes of warming up followed by four 45-second bursts of activity, each of which was followed by a 90-second rest interval. At the end of the sessions there was a five minute period of cool-down exercise.

The students could choose from among four different types of exercise based around four different activities: basketball, boxing, dance and soccer. The basketball drills, for example, involved such activities receiving and returning a chest pass, then running to a cone and running back; and bouncing a basketball five times, then running to the end of a gym and running back. The dance exercises included high leg kicks while clapping pom poms under the elevated leg, and stationary high-knees running. All of the subjects in both the control group and the intervention group were also told to wear accelerometers during waking hours for one week before and one week after the study to measure overall activity level.

At the end of the study, both groups went through the same medical exams they had at the beginning. On at least three metrics, the intervention group was in distinctly better shape than the control group, with triglycerides 26% lower on average, waist circumference 1.5 in. (3.9 cm) smaller and 16 more minutes of daily physical activity recorded by the accelerometers, not including the exercise sessions. Blood pressure, total cholesterol, and HDL (or good) cholesterol were also better in the intervention group, though not quite at a level of statistical significance.

Certainly, the study was limited: a sample group of 101 is not terribly big and the short-term nature of the intervention does not demonstrate much either way about long-term results. However, the increased activity during non-exercise hours did suggest that once kids start moving more in a controlled setting, they may carry that over into their unmonitored hours.

Best of all, the researchers believe, is that the FFAB idea is, as they call it, “novel and scalable,” a relatively untried approach that would be easy to implement in a larger and more sustained way. At a time when too many kids are suffering the physical consequences of getting almost no exercise at all, even a little bit might make a big difference.

http://time.com/4434878/physical-education-childhood-obesity/

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FDA approves expanded pediatric indication for t:slim pump

The FDA approved an expanded pediatric indication for the t:slim insulin pump, lowering its indicated age for use in children from those aged at least 12 years to age 6 years, Tandem Diabetes Care announced in a press release.

The t:slim pump is the first and only touchscreen insulin pump cleared by the FDA. The expanded pediatric indication applies to the current t:slim pump features, with no changes to the existing user interface.

“The t:slim Pump has the look and feel of a modern consumer device, which we believe makes it especially well-suited for school-aged children who have grown up in a world of smartphones and tablets,” Kim Blickenstaff, president and chief executive officer of Tandem Diabetes Care, said in the release. “This FDA clearance allows us to share this product with a broader group of children with diabetes and their parents, who we think can benefit greatly from our technology.”

http://www.healio.com/endocrinology/diabetes/news/online/%7Bb41a9828-094f-453a-878c-fa4b12746057%7D/fda-approves-expanded-pediatric-indication-for-tslim-pump

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Adolescent girls with type 1 diabetes have worse perception of condition than boys

Teenage girls with type 1 diabetes are more likely to have negative perceptions of the condition compared with teenage boys with type 1 diabetes, a study finds.

Researchers at Oslo University Hospital, Norway stress that a tailored treatment approach could be warranted for males and females with type 1 diabetes.

The Oslo team evaluated 105 males and females aged between 12 and 20 years, all of whom had type 1 diabetes. They aimed to investigate psychological barriers to achieving optimal insulin therapy, such as illness perceptions and coping strategies.

The researchers focused specifically on gender differences and mode of treatment: 66 per cent used insulin pumps and 34 per cent used an insulin pen.

Participants were asked to complete three questionnaires, and diabetes clinical data was collected from the Norwegian Childhood Diabetes Registry.

On the brief illness perception questionnaire, girls had a higher score, meaning they had significantly more negative illness perceptions.

Females also scored significantly higher than males for concerns about insulin. Those using an insulin pen had more negative views on treatment control to participants who used an insulin pump.

However, there were no differences between boys and girls for perception of insulin necessity.

Despite the girls tending to be more concerned about insulin and their condition on the whole, girls were found to score significantly higher with the positive coping strategies ‘being social’ and ‘solving family problems’.

“Addressing psychological aspects may be a clinically important supplement to standard somatic T1D care,” the researchers wrote.

“The consistent finding of gender differences across the psychological measures implies that a tailored treatment approach for males and females with T1D may be warranted.”

The study appears in the journal BMJ Open Diabetes &Care.

http://www.diabetes.co.uk/news/2016/jul/adolescent-girls-with-type-1-diabetes-have-worse-perception-of-condition-than-boys-93785365.html

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Huge study of diabetes risk shows many common genes at play

A study examining the genes of more than 120,000 people from Europe, Asia, Africa and the Americas has offered the clearest picture yet of the genes that drive type 2 diabetes.

The study, published on Monday in the journal Nature, puts to rest a decades-long debate over the genetics that influence the risk of diabetes, which affects one in 10 people over the course of their lifetime.

And it has identified more than a dozen specific genes directly involved in the development of type 2 diabetes that might serve as potential drug targets.

“There was a whole furious debate that arose about this,” said Dr. Francis Collins, director of the National Institutes of Health, one of more than 300 scientists collaborating on the work.

Prior studies turned up more than 80 spots in the genome associated with the development of adult-onset diabetes, but most of these genetic errors were common, meaning they occurred frequently in the population, and they explained only a small fraction of disease risk.

These discoveries were based on genome-wide association studies or GWAS, which used gene chips that scan thousands of genes at a time. Researchers used these to scan DNA from large populations of individuals with a specific disease and compare them with DNA from similar groups of healthy people.

Critics, including geneticist Dr. David Goldstein at Columbia University, argued that such studies were a waste of resources because they only found common variants that explained just a small fraction of the risk for disease.

He said the really important drivers of common diseases such as diabetes and schizophrenia were more likely to be found in extremely rare genes, those occurring in individuals or in families, not those shared by large populations of people.

Goldstein “argued very persuasively that it was all about rare variants and we were all going down the wrong road looking at the common ones,” Collins said in a telephone interview.

The new study took a deeper look, using next-generation sequencing to search the entire genetic code of 2,657 people with and without diabetes to assess the contribution of both rare and common genes driving diabetes.

They also sequenced all of the protein-making genes in 12,940 people, and used statistical methods to estimate risk in another 111,548 people with less complete DNA data.

They found that, indeed, most of the genetic risk for type 2 diabetes is caused by common mistakes in the genetic code, with each mistake contributing only a small portion of an individual’s risk for developing the disease.

“What this study says quite definitively for diabetes is the vast majority of hereditary risk variants are in fact these common ones, and the rare ones, while they pop up here and there, are a much smaller contribution,” Collins said.

The study also turned up more than a dozen examples where variants alter the way proteins are made, suggesting that these gene variants have some direct impact on the development of type 2 diabetes.

“These represent promising avenues for efforts to design new ways to treat or prevent the disease,” said Mark McCarthy, a senior author of the study from Oxford University.

All of the data will be made publicly available online through the Accelerating Medicines Partnership, a public-private partnership between the NIH, the U.S. Food and Drug Administration, 10 drug companies and several nonprofits.

Goldstein said the work was “a careful, solid investigation” that does not change his view much overall, adding that it was time to “quit arguing.”

“What I care about now is finding the exact variants that infer risk, and understanding how they do so,” he said.

Mon Jul 11, 2016

(Editing by Bernadette Baum)

http://www.reuters.com/article/us-health-diabetes-genes-idUSKCN0ZR1VG

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US study finds hypoglycemia makes people with type 1 diabetes fearful of exercise

Many people with type 1 diabetes have problems keeping their blood glucose levels under control when exercising, according to a new US study.

Exercise is extremely beneficial for people with type 1 diabetes because it can help regulate blood sugar levels and reduce the risk of cardiovascular disease. But hypoglycemia always needs to be carefully managed before, during and after exercise.

In this new study, a research team led by Dr Jordan Pinsker at the William Sansum Diabetes Centre, California, asked adults with type 1 diabetes to complete an online survey which focused on diabetes self-management and exercise.

The 502 adults who completed the survey were recruited from the Type 1 Diabetes Exchange’s online patient community, Glu.

Prior to filling in the survey, Pinsker’s team wanted to investigate if it was possible to reduce the risk of early- and late-onset hypoglycemia following exercise .

They explored this possibility by making considered changes in carbohydrate intake and insulin use. Patients’ exercise preparations and insulin management techniques were examined before and after physical activity, and the researchers analysed how management changes could affect their routines.

The study revealed that 79 per cent of participants increased their carbohydrate intake before exercise; 69 per cent increased carb intake after exercise. Furthermore, 53 per cent decreased their bolus insulin before exercise, while 46 per cent decreased it after exercise.

Even after making changes to their management regimen, 70 per cent of people reported having low blood sugar after exercise. This, according to Pinsker’s team, needs to be addressed.

Participants found it hard to control their blood sugar levels during exercise and felt worried that exercising would lead to them experiencing hypoglycemia. This was the case among users of both insulin pump therapy and continuous glucose monitoring (CGM).

“These findings highlight the need for exercise-management strategies tailored to individuals’ overall diabetes management are needed for people to better manage their condition and avoid hypos,” said the study authors.

The findings appear in the Canadian Journal of Diabetes.

For more information on managing your blood sugar levels during exercise, check out our Diabetes and Sport section.

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