FDA Approves of First-of-Its-Kind Insulin Device That Gives Hope for 'Artificial Pancreas'

KatarzynaBialasiewicz/iStock/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration approved a first-of-its-kind insulin device today designed to automatically deliver insulin for type 1 diabetics. The device has many in the diabetic and health care community hoping it could lead to the development of fully artificial pancreas.

“The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases -- especially those that require day-to-day maintenance and ongoing attention,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," he added.

The device, called the the MiniMed 670G hybrid closed loop system, is designed to adjust insulin levels with almost no assistance from the user, according to the FDA.

Created by Medtronic, this device works by having a sensor measure glucose levels under the skin and using a pump and patch that can deliver varying levels of insulin at the right time, without a person manually monitoring their blood sugar. However, since a user has to manually change the insulin levels to counteract meals, the device is not considered a fully automated "artificial pancreas," according to the FDA.

"The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes," said Dr. Francine Kaufman, chief medical officer of the Diabetes Group at Medtronic.

Derek Rapp, president and CEO of the Juvenile Diabetes Research Foundation, said that the device could be a "life-changing breakthrough."

"Today's announcement is a historical achievement for JDRF [Juvenile Diabetes Research Foundation] and the entire T1D [type 1 diabetics] community," Rapp said in a statement. "After years of laying the ground work, this life-changing breakthrough is a true testament to the reason JDRF exists, which is to accelerate ways to cure, prevent and treat this disease."

Les Hazelton used the device in a medical trial and said he felt better after having his insulin automatically regulated, according to the JDRF.

"Bottom line: I feel better today and since going into this study, than at any point after I was diagnosed -- physically, emotionally, confident in how I'm managing my diabetes," Hazelton said in a statement released by the JDRF. "You can get emotional about it. On the good days, if there are enough of them, you recall how you feel -- that's how I feel almost every day now. That's what it has done to help me."

The FDA has been working to advance the development of an artificial pancreas systems for years.

Type 1 diabetes, also called juvenile diabetes, is a chronic condition in which the pancreas produces little or no insulin because the immune system has attacked and destroyed cells that create insulin, according to the U.S. Centers for Disease Control and Prevention. Type 2 diabetes, once called adult-onset diabetes, develops when the body starts to become resistant to the effects of insulin, forcing the pancreas to create more insulin. Eventually the pancreas will not be able to make enough insulin to respond to blood sugar levels.

Copyright © 2016, ABC Radio. All rights reserved.


Baby Born From 'Three Parents' Brings Hope to Those With Mitochondrial Disease

Wavebreakmedia Ltd/iStock/Thinkstock(NEW YORK) -- An infant born thanks to a breakthrough procedure that used genetic material from three people could give hope to thousands in the U.S. struggling with mitochondrial disease.

The baby boy was born without a mutation in his mitochondria, which he would otherwise have inherited from his mother, and is the first infant to be born as the result of a new procedure that involves genetic material from three people. While popularly called a "three-parent" baby, the infant gets 99.9 percent of his genetic material from his two biological parents, with a fraction of material coming from a donor's healthy mitochondria.

The breakthrough was revealed Tuesday by the American Society for Reproductive Medicine (ASRM), a multidisciplinary organization dedicated to the advancement of the science and practice of reproductive medicine. Dr. John Zhang, a New York-based doctor at the New Hope Fertility Clinic, is credited with performing the procedure and has submitted an abstract about the case to ASRM.

The ASRM did not reveal the sex of the infant but the New Scientist reported that it was a boy.

Zhang is expected to present more about the child and his process at an ASRM meeting in October.

The infant was reportedly born thanks to spindle nuclear transfer -- in which the "spindle" of the egg that contains a mother's chromosomes but not her mitochondria is places into a donor egg. The donor egg's nuclear genetic material is removed. The eggs were then fertilized with the sperm of the woman's partner, according to the ASRM.

It is a variation on a procedure approved in the U.K. in which the nucleus of a fertilized egg from a couple is transferred to a fertilized donor egg. In that procedure, the donor's nucleus is removed and destroyed. The destruction of that nucleus reportedly was not acceptable to the couple, leading them to seek out an alternative through Zhang, according to the New Scientist report.

Zhang and the couple went to Mexico to perform the procedure, since it has not been approved in the U.S., according to New Scientist.

Every year, 1,000 to 4,000 children are born with mitochondrial disease in the U.S. and many families have no idea that their children are at risk for developing the dangerous disease until they're diagnosed, according to the United Mitochondrial Disease Foundation. Symptoms include fatigue, gastrointestinal problems and seizures, and can start as key organs lack energy to function properly.

Mitochondria are the structures inside the cell that generate energy and have DNA distinct from the cell's nuclear DNA. Mitochondrial DNA is inherited from the mother only.

Tracie Leeper, of Denver, Colorado, is a carrier for mitochondrial disease, as is her husband. The couple did not know they were carriers until their son Jack was diagnosed at 10 months old. He died last year at 18 months after being born with Leigh disease, one kind of mitochondrial disease. Leeper said she's happy about the breakthrough so that others with mitochondrial disease may have more reproduction options. However, Leeper said she still wanted more information about the child's health.

"It's definitely mixed [emotions]. I'm so excited for the science," Leeper said, noting, however, that questions remain. "Is he going to get sick in a year or is it going to manifest in a different way?"

Leeper and her husband had a 25 percent chance of having a child with Leigh disease. The couple is now undergoing traditional IVF to diminish the chance that will occur.

Mitochondrial disease often results from a mutation in the mitochondrial DNA, which can be passed solely from the mother to the child. It can also be caused by a nuclear DNA mutation in either mother or father that causes dysfunction in mitochondria. Since mitochondria are the energy sources for cells in the body, if they fail or do not work properly, it causes a range of symptoms that can be fatal in severe cases.

“This work represents an important advancement in reproductive medicine," ASRM President Dr. Owen Davis said in a statement on Tuesday. "Mitochondrial disease has been an important, and challenging problem. If subsequent research determines the safety and efficacy of spindle nuclear transfer, we look forward to it being an option for patients who risk transmitting mitochondrial diseases to their children."

Philip Yeske, the science officer for the United Mitochondrial Foundation, said the procedure may sound like science fiction but that people should remember the child's DNA will be 99.9 percent from their biological parents and not the donor. For parents who risk passing this disease to their children, the procedure could literally be a lifesaver.

"First and foremost this is absolutely about the prevention about the transmission of disease from mother to child," Yeske said. "These techniques afford [women with mitochondrial disease] the opportunity to have a biologically related child without the disease."

However, he said researchers will need to continue to study the child to see if they develop any further complications.

"What we lack are long-term studies introducing a third genome, whether that has implications for that child," Yeske explained.

There are an estimated 12,000 women of child-bearing age in the U.S. with mitochondrial disease, Yeske said. The procedure will not help everyone with mitochondrial disease, as some mutations arise from the nuclear DNA that is not changed in through this procedure.

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Alan Cumming on How Meditation, Kindness Has Helped Him Find Happiness

ABC News(NEW YORK) --  Alan Cumming wears many hats. He’s is an award-winning Broadway actor, best known for his role in "Cabaret," and became an on-screen name in TV’s "The Good Wife" and as Nightcrawler in “X-Men 2." On top of his acting career, he is also a New York Times best-selling author, director, comedian and activist.

When he sat down with ABC News’ Dan Harris for the "10% Happier" podcast, he had a different, more literal, hat on –- a bright red baseball cap that had "Make America Gay Again" written in big white letters.

Cumming spoke about his meditation practice, his love of Crocs shoes and his new book out this month called, “You Gotta Get Bigger Dreams: My Life in Stories and Pictures,” a collections of adventures and Cumming’s personal photographs.

 Cumming said his busy schedule makes it hard for him to keep up a regular routine with meditation. But when he does practice, he said he sits in a low chair with his hands on his knees and his eyes closed.

"I breathe," he said. "I start to think about my breathing."

Meditation was something Cumming said he started doing on his own as a way to take a few moments to "block everything out for a while." Over time, he said, it’s helped him to "respond, not react," to situations –- a core lesson in mindfulness.

"You know sometimes when you think, 'I could get really stressed out about this or people are really annoying me,'" Cumming said. "It makes such sense ... [to] take a step back and think, 'Hmm, what’s the best situation here? What’s the best way to deal with this?' and then make a qualified and studied decision."

"I’ve noticed it with other people, like people riding me," he added. "I’ll say, 'OK, don’t reply to that email right now. Let’s just wait a minute. Let’s rest and see how we feel after five minutes.’”

 Growing up in Scotland, Cumming said he had a tumultuous childhood and a strenuous relationship with his late father, which he detailed in his 2014 New York Times best-selling memoir, "Not My Father’s Son." He said living in a tense environment from an early age helped him learn how to deal with "difficult people," and as an adult, he learned how to feel comfortable in his own skin.

"[I made] a decision to not allow shame into my life," Cumming said. "It wasn’t easy and there were lots of hiccups along the way."

He made the conscious choice to start saying, "'I’m good enough, I’m fine. It wasn’t me and I’m going to be OK. And I’m going to move forward and not let this baggage from my past dictate my present or my future."

Meditation, he said, was a help in making that happen. "I think I kind of like the way that meditation works," he said. "I mesmerized myself, or changed myself into just thinking, 'No.'"

Cumming said his childhood was one of the reasons he spends so much time focusing on kindness and trying to being kind to others. He believes there is no situation that can't be dealt with in a better way than being kind to the other person.

"My mom always says, 'It doesn’t cost anything to be nice,'" he added. "I think even when you want to punch someone in the face, take a step back and try to be kind about it and it will go better."

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Your Body: Finding the Right Type of Cancer Screening for Your Breast Density

iStock/ThinkstockBy DR. JENNIFER ASHTON, ABC News Senior Medical Contributor

Continued controversy over breast cancer screening frequency in women over 50.

If you have dense breast it may be harder to identity possible presence of cancer. So those with dense breast, who are also at higher risk for breast cancer, should be screened yearly with mammography.

The question of whether or not to also get a sonogram as part of breast cancer screening is still up in the air. Many doctors, myself included, feel that sonograms are important for women with dense breast at any age.

Since sonograms can detect tumors that mammograms often miss, my prescription is that you talk to your doctor about the right type of screening for you. Should it be a mammogram? A mammogram and sonogram? And how often should you get screened?

By law in many states, you need to be informed if you have dense breasts on your mammogram report. So ask, “Am I dense?”

Copyright © 2016, ABC Radio. All rights reserved.


Couple to Celebrate 77th Wedding Anniversary, 100th Birthdays Together

Randall Johnson(NEW YORK) --  One Illinois couple has a major milestone to celebrate: 77 years of marriage. But that's not all. In a few months Vera and John Peterson of Freeport, Illinois, will be blowing out birthday candles for John's 100 birthday.

"I met this tall, handsome guy and you know, it took a while," Vera Peterson, 100, told ABC News. "It has been wonderful. I'm not saying that everything was all roses. There was a few thorns as always, and I think everyone has that. It can't be perfect, but we have to have give and take."

The Petersons were married on Sept. 28, 1939.

Together, Vera and John, 99, have seven children, 18 grandchildren, 34 great-grandchildren and three great, great-grandchildren.

Randall Peterson, 76, the eldest child of the couple, said his father was a farmer most of his life before becoming a carpenter.

Vera was a stay-at-home mom until her children were grown up. She later worked at a nursing home for 20 years.

"It's amazing feat, especially this day in age," Peterson of Chadwick, Illinois, told ABC News of his parents' anniversary. "Mom's 100 and Dad's going to be 100 in March, which is also amazing. They have their own sense of humor, which we enjoy."

Pam Queckboerner describes her grandparents as genuine people with a spiritual connection.

"They care for each other from the bottom of their hearts," she said. "They live and breathe each other, so I think that has kept them going. They are very caring, loving and giving."

For their anniversary, the Petersons are having a low key, celebratory dinner with family.

As for their secret to a long marriage, John Peterson credits his favorite saying: "Yes dear!"

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Two-Legged Piglet Named Miracle Walks on Front Legs

Ari Smith(NEW YORK) -- Three weeks ago, an adorable miniature pig named Miracle was born on a farm in Colorado. Miracle was born without his hind legs but the little piglet has proven to be a fighter.

Ari Smith, a mini pig breeder and founder of Colorado Cutie Pigs, didn't think that Miracle would survive without his back legs. But the piglet has adapted to his disability, getting around on his front legs instead.

 "It was amazing to watch, because he doesn't know anything's wrong with him. He just thinks [how he walks] is normal," Smith told ABC News Denver affiliate KMGH.

Miracle has no problem trotting around the farm as he balances on his front legs, but Smith said she will have a wheelchair specially made for him.

Colorado Cutie Pigs has reached out to members of the community to find someone who can care for Miracle's special needs and give him a forever home.

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Elderly Couple Reunited After Forced to Live Apart for Months

Courtesy Ashley Bartyik(NEW YORK) -- An elderly Canadian couple has finally been reunited after being forced to live in separate nursing homes for more than eight months, according to their granddaughter.

The reunion, which was filled with "tears of joy," came after Wolfram Gottschalk, 83, and Anita Gottschalk, 81, were photographed crying in late August during a visitation a few months after they were first separated, according to their granddaughter, Ashley Bartyik.

"This is the saddest photo I have ever taken," Bartyik, 29, captioned the photo posted to Facebook.

At the time, Bartyik told ABC News she and her family had been pleading with Fraser Health Authority, which manages the assisted living residences, to allow her grandparents, who had been married for over 62 years, to live together.

Bartyik added that that she was worried her grandparents' heartbreak and stress "could literally kill them."

Fraser Health previously said that it had been working to get the couple together but space was unavailable.

"We certainly understand how heartbreaking this is for the family," Fraser Health spokeswoman Tasleem Juma told ABC News partner CTV News at the time. "It’s upsetting for us as well."

But nearly a month later -- and after the heartbreaking photo of Wolfram and Anita had been shared more than 10,000 times on Facebook -- the couple's wishes have been finally granted, Bartyik announced on social media last week.

Wolfram was moved into the same facility as Anita on Thursday, Sept. 22, and the two were captured smiling, kissing and embracing in heartwarming photos and video Bartyik posted to Facebook.

"They can now be under the same roof for their remaining years, and we couldn’t be more grateful," Bartyik wrote in her post on Facebook. "They would like to thank Fraser Health for this reunion, and also the media for helping to get their story heard. They also wish to thank everyone around the world that liked, shared, or discussed their story."

The 29-year-old added that though her grandparents were now reunited, "the story isn't over" and that she would continue advocating for other couples separated by the health system in the British Columbia area.

Fraser Health cared "deeply about reuniting couples in long-term care as quickly as possible," Juma told ABC News in a statement Tuesday, adding that the health authority was happy to be able to reunite Wolfram and Anita.

Juma explained that Fraser Health had been working with Bartyik's family "for some time to ensure we were able to reunite their loved ones as quickly as possible." She added that health authority had "presented the family with options for reunification and they chose the option that suited them best until a bed became available at their preferred site."

"Couple reunification is a priority for us," she said. "This can sometimes take longer when individuals need different levels of care, and especially when families have a preference for a particular site. Still, we do everything in our power to bring couples together quickly."

Bartyik did not immediately respond to ABC News' requests for additional comment Tuesday.

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Blood Clot Removal Could Help More Stroke Victims, Study Finds 

Hayden Bird/Getty Images(NEW YORK) -- The window for helping certain stroke patients with a potentially life-saving blood clot removal surgical treatment may be longer than previously thought, according to a study published Tuesday in the Journal of the American Medical Association.

Traditionally stroke is treated with medications that stabilize or diminish blood clots in the brain. In select patients surgical intervention to remove the clot may be possible to mitigate effects of the stroke.

Currently, the American Stroke Association advises that blood clot removal for some patients -- an emergency procedure called endovascular thrombectomy recently developed and increasingly used in addition to medical therapies -- should be done within six hours after stroke symptoms to lower the amount of disability patients will face later. But this analysis showed that the time for treatment could be slightly longer -- up to 7.3 hours.

This study could affect the current guidelines on treating stroke patients, according to Dr. Cathy Sila, Director of the Comprehensive Stroke Center at University Hospitals Cleveland Medical Center. She said there is "compelling rationale to move that window a little bit."

As a result of having lost blood flow to the brain for an extended time, stroke victims often suffer physical disabilities and lose varying degrees of their independence. They often require longer-term care and therapies.

"Long-term disability of stroke is more expensive than cost of hospitalization," Sila told ABC News Tuesday.

Authors from multiple institutions including the University of Calgary, pooled data from five studies on stroke treatments to see if providing endovascular thrombectomy in addition to standard medical treatment past six hours would help patients. They analyzed those studies for patients who have had large blood vessel strokes, seeking to understand how much of an effect blood clot removal surgery performed after six hours would have on their longer-term recovery. They used a benchmark of three months after the stroke to assess patients' level of disability.

In total, 1,287 patients were enrolled in the five trials studied. The researchers examined clinical data and brain imaging in addition to the patients’ physical function. They found that the patients who received standard medical therapy along with an endovascular thrombectomy up to 7.3 hours after developing stroke symptoms were less likely than patients who were treated with only medications to report disability three months later.

When they examined the patients three months after the stroke, each hour delay in receiving the treatment corresponded in worse outcomes for the patients, including more severe disability and less functional independence.

This meant that even the patients who received the treatment outside of the generally accepted 6 hours cut off up to the 7.3 hours point tended to report less disability during their recovery. However, if people received the treatment after 7.3 hours from onset of symptoms there was no statistical improvement.

Dr. Mayank Goyal, a co-author of the study and professor of Radiology, University of Calgary, said he hopes the study will help raise awareness about the importance of getting prompt treatment for a stroke and having an efficient system to provide this procedure.

"Time is brain," Goyal told ABC News. "The faster we can re-establish blood flow to brain, the higher the likelihood of the patients having a good outcome and going back to independent living."

Sila said further study is needed to find out if these kinds of procedures could benefit people even after the 7.3 hours from symptom onset. She pointed out that these studies are important since they can help change guidelines and push insurance companies to cover the procedure for more patients.

"We need to have this kind of data so third party payers would have it to base [costs] on," she said.

Copyright © 2016, ABC Radio. All rights reserved.


More Americans Admit a Heavy Drinking Day in Past Year, CDC Says

Johannes Simon/Getty Images(NEW YORK) -- In the first three months of 2016, slightly more U.S. adults say they had at least one “heavy drinking day” in the past year – 25.4 percent, according to the Centers for Disease Control and Prevention (CDC).

Using a large national survey, CDC researchers found that the percentage of men who had at least one day of heavy drinking was 32.4 percent (higher than the 2015 figure of 29.9 percent) and 18.9 percent of women said the same (the 2015 figure was 17.4 percent, but the female figures are close enough that they might be due, statistically, to chance).

For both sexes, the numbers are significantly higher than they were a decade ago.

Although the report from the CDC only provides new data, it could spark more discussions about alcohol and binge drinking.

Copyright © 2016, ABC Radio. All rights reserved.


This Mom Threw Out Her Kids' Toys and Got Her Life Back

Courtesy Allie Casazza(NEW YORK) -- Allie Casazza was drowning -- in toys.

“I had this huge room in my house, dedicated to toys,” she told ABC News. “Bins overflowing with stuff. A $150 light-up unicorn no one played with. The playroom was the bane of my existence.”

She describes a scene familiar to many moms.

“I’d send the kids into the playroom and they’d dump out a few things. They’d be back moments later, saying they were bored and asking for snacks," she said.

Trying to keep herself sane, she would clean up the toys and the room several times a day, just to have it destroyed again.

“I didn’t enjoy motherhood,” the Bentonville, Arkansas, mom said. “I didn’t enjoy [my kids]. They were a bother to me.”

Every day she would wait for nap time and bedtime.

“I thought that was ‘just the way it was,'” she said. “I was in survival mode.”

One day, Casazza had enough. She gave nearly every toy in the house away. Not as a punishment, she said, but for the good of the family. That one action "saved my motherhood, my marriage," she said.

Her struggle is common. It turns out that an excess of stuff can have a negative effect on moms. A 2012 study from UCLA’s Center on the Everyday Lives of Family found managing the volume of possessions “was such a crushing problem in many homes that it actually elevated levels of stress hormones for mothers."

Casazza waited for the temper-tantrums from the kids. Instead, they were excited she had cleaned out the room. And literally overnight, she said, things in her home changed.

“I had been so resentful of my husband, telling him, ‘you have no idea what I go through all day,’ but after the toys were gone I immediately felt lighter. I had so much less stress," she said.

And the whining about being bored? No more.

Noelle Swift, a mom from Wood-Ridge, New Jersey, told ABC News the decision to limit her 28-month-old’s toys was made before he was born. He has plenty of books, but his toys can very easily fit on two shelves. As a result, Swift said, he can play with one toy for hours on end. And since everything has a very clear place, he also puts his toys away.

“I want him to value the toys he has,” she said.

Beth Becher is a mom and the owner of B Organized, a professional organization service. She said her clients’ lives are “forever changed” when they finally get rid of the clutter. A major theme among moms having trouble clearing the toys is guilt, she said.

“It’s always, ‘but my mother-in-law gave my son that for his first birthday,’ even if it’s broken,” she said.

Her mantra is: “If you don’t need it, use it or love it, get rid of it."

Her daughter has very few toys, and she sets limits with family when it comes to gift giving.

Some clients, she said, can’t go into a store with their kids because they will inevitably leave with a new toy.

“We’re hurting our children,” she said. “It has to stop.” When she leaves a client's home and returns to her own, she feels like she can "breathe.”

She also said finding a place you can feel good about donating to is the first step to alleviating some of the guilt of letting go.

Casazza’s toy toss led to a greater household-wide purge and the family decided to downsize. Without all the things that were weighing them down, Casazza said, she was able to start her own business. The Purposeful Housewife is dedicated to living minimally. She even decided to homeschool her kids. It’s a far cry from the mom who counted the moments until nap time.

She said her four kids are exceptionally close, and they use their imaginations to make up games with things as simple as a broomstick.

“That’s all they do all day. Together. There’s no more ‘I was playing with that,’" she said, “because they don’t have those things anymore.”

Today she loves being a mom. “It’s such a short season when your kids are young. Now I can enjoy it," she remarked.

Copyright © 2016, ABC Radio. All rights reserved.

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