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

A clinical trial at four pediatric diabetes centers in the United States has found that a new artificial pancreas system — which automatically monitors and regulates blood glucose levels — is safe and effective at managing blood glucose levels in children as young as age six with type 1 diabetes. The trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health. Results from the trial were published August 26 in the New England Journal of Medicine.

“Fewer than 1 in 5 children with type 1 diabetes are able to successfully keep their blood glucose in a healthy range with current treatment, which may have serious consequences on their long-term health and quality of life,” said Guillermo Arreaza-Rubín, M.D., director of NIDDK’s Diabetes Technology Program and project scientist for the study. “Earlier research showed that the system tested in this study was safe and effective for people ages 14 and older. This trial now shows us this system works in a real-world setting with younger children.”

The artificial pancreas, also known as closed-loop control, is an “all-in-one” diabetes management system that tracks blood glucose levels using a continuous glucose monitor (CGM) and automatically delivers the insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or CGM with delivery of insulin by multiple daily injections or a pump controlled by the patient or caregiver.

The study enrolled 101 children between ages 6 and 13 and assigned them to either the experimental group, which used the new artificial pancreas system or to the control group which used a standard CGM and separate insulin pump. Check-ins and data collection were conducted every other week for four months.

Study participants were instructed to continue about their daily lives so that the researchers could best understand how the system works in the typical routines of the children.

The study found that youth using the artificial pancreas system had 7% improvement in keeping blood glucose in range during the daytime, and a 26% improvement in nighttime control compared to the control group. Nighttime control is of particular importance for people with type 1 diabetes, as severe, unchecked hypoglycemia can lead to seizure, coma or even death. The overall time-in-range goal for the artificial pancreas reflected a nearly 11% improvement, which translated to 2.6 more hours per day in range.

“The improvement in blood glucose control in this study was impressive, especially during the overnight hours, letting parents and caregivers sleep better at night knowing their kids are safer,” said protocol chair R. Paul Wadwa, M.D., professor of pediatrics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado, Aurora (CU). “Artificial pancreas technology can mean fewer times children and their families have to stop everything to take care of their diabetes. Instead, kids can focus on being kids.”

Sixteen adverse events, all classified as minor, occurred in the artificial pancreas group during the study, with most due to problems with the insulin pump equipment. Three events occurred in the control group. No cases of severe hypoglycemia or diabetic ketoacidosis occurred during the study.

“For decades, NIDDK has funded research and technology development to create a user-friendly automated device that could ease the constant burden of type 1 diabetes, from the finger sticks and insulin injections, to the insulin dose calculations and constant monitoring while improving diabetes control outcomes and preventing both short- and long-term complications of the disease,” said Arreaza-Rubín.

“The artificial pancreas is a culmination of these years of effort, and it’s exciting to see how this technology may benefit children with type 1 diabetes and their families, and hopefully benefit everyone with diabetes in the future.”

The artificial pancreas technology used in this study, the Control-IQ system, has an insulin pump that is programmed with advanced control algorithms based on a mathematical model using the person’s glucose monitoring information to automatically adjust the insulin dose. This technology was derived from a system originally developed at the University of Virginia (UVA), Charlottesville, with funding support from NIDDK.

This four-month study was part of a series of trials conducted in the International Diabetes Closed-Loop (iDCL) Study. In addition to CU and UVA, study sites included Stanford University School of Medicine, Palo Alto, California; and Yale University School of Medicine, New Haven, Connecticut. Jaeb Center for Health Research served as the data coordinating center.

Based on data from the iDCL trials, Tandem Diabetes Care has received clearance from the U.S. Food and Drug Administration for use of the Control-IQ system in children as young as age six years.

“As we continue to search for a cure for type 1 diabetes, making artificial pancreas technology that is safe and effective, such as the technology used in this study, available to children with type 1 diabetes is a major step in improving the quality of life and disease management in these youth,” said NIDDK Director Dr. Griffin P. Rodgers.

The iDCL Study is one of four major research efforts funded by NIDDK through the Special Statutory Funding Program for Type 1 Diabetes to test and refine advanced artificial pancreas systems. The studies, with additional results forthcoming, are looking at factors including safety, efficacy, user-friendliness, physical and emotional health of participants, and cost.

This study was funded by NIDDK and Tandem Diabetes, Inc. Tandem provided the experimental closed-loop systems used in the trial, system-related supplies including the Dexcom CGM and Roche glucometer, and technical expertise.

Remedies for Nausea and Vomiting

Nausea and Vomiting: What’s Wrong?

Your child’s nausea has turned to vomiting, and you want to help him fast. Luckily, bouts of vomiting in kids aren’t usually harmful, and they pass quickly. Common causes are stomach viruses and sometimes food poisoning. Check in with your doctor if your child is less than 12 weeks old, acts sick, or if you are worried.

Signs of Dehydration

One of the best things you can do is watch for dehydration. Kids get dehydrated more quickly than adults. Watch your child for: acting tired or cranky, dry mouth, fewer tears when crying, cool skin, sunken-looking eyes, not urinating as often as normal, and when he does go, not peeing very much or urine that is darker yellow.

Treating Dehydration

To prevent and relieve dehydration, try to get your child to drink in very small amounts. Even if vomiting continues, she’s still absorbing some of what you give her. Try ice chips, sips of water, sports drinks, or oral rehydration solutions like CeraLyte, Enfalyte, or Pedialyte. After she vomits, start with a small amount: a few tablespoons every few minutes. Over time, give her more as she is able to hold it down. Make sure she urinates regularly.

What About Flat Soda?

For many years, parents used flat lemon/lime soda and ginger ale to help kids replace fluids, and many doctors still recommend those. But research has begun to show that oral rehydration solutions are better for kids. These drinks offer the right amounts of sugar and salt. An alternative can be a sports drink mixed with an equal amount of water.

Liquid Diet

When it’s been several hours since your child last vomited, you can begin a clear liquid diet beyond just water, electrolyte drinks, or oral rehydration solutions. Stick with liquids you can see through. They are easier to digest, yet they offer nutrients to give your child energy. Think clear broth, cranberry juice, apple juice. Popsicles and Jell-O can work well, too.

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Talking to Your Child About Bedwetting: Dos and Don’ts

As many as one out of five children wets the bed at night. Also called nocturnal enuresis, bedwetting is as common as it is misunderstood.

How you, as a parent, handle your child’s bedwetting can have a big effect on how successful your child is at staying dry. When you’re ready to talk with your child about bedwetting, here are a few simple tips that can help.

Bedwetting: Talking to Your Child
Educate. In a class of 30 children, as many as six kids may wet the bed. Letting your child know that other kids have the same problem can take the weight off his shoulders and help him feel he’s not alone.
Tell your child if you used to wet the bed. Was bedwetting a problem for you as a kid? If you or a close family member used to wet the bed at night, let your child know. This helps them understand that bedwetting may be hereditary and is not completely their fault.
Tell them they’re not to blame. Even if there’s no family history of bedwetting, make sure your child knows they’re not to blame for wetting the bed. Explain what can cause bedwetting, including how some children have small bladders or are such deep sleepers they don’t feel bladder contractions in the night.
Tell your child a doctor can help. Talk to your child about seeing a pediatrician or other health care professional to discuss bedwetting treatments. An examination by a doctor can also help rule out medical causes for wetting the bed, such as urological problems or a reaction to certain medications.
Talk to your child about treatment options. Make sure your child understands what’s available to help him overcome wetting the bed, including enuresis alarms, medication, and lifestyle changes. Generally, treatments such as medication are used for children older than 6. Explain, too, how each option works and what to expect from each treatment.
Talk about changing habits. Going to the bathroom before bed, avoiding caffeinated and salty foods, drinking a little less fluid close to bedtime — these and similar changes can help your child achieve dry nights, so talk to him about how he can help himself.
Be encouraging. When your child successfully follows the bedwetting treatment you’ve chosen — whether he’s had a dry night or not — give him praise and encouragement.
Stay low-key. After a child wets the bed, be sure to remain calm and positive.
Encourage your child to go on sleepovers. Your child doesn’t need to miss out. With the use of absorbent pants, medication, and the help of other parents, let your child know they can go on sleepovers or away to camp.
Ask if it’s OK to share. Many kids don’t mind it if other adults know about their bedwetting — especially if that adult can help, such as a parent at a sleepover, or a counselor at camp. But do check with your child first.
Talk to your child about taking part in cleaning up. Sharing the responsibility of changing and washing the wet sheets helps a child actively tackle the problem of bedwetting. Help them with the activity, and praise them for taking part.

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Baby Talk: Communicating With Your Baby

Your baby’s first year will be a flurry of changes — and not just diapers. From the first smiles, gurgles, and coos to learning to say “mama” or “dada,” babies love to communicate with their own form of baby talk. And they hope you’ll “baby talk” right back.

All through this first year, you can do a lot to encourage your baby’s communication skills. And it’s easy. All you need do is smile, talk, sing, and read to your baby.

Why focus on communicating with your baby? Because early speech and language skills are associated with success in developing reading, writing, and interpersonal skills, both later in childhood and later in life.

Baby Talk: Smile and Pay Attention

Long before they can speak clearly, babies understand the general meaning of what you’re saying. They also absorb emotional tone. Encourage baby’s early attempts to communicate with you with loving attention:

  • Smile often at your baby, especially when he is cooing, gurgling, or otherwise vocalizing with baby talk.
  • Look at your baby as he or she babbles and laughs, rather than looking away, interrupting, or talking with someone else.
  • Be patient as you try to decode your infant’s baby talk and nonverbal communication, like facial expressions, gurgling, or babbling sounds that could signal either frustration or joy.
  • Make time to give your baby lots of loving attention, so he can “speak” to you with his or her baby talk, even when you’re busy with other tasks.

Baby Talk: Imitate Your Baby

Right from the start, baby talk should be a two-way street. By imitating your baby, you’ll send an important message: what he is feeling and trying to communicate matters to you.

  • Have back-and-forth conversations in baby talk to teach your baby the give-and-take of adult conversation.
  • Imitate baby’s vocalizations — “ba-ba” or “goo-goo” — then wait for him to make another sound, and repeat that back.
  • Do your best to respond, even when you don’t understand what your baby is trying to say.
  • Reinforce communication by smiling and mirroring facial expressions.
  • Because gestures are a way babies try to communicate, imitate your baby’s gestures, as well.

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Home cleaning products may up risk of childhood asthma

New parents who obsessively clean their homes to protect babies from germs might want to relax a bit, suggests a new study linking high exposure to cleaning products with an increased risk of childhood asthma.
Researchers surveyed parents about how often they used 26 common household cleaners over babies’ first three to four months of life. By the time the kids were 3 years old, children with the highest exposure to cleaning products were 37% more likely to have been diagnosed with asthma than those with the least exposure.

With greater exposure to cleaning products, kids were also 35% more likely to have chronic wheezing and 49% more likely to have chronic allergies, the study found.

“Parents are striving to maintain a healthy home for their children,” said study coauthor Dr. Tim Takaro of Simon Fraser University in Vancouver, Canada.

“We want parents to question the socially accepted norm that a home needs to smell like chemical-based cleaning products in order to be clean,” Takaro by email. “Instead, we propose that the smell of a healthy home is no smell at all.”

In other words, parents should read labels and look for items that are free of dye and perfume, and consider natural cleaning products instead of chemical alternatives.

The first months of life are critical for development of the immune and respiratory systems, and exposure to chemicals inside the home is particularly problematic because infants spend so much time indoors, the study team writes in the journal CMAJ.

Chemicals in cleaning products can cause chronic inflammation that may contribute to development of asthma or make symptoms more frequent or severe, the researchers note.

Most kids in the study were white, and most parents were non-smokers without any history of asthma.

Because asthma can be difficult to diagnose with breathing tests in very young children, researchers also tested kids’ skin for allergies and asked parents how often children experienced symptoms like wheezing.

The most commonly used cleaning products in the study were dishwashing soap, dishwasher detergent, multipurpose spray cleaners, glass cleaners and laundry soap.

The study wasn’t designed to prove whether or how any specific cleaning products or chemicals in these products might directly cause asthma symptoms.

The American Lung Association recommends against using cleaning products that contain volatile organic compounds, fragrance and other irritants, but manufacturers in Canada and the United States are not required to list all ingredients in cleaning products. Some “green” products may contain harmful substances, as these products are not regulated, the study team notes.

“While much remains unknown, we think that these cleaning products (and the chemicals they contain) act as irritants to the airways of growing children,” Dr. Elissa Abrams of the University of Manitoba, in Winnipeg, Canada, who wrote a commentary accompanying the study.

Young children who spend a lot of time indoors, and especially babies and toddlers who touch everything with their hands and mouths, may be especially vulnerable, Abrams said by email.

“The take-home message is that parents should be careful which cleaning products they use in the home,” Abrams said.

Parents Can Help Their Sleep-Deprived Teens

Mom and dad may be key in curbing the epidemic of drowsy teens, a new study suggests.

American teens aren’t getting enough sleep, which can lead to anxiety, depression and suicidal thoughts. Sleepy teens also are more likely to get into car crashes and have a greater risk of being injured while playing sports.

The lack of sleep may be due to too much homework, too many extracurricular activities, too much caffeine, early school start times and too much screen time, researchers say.

But parents can play a pivotal role in helping their teens get the rest they need.

“Greater enforcement of parent-set bedtimes for teenagers aged 14 to 17 are associated with longer sleep duration,” said study lead author Jack Peltz, who conducted the research while at the University of Rochester in New York. He is now an assistant professor of psychology at Daemen College in Amherst, N.Y.

For the study, teens kept a sleep diary over seven days and parents gave information about their enforcement of sleep-related rules and bedtimes.
The study found that enforced bedtimes, along with later school start times, had the greatest influence on sleep duration, daytime energy and depressive symptoms. But more than 50% of parents had no specific or enforced bedtime rules.

Contrary to their expectations, the researchers didn’t find that caffeine or screen time had any effect on how long teens slept.

The study team acknowledged that enforcing a specific bedtime for teens is difficult, but doing so improves their mental health.

“Ideally, parents should be able to work collaboratively with their teenagers to develop bedtimes that still support the child’s autonomy,” Peltz said in a University of Rochester news release.

Study co-author Dr. Heidi Connolly, chief of the Division of Pediatric Sleep Medicine at Rochester, said most teens need nine to 10 hours of sleep each night. That’s also the recommendation of the American Academy of Sleep Medicine and the American Academy of Pediatrics.

“It’s inherently more difficult for teenagers to fall asleep earlier than later because of their circadian rhythm,” Connolly said in the release. “That’s why it’s so important for high school start times to be later, as the American Academy of Pediatrics has recommended across the board.”

Getting enough sleep means feeling well-rested during the day, and waking up at your usual wake-up time even when allowed to sleep in, the researchers said.

When to Call a Pediatrician

It’s 2 a.m. Your baby is crying and you can’t soothe her. She has a fever and a stuffed nose. Do you call the pediatrician, or do you wait until morning?

New parenthood is full of uncertainty. When you’re a first-time parent, it’s easy to second-guess every decision you make.

“It can be hard sometimes to know when or when not to call,” says Katie Lockwood, MD, a pediatrician at Children’s Hospital of Philadelphia. “I reassure parents to follow their instincts. If something doesn’t feel right or if they’re not sure if something is normal or not, pediatrician offices would rather you err on the side of calling us.”

A few key symptoms can be your guide as you decide whether to grab your phone and call your pediatrician.
Fever
How to handle a fever depends on your child’s age. In a baby under 2 months old, a rectal temperature of 100.4 F or higher is an emergency.

“Go straight to the ER,” advises Lockwood. “Sometimes babies can have a serious infection, and the only sign is a fever.” The hospital will do a full workup that includes blood and urine tests, and sometimes a spinal tap.

In older children, the number on the thermometer is less telling than other clues. “Most important is how the child is acting with the fever and how long they’ve had it,” Lockwood says. “If a child has a 101 [degree] fever but they’re really irritable, they won’t eat, they’re not acting like themselves, or they won’t stop crying, that’s concerning to me.” This rule applies for vaccinated children; in unvaccinated infants, most fevers should be seen by a doctor right away.
Three days is usually the magic number for viral fevers to last, she says. Any fever that lasts longer deserves a call to your doctor. It may have turned into a bacterial infection like pneumonia.

Vomiting and Diarrhea
These symptoms usually signal a viral infection. On their own, they’re nothing to worry about. But when they’re too intense, they can be a problem.
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Is My Child Ready for a Cell Phone?

Children are starting to carry cell phones at younger ages. In a recent study, 22% of kids in grade school reported having their own cell phone compared with 60% of tweens and 84% of teens.

Like many parents, you may wonder whether your child is ready for a cell phone.

As you might imagine, there are pros and cons.

When It Makes Sense

Many parents cite safety as the main reason for giving their child a cell phone. They want to be able to reach their child whenever they need to. They also want to give their child the security of being able to reach them whenever he needs to.

This is especially true if your child is home alone after school or walks home alone, says Barbara Greenberg, PhD, a clinical psychologist in Fairfield County, CT.

Brittany Grant-Davis gave her 6-year-old a cell phone after his school bus, driven by a substitute driver, got lost on the way home. Grant-Davis, who lives in a Chicago suburb, says neither the school nor the bus company could tell her where the bus was.

“It was one of the scariest times of my life,” she says. After a very tense hour, the bus pulled up. Grant-Davis decided to give her son a cell phone to keep in his backpack.

Children who live in two households often get cell phones at younger ages. This is so they can reach the other parent, Greenberg says.

“If the cell phone is truly for accessing their parents or for children in a joint-custody situation who may be confused about which parent’s house to go to, that’s somewhat valid,” she says.

Greenberg says she’s not in favor of a 6-year-old having a cell phone in most other cases.

Weigh the Risks

If your child has a smartphone, he has access to websites that may be inappropriate. He may see content that is violent and could be related to death or sex.

“Lots of kids have fantasies in their mind about things they don’t understand,” Greenberg says.

There’s also the issue of sleep deprivation, Greenberg says.

How to Motivate Your Kids (Without Bribery!)

Show Them How

Want your child to eat her vegetables? Eat your vegetables. Get up and go for a walk together to show her that moving is fun. You’re the best role model your child can have. So start early. Kids begin to mimic their parents at a very young age. Resist the urge to bribe your child with food, toys, or other treats to cooperate. That teaches unhealthy habits.

Reward Them With Mom or Dad Time

Instead of bribing your child with video game or TV time (or anything where they’re just sitting), make active time together a reward. Go mini-golfing. Take a bike ride together. Or let your child plan a day full of active things they enjoy. Why this works: Kids crave your attention — especially if they have to share time with siblings. Never underestimate how much one-on-one attention means to your kids — even your teen.

Don’t Use Food as a Reward

Making sweets or junk food a prize teaches your kids to use food to fix their feelings. That can set them up for an unhealthy relationship with food. According to one study, adults who were rewarded and punished with food as kids were more likely to binge eat and diet. Withholding treats because of misbehavior — “No ice cream for you!” — isn’t good either. The forbidden food becomes more attractive.

Praise Effort, Not Just Results

Children need praise. If you want to motivate them, focus on their effort more than the end result. When your child shows you a picture he made, don’t just say it’s great. Praise him for how hard he worked on it. Note specific details. If your child is trying to learn a new sport, talk about how proud you are that he’s practicing kicks or running. Don’t focus on winning or losing a game.

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How Well Does Stroke Thrombectomy Work for Children? – Multicenter study suggests most recover with little disability

by Crystal Phend

Stent retrievers and other endovascular thrombectomy treatments appeared as safe for selected children as seen in adult trials, and also had good neurologic outcomes, in the Save ChildS Study.

Among 73 children treated at 27 centers in the U.S. and Europe, the most feared complication — symptomatic intracerebral hemorrhage — occurred in only one, for a 1.37% rate that was favorable compared with the 2.79% rate in the HERMES meta-analysis of adult trials.

No vascular complications, such as dissections or vessel rupture, were reported by Peter Sporns, MD, MHBA, of Universitätsklinikum Muenster in Germany, and colleagues in JAMA Neurology.

The only periprocedural complication was transient vasospasm on angiography in four patients (5%) that resolved without clinical sequelae. Malignant infarction followed by decompressive hemicraniectomy occurred in three children (4%). One patient with preexisting congenital heart disease died of cardiac arrest after complete recanalization.

“This study may support clinicians’ practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence,” the researchers concluded.

Neurologic improvement also “showed a similar pattern as observed in the adult trials,” as median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score improved from 14.0 at admission to 4.0 at day 7.

Median modified Rankin scale (mRS) score was 1.0 on the 6-point scale at both 6 and 24 months, with 80% having a favorable neurologic outcome (mRS ≤2) at discharge and more than 85% at the same point by 180 days.

None of the seven trials in the adult-trial meta-analysis reached much beyond 70% at 90 days on that measure.

However, an accompanying editorial expressed deep reservations about how much could be made of the findings, given the methods.

First, 24-month neurologic outcome data were missing for more than one-third of the children, “introducing the possibility of selection bias,” wrote Christine Fox, MD, of the University of California San Francisco, and Nomazulu Dlamini, MBBS, PhD, of the Hospital for Sick Children in Toronto.

“Data for earlier outcomes were more complete, but because deficits may emerge over time in children, early outcomes may not provide the full picture,” they wrote. “Cognitive and language deficits may initially go unrecognized in a toddler but become apparent as skills required for success in school grow increasingly complex.”

And using historical data from the meta-analysis for comparison “has pitfalls,” they added. “Given differences in the interpretation of outcome instruments and timing of outcome measures in the Save ChildS study compared with the HERMES trials, comparisons between these studies are of questionable value.”

Clinical trials are unlikely to be done to support the guidelines suggesting mechanical thrombectomy with stent retrievers as reasonable to consider for some patients <18 years with large-vessel occlusion, Sporns' group noted. The one trial that had started had to be abandoned for lack of recruitment. Sporns' study included all patients ages ≤18 years diagnosed with arterial ischemic stroke who underwent endovascular recanalization from 2000 through 2018 at participating centers. Most treatment was with clot retrievers (82%), while distal thromboaspiration was used in 10%, along with a smattering of other tools. All patients immediately went to the pediatric ICU after endovascular treatment. The researchers cautioned that, although all types of stroke sources were included, only seven patients had focal or bilateral cerebral arteriopathy. "Thus, an a priori selection bias of thrombectomy against children with potential inflammatory vasculopathy may be inherent to a seemingly low overall hemorrhagic risk," they wrote. "Vascular fragility and risk of hemorrhage need to be considered and weighted carefully against a potential benefit of a recanalization treatment in this specific patient population," they noted. "Underlying abnormalities are often unknown at the time of admission; therefore, the emergency decision on whether to perform thrombectomy frequently has to be made without detailed knowledge about the cause of the stroke."