Pediatrics

Insulet’s investigational Omnipod 5 automated insulin delivery system improves glycemic control in people with type 1 diabetes aged as young as 2 years, new data suggest.

The Omnipod 5 system combines a tubing-free insulin-filled delivery “Pod” with the Dexcom G6 continuous glucose monitor and an algorithm built into the Pod connecting the two devices via a smartphone app to semiautomate insulin delivery. It is currently under review by the Food and Drug Administration. The company expects to launch it in limited release during the second half of 2021. 

Results from a pivotal trial of the system in children aged 2-5.9 years with type 1 diabetes were presented during the annual scientific sessions of the American Diabetes Association.

Follow-up data at 6 months were also presented for another pivotal study of 112 children aged 6-13.9 years and 129 adults aged 14-70 years. Those primary 3-month data were reported earlier this year at the Endocrine Society’s annual meeting and subsequently published online June 7, 2021, in Diabetes Care. Another study presented at ADA looked at quality of life in children using Omnipod 5 and their caregivers. 

If approved by the FDA, the Omnipod 5 would be the third commercially available automated insulin delivery system – also called hybrid closed-loop or artificial pancreas systems – in the United States. It would be the second approved for children as young as 2 years of age and the first to deliver insulin subcutaneously without tubing.
 

‘No-tubing’ feature will be a draw for parents of young children

Asked to comment, pediatric endocrinologist Laura M. Jacobsen, MD, of the University of Florida, Gainesville, said in an interview: “I think the big advantage for the Omnipod 5 is that [if approved it will be] the only tubeless automated insulin delivery system in the U.S.”

“The automated delivery systems have just been wonderful for helping patients achieve time in range, especially overnight. And the fact that this goes down to such a young age where that can be very difficult is wonderful.”

Another difference between the Omnipod 5 and other systems is the ability to adjust glucose targets (from 110 to 150 mg/dL), although newer versions of the currently available hybrid closed-loop systems are expected to include that feature as well. “They’re all slightly different in the way the algorithms work, but I think the end result is similar,” Dr. Jacobsen said.

But, she said, the no-tubing feature might be particularly helpful for some very active young kids. “A lot of small kids do use the tubed pumps, and you can make it work with a lot of kids, but with some kids it just won’t ... the tubing gets caught. I think this really helps parents make the step. A lot of them don’t want to try the tubing whereas they see the Omnipod and might feel a little more confidence to try a pump.”

Overall, said Dr. Jacobsen, who has no financial disclosures with Insulet, Dexcom, or any of their competitors, “I think any addition to the technology field to improve quality of life for people with type 1 diabetes is important and people need choices.”
 

Pivotal data show benefit in ‘difficult-to-manage’ preschool children

Pivotal 3-month data for the Omnipod 5 in children aged 2-5.9 years with type 1 diabetes were presented on June 26 by pediatric endocrinologist Jennifer Sherr, MD, PhD, Yale University, New Haven, Conn.

“As a pediatric endocrinologist, I can attest to the difficulty of managing this age group, due to grazing eating patterns and erratic physical activity. Oftentimes, care providers may fear hypoglycemia as these youth can not verbalize or self-treat lows,” she remarked.

A total of 80 children were enrolled at 10 institutions across the United Sates. There was a single 14-day standard therapy phase (baseline), followed by 3 months of automated insulin delivery during which the children’s eating and exercise were unrestricted.

At 3 months, average hemoglobin A1c had fallen from 7.4% at baseline to 6.9%, a significant difference (P < .05). The proportions achieving the target A1c of less than 7% were 54% at 3 months versus 31% at baseline. The reduction was even greater among the 25 with baseline A1c of 8% or greater, although it was significant even among the 55 who started with a lower A1c (–1.06 vs. –0.31 percentage points; both P < .05). 

Time in range rose from 57.2% at baseline to 68.1% at 3 months (P < .05).

“These youngsters are spending an average of 2.6 more hours/day in range,” Dr. Sherr commented, noting that the difference became apparent shortly after study start and was maintained during the 3 months.

Dr. Sherr noted that this 10.9% improvement in time in range with Omnipod 5 was similar to improvements in the previously reported pivotal study of older children and adults. Data from that study showed improvement in time in range from a gain of 15.6% for the 6 to 13.9 year olds to 8.0% for those aged 26-49 years. Interestingly, improvements in time in range were seen even in the oldest group, aged 50-70, who increased from an already high baseline of 69.9% to 79.1% with Omnipod 5 after 3 months.

In her current study, in the youngest age group, the improvement in time in range was achieved primarily by a reduction of time above range, from 2.4 fewer hours/day above 180 mg/dL, while time below 70 mg/dL was reduced by 4 minutes/day. Overnight time in range improved by 1.4 hours/night, with most of the improvements in reduction of hyperglycemia.

The proportions meeting the combined goals of less than 4% time below range and greater than 60% time in range rose from 29% to 65%.

There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the 3-month study phase.

Another important related metric, sleep quality for parents/caregivers, also improved. The percentage reporting overall sleep quality of “very good” or “fairly good” increased from 65% at baseline to 90% with Omnipod 5, while “very bad” sleep quality fell from 8.8% to 0%.

All 80 patients completed the study and elected to continue in a 12-month extension phase.
 

Ongoing benefit seen in older children and adults

In a late-breaking poster presented on June 25, Anders L. Carlson, MD, medical director at the International Diabetes Center at Park Nicollet, Minneapolis, presented more follow-up data to the previously reported 3-month pivotal study, including 108 older children and 109 adults from the original study.

A1c remained lower after 6 months than at baseline for both children and adults (P < .001). In the children, A1c levels weren’t significantly different at the end of 6 versus 3 months, while in the adults there was an additional 0.1 percentage point decrease (P < .01).

There was one episode of diabetic ketoacidosis and no severe hypoglycemic episodes in the 3-month extension. “Sustained reduction of A1c indicates the potential long-term benefit of the Omnipod 5 System,” Dr. Carlson and colleagues concluded.
 

Reduced diabetes distress, don’t forget parents’ quality of life

Meanwhile, psychologist Korey K. Hood, PhD, of Stanford (Calif.) University, presented quality of life data at the meeting for 83 children aged 6-11.9 years and 42 teens aged 12-17.9 years using the Omnipod 5 from the larger study population and their parents.

Significant improvements were seen for both the youth and their caregivers in the Problem Areas in Diabetes score, a measure of diabetes-related emotional distress. Changes were less dramatic on the Hypoglycemic Confidence Scale, although improvements were significant for the caregivers of the younger children.

“We know this is a group that is really worried about hypoglycemia across a lot of situations, not just sleep but also school and outside of the home. So, to increase their confidence to this extent I think is a pretty important finding,” Dr. Hood commented.

There were nonsignificant trends in improvement across groups on the Pittsburgh Sleep Quality Index, but overall sleep quality did significantly improve among parents of the younger children. And on the World Health Organization–5 quality of life survey, significant improvements again were seen among the caregivers of young children.

“Reduced diabetes distress and improved quality of life are key benefits of using the Omnipod 5 [automated insulin delivery] system that are complementary to the glycemic benefits achieved,” Dr. Hood said.

Dr. Jacobsen has reported no relevant financial relationships. Dr. Sherr has reported being an adviser for, consultant for, and/or grant recipient from Bigfoot Biomedical, Cecelia Health, Insulet, Medtronic Diabetes, Eli Lilly, Lexicon, Sanofi, and the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Hood has reported being a consultant for Cecelia Health, Havas, and Cercacor.

A version of this article first appeared on Medscape.com.

Insulet’s investigational Omnipod 5 automated insulin delivery system improves glycemic control in people with type 1 diabetes aged as young as 2 years, new data suggest.

The Omnipod 5 system combines a tubing-free insulin-filled delivery “Pod” with the Dexcom G6 continuous glucose monitor and an algorithm built into the Pod connecting the two devices via a smartphone app to semiautomate insulin delivery. It is currently under review by the Food and Drug Administration. The company expects to launch it in limited release during the second half of 2021. 

Results from a pivotal trial of the system in children aged 2-5.9 years with type 1 diabetes were presented during the annual scientific sessions of the American Diabetes Association.

Follow-up data at 6 months were also presented for another pivotal study of 112 children aged 6-13.9 years and 129 adults aged 14-70 years. Those primary 3-month data were reported earlier this year at the Endocrine Society’s annual meeting and subsequently published online June 7, 2021, in Diabetes Care. Another study presented at ADA looked at quality of life in children using Omnipod 5 and their caregivers. 

If approved by the FDA, the Omnipod 5 would be the third commercially available automated insulin delivery system – also called hybrid closed-loop or artificial pancreas systems – in the United States. It would be the second approved for children as young as 2 years of age and the first to deliver insulin subcutaneously without tubing.
 

‘No-tubing’ feature will be a draw for parents of young children

Asked to comment, pediatric endocrinologist Laura M. Jacobsen, MD, of the University of Florida, Gainesville, said in an interview: “I think the big advantage for the Omnipod 5 is that [if approved it will be] the only tubeless automated insulin delivery system in the U.S.”

“The automated delivery systems have just been wonderful for helping patients achieve time in range, especially overnight. And the fact that this goes down to such a young age where that can be very difficult is wonderful.”

Another difference between the Omnipod 5 and other systems is the ability to adjust glucose targets (from 110 to 150 mg/dL), although newer versions of the currently available hybrid closed-loop systems are expected to include that feature as well. “They’re all slightly different in the way the algorithms work, but I think the end result is similar,” Dr. Jacobsen said.

But, she said, the no-tubing feature might be particularly helpful for some very active young kids. “A lot of small kids do use the tubed pumps, and you can make it work with a lot of kids, but with some kids it just won’t ... the tubing gets caught. I think this really helps parents make the step. A lot of them don’t want to try the tubing whereas they see the Omnipod and might feel a little more confidence to try a pump.”

Overall, said Dr. Jacobsen, who has no financial disclosures with Insulet, Dexcom, or any of their competitors, “I think any addition to the technology field to improve quality of life for people with type 1 diabetes is important and people need choices.”
 

Pivotal data show benefit in ‘difficult-to-manage’ preschool children

Pivotal 3-month data for the Omnipod 5 in children aged 2-5.9 years with type 1 diabetes were presented on June 26 by pediatric endocrinologist Jennifer Sherr, MD, PhD, Yale University, New Haven, Conn.

“As a pediatric endocrinologist, I can attest to the difficulty of managing this age group, due to grazing eating patterns and erratic physical activity. Oftentimes, care providers may fear hypoglycemia as these youth can not verbalize or self-treat lows,” she remarked.

A total of 80 children were enrolled at 10 institutions across the United Sates. There was a single 14-day standard therapy phase (baseline), followed by 3 months of automated insulin delivery during which the children’s eating and exercise were unrestricted.

At 3 months, average hemoglobin A1c had fallen from 7.4% at baseline to 6.9%, a significant difference (P < .05). The proportions achieving the target A1c of less than 7% were 54% at 3 months versus 31% at baseline. The reduction was even greater among the 25 with baseline A1c of 8% or greater, although it was significant even among the 55 who started with a lower A1c (–1.06 vs. –0.31 percentage points; both P < .05). 

Time in range rose from 57.2% at baseline to 68.1% at 3 months (P < .05).

“These youngsters are spending an average of 2.6 more hours/day in range,” Dr. Sherr commented, noting that the difference became apparent shortly after study start and was maintained during the 3 months.

Dr. Sherr noted that this 10.9% improvement in time in range with Omnipod 5 was similar to improvements in the previously reported pivotal study of older children and adults. Data from that study showed improvement in time in range from a gain of 15.6% for the 6 to 13.9 year olds to 8.0% for those aged 26-49 years. Interestingly, improvements in time in range were seen even in the oldest group, aged 50-70, who increased from an already high baseline of 69.9% to 79.1% with Omnipod 5 after 3 months.

In her current study, in the youngest age group, the improvement in time in range was achieved primarily by a reduction of time above range, from 2.4 fewer hours/day above 180 mg/dL, while time below 70 mg/dL was reduced by 4 minutes/day. Overnight time in range improved by 1.4 hours/night, with most of the improvements in reduction of hyperglycemia.

The proportions meeting the combined goals of less than 4% time below range and greater than 60% time in range rose from 29% to 65%.

There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the 3-month study phase.

Another important related metric, sleep quality for parents/caregivers, also improved. The percentage reporting overall sleep quality of “very good” or “fairly good” increased from 65% at baseline to 90% with Omnipod 5, while “very bad” sleep quality fell from 8.8% to 0%.

All 80 patients completed the study and elected to continue in a 12-month extension phase.
 

Ongoing benefit seen in older children and adults

In a late-breaking poster presented on June 25, Anders L. Carlson, MD, medical director at the International Diabetes Center at Park Nicollet, Minneapolis, presented more follow-up data to the previously reported 3-month pivotal study, including 108 older children and 109 adults from the original study.

A1c remained lower after 6 months than at baseline for both children and adults (P < .001). In the children, A1c levels weren’t significantly different at the end of 6 versus 3 months, while in the adults there was an additional 0.1 percentage point decrease (P < .01).

There was one episode of diabetic ketoacidosis and no severe hypoglycemic episodes in the 3-month extension. “Sustained reduction of A1c indicates the potential long-term benefit of the Omnipod 5 System,” Dr. Carlson and colleagues concluded.
 

Reduced diabetes distress, don’t forget parents’ quality of life

Meanwhile, psychologist Korey K. Hood, PhD, of Stanford (Calif.) University, presented quality of life data at the meeting for 83 children aged 6-11.9 years and 42 teens aged 12-17.9 years using the Omnipod 5 from the larger study population and their parents.

Significant improvements were seen for both the youth and their caregivers in the Problem Areas in Diabetes score, a measure of diabetes-related emotional distress. Changes were less dramatic on the Hypoglycemic Confidence Scale, although improvements were significant for the caregivers of the younger children.

“We know this is a group that is really worried about hypoglycemia across a lot of situations, not just sleep but also school and outside of the home. So, to increase their confidence to this extent I think is a pretty important finding,” Dr. Hood commented.

There were nonsignificant trends in improvement across groups on the Pittsburgh Sleep Quality Index, but overall sleep quality did significantly improve among parents of the younger children. And on the World Health Organization–5 quality of life survey, significant improvements again were seen among the caregivers of young children.

“Reduced diabetes distress and improved quality of life are key benefits of using the Omnipod 5 [automated insulin delivery] system that are complementary to the glycemic benefits achieved,” Dr. Hood said.

Dr. Jacobsen has reported no relevant financial relationships. Dr. Sherr has reported being an adviser for, consultant for, and/or grant recipient from Bigfoot Biomedical, Cecelia Health, Insulet, Medtronic Diabetes, Eli Lilly, Lexicon, Sanofi, and the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Hood has reported being a consultant for Cecelia Health, Havas, and Cercacor.

A version of this article first appeared on Medscape.com.

Insulet’s investigational Omnipod 5 automated insulin delivery system improves glycemic control in people with type 1 diabetes aged as young as 2 years, new data suggest.

The Omnipod 5 system combines a tubing-free insulin-filled delivery “Pod” with the Dexcom G6 continuous glucose monitor and an algorithm built into the Pod connecting the two devices via a smartphone app to semiautomate insulin delivery. It is currently under review by the Food and Drug Administration. The company expects to launch it in limited release during the second half of 2021. 

Results from a pivotal trial of the system in children aged 2-5.9 years with type 1 diabetes were presented during the annual scientific sessions of the American Diabetes Association.

Follow-up data at 6 months were also presented for another pivotal study of 112 children aged 6-13.9 years and 129 adults aged 14-70 years. Those primary 3-month data were reported earlier this year at the Endocrine Society’s annual meeting and subsequently published online June 7, 2021, in Diabetes Care. Another study presented at ADA looked at quality of life in children using Omnipod 5 and their caregivers. 

If approved by the FDA, the Omnipod 5 would be the third commercially available automated insulin delivery system – also called hybrid closed-loop or artificial pancreas systems – in the United States. It would be the second approved for children as young as 2 years of age and the first to deliver insulin subcutaneously without tubing.
 

‘No-tubing’ feature will be a draw for parents of young children

Asked to comment, pediatric endocrinologist Laura M. Jacobsen, MD, of the University of Florida, Gainesville, said in an interview: “I think the big advantage for the Omnipod 5 is that [if approved it will be] the only tubeless automated insulin delivery system in the U.S.”

“The automated delivery systems have just been wonderful for helping patients achieve time in range, especially overnight. And the fact that this goes down to such a young age where that can be very difficult is wonderful.”

Another difference between the Omnipod 5 and other systems is the ability to adjust glucose targets (from 110 to 150 mg/dL), although newer versions of the currently available hybrid closed-loop systems are expected to include that feature as well. “They’re all slightly different in the way the algorithms work, but I think the end result is similar,” Dr. Jacobsen said.

But, she said, the no-tubing feature might be particularly helpful for some very active young kids. “A lot of small kids do use the tubed pumps, and you can make it work with a lot of kids, but with some kids it just won’t ... the tubing gets caught. I think this really helps parents make the step. A lot of them don’t want to try the tubing whereas they see the Omnipod and might feel a little more confidence to try a pump.”

Overall, said Dr. Jacobsen, who has no financial disclosures with Insulet, Dexcom, or any of their competitors, “I think any addition to the technology field to improve quality of life for people with type 1 diabetes is important and people need choices.”
 

Pivotal data show benefit in ‘difficult-to-manage’ preschool children

Pivotal 3-month data for the Omnipod 5 in children aged 2-5.9 years with type 1 diabetes were presented on June 26 by pediatric endocrinologist Jennifer Sherr, MD, PhD, Yale University, New Haven, Conn.

“As a pediatric endocrinologist, I can attest to the difficulty of managing this age group, due to grazing eating patterns and erratic physical activity. Oftentimes, care providers may fear hypoglycemia as these youth can not verbalize or self-treat lows,” she remarked.

A total of 80 children were enrolled at 10 institutions across the United Sates. There was a single 14-day standard therapy phase (baseline), followed by 3 months of automated insulin delivery during which the children’s eating and exercise were unrestricted.

At 3 months, average hemoglobin A1c had fallen from 7.4% at baseline to 6.9%, a significant difference (P < .05). The proportions achieving the target A1c of less than 7% were 54% at 3 months versus 31% at baseline. The reduction was even greater among the 25 with baseline A1c of 8% or greater, although it was significant even among the 55 who started with a lower A1c (–1.06 vs. –0.31 percentage points; both P < .05). 

Time in range rose from 57.2% at baseline to 68.1% at 3 months (P < .05).

“These youngsters are spending an average of 2.6 more hours/day in range,” Dr. Sherr commented, noting that the difference became apparent shortly after study start and was maintained during the 3 months.

Dr. Sherr noted that this 10.9% improvement in time in range with Omnipod 5 was similar to improvements in the previously reported pivotal study of older children and adults. Data from that study showed improvement in time in range from a gain of 15.6% for the 6 to 13.9 year olds to 8.0% for those aged 26-49 years. Interestingly, improvements in time in range were seen even in the oldest group, aged 50-70, who increased from an already high baseline of 69.9% to 79.1% with Omnipod 5 after 3 months.

In her current study, in the youngest age group, the improvement in time in range was achieved primarily by a reduction of time above range, from 2.4 fewer hours/day above 180 mg/dL, while time below 70 mg/dL was reduced by 4 minutes/day. Overnight time in range improved by 1.4 hours/night, with most of the improvements in reduction of hyperglycemia.

The proportions meeting the combined goals of less than 4% time below range and greater than 60% time in range rose from 29% to 65%.

There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the 3-month study phase.

Another important related metric, sleep quality for parents/caregivers, also improved. The percentage reporting overall sleep quality of “very good” or “fairly good” increased from 65% at baseline to 90% with Omnipod 5, while “very bad” sleep quality fell from 8.8% to 0%.

All 80 patients completed the study and elected to continue in a 12-month extension phase.
 

Ongoing benefit seen in older children and adults

In a late-breaking poster presented on June 25, Anders L. Carlson, MD, medical director at the International Diabetes Center at Park Nicollet, Minneapolis, presented more follow-up data to the previously reported 3-month pivotal study, including 108 older children and 109 adults from the original study.

A1c remained lower after 6 months than at baseline for both children and adults (P < .001). In the children, A1c levels weren’t significantly different at the end of 6 versus 3 months, while in the adults there was an additional 0.1 percentage point decrease (P < .01).

There was one episode of diabetic ketoacidosis and no severe hypoglycemic episodes in the 3-month extension. “Sustained reduction of A1c indicates the potential long-term benefit of the Omnipod 5 System,” Dr. Carlson and colleagues concluded.
 

Reduced diabetes distress, don’t forget parents’ quality of life

Meanwhile, psychologist Korey K. Hood, PhD, of Stanford (Calif.) University, presented quality of life data at the meeting for 83 children aged 6-11.9 years and 42 teens aged 12-17.9 years using the Omnipod 5 from the larger study population and their parents.

Significant improvements were seen for both the youth and their caregivers in the Problem Areas in Diabetes score, a measure of diabetes-related emotional distress. Changes were less dramatic on the Hypoglycemic Confidence Scale, although improvements were significant for the caregivers of the younger children.

“We know this is a group that is really worried about hypoglycemia across a lot of situations, not just sleep but also school and outside of the home. So, to increase their confidence to this extent I think is a pretty important finding,” Dr. Hood commented.

There were nonsignificant trends in improvement across groups on the Pittsburgh Sleep Quality Index, but overall sleep quality did significantly improve among parents of the younger children. And on the World Health Organization–5 quality of life survey, significant improvements again were seen among the caregivers of young children.

“Reduced diabetes distress and improved quality of life are key benefits of using the Omnipod 5 [automated insulin delivery] system that are complementary to the glycemic benefits achieved,” Dr. Hood said.

Dr. Jacobsen has reported no relevant financial relationships. Dr. Sherr has reported being an adviser for, consultant for, and/or grant recipient from Bigfoot Biomedical, Cecelia Health, Insulet, Medtronic Diabetes, Eli Lilly, Lexicon, Sanofi, and the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Hood has reported being a consultant for Cecelia Health, Havas, and Cercacor.

A version of this article first appeared on Medscape.com.

For racial or ethnic minority youths with type 1 diabetes, participating in an interventional program improves access to care, new research shows.

Youth categorized as Black, Indigenous, and other people of color (BIPOC) had significantly improved outpatient attendance during and after participating in Novel Interventions in Children’s Healthcare (NICH), a systems intervention for children with chronic health conditions and their families.

By comparison, no improvements in care access were observed among BIPOC children who were not able to access the program because of insurance or other reasons, David V. Wagner, PhD, Associate Professor and NICH research director at Oregon Health & Science University, Portland, reported at the annual scientific sessions of the American Diabetes Association.

The findings demonstrate a need for intensive, home-based services that aim to correct health inequities, said Dr. Wagner, who presented the findings along with Winniebhelle Cadiz, a scholar in the BUILD EXITO undergraduate research training program at Portland (Ore.) State University.

The NICH program hinges on trained interventionists who visit families at home, attend clinic visits, and work with schools and other contacts to help solve problems that keep children from following medical instructions, according to a program description.

“Families report having somebody by their side to help them navigate the system, address the transportation difficulties experienced, and help them and build that relationship with their health care provider seems to be hugely influential in terms of helping them navigate and access care,” Dr. Wagner said in a presentation of the study.
 

A NICH for youths with chronic health conditions

The NICH program differs from some other programs that have been developed in an attempt to improve health outcomes among youths in the community, according to Dr. Wagner.

“Many of the programs that exist out there are often piloted on, and seemingly built for, those who have more resources,” he said in his presentation. “Those who are in greatest need often have difficulty accessing and responding to the services.”

NICH doesn’t take the place of existing services, but is “an addition to the continuum of care” for youths and families who are struggling because of lack of resources or marginalization in the health care system, Dr. Wagner said.

While NICH is not specific to any one chronic health condition, several previous investigations have specifically looked at the impact of the NICH program on access to care in youths with type 1 diabetes.

Youths participating in the program for a year had fewer ED visits, including fewer visits with diabetic ketoacidosis (DKA), as well as fewer and shorter admissions as compared with the year prior to participating in the program, Dr. Wagner said.

In another study, youths had fewer admissions for diabetes or DKA and less frequent pediatric ICU contact during the NICH program, as compared with before the program.

Another study showed that, while NICH had no impact overall on access to care among youths with type 1 diabetes, BIPOC youths had an improvement in the mean number of outpatient visits as compared with preprogram levels. However, because none of those studies included a control group, Dr. Wagner said, it remained unclear whether this systems intervention might improve outpatient access among youths with type 1 diabetes as compared with those who did not participate.
 

Intervention linked to increased BIPOC care access

The latest study includes 144 youths with type 1 diabetes referred for the program. The mean age was 13.7 years, 58% were female, and 81% were non-Hispanic White. While 51 youths were able to participate in NICH, the remaining 93 were not served by the program because of insurance denial or nonresponse, according to investigators.

While participation in the program made no difference in access to care overall, results of this study suggest NICH reduced access disparities among BIPOC youths, the investigators said.

Those BIPOC youth, 28 in total, had significantly worse access to care prior to referral. However, BIPOC youth participation in NICH was associated with improved attendance at endocrinology appointments and outpatient attendance overall.

A mean change of 1.9 more appointments per year was seen among BIPOC youth who participated in NICH, compared with a mean decrease of 0.5 appointments per year among BIPOC youth not served by the program (P = .03), according to the study abstract.

Prior to NICH participation, outpatient attendance among BIPOC youths was about 2.5 visits per year, data presented by the investigators show.
 

Systemic changes needed

This study is representative of systemic changes that are needed to improve access to quality care for BIPOC youth, according Cynthia E. Muñoz, PhD, MPH, ADA’s president of health care and education.

“We know that there are increased risks for poor health outcomes for these children and youths, and we know that there is a risk for mental health and psychosocial challenges for youth from these communities,” said Dr. Muñoz, a bilingual licensed psychologist and assistant professor of clinical pediatrics at the University of Southern California, Los Angeles.

In his presentation, Dr. Wagner said lumping racial and ethnic minority participants under a single BIPOC header probably wasn’t ideal because of the diversity and differences among racial and ethnic minorities. However, it was necessary in this particular study because of limited sample size.

Dr. Wagner and coauthors disclosed no conflicts of interest related to the research, which was supported by the Leona M. and Harry B. Helmsley Charitable Trust.

For racial or ethnic minority youths with type 1 diabetes, participating in an interventional program improves access to care, new research shows.

Youth categorized as Black, Indigenous, and other people of color (BIPOC) had significantly improved outpatient attendance during and after participating in Novel Interventions in Children’s Healthcare (NICH), a systems intervention for children with chronic health conditions and their families.

By comparison, no improvements in care access were observed among BIPOC children who were not able to access the program because of insurance or other reasons, David V. Wagner, PhD, Associate Professor and NICH research director at Oregon Health & Science University, Portland, reported at the annual scientific sessions of the American Diabetes Association.

The findings demonstrate a need for intensive, home-based services that aim to correct health inequities, said Dr. Wagner, who presented the findings along with Winniebhelle Cadiz, a scholar in the BUILD EXITO undergraduate research training program at Portland (Ore.) State University.

The NICH program hinges on trained interventionists who visit families at home, attend clinic visits, and work with schools and other contacts to help solve problems that keep children from following medical instructions, according to a program description.

“Families report having somebody by their side to help them navigate the system, address the transportation difficulties experienced, and help them and build that relationship with their health care provider seems to be hugely influential in terms of helping them navigate and access care,” Dr. Wagner said in a presentation of the study.
 

A NICH for youths with chronic health conditions

The NICH program differs from some other programs that have been developed in an attempt to improve health outcomes among youths in the community, according to Dr. Wagner.

“Many of the programs that exist out there are often piloted on, and seemingly built for, those who have more resources,” he said in his presentation. “Those who are in greatest need often have difficulty accessing and responding to the services.”

NICH doesn’t take the place of existing services, but is “an addition to the continuum of care” for youths and families who are struggling because of lack of resources or marginalization in the health care system, Dr. Wagner said.

While NICH is not specific to any one chronic health condition, several previous investigations have specifically looked at the impact of the NICH program on access to care in youths with type 1 diabetes.

Youths participating in the program for a year had fewer ED visits, including fewer visits with diabetic ketoacidosis (DKA), as well as fewer and shorter admissions as compared with the year prior to participating in the program, Dr. Wagner said.

In another study, youths had fewer admissions for diabetes or DKA and less frequent pediatric ICU contact during the NICH program, as compared with before the program.

Another study showed that, while NICH had no impact overall on access to care among youths with type 1 diabetes, BIPOC youths had an improvement in the mean number of outpatient visits as compared with preprogram levels. However, because none of those studies included a control group, Dr. Wagner said, it remained unclear whether this systems intervention might improve outpatient access among youths with type 1 diabetes as compared with those who did not participate.
 

Intervention linked to increased BIPOC care access

The latest study includes 144 youths with type 1 diabetes referred for the program. The mean age was 13.7 years, 58% were female, and 81% were non-Hispanic White. While 51 youths were able to participate in NICH, the remaining 93 were not served by the program because of insurance denial or nonresponse, according to investigators.

While participation in the program made no difference in access to care overall, results of this study suggest NICH reduced access disparities among BIPOC youths, the investigators said.

Those BIPOC youth, 28 in total, had significantly worse access to care prior to referral. However, BIPOC youth participation in NICH was associated with improved attendance at endocrinology appointments and outpatient attendance overall.

A mean change of 1.9 more appointments per year was seen among BIPOC youth who participated in NICH, compared with a mean decrease of 0.5 appointments per year among BIPOC youth not served by the program (P = .03), according to the study abstract.

Prior to NICH participation, outpatient attendance among BIPOC youths was about 2.5 visits per year, data presented by the investigators show.
 

Systemic changes needed

This study is representative of systemic changes that are needed to improve access to quality care for BIPOC youth, according Cynthia E. Muñoz, PhD, MPH, ADA’s president of health care and education.

“We know that there are increased risks for poor health outcomes for these children and youths, and we know that there is a risk for mental health and psychosocial challenges for youth from these communities,” said Dr. Muñoz, a bilingual licensed psychologist and assistant professor of clinical pediatrics at the University of Southern California, Los Angeles.

In his presentation, Dr. Wagner said lumping racial and ethnic minority participants under a single BIPOC header probably wasn’t ideal because of the diversity and differences among racial and ethnic minorities. However, it was necessary in this particular study because of limited sample size.

Dr. Wagner and coauthors disclosed no conflicts of interest related to the research, which was supported by the Leona M. and Harry B. Helmsley Charitable Trust.

For racial or ethnic minority youths with type 1 diabetes, participating in an interventional program improves access to care, new research shows.

Youth categorized as Black, Indigenous, and other people of color (BIPOC) had significantly improved outpatient attendance during and after participating in Novel Interventions in Children’s Healthcare (NICH), a systems intervention for children with chronic health conditions and their families.

By comparison, no improvements in care access were observed among BIPOC children who were not able to access the program because of insurance or other reasons, David V. Wagner, PhD, Associate Professor and NICH research director at Oregon Health & Science University, Portland, reported at the annual scientific sessions of the American Diabetes Association.

The findings demonstrate a need for intensive, home-based services that aim to correct health inequities, said Dr. Wagner, who presented the findings along with Winniebhelle Cadiz, a scholar in the BUILD EXITO undergraduate research training program at Portland (Ore.) State University.

The NICH program hinges on trained interventionists who visit families at home, attend clinic visits, and work with schools and other contacts to help solve problems that keep children from following medical instructions, according to a program description.

“Families report having somebody by their side to help them navigate the system, address the transportation difficulties experienced, and help them and build that relationship with their health care provider seems to be hugely influential in terms of helping them navigate and access care,” Dr. Wagner said in a presentation of the study.
 

A NICH for youths with chronic health conditions

The NICH program differs from some other programs that have been developed in an attempt to improve health outcomes among youths in the community, according to Dr. Wagner.

“Many of the programs that exist out there are often piloted on, and seemingly built for, those who have more resources,” he said in his presentation. “Those who are in greatest need often have difficulty accessing and responding to the services.”

NICH doesn’t take the place of existing services, but is “an addition to the continuum of care” for youths and families who are struggling because of lack of resources or marginalization in the health care system, Dr. Wagner said.

While NICH is not specific to any one chronic health condition, several previous investigations have specifically looked at the impact of the NICH program on access to care in youths with type 1 diabetes.

Youths participating in the program for a year had fewer ED visits, including fewer visits with diabetic ketoacidosis (DKA), as well as fewer and shorter admissions as compared with the year prior to participating in the program, Dr. Wagner said.

In another study, youths had fewer admissions for diabetes or DKA and less frequent pediatric ICU contact during the NICH program, as compared with before the program.

Another study showed that, while NICH had no impact overall on access to care among youths with type 1 diabetes, BIPOC youths had an improvement in the mean number of outpatient visits as compared with preprogram levels. However, because none of those studies included a control group, Dr. Wagner said, it remained unclear whether this systems intervention might improve outpatient access among youths with type 1 diabetes as compared with those who did not participate.
 

Intervention linked to increased BIPOC care access

The latest study includes 144 youths with type 1 diabetes referred for the program. The mean age was 13.7 years, 58% were female, and 81% were non-Hispanic White. While 51 youths were able to participate in NICH, the remaining 93 were not served by the program because of insurance denial or nonresponse, according to investigators.

While participation in the program made no difference in access to care overall, results of this study suggest NICH reduced access disparities among BIPOC youths, the investigators said.

Those BIPOC youth, 28 in total, had significantly worse access to care prior to referral. However, BIPOC youth participation in NICH was associated with improved attendance at endocrinology appointments and outpatient attendance overall.

A mean change of 1.9 more appointments per year was seen among BIPOC youth who participated in NICH, compared with a mean decrease of 0.5 appointments per year among BIPOC youth not served by the program (P = .03), according to the study abstract.

Prior to NICH participation, outpatient attendance among BIPOC youths was about 2.5 visits per year, data presented by the investigators show.
 

Systemic changes needed

This study is representative of systemic changes that are needed to improve access to quality care for BIPOC youth, according Cynthia E. Muñoz, PhD, MPH, ADA’s president of health care and education.

“We know that there are increased risks for poor health outcomes for these children and youths, and we know that there is a risk for mental health and psychosocial challenges for youth from these communities,” said Dr. Muñoz, a bilingual licensed psychologist and assistant professor of clinical pediatrics at the University of Southern California, Los Angeles.

In his presentation, Dr. Wagner said lumping racial and ethnic minority participants under a single BIPOC header probably wasn’t ideal because of the diversity and differences among racial and ethnic minorities. However, it was necessary in this particular study because of limited sample size.

Dr. Wagner and coauthors disclosed no conflicts of interest related to the research, which was supported by the Leona M. and Harry B. Helmsley Charitable Trust.

The incidence of type 2 diabetes in children appears to have doubled during the COVID-19 pandemic, data from two new U.S. studies suggest, with the lead investigator of one saying she was “surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”

Anetta_R/Thinkstock

Findings from the two separate retrospective chart reviews – one conducted in Washington, D.C., and the other in Baton Rouge, La. – were presented June 25 at the annual scientific sessions of the American Diabetes Association.

Although the two studies differed somewhat in the clinical parameters examined, both revealed a similar doubling of the rates of hospitalizations for type 2 diabetes among youth during 2020, compared with the same time period in 2019, as well as greater severity of metabolic disturbance.

And, as has been previously described with type 2 diabetes in youth, African American ethnicity predominated in both cohorts.

“Although we could not assess the cause of the increases in type 2 diabetes from our data, these disparities suggest that indirect effects of social distancing measures, including school closure and unemployment, are placing undue burden on underserved communities. Decreases in well-child care and fears of seeking medical care during the pandemic may have also contributed,” lead investigator of one of the studies, pediatric endocrinologist Brynn E. Marks, MD, Children’s National Hospital, Washington, said in an interview.
 

More hospitalizations, racial disparities aggravated by COVID-19

Lead author of the other study, Daniel S. Hsia, MD, Pennington Biomedical Research Center, Baton Rouge, said in an interview: “Since the pandemic, our data suggest that more children may be diagnosed with type 2 diabetes and may require hospitalization when they are diagnosed. Looking at both datasets, there appears to be a racial disparity in type 2 diabetes diagnoses that has only been exacerbated by the COVID-19 pandemic.”

Of concern, Dr. Hsia said, “The incidence rate of type 2 diabetes in children was already on the rise before the pandemic. While there may be a brief leveling off now that children are getting regular health care and going back to school in person, I believe these rates will continue to rise especially in light of the childhood obesity rates not improving.”

Their dataset captured all youth who were newly diagnosed with type 2 diabetes during the first full year of the COVID-19 pandemic, from March 11, 2020, to March 10, 2021, and compared those data with the time period from March 11, 2019, to March 10, 2020.

During the pandemic, the number of cases of type 2 diabetes increased by 182%, from 50 in 2019 to 141 in 2020. The average age at diagnosis was about 14 years in both time periods.

In the prepandemic period, 18 (36%) diagnosed with type 2 diabetes required inpatient admission, compared with 85 (60.3%) during the pandemic. At Children’s National, youth with suspected new-onset type 2 diabetes aren’t typically hospitalized unless they have severe hyperglycemia, ketosis, or are unable to schedule urgent outpatient follow-up, Dr. Marks noted.

The proportions of youth with new-onset type 2 diabetes who presented in diabetic ketoacidosis (DKA) rose from 2 (4%) prepandemic to 33 (23.4%) during the pandemic. Presentation with hyperosmolar DKA rose from 0 to 13 (9.2%).

However, during the pandemic only five youth were actively infected with SARS-CoV-2 at the time of type 2 diabetes diagnosis among the 90 tested.

Dr. Marks said: “We believe the increase in inpatient admissions was due to more severe presentation during the pandemic. ...We were surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”
 

Shift in diagnoses to type 2 diabetes

The pandemic also appears to have shifted the proportion of youth diagnosed with type 2 diabetes, compared with type 1 diabetes. Whereas 24% of youth with new-onset diabetes prepandemic had type 2 diabetes and the rest had type 1 diabetes, during pandemic the proportion with type 2 diabetes rose to 44%.

“Rates of type 2 diabetes rose steadily at a rate of 1.45 cases per month throughout the course of the pandemic, suggesting a cumulative effect of the indirect effects of social distancing measures,” Dr. Marks said.

Furthermore, she added, whereas 60% of youth diagnosed with type 2 diabetes before the pandemic were female, the rate fell to 40% during the pandemic. This trend might be because of activity levels in that, while male adolescents are typically more active, rates of exercise fell in both sexes during the pandemic but declined more sharply in males such that activity levels between the sexes became equal.  

Although type 2 diabetes in youth has always been more common in ethnic minorities, the pandemic appears to have exacerbated these disparities.

While 58% of youth diagnosed with type 2 diabetes prepandemic identified as non-Hispanic Black, that proportion rose to 76.7% during the pandemic. Among Black youth with new-onset type 2 diabetes, 31 of 33 presented in DKA, and 12 of the 13 who presented in hyperosmolar DKA during the pandemic were Black.

“Strategies to promote health equity and address the undue burden of the COVID-19 pandemic on underserved communities must be developed to avoid worsening disparities and long-term health outcomes,” Dr. Marks said.
 

‘A microcosm’: Similar findings in a smaller population

Dr. Hsia and colleagues looked at a smaller number of patients in a shorter time period. In March–December 2019, the hospitalization rate for new-onset type 2 diabetes was 0.27% (8 out of 2,964 hospitalizations), compared with 0.62% (17 out of 2,729 hospitalizations) during the same period in 2020 (P < .048) – also more than a doubling. Age at admission, sex, and body mass index didn’t differ between the two groups.

Criteria for DKA were met by three children in 2019 versus eight in 2020, and hyperosmolar hyperglycemic syndrome in zero versus two, respectively. Mean hemoglobin A1c on admission was 12.4% in 2019 versus 13.1% in 2020 (P = .59), and mean serum glucose was 441 mg/dL versus 669 mg/dL (P = .14), respectively. Serum osmolality on admission was 314 mmol/kg in 2019 versus 335 mmol/kg in 2020 (P = .19).

“Clinically speaking the differences in the lab values were significant, but we did not have enough numbers ... to see a statistically significant difference. I think by looking at more centers, our site likely represents a microcosm of what is happening across the country,” Dr. Hsia said.

In 2019, 7 of the 8 children were African American, as were 16 of the 17 children in 2020. The other single child in each group was White.

Dr. Hsia said: “Larger studies that include more patients are needed to confirm our initial findings. More research is needed to understand why this increasing trend of type 2 diabetes diagnoses in children may be occurring [and] to better understand how stay-at-home orders and other restrictions due to COVID-19 have worsened risk factors for type 2 diabetes.”

“These include decreased physical activity, more screen time, disturbed sleep, and increased intake of processed foods, which can all lead to weight gain,” he concluded.

Dr. Marks reported receiving research support from Tandem, Dexcom, and the Cystic Fibrosis Foundation. Dr. Hsia reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The incidence of type 2 diabetes in children appears to have doubled during the COVID-19 pandemic, data from two new U.S. studies suggest, with the lead investigator of one saying she was “surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”

Anetta_R/Thinkstock

Findings from the two separate retrospective chart reviews – one conducted in Washington, D.C., and the other in Baton Rouge, La. – were presented June 25 at the annual scientific sessions of the American Diabetes Association.

Although the two studies differed somewhat in the clinical parameters examined, both revealed a similar doubling of the rates of hospitalizations for type 2 diabetes among youth during 2020, compared with the same time period in 2019, as well as greater severity of metabolic disturbance.

And, as has been previously described with type 2 diabetes in youth, African American ethnicity predominated in both cohorts.

“Although we could not assess the cause of the increases in type 2 diabetes from our data, these disparities suggest that indirect effects of social distancing measures, including school closure and unemployment, are placing undue burden on underserved communities. Decreases in well-child care and fears of seeking medical care during the pandemic may have also contributed,” lead investigator of one of the studies, pediatric endocrinologist Brynn E. Marks, MD, Children’s National Hospital, Washington, said in an interview.
 

More hospitalizations, racial disparities aggravated by COVID-19

Lead author of the other study, Daniel S. Hsia, MD, Pennington Biomedical Research Center, Baton Rouge, said in an interview: “Since the pandemic, our data suggest that more children may be diagnosed with type 2 diabetes and may require hospitalization when they are diagnosed. Looking at both datasets, there appears to be a racial disparity in type 2 diabetes diagnoses that has only been exacerbated by the COVID-19 pandemic.”

Of concern, Dr. Hsia said, “The incidence rate of type 2 diabetes in children was already on the rise before the pandemic. While there may be a brief leveling off now that children are getting regular health care and going back to school in person, I believe these rates will continue to rise especially in light of the childhood obesity rates not improving.”

Their dataset captured all youth who were newly diagnosed with type 2 diabetes during the first full year of the COVID-19 pandemic, from March 11, 2020, to March 10, 2021, and compared those data with the time period from March 11, 2019, to March 10, 2020.

During the pandemic, the number of cases of type 2 diabetes increased by 182%, from 50 in 2019 to 141 in 2020. The average age at diagnosis was about 14 years in both time periods.

In the prepandemic period, 18 (36%) diagnosed with type 2 diabetes required inpatient admission, compared with 85 (60.3%) during the pandemic. At Children’s National, youth with suspected new-onset type 2 diabetes aren’t typically hospitalized unless they have severe hyperglycemia, ketosis, or are unable to schedule urgent outpatient follow-up, Dr. Marks noted.

The proportions of youth with new-onset type 2 diabetes who presented in diabetic ketoacidosis (DKA) rose from 2 (4%) prepandemic to 33 (23.4%) during the pandemic. Presentation with hyperosmolar DKA rose from 0 to 13 (9.2%).

However, during the pandemic only five youth were actively infected with SARS-CoV-2 at the time of type 2 diabetes diagnosis among the 90 tested.

Dr. Marks said: “We believe the increase in inpatient admissions was due to more severe presentation during the pandemic. ...We were surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”
 

Shift in diagnoses to type 2 diabetes

The pandemic also appears to have shifted the proportion of youth diagnosed with type 2 diabetes, compared with type 1 diabetes. Whereas 24% of youth with new-onset diabetes prepandemic had type 2 diabetes and the rest had type 1 diabetes, during pandemic the proportion with type 2 diabetes rose to 44%.

“Rates of type 2 diabetes rose steadily at a rate of 1.45 cases per month throughout the course of the pandemic, suggesting a cumulative effect of the indirect effects of social distancing measures,” Dr. Marks said.

Furthermore, she added, whereas 60% of youth diagnosed with type 2 diabetes before the pandemic were female, the rate fell to 40% during the pandemic. This trend might be because of activity levels in that, while male adolescents are typically more active, rates of exercise fell in both sexes during the pandemic but declined more sharply in males such that activity levels between the sexes became equal.  

Although type 2 diabetes in youth has always been more common in ethnic minorities, the pandemic appears to have exacerbated these disparities.

While 58% of youth diagnosed with type 2 diabetes prepandemic identified as non-Hispanic Black, that proportion rose to 76.7% during the pandemic. Among Black youth with new-onset type 2 diabetes, 31 of 33 presented in DKA, and 12 of the 13 who presented in hyperosmolar DKA during the pandemic were Black.

“Strategies to promote health equity and address the undue burden of the COVID-19 pandemic on underserved communities must be developed to avoid worsening disparities and long-term health outcomes,” Dr. Marks said.
 

‘A microcosm’: Similar findings in a smaller population

Dr. Hsia and colleagues looked at a smaller number of patients in a shorter time period. In March–December 2019, the hospitalization rate for new-onset type 2 diabetes was 0.27% (8 out of 2,964 hospitalizations), compared with 0.62% (17 out of 2,729 hospitalizations) during the same period in 2020 (P < .048) – also more than a doubling. Age at admission, sex, and body mass index didn’t differ between the two groups.

Criteria for DKA were met by three children in 2019 versus eight in 2020, and hyperosmolar hyperglycemic syndrome in zero versus two, respectively. Mean hemoglobin A1c on admission was 12.4% in 2019 versus 13.1% in 2020 (P = .59), and mean serum glucose was 441 mg/dL versus 669 mg/dL (P = .14), respectively. Serum osmolality on admission was 314 mmol/kg in 2019 versus 335 mmol/kg in 2020 (P = .19).

“Clinically speaking the differences in the lab values were significant, but we did not have enough numbers ... to see a statistically significant difference. I think by looking at more centers, our site likely represents a microcosm of what is happening across the country,” Dr. Hsia said.

In 2019, 7 of the 8 children were African American, as were 16 of the 17 children in 2020. The other single child in each group was White.

Dr. Hsia said: “Larger studies that include more patients are needed to confirm our initial findings. More research is needed to understand why this increasing trend of type 2 diabetes diagnoses in children may be occurring [and] to better understand how stay-at-home orders and other restrictions due to COVID-19 have worsened risk factors for type 2 diabetes.”

“These include decreased physical activity, more screen time, disturbed sleep, and increased intake of processed foods, which can all lead to weight gain,” he concluded.

Dr. Marks reported receiving research support from Tandem, Dexcom, and the Cystic Fibrosis Foundation. Dr. Hsia reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The incidence of type 2 diabetes in children appears to have doubled during the COVID-19 pandemic, data from two new U.S. studies suggest, with the lead investigator of one saying she was “surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”

Anetta_R/Thinkstock

Findings from the two separate retrospective chart reviews – one conducted in Washington, D.C., and the other in Baton Rouge, La. – were presented June 25 at the annual scientific sessions of the American Diabetes Association.

Although the two studies differed somewhat in the clinical parameters examined, both revealed a similar doubling of the rates of hospitalizations for type 2 diabetes among youth during 2020, compared with the same time period in 2019, as well as greater severity of metabolic disturbance.

And, as has been previously described with type 2 diabetes in youth, African American ethnicity predominated in both cohorts.

“Although we could not assess the cause of the increases in type 2 diabetes from our data, these disparities suggest that indirect effects of social distancing measures, including school closure and unemployment, are placing undue burden on underserved communities. Decreases in well-child care and fears of seeking medical care during the pandemic may have also contributed,” lead investigator of one of the studies, pediatric endocrinologist Brynn E. Marks, MD, Children’s National Hospital, Washington, said in an interview.
 

More hospitalizations, racial disparities aggravated by COVID-19

Lead author of the other study, Daniel S. Hsia, MD, Pennington Biomedical Research Center, Baton Rouge, said in an interview: “Since the pandemic, our data suggest that more children may be diagnosed with type 2 diabetes and may require hospitalization when they are diagnosed. Looking at both datasets, there appears to be a racial disparity in type 2 diabetes diagnoses that has only been exacerbated by the COVID-19 pandemic.”

Of concern, Dr. Hsia said, “The incidence rate of type 2 diabetes in children was already on the rise before the pandemic. While there may be a brief leveling off now that children are getting regular health care and going back to school in person, I believe these rates will continue to rise especially in light of the childhood obesity rates not improving.”

Their dataset captured all youth who were newly diagnosed with type 2 diabetes during the first full year of the COVID-19 pandemic, from March 11, 2020, to March 10, 2021, and compared those data with the time period from March 11, 2019, to March 10, 2020.

During the pandemic, the number of cases of type 2 diabetes increased by 182%, from 50 in 2019 to 141 in 2020. The average age at diagnosis was about 14 years in both time periods.

In the prepandemic period, 18 (36%) diagnosed with type 2 diabetes required inpatient admission, compared with 85 (60.3%) during the pandemic. At Children’s National, youth with suspected new-onset type 2 diabetes aren’t typically hospitalized unless they have severe hyperglycemia, ketosis, or are unable to schedule urgent outpatient follow-up, Dr. Marks noted.

The proportions of youth with new-onset type 2 diabetes who presented in diabetic ketoacidosis (DKA) rose from 2 (4%) prepandemic to 33 (23.4%) during the pandemic. Presentation with hyperosmolar DKA rose from 0 to 13 (9.2%).

However, during the pandemic only five youth were actively infected with SARS-CoV-2 at the time of type 2 diabetes diagnosis among the 90 tested.

Dr. Marks said: “We believe the increase in inpatient admissions was due to more severe presentation during the pandemic. ...We were surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”
 

Shift in diagnoses to type 2 diabetes

The pandemic also appears to have shifted the proportion of youth diagnosed with type 2 diabetes, compared with type 1 diabetes. Whereas 24% of youth with new-onset diabetes prepandemic had type 2 diabetes and the rest had type 1 diabetes, during pandemic the proportion with type 2 diabetes rose to 44%.

“Rates of type 2 diabetes rose steadily at a rate of 1.45 cases per month throughout the course of the pandemic, suggesting a cumulative effect of the indirect effects of social distancing measures,” Dr. Marks said.

Furthermore, she added, whereas 60% of youth diagnosed with type 2 diabetes before the pandemic were female, the rate fell to 40% during the pandemic. This trend might be because of activity levels in that, while male adolescents are typically more active, rates of exercise fell in both sexes during the pandemic but declined more sharply in males such that activity levels between the sexes became equal.  

Although type 2 diabetes in youth has always been more common in ethnic minorities, the pandemic appears to have exacerbated these disparities.

While 58% of youth diagnosed with type 2 diabetes prepandemic identified as non-Hispanic Black, that proportion rose to 76.7% during the pandemic. Among Black youth with new-onset type 2 diabetes, 31 of 33 presented in DKA, and 12 of the 13 who presented in hyperosmolar DKA during the pandemic were Black.

“Strategies to promote health equity and address the undue burden of the COVID-19 pandemic on underserved communities must be developed to avoid worsening disparities and long-term health outcomes,” Dr. Marks said.
 

‘A microcosm’: Similar findings in a smaller population

Dr. Hsia and colleagues looked at a smaller number of patients in a shorter time period. In March–December 2019, the hospitalization rate for new-onset type 2 diabetes was 0.27% (8 out of 2,964 hospitalizations), compared with 0.62% (17 out of 2,729 hospitalizations) during the same period in 2020 (P < .048) – also more than a doubling. Age at admission, sex, and body mass index didn’t differ between the two groups.

Criteria for DKA were met by three children in 2019 versus eight in 2020, and hyperosmolar hyperglycemic syndrome in zero versus two, respectively. Mean hemoglobin A1c on admission was 12.4% in 2019 versus 13.1% in 2020 (P = .59), and mean serum glucose was 441 mg/dL versus 669 mg/dL (P = .14), respectively. Serum osmolality on admission was 314 mmol/kg in 2019 versus 335 mmol/kg in 2020 (P = .19).

“Clinically speaking the differences in the lab values were significant, but we did not have enough numbers ... to see a statistically significant difference. I think by looking at more centers, our site likely represents a microcosm of what is happening across the country,” Dr. Hsia said.

In 2019, 7 of the 8 children were African American, as were 16 of the 17 children in 2020. The other single child in each group was White.

Dr. Hsia said: “Larger studies that include more patients are needed to confirm our initial findings. More research is needed to understand why this increasing trend of type 2 diabetes diagnoses in children may be occurring [and] to better understand how stay-at-home orders and other restrictions due to COVID-19 have worsened risk factors for type 2 diabetes.”

“These include decreased physical activity, more screen time, disturbed sleep, and increased intake of processed foods, which can all lead to weight gain,” he concluded.

Dr. Marks reported receiving research support from Tandem, Dexcom, and the Cystic Fibrosis Foundation. Dr. Hsia reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes.

The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues.

“Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics. “Previous studies assessing this burden have focused on out-of-pocket spending for maternal care, including hospitalizations for delivery. However, there are no recent national data on out-of-pocket spending across the childbirth episode, including both deliveries and newborn hospitalizations.”

To address this knowledge gap, Dr. Chua and colleagues turned to Optum’s deidentified Clinformatics Data Mart, comprising 12 million privately insured individuals across the United States. The investigators identified 398,410 childbirth episodes occurring between 2016 and 2019. Each episode was defined as one delivery and at least one newborn hospitalization under the same family plan.

Out-of-pocket cost included copayment plus coinsurance and deductibles. Primary outcomes included mean total out-of-pocket spending and proportion of episodes exceeding $5,000 or $10,000. Subgroup analyses compared differences in spending between episodes involving neonatal intensive care or cesarean birth.

The mean out-of-pocket spending was $2,281 for delivery and $788 for newborn hospitalization, giving a total of $3,068 per childbirth episode. Coinsurance and deductibles accounted for much of that cost, at 55.8% and 42.1%, respectively, whereas copayments accounted for a relatively minor portion (2.2%).

Almost all episodes (95%) cost more than zero dollars, while 17.1% cost more than $5,000 and 1.0% cost more than $10,000. Total mean out-of-pocket spending was higher for episodes involving cesarean birth ($3,389) or neonatal intensive care ($4,969), the latter of which cost more than $10,000 in 8.8% of episodes.

“Because details on plan benefit design were unavailable, the generalizability of findings to all privately insured Americans is unclear,” the investigators noted. “However, the proportion of childbirth episodes covered by high-deductible health plans in this study is consistent with the prevalence of such plans among Americans with employer-sponsored insurance.”

The findings suggest that financial reform is needed, Dr. Chua and colleagues concluded.

“To avoid imposing undue financial burden on families, private insurers should improve childbirth coverage,” they wrote. “An incremental step would be providing first-dollar coverage of deliveries and newborn hospitalizations before deductibles are met. Ideally, however, insurers would waive most or all cost-sharing for these hospitalizations, consistent with the approach taken by Medicaid programs and many developed countries.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, the size of the study is commendable, but some details are lacking.

“Although the overall sample size allows for a robust analysis, deciding to not report the confidence intervals in this report does not allow for understanding of [the findings with] smaller sample sizes,” Dr. Sutton said in an interview.

(Dr. Chua and colleagues noted that they did not report confidence intervals because “all differences between subgroups were significant owing to large sample sizes.”)

“Still,” Dr. Sutton went on, “this is an important study that has implications for financial counseling that may need to be a part of preconceptional, prenatal, and postnatal visits for privately insured families to help with planning and to decrease the chances of childbirth-related financial hardships. Additionally, policy-level changes that decrease or eliminate these private insurance–related childbirth-episode costs that may negatively impact some families with lower incomes, are warranted.”

The study was funded by the National Institutes of Health. Dr. Chua disclosed a grant from the National Institute on Drug Abuse, while Dr. Moniz is supported by the Agency for Healthcare Research and Quality. Dr. Sutton had no relevant disclosures.

Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes.

The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues.

“Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics. “Previous studies assessing this burden have focused on out-of-pocket spending for maternal care, including hospitalizations for delivery. However, there are no recent national data on out-of-pocket spending across the childbirth episode, including both deliveries and newborn hospitalizations.”

To address this knowledge gap, Dr. Chua and colleagues turned to Optum’s deidentified Clinformatics Data Mart, comprising 12 million privately insured individuals across the United States. The investigators identified 398,410 childbirth episodes occurring between 2016 and 2019. Each episode was defined as one delivery and at least one newborn hospitalization under the same family plan.

Out-of-pocket cost included copayment plus coinsurance and deductibles. Primary outcomes included mean total out-of-pocket spending and proportion of episodes exceeding $5,000 or $10,000. Subgroup analyses compared differences in spending between episodes involving neonatal intensive care or cesarean birth.

The mean out-of-pocket spending was $2,281 for delivery and $788 for newborn hospitalization, giving a total of $3,068 per childbirth episode. Coinsurance and deductibles accounted for much of that cost, at 55.8% and 42.1%, respectively, whereas copayments accounted for a relatively minor portion (2.2%).

Almost all episodes (95%) cost more than zero dollars, while 17.1% cost more than $5,000 and 1.0% cost more than $10,000. Total mean out-of-pocket spending was higher for episodes involving cesarean birth ($3,389) or neonatal intensive care ($4,969), the latter of which cost more than $10,000 in 8.8% of episodes.

“Because details on plan benefit design were unavailable, the generalizability of findings to all privately insured Americans is unclear,” the investigators noted. “However, the proportion of childbirth episodes covered by high-deductible health plans in this study is consistent with the prevalence of such plans among Americans with employer-sponsored insurance.”

The findings suggest that financial reform is needed, Dr. Chua and colleagues concluded.

“To avoid imposing undue financial burden on families, private insurers should improve childbirth coverage,” they wrote. “An incremental step would be providing first-dollar coverage of deliveries and newborn hospitalizations before deductibles are met. Ideally, however, insurers would waive most or all cost-sharing for these hospitalizations, consistent with the approach taken by Medicaid programs and many developed countries.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, the size of the study is commendable, but some details are lacking.

“Although the overall sample size allows for a robust analysis, deciding to not report the confidence intervals in this report does not allow for understanding of [the findings with] smaller sample sizes,” Dr. Sutton said in an interview.

(Dr. Chua and colleagues noted that they did not report confidence intervals because “all differences between subgroups were significant owing to large sample sizes.”)

“Still,” Dr. Sutton went on, “this is an important study that has implications for financial counseling that may need to be a part of preconceptional, prenatal, and postnatal visits for privately insured families to help with planning and to decrease the chances of childbirth-related financial hardships. Additionally, policy-level changes that decrease or eliminate these private insurance–related childbirth-episode costs that may negatively impact some families with lower incomes, are warranted.”

The study was funded by the National Institutes of Health. Dr. Chua disclosed a grant from the National Institute on Drug Abuse, while Dr. Moniz is supported by the Agency for Healthcare Research and Quality. Dr. Sutton had no relevant disclosures.

Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes.

The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues.

“Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics. “Previous studies assessing this burden have focused on out-of-pocket spending for maternal care, including hospitalizations for delivery. However, there are no recent national data on out-of-pocket spending across the childbirth episode, including both deliveries and newborn hospitalizations.”

To address this knowledge gap, Dr. Chua and colleagues turned to Optum’s deidentified Clinformatics Data Mart, comprising 12 million privately insured individuals across the United States. The investigators identified 398,410 childbirth episodes occurring between 2016 and 2019. Each episode was defined as one delivery and at least one newborn hospitalization under the same family plan.

Out-of-pocket cost included copayment plus coinsurance and deductibles. Primary outcomes included mean total out-of-pocket spending and proportion of episodes exceeding $5,000 or $10,000. Subgroup analyses compared differences in spending between episodes involving neonatal intensive care or cesarean birth.

The mean out-of-pocket spending was $2,281 for delivery and $788 for newborn hospitalization, giving a total of $3,068 per childbirth episode. Coinsurance and deductibles accounted for much of that cost, at 55.8% and 42.1%, respectively, whereas copayments accounted for a relatively minor portion (2.2%).

Almost all episodes (95%) cost more than zero dollars, while 17.1% cost more than $5,000 and 1.0% cost more than $10,000. Total mean out-of-pocket spending was higher for episodes involving cesarean birth ($3,389) or neonatal intensive care ($4,969), the latter of which cost more than $10,000 in 8.8% of episodes.

“Because details on plan benefit design were unavailable, the generalizability of findings to all privately insured Americans is unclear,” the investigators noted. “However, the proportion of childbirth episodes covered by high-deductible health plans in this study is consistent with the prevalence of such plans among Americans with employer-sponsored insurance.”

The findings suggest that financial reform is needed, Dr. Chua and colleagues concluded.

“To avoid imposing undue financial burden on families, private insurers should improve childbirth coverage,” they wrote. “An incremental step would be providing first-dollar coverage of deliveries and newborn hospitalizations before deductibles are met. Ideally, however, insurers would waive most or all cost-sharing for these hospitalizations, consistent with the approach taken by Medicaid programs and many developed countries.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, the size of the study is commendable, but some details are lacking.

“Although the overall sample size allows for a robust analysis, deciding to not report the confidence intervals in this report does not allow for understanding of [the findings with] smaller sample sizes,” Dr. Sutton said in an interview.

(Dr. Chua and colleagues noted that they did not report confidence intervals because “all differences between subgroups were significant owing to large sample sizes.”)

“Still,” Dr. Sutton went on, “this is an important study that has implications for financial counseling that may need to be a part of preconceptional, prenatal, and postnatal visits for privately insured families to help with planning and to decrease the chances of childbirth-related financial hardships. Additionally, policy-level changes that decrease or eliminate these private insurance–related childbirth-episode costs that may negatively impact some families with lower incomes, are warranted.”

The study was funded by the National Institutes of Health. Dr. Chua disclosed a grant from the National Institute on Drug Abuse, while Dr. Moniz is supported by the Agency for Healthcare Research and Quality. Dr. Sutton had no relevant disclosures.

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

A version of this article first appeared on Medscape.com.

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

A version of this article first appeared on Medscape.com.

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

A version of this article first appeared on Medscape.com.

Supplementing breastfed infants with bifidobacteria promotes development of a well-regulated immune system, theoretically reducing risk of immune-mediated conditions like allergies and asthma, according to investigators.

These findings support the importance of early gut colonization with beneficial microbes, an event that may affect the immune system throughout life, reported lead author Bethany M. Henrick, PhD, director of immunology and diagnostics at Evolve Biosystems, Davis, Calif., and adjunct assistant professor at the University of Nebraska, Lincoln, and colleagues.

“Dysbiosis of the infant gut microbiome is common in modern societies and a likely contributing factor to the increased incidences of immune-mediated disorders,” the investigators wrote in Cell. “Therefore, there is great interest in identifying microbial factors that can support healthier immune system imprinting and hopefully prevent cases of allergy, autoimmunity, and possibly other conditions involving the immune system.”

Prevailing theory suggests that the rising incidence of neonatal intestinal dysbiosis – which is typical in developed countries – may be caused by a variety of factors, including cesarean sections; modern hygiene practices; antibiotics, antiseptics, and other medications; diets high in fat and sugar; and infant formula.

According to Dr. Henrick and colleagues, a healthy gut microbiome plays the greatest role in immunological development during the first 3 months post partum; specifically, a lack of bifidobacteria during this time has been linked with increased risks of autoimmunity and enteric inflammation, although underlying immune mechanisms remain unclear.

Bifidobacteria also exemplify the symbiotic relationship between mothers, babies, and beneficial microbes. The investigators pointed out that breast milk contains human milk oligosaccharides (HMOs), which humans cannot digest, but are an excellent source of energy for bifidobacteria and other beneficial microbes, giving them a “selective nutritional advantage.”

Bifidobacteria should therefore be common residents within the infant gut, but this is often not now the case, leading Dr. Henrick and colleagues to zero in on the microbe, in hopes of determining the exactly how beneficial bacteria shape immune development.

It is only recently that the necessary knowledge and techniques to perform studies like this one have become available, the investigators wrote, noting a better understanding of cell-regulatory relationships, advances in immune profiling at the systems level, and new technology that allows for profiling small-volume samples from infants.

The present study involved a series of observational experiments and a small interventional trial.

First, the investigators conducted a wide array of blood- and fecal-based longitudinal analyses from 208 infants in Sweden to characterize immune cell expansion and microbiome colonization of the gut, with a focus on bifidobacteria.

Their results showed that infants lacking bifidobacteria, and HMO-utilization genes (which are expressed by bifidobacteria and other beneficial microbes), had higher levels of systemic inflammation, including increased T helper 2 (Th2) and Th17 responses.

“Infants not colonized by Bifidobacteriaceae or in cases where these microbes fail to expand during the first months of life there is evidence of systemic and intestinal inflammation, increased frequencies of activated immune cells, and reduced levels of regulatory cells indicative of systemic immune dysregulation,” the investigators wrote.

The interventional part of the study involved 60 breastfed infants in California. Twenty-nine of the newborns were given 1.8 x 10¹⁰ colony-forming units (CFUs) of B. longum subsp. infantis EVC001 daily from postnatal day 7 to day 28, while the remaining 31 infants were given no supplementation.

Fecal samples were collected on day 6 and day 60. At day 60, supplemented infants had high levels of HMO-utilization genes, plus significantly greater alpha diversity (P = .0001; Wilcoxon), compared with controls. Infants receiving EVC001 also had less inflammatory fecal cytokines, suggesting that microbes expressing HMO-utilization genes cause a shift away from proinflammatory Th2 and Th17 responses, and toward Th1.

“It is not the simple presence of bifidobacteria that is responsible for the immune effects but the metabolic partnership between the bacteria and HMOs,” the investigators noted.

According to principal investigator Petter Brodin, MD, PhD, professor of pediatric immunology at Karolinska Institutet, Solna, Sweden, the findings deserve further investigation.

“Our data indicate that substitution with beneficial microbes efficiently metabolizing HMOs could open a way to prevent cases of immune-mediated diseases, but larger, randomized trials aimed at this will be required to determine this potential,” Dr. Brodin said in an interview.

Carolynn Dude, MD, PhD, assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, agreed that more work is needed.

“While this study provides some insight into the mechanisms that may set up a newborn for poor health outcomes later in life, the data is still very limited, and more long-term follow-up on these infants is needed before recommending any sort of bacterial supplementation to a newborn,” Dr. Dude said in an interview.

Dr. Brodin and colleagues are planning an array of related studies, including larger clinical trials; further investigations into mechanisms of action; comparisons between the present cohort and infants in Kenya, where immune-mediated diseases are rare; and evaluations of vaccine responses and infectious disease susceptibility.

The study was supported by the European Research Council, the Swedish Research Council, the Marianne & Marcus Wallenberg Foundation, and others. The investigators disclosed relationships with Cytodelics, Scailyte, Kancera, and others. Dr. Dude reported no relevant conflicts of interest.

Supplementing breastfed infants with bifidobacteria promotes development of a well-regulated immune system, theoretically reducing risk of immune-mediated conditions like allergies and asthma, according to investigators.

These findings support the importance of early gut colonization with beneficial microbes, an event that may affect the immune system throughout life, reported lead author Bethany M. Henrick, PhD, director of immunology and diagnostics at Evolve Biosystems, Davis, Calif., and adjunct assistant professor at the University of Nebraska, Lincoln, and colleagues.

“Dysbiosis of the infant gut microbiome is common in modern societies and a likely contributing factor to the increased incidences of immune-mediated disorders,” the investigators wrote in Cell. “Therefore, there is great interest in identifying microbial factors that can support healthier immune system imprinting and hopefully prevent cases of allergy, autoimmunity, and possibly other conditions involving the immune system.”

Prevailing theory suggests that the rising incidence of neonatal intestinal dysbiosis – which is typical in developed countries – may be caused by a variety of factors, including cesarean sections; modern hygiene practices; antibiotics, antiseptics, and other medications; diets high in fat and sugar; and infant formula.

According to Dr. Henrick and colleagues, a healthy gut microbiome plays the greatest role in immunological development during the first 3 months post partum; specifically, a lack of bifidobacteria during this time has been linked with increased risks of autoimmunity and enteric inflammation, although underlying immune mechanisms remain unclear.

Bifidobacteria also exemplify the symbiotic relationship between mothers, babies, and beneficial microbes. The investigators pointed out that breast milk contains human milk oligosaccharides (HMOs), which humans cannot digest, but are an excellent source of energy for bifidobacteria and other beneficial microbes, giving them a “selective nutritional advantage.”

Bifidobacteria should therefore be common residents within the infant gut, but this is often not now the case, leading Dr. Henrick and colleagues to zero in on the microbe, in hopes of determining the exactly how beneficial bacteria shape immune development.

It is only recently that the necessary knowledge and techniques to perform studies like this one have become available, the investigators wrote, noting a better understanding of cell-regulatory relationships, advances in immune profiling at the systems level, and new technology that allows for profiling small-volume samples from infants.

The present study involved a series of observational experiments and a small interventional trial.

First, the investigators conducted a wide array of blood- and fecal-based longitudinal analyses from 208 infants in Sweden to characterize immune cell expansion and microbiome colonization of the gut, with a focus on bifidobacteria.

Their results showed that infants lacking bifidobacteria, and HMO-utilization genes (which are expressed by bifidobacteria and other beneficial microbes), had higher levels of systemic inflammation, including increased T helper 2 (Th2) and Th17 responses.

“Infants not colonized by Bifidobacteriaceae or in cases where these microbes fail to expand during the first months of life there is evidence of systemic and intestinal inflammation, increased frequencies of activated immune cells, and reduced levels of regulatory cells indicative of systemic immune dysregulation,” the investigators wrote.

The interventional part of the study involved 60 breastfed infants in California. Twenty-nine of the newborns were given 1.8 x 10¹⁰ colony-forming units (CFUs) of B. longum subsp. infantis EVC001 daily from postnatal day 7 to day 28, while the remaining 31 infants were given no supplementation.

Fecal samples were collected on day 6 and day 60. At day 60, supplemented infants had high levels of HMO-utilization genes, plus significantly greater alpha diversity (P = .0001; Wilcoxon), compared with controls. Infants receiving EVC001 also had less inflammatory fecal cytokines, suggesting that microbes expressing HMO-utilization genes cause a shift away from proinflammatory Th2 and Th17 responses, and toward Th1.

“It is not the simple presence of bifidobacteria that is responsible for the immune effects but the metabolic partnership between the bacteria and HMOs,” the investigators noted.

According to principal investigator Petter Brodin, MD, PhD, professor of pediatric immunology at Karolinska Institutet, Solna, Sweden, the findings deserve further investigation.

“Our data indicate that substitution with beneficial microbes efficiently metabolizing HMOs could open a way to prevent cases of immune-mediated diseases, but larger, randomized trials aimed at this will be required to determine this potential,” Dr. Brodin said in an interview.

Carolynn Dude, MD, PhD, assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, agreed that more work is needed.

“While this study provides some insight into the mechanisms that may set up a newborn for poor health outcomes later in life, the data is still very limited, and more long-term follow-up on these infants is needed before recommending any sort of bacterial supplementation to a newborn,” Dr. Dude said in an interview.

Dr. Brodin and colleagues are planning an array of related studies, including larger clinical trials; further investigations into mechanisms of action; comparisons between the present cohort and infants in Kenya, where immune-mediated diseases are rare; and evaluations of vaccine responses and infectious disease susceptibility.

The study was supported by the European Research Council, the Swedish Research Council, the Marianne & Marcus Wallenberg Foundation, and others. The investigators disclosed relationships with Cytodelics, Scailyte, Kancera, and others. Dr. Dude reported no relevant conflicts of interest.

Supplementing breastfed infants with bifidobacteria promotes development of a well-regulated immune system, theoretically reducing risk of immune-mediated conditions like allergies and asthma, according to investigators.

These findings support the importance of early gut colonization with beneficial microbes, an event that may affect the immune system throughout life, reported lead author Bethany M. Henrick, PhD, director of immunology and diagnostics at Evolve Biosystems, Davis, Calif., and adjunct assistant professor at the University of Nebraska, Lincoln, and colleagues.

“Dysbiosis of the infant gut microbiome is common in modern societies and a likely contributing factor to the increased incidences of immune-mediated disorders,” the investigators wrote in Cell. “Therefore, there is great interest in identifying microbial factors that can support healthier immune system imprinting and hopefully prevent cases of allergy, autoimmunity, and possibly other conditions involving the immune system.”

Prevailing theory suggests that the rising incidence of neonatal intestinal dysbiosis – which is typical in developed countries – may be caused by a variety of factors, including cesarean sections; modern hygiene practices; antibiotics, antiseptics, and other medications; diets high in fat and sugar; and infant formula.

According to Dr. Henrick and colleagues, a healthy gut microbiome plays the greatest role in immunological development during the first 3 months post partum; specifically, a lack of bifidobacteria during this time has been linked with increased risks of autoimmunity and enteric inflammation, although underlying immune mechanisms remain unclear.

Bifidobacteria also exemplify the symbiotic relationship between mothers, babies, and beneficial microbes. The investigators pointed out that breast milk contains human milk oligosaccharides (HMOs), which humans cannot digest, but are an excellent source of energy for bifidobacteria and other beneficial microbes, giving them a “selective nutritional advantage.”

Bifidobacteria should therefore be common residents within the infant gut, but this is often not now the case, leading Dr. Henrick and colleagues to zero in on the microbe, in hopes of determining the exactly how beneficial bacteria shape immune development.

It is only recently that the necessary knowledge and techniques to perform studies like this one have become available, the investigators wrote, noting a better understanding of cell-regulatory relationships, advances in immune profiling at the systems level, and new technology that allows for profiling small-volume samples from infants.

The present study involved a series of observational experiments and a small interventional trial.

First, the investigators conducted a wide array of blood- and fecal-based longitudinal analyses from 208 infants in Sweden to characterize immune cell expansion and microbiome colonization of the gut, with a focus on bifidobacteria.

Their results showed that infants lacking bifidobacteria, and HMO-utilization genes (which are expressed by bifidobacteria and other beneficial microbes), had higher levels of systemic inflammation, including increased T helper 2 (Th2) and Th17 responses.

“Infants not colonized by Bifidobacteriaceae or in cases where these microbes fail to expand during the first months of life there is evidence of systemic and intestinal inflammation, increased frequencies of activated immune cells, and reduced levels of regulatory cells indicative of systemic immune dysregulation,” the investigators wrote.

The interventional part of the study involved 60 breastfed infants in California. Twenty-nine of the newborns were given 1.8 x 10¹⁰ colony-forming units (CFUs) of B. longum subsp. infantis EVC001 daily from postnatal day 7 to day 28, while the remaining 31 infants were given no supplementation.

Fecal samples were collected on day 6 and day 60. At day 60, supplemented infants had high levels of HMO-utilization genes, plus significantly greater alpha diversity (P = .0001; Wilcoxon), compared with controls. Infants receiving EVC001 also had less inflammatory fecal cytokines, suggesting that microbes expressing HMO-utilization genes cause a shift away from proinflammatory Th2 and Th17 responses, and toward Th1.

“It is not the simple presence of bifidobacteria that is responsible for the immune effects but the metabolic partnership between the bacteria and HMOs,” the investigators noted.

According to principal investigator Petter Brodin, MD, PhD, professor of pediatric immunology at Karolinska Institutet, Solna, Sweden, the findings deserve further investigation.

“Our data indicate that substitution with beneficial microbes efficiently metabolizing HMOs could open a way to prevent cases of immune-mediated diseases, but larger, randomized trials aimed at this will be required to determine this potential,” Dr. Brodin said in an interview.

Carolynn Dude, MD, PhD, assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, agreed that more work is needed.

“While this study provides some insight into the mechanisms that may set up a newborn for poor health outcomes later in life, the data is still very limited, and more long-term follow-up on these infants is needed before recommending any sort of bacterial supplementation to a newborn,” Dr. Dude said in an interview.

Dr. Brodin and colleagues are planning an array of related studies, including larger clinical trials; further investigations into mechanisms of action; comparisons between the present cohort and infants in Kenya, where immune-mediated diseases are rare; and evaluations of vaccine responses and infectious disease susceptibility.

The study was supported by the European Research Council, the Swedish Research Council, the Marianne & Marcus Wallenberg Foundation, and others. The investigators disclosed relationships with Cytodelics, Scailyte, Kancera, and others. Dr. Dude reported no relevant conflicts of interest.

A software program based on artificial intelligence (AI) is effective for distinguishing young children with autism spectrum disorder (ASD) from those with other conditions, according to results of a pivotal trial presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

The AI-based software, which will be submitted to regulatory approval as a device, employs an algorithm that assembles inputs from a caregiver questionnaire, a video, and a clinician questionnaire, according to Sharief Taraman, MD, a pediatric neurologist at CHOC, a pediatric health care system in Orange County, Calif.

Although the device could be employed in a variety of settings, it is envisioned for use by primary care physicians. This will circumvent the need for specialist evaluation except in challenging cases. Currently, nearly all children with ASD are diagnosed in specialty care, according to data cited by Dr. Taraman.

“The lack of diagnostic tools for ASD in primary care settings contributes to an average delay of 3 years between first parental concern and diagnosis and to long wait lists for specialty evaluation,” he reported at the virtual meeting, presented by MedscapeLive.

When used with clinical judgment and criteria from the American Psychiatric Association’s 5th edition of the Diagnostic and Statistical Manual (DSM-5), the data from the trial suggest the diagnostic tool in the hands of primary care physicians “could efficiently and accurately assess ASD in children 18 to 72 months old,” said Dr. Taraman, also an associate clinical professor of pediatrics at the University of California, Irvine.*

The AI-assisted software was evaluated in 425 children at 14 sites in 6 states. The study population was reflective of U.S. demographics. Although only 36% of the children were female, this is consistent with ASD prevalence. Only 60% of the subjects were White. Nearly 30% were Black or Latinx and other populations, such as those of Asian heritage, were represented.

Children between the ages of 18 and 72 months were eligible if both a caregiver and a health care professional were concerned that the child had ASD. About the same time that a caregiver completed a 20-item questionnaire and the primary care physician completed a 15-item questionnaire on a mobile device, the caregiver uploaded two videos of 1-2 minutes in length.

This information, along with a 33-item questionnaire completed by an analyst of the submitted videos, was then processed by the software algorithm. It provided a patient status of positive or negative for ASD, or it concluded that the status was indeterminate.

“To reduce the risk of false classifications, the indeterminate status was included as a safety feature,” Dr. Taraman explained. However, Dr. Taraman considers an indeterminate designation potentially actionable. Rather than a negative result, this status suggests a complex neurodevelopmental disorder and indicates the need for further evaluation.

The reference standard diagnosis, completed in all participants in this study, was a specialist evaluation completed independently by two experts. The presence or absence of ASD was confirmed if the experts agreed. If they did not, a third specialist made the final determination.

On the basis of the software, there was a determinate result in 52% of the children. In comparison to the specialist determinations, all were correctly classified except for one child, in which the software was determined to have made a false-negative diagnosis. A diagnosis of ASD was reached in 29% of the study participants.

For those with a determinate designation, the sensitivity was 98.4% and the specificity was 78.9%. This translated into positive predictive and negative predictive values of 80.8% and 98.3%, respectively.

Of those identified as indeterminate by the AI-assisted algorithm, 91% were ultimately considered by specialist evaluation to have complex issues. In this group, ASD was part of the complex clinical picture in 20%. The others had non-ASD neurodevelopmental conditions, according to Dr. Taraman.

When the accuracy was evaluated across ages, ethnicity, and factors such as parent education or family income, the tool performed consistently, Dr. Taraman reported. This is important, he said, because the presence or absence of ASD is misdiagnosed in many underserved populations.

The focus on developing a methodology specific for use in primary care was based on evidence that the delay in the diagnosis of ASD is attributable to long wait times for specialty evaluations.

“There will never be enough specialists. There is a need for a way to streamline the diagnosis of ASD,” Dr. Taraman maintained. This is helpful not only to parents concerned about their children, he said, but also there are data to suggest that early intervention improves outcomes.

A specialist in ASD, Paul Carbone, MD, medical director of the child development program at the University of Utah, Salt Lake City, agreed. He said early diagnosis and intervention should be a goal.

“Reducing the age of ASD diagnosis is a priority because early entry into autism-specific interventions is a strong predictor of optimal developmental outcomes for children,” Dr. Carbone said.

Although he is not familiar with this experimental AI-assisted diagnostic program, he has published on the feasibility of ASD diagnosis at the primary care level. In his study, Dr. Carbone examined the Modified Checklist for Autism in Toddlers (M-CHAT) as one of several methodologies that might be considered.

Diagnosis of ASD “can be achieved through systematic processes within primary care that facilitate universal development surveillance and autism screening followed by prompt and timely diagnostic evaluations of at-risk children,” Dr. Carbone said.

MedscapeLive and this news organization are owned by the same parent company. Dr. Taraman reported a financial relationship with Cognoa, the company that is developing the ASD software for clinical use. Dr. Carbone reported that he has no conflicts of interest.

*Updated, 7/7/21

A software program based on artificial intelligence (AI) is effective for distinguishing young children with autism spectrum disorder (ASD) from those with other conditions, according to results of a pivotal trial presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

The AI-based software, which will be submitted to regulatory approval as a device, employs an algorithm that assembles inputs from a caregiver questionnaire, a video, and a clinician questionnaire, according to Sharief Taraman, MD, a pediatric neurologist at CHOC, a pediatric health care system in Orange County, Calif.

Although the device could be employed in a variety of settings, it is envisioned for use by primary care physicians. This will circumvent the need for specialist evaluation except in challenging cases. Currently, nearly all children with ASD are diagnosed in specialty care, according to data cited by Dr. Taraman.

“The lack of diagnostic tools for ASD in primary care settings contributes to an average delay of 3 years between first parental concern and diagnosis and to long wait lists for specialty evaluation,” he reported at the virtual meeting, presented by MedscapeLive.

When used with clinical judgment and criteria from the American Psychiatric Association’s 5th edition of the Diagnostic and Statistical Manual (DSM-5), the data from the trial suggest the diagnostic tool in the hands of primary care physicians “could efficiently and accurately assess ASD in children 18 to 72 months old,” said Dr. Taraman, also an associate clinical professor of pediatrics at the University of California, Irvine.*

The AI-assisted software was evaluated in 425 children at 14 sites in 6 states. The study population was reflective of U.S. demographics. Although only 36% of the children were female, this is consistent with ASD prevalence. Only 60% of the subjects were White. Nearly 30% were Black or Latinx and other populations, such as those of Asian heritage, were represented.

Children between the ages of 18 and 72 months were eligible if both a caregiver and a health care professional were concerned that the child had ASD. About the same time that a caregiver completed a 20-item questionnaire and the primary care physician completed a 15-item questionnaire on a mobile device, the caregiver uploaded two videos of 1-2 minutes in length.

This information, along with a 33-item questionnaire completed by an analyst of the submitted videos, was then processed by the software algorithm. It provided a patient status of positive or negative for ASD, or it concluded that the status was indeterminate.

“To reduce the risk of false classifications, the indeterminate status was included as a safety feature,” Dr. Taraman explained. However, Dr. Taraman considers an indeterminate designation potentially actionable. Rather than a negative result, this status suggests a complex neurodevelopmental disorder and indicates the need for further evaluation.

The reference standard diagnosis, completed in all participants in this study, was a specialist evaluation completed independently by two experts. The presence or absence of ASD was confirmed if the experts agreed. If they did not, a third specialist made the final determination.

On the basis of the software, there was a determinate result in 52% of the children. In comparison to the specialist determinations, all were correctly classified except for one child, in which the software was determined to have made a false-negative diagnosis. A diagnosis of ASD was reached in 29% of the study participants.

For those with a determinate designation, the sensitivity was 98.4% and the specificity was 78.9%. This translated into positive predictive and negative predictive values of 80.8% and 98.3%, respectively.

Of those identified as indeterminate by the AI-assisted algorithm, 91% were ultimately considered by specialist evaluation to have complex issues. In this group, ASD was part of the complex clinical picture in 20%. The others had non-ASD neurodevelopmental conditions, according to Dr. Taraman.

When the accuracy was evaluated across ages, ethnicity, and factors such as parent education or family income, the tool performed consistently, Dr. Taraman reported. This is important, he said, because the presence or absence of ASD is misdiagnosed in many underserved populations.

The focus on developing a methodology specific for use in primary care was based on evidence that the delay in the diagnosis of ASD is attributable to long wait times for specialty evaluations.

“There will never be enough specialists. There is a need for a way to streamline the diagnosis of ASD,” Dr. Taraman maintained. This is helpful not only to parents concerned about their children, he said, but also there are data to suggest that early intervention improves outcomes.

A specialist in ASD, Paul Carbone, MD, medical director of the child development program at the University of Utah, Salt Lake City, agreed. He said early diagnosis and intervention should be a goal.

“Reducing the age of ASD diagnosis is a priority because early entry into autism-specific interventions is a strong predictor of optimal developmental outcomes for children,” Dr. Carbone said.

Although he is not familiar with this experimental AI-assisted diagnostic program, he has published on the feasibility of ASD diagnosis at the primary care level. In his study, Dr. Carbone examined the Modified Checklist for Autism in Toddlers (M-CHAT) as one of several methodologies that might be considered.

Diagnosis of ASD “can be achieved through systematic processes within primary care that facilitate universal development surveillance and autism screening followed by prompt and timely diagnostic evaluations of at-risk children,” Dr. Carbone said.

MedscapeLive and this news organization are owned by the same parent company. Dr. Taraman reported a financial relationship with Cognoa, the company that is developing the ASD software for clinical use. Dr. Carbone reported that he has no conflicts of interest.

*Updated, 7/7/21

A software program based on artificial intelligence (AI) is effective for distinguishing young children with autism spectrum disorder (ASD) from those with other conditions, according to results of a pivotal trial presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

The AI-based software, which will be submitted to regulatory approval as a device, employs an algorithm that assembles inputs from a caregiver questionnaire, a video, and a clinician questionnaire, according to Sharief Taraman, MD, a pediatric neurologist at CHOC, a pediatric health care system in Orange County, Calif.

Although the device could be employed in a variety of settings, it is envisioned for use by primary care physicians. This will circumvent the need for specialist evaluation except in challenging cases. Currently, nearly all children with ASD are diagnosed in specialty care, according to data cited by Dr. Taraman.

“The lack of diagnostic tools for ASD in primary care settings contributes to an average delay of 3 years between first parental concern and diagnosis and to long wait lists for specialty evaluation,” he reported at the virtual meeting, presented by MedscapeLive.

When used with clinical judgment and criteria from the American Psychiatric Association’s 5th edition of the Diagnostic and Statistical Manual (DSM-5), the data from the trial suggest the diagnostic tool in the hands of primary care physicians “could efficiently and accurately assess ASD in children 18 to 72 months old,” said Dr. Taraman, also an associate clinical professor of pediatrics at the University of California, Irvine.*

The AI-assisted software was evaluated in 425 children at 14 sites in 6 states. The study population was reflective of U.S. demographics. Although only 36% of the children were female, this is consistent with ASD prevalence. Only 60% of the subjects were White. Nearly 30% were Black or Latinx and other populations, such as those of Asian heritage, were represented.

Children between the ages of 18 and 72 months were eligible if both a caregiver and a health care professional were concerned that the child had ASD. About the same time that a caregiver completed a 20-item questionnaire and the primary care physician completed a 15-item questionnaire on a mobile device, the caregiver uploaded two videos of 1-2 minutes in length.

This information, along with a 33-item questionnaire completed by an analyst of the submitted videos, was then processed by the software algorithm. It provided a patient status of positive or negative for ASD, or it concluded that the status was indeterminate.

“To reduce the risk of false classifications, the indeterminate status was included as a safety feature,” Dr. Taraman explained. However, Dr. Taraman considers an indeterminate designation potentially actionable. Rather than a negative result, this status suggests a complex neurodevelopmental disorder and indicates the need for further evaluation.

The reference standard diagnosis, completed in all participants in this study, was a specialist evaluation completed independently by two experts. The presence or absence of ASD was confirmed if the experts agreed. If they did not, a third specialist made the final determination.

On the basis of the software, there was a determinate result in 52% of the children. In comparison to the specialist determinations, all were correctly classified except for one child, in which the software was determined to have made a false-negative diagnosis. A diagnosis of ASD was reached in 29% of the study participants.

For those with a determinate designation, the sensitivity was 98.4% and the specificity was 78.9%. This translated into positive predictive and negative predictive values of 80.8% and 98.3%, respectively.

Of those identified as indeterminate by the AI-assisted algorithm, 91% were ultimately considered by specialist evaluation to have complex issues. In this group, ASD was part of the complex clinical picture in 20%. The others had non-ASD neurodevelopmental conditions, according to Dr. Taraman.

When the accuracy was evaluated across ages, ethnicity, and factors such as parent education or family income, the tool performed consistently, Dr. Taraman reported. This is important, he said, because the presence or absence of ASD is misdiagnosed in many underserved populations.

The focus on developing a methodology specific for use in primary care was based on evidence that the delay in the diagnosis of ASD is attributable to long wait times for specialty evaluations.

“There will never be enough specialists. There is a need for a way to streamline the diagnosis of ASD,” Dr. Taraman maintained. This is helpful not only to parents concerned about their children, he said, but also there are data to suggest that early intervention improves outcomes.

A specialist in ASD, Paul Carbone, MD, medical director of the child development program at the University of Utah, Salt Lake City, agreed. He said early diagnosis and intervention should be a goal.

“Reducing the age of ASD diagnosis is a priority because early entry into autism-specific interventions is a strong predictor of optimal developmental outcomes for children,” Dr. Carbone said.

Although he is not familiar with this experimental AI-assisted diagnostic program, he has published on the feasibility of ASD diagnosis at the primary care level. In his study, Dr. Carbone examined the Modified Checklist for Autism in Toddlers (M-CHAT) as one of several methodologies that might be considered.

Diagnosis of ASD “can be achieved through systematic processes within primary care that facilitate universal development surveillance and autism screening followed by prompt and timely diagnostic evaluations of at-risk children,” Dr. Carbone said.

MedscapeLive and this news organization are owned by the same parent company. Dr. Taraman reported a financial relationship with Cognoa, the company that is developing the ASD software for clinical use. Dr. Carbone reported that he has no conflicts of interest.

*Updated, 7/7/21

Approximately one-third of individuals with autism spectrum disorder (ASD) are prescribed multiple medications to manage comorbidities and symptoms, according to data from a retrospective cohort study of more than 26,000 patients.

“Clinicians caring for patients with ASD are tasked with the challenges of managing the primary disease, as well as co-occurring medical conditions, and coordinating with educational and social service professionals to provide holistic care,” wrote Aliya G. Feroe of Harvard Medical School, Boston, and colleagues.

The medication classes used to treat individuals with ASD include ADHD medications, antipsychotics, antidepressants, mood stabilizers, benzodiazepines, anxiolytics, and hypnotics, but the prescription rates of these medications in ASD patients have not been examined in large studies, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 26,722 individuals with ASD using a United States health care database from Jan. 1, 2014, to Dec. 31, 2019. Data included records of inpatient and outpatient claims, and records of prescriptions filled through commercial pharmacies. Individuals received at least 1 of 24 of the most common medication groups for ASD or comorbidities. The average age of the study participants was 14 years, and 78% were male. Diagnostic codes for ASD were based on the International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.

Over the 6-year study period, approximately one-third of the participants were taking three or more medications at once, ranging from 28.6% to 31.5%. In any 1 year, approximately 41% of children were prescribed a single medication, 17% received two prescriptions, 7.9% received four, and 3.4% received five. Medication changes occurred more frequently within classes than between classes, and reasons for these changes may include patient preference, adverse effects, and cost, the researchers noted.

The overall number of children prescribed particular drugs remained consistent, the researchers noted. “For example, the total number of individuals prescribed methylphenidate shifted from 832 in 2014 to 850 in 2015, 899 in 2016, 863 in 2017, and 838 in 2018,” they wrote.

In 15 of the 24 medication groups included in the study, at least 15% of the individuals had unspecified anxiety disorder, anxiety neurosis, or major depressive disorder; in 11 of the medication groups, at least 15% had some form of ADHD. ADHD prevalence in patients taking stimulants varied based on ADHD type, the researchers said.

The most common comorbidities in patients taking antipsychotics were combined type ADHD (11.6%-17.8%) and anxiety disorder (13.1%-30.1%). The study findings suggest that many clinicians are incorporating medications into ASD management, the researchers said.

“Although there is no medical treatment for the core deficits of social communication and repetitive behavioral patterns in ASD, the American Academy of Pediatrics recommends that clinicians consider medications in the management of common comorbid conditions, including seizures, ADHD, anxiety disorders, mood disorders, and disruptive behavior disorders,” they said.

The findings were limited by several factors including the potential for inconsistent reporting of diagnoses and pharmacy claims, the researchers noted. Other limitations included a lack of direct clinical assessment to validate diagnoses and the absence of validated diagnostic instruments to screen for comorbidities, they added.

“Our findings suggest that clinicians may be increasingly using integrated approaches to treating patients with ASD and co-occurring conditions, and further work is necessary to determine the relative effects of pharmacotherapy vs. behavioral interventions on outcomes in patients with ASD,” the researchers concluded.
 

Many reasons for multiple medications

“The researchers put in a lot of effort to provide data on a large scale,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.

“The findings illustrate the reality that autistic children are prescribed a lot of medications for a lot of reasons, some of which are not entirely clear,” Dr. Lessin said. The study also reflects the chronic lack of behavioral health services for children, he noted. Many children with ASD are referred for services they are unable to access, he said. “As a result, they see doctors who can only prescribe medications to try to control behavior or symptoms for which the cause is unclear,” and which could be ASD or other comorbidities, he emphasized.

The large sample size strengthens the study findings, but some of the challenges include the use of claims data, which do not indicate how diagnoses were made, said Dr. Lessin. An additional limitation is the fact that many medications for children with autism are used off label, so the specific reason for their use may be unknown, he said.

The take-home message for clinicians is that children with ASD are getting a lot of medications, and pediatricians are not usually responsible for multiple medications,” Dr. Lessin said. Ultimately, the study is “a plea for more research,” to tease out details of what medications are indicated and helpful, he said.

The study received no outside funding. The researchers and Dr. Lessin had no financial conflicts to disclose. Dr. Lessin serves on the Pediatric News editorial advisory board.

Approximately one-third of individuals with autism spectrum disorder (ASD) are prescribed multiple medications to manage comorbidities and symptoms, according to data from a retrospective cohort study of more than 26,000 patients.

“Clinicians caring for patients with ASD are tasked with the challenges of managing the primary disease, as well as co-occurring medical conditions, and coordinating with educational and social service professionals to provide holistic care,” wrote Aliya G. Feroe of Harvard Medical School, Boston, and colleagues.

The medication classes used to treat individuals with ASD include ADHD medications, antipsychotics, antidepressants, mood stabilizers, benzodiazepines, anxiolytics, and hypnotics, but the prescription rates of these medications in ASD patients have not been examined in large studies, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 26,722 individuals with ASD using a United States health care database from Jan. 1, 2014, to Dec. 31, 2019. Data included records of inpatient and outpatient claims, and records of prescriptions filled through commercial pharmacies. Individuals received at least 1 of 24 of the most common medication groups for ASD or comorbidities. The average age of the study participants was 14 years, and 78% were male. Diagnostic codes for ASD were based on the International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.

Over the 6-year study period, approximately one-third of the participants were taking three or more medications at once, ranging from 28.6% to 31.5%. In any 1 year, approximately 41% of children were prescribed a single medication, 17% received two prescriptions, 7.9% received four, and 3.4% received five. Medication changes occurred more frequently within classes than between classes, and reasons for these changes may include patient preference, adverse effects, and cost, the researchers noted.

The overall number of children prescribed particular drugs remained consistent, the researchers noted. “For example, the total number of individuals prescribed methylphenidate shifted from 832 in 2014 to 850 in 2015, 899 in 2016, 863 in 2017, and 838 in 2018,” they wrote.

In 15 of the 24 medication groups included in the study, at least 15% of the individuals had unspecified anxiety disorder, anxiety neurosis, or major depressive disorder; in 11 of the medication groups, at least 15% had some form of ADHD. ADHD prevalence in patients taking stimulants varied based on ADHD type, the researchers said.

The most common comorbidities in patients taking antipsychotics were combined type ADHD (11.6%-17.8%) and anxiety disorder (13.1%-30.1%). The study findings suggest that many clinicians are incorporating medications into ASD management, the researchers said.

“Although there is no medical treatment for the core deficits of social communication and repetitive behavioral patterns in ASD, the American Academy of Pediatrics recommends that clinicians consider medications in the management of common comorbid conditions, including seizures, ADHD, anxiety disorders, mood disorders, and disruptive behavior disorders,” they said.

The findings were limited by several factors including the potential for inconsistent reporting of diagnoses and pharmacy claims, the researchers noted. Other limitations included a lack of direct clinical assessment to validate diagnoses and the absence of validated diagnostic instruments to screen for comorbidities, they added.

“Our findings suggest that clinicians may be increasingly using integrated approaches to treating patients with ASD and co-occurring conditions, and further work is necessary to determine the relative effects of pharmacotherapy vs. behavioral interventions on outcomes in patients with ASD,” the researchers concluded.
 

Many reasons for multiple medications

“The researchers put in a lot of effort to provide data on a large scale,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.

“The findings illustrate the reality that autistic children are prescribed a lot of medications for a lot of reasons, some of which are not entirely clear,” Dr. Lessin said. The study also reflects the chronic lack of behavioral health services for children, he noted. Many children with ASD are referred for services they are unable to access, he said. “As a result, they see doctors who can only prescribe medications to try to control behavior or symptoms for which the cause is unclear,” and which could be ASD or other comorbidities, he emphasized.

The large sample size strengthens the study findings, but some of the challenges include the use of claims data, which do not indicate how diagnoses were made, said Dr. Lessin. An additional limitation is the fact that many medications for children with autism are used off label, so the specific reason for their use may be unknown, he said.

The take-home message for clinicians is that children with ASD are getting a lot of medications, and pediatricians are not usually responsible for multiple medications,” Dr. Lessin said. Ultimately, the study is “a plea for more research,” to tease out details of what medications are indicated and helpful, he said.

The study received no outside funding. The researchers and Dr. Lessin had no financial conflicts to disclose. Dr. Lessin serves on the Pediatric News editorial advisory board.

Approximately one-third of individuals with autism spectrum disorder (ASD) are prescribed multiple medications to manage comorbidities and symptoms, according to data from a retrospective cohort study of more than 26,000 patients.

“Clinicians caring for patients with ASD are tasked with the challenges of managing the primary disease, as well as co-occurring medical conditions, and coordinating with educational and social service professionals to provide holistic care,” wrote Aliya G. Feroe of Harvard Medical School, Boston, and colleagues.

The medication classes used to treat individuals with ASD include ADHD medications, antipsychotics, antidepressants, mood stabilizers, benzodiazepines, anxiolytics, and hypnotics, but the prescription rates of these medications in ASD patients have not been examined in large studies, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 26,722 individuals with ASD using a United States health care database from Jan. 1, 2014, to Dec. 31, 2019. Data included records of inpatient and outpatient claims, and records of prescriptions filled through commercial pharmacies. Individuals received at least 1 of 24 of the most common medication groups for ASD or comorbidities. The average age of the study participants was 14 years, and 78% were male. Diagnostic codes for ASD were based on the International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.

Over the 6-year study period, approximately one-third of the participants were taking three or more medications at once, ranging from 28.6% to 31.5%. In any 1 year, approximately 41% of children were prescribed a single medication, 17% received two prescriptions, 7.9% received four, and 3.4% received five. Medication changes occurred more frequently within classes than between classes, and reasons for these changes may include patient preference, adverse effects, and cost, the researchers noted.

The overall number of children prescribed particular drugs remained consistent, the researchers noted. “For example, the total number of individuals prescribed methylphenidate shifted from 832 in 2014 to 850 in 2015, 899 in 2016, 863 in 2017, and 838 in 2018,” they wrote.

In 15 of the 24 medication groups included in the study, at least 15% of the individuals had unspecified anxiety disorder, anxiety neurosis, or major depressive disorder; in 11 of the medication groups, at least 15% had some form of ADHD. ADHD prevalence in patients taking stimulants varied based on ADHD type, the researchers said.

The most common comorbidities in patients taking antipsychotics were combined type ADHD (11.6%-17.8%) and anxiety disorder (13.1%-30.1%). The study findings suggest that many clinicians are incorporating medications into ASD management, the researchers said.

“Although there is no medical treatment for the core deficits of social communication and repetitive behavioral patterns in ASD, the American Academy of Pediatrics recommends that clinicians consider medications in the management of common comorbid conditions, including seizures, ADHD, anxiety disorders, mood disorders, and disruptive behavior disorders,” they said.

The findings were limited by several factors including the potential for inconsistent reporting of diagnoses and pharmacy claims, the researchers noted. Other limitations included a lack of direct clinical assessment to validate diagnoses and the absence of validated diagnostic instruments to screen for comorbidities, they added.

“Our findings suggest that clinicians may be increasingly using integrated approaches to treating patients with ASD and co-occurring conditions, and further work is necessary to determine the relative effects of pharmacotherapy vs. behavioral interventions on outcomes in patients with ASD,” the researchers concluded.
 

Many reasons for multiple medications

“The researchers put in a lot of effort to provide data on a large scale,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.

“The findings illustrate the reality that autistic children are prescribed a lot of medications for a lot of reasons, some of which are not entirely clear,” Dr. Lessin said. The study also reflects the chronic lack of behavioral health services for children, he noted. Many children with ASD are referred for services they are unable to access, he said. “As a result, they see doctors who can only prescribe medications to try to control behavior or symptoms for which the cause is unclear,” and which could be ASD or other comorbidities, he emphasized.

The large sample size strengthens the study findings, but some of the challenges include the use of claims data, which do not indicate how diagnoses were made, said Dr. Lessin. An additional limitation is the fact that many medications for children with autism are used off label, so the specific reason for their use may be unknown, he said.

The take-home message for clinicians is that children with ASD are getting a lot of medications, and pediatricians are not usually responsible for multiple medications,” Dr. Lessin said. Ultimately, the study is “a plea for more research,” to tease out details of what medications are indicated and helpful, he said.

The study received no outside funding. The researchers and Dr. Lessin had no financial conflicts to disclose. Dr. Lessin serves on the Pediatric News editorial advisory board.

The proportion of children aged 12-15 years who have completed their COVID-19 vaccine regimen jumped by over 50% in just 1 week, but there has been a slowdown in first vaccinations, according to data from the Centers for Disease Control and Prevention.

As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.

For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.

Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.

Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.

[email protected]

The proportion of children aged 12-15 years who have completed their COVID-19 vaccine regimen jumped by over 50% in just 1 week, but there has been a slowdown in first vaccinations, according to data from the Centers for Disease Control and Prevention.

As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.

For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.

Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.

Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.

[email protected]

The proportion of children aged 12-15 years who have completed their COVID-19 vaccine regimen jumped by over 50% in just 1 week, but there has been a slowdown in first vaccinations, according to data from the Centers for Disease Control and Prevention.

As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.

For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.

Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.

Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.

[email protected]

As pandemic restrictions ease and young athletes once again take to fields, courts, tracks, and rinks, doctors are sharing ways to help them get back to sports safely.

That means taking steps to prevent COVID-19.

It also means trying to avoid sports-related injuries, which may be more likely if young athletes didn’t move around so much during the pandemic.

For adolescents who are eligible, getting a COVID-19 vaccine may be the most important thing they can do, according to the American Academy of Pediatrics.

“The AAP encourages all people who are eligible to receive the COVID-19 vaccine as soon as it is available,” the organization wrote in updated guidance on returning to sports and physical activity.

“I don’t think it can be overemphasized how important these vaccines are, both for the individual and at the community level,” says Aaron L. Baggish, MD, an associate professor of medicine at Harvard Medical School, Boston, and director of the Cardiovascular Performance Program at Massachusetts General Hospital in Boston.

Dr. Baggish, team cardiologist for the New England Patriots, the Boston Bruins, the New England Revolution, U.S. Men’s and Women’s Soccer, and U.S. Rowing, as well as medical director for the Boston Marathon, has studied the effects of COVID-19 on the heart in college athletes and written return-to-play recommendations for athletes of high school age and older.

“Millions of people have received these vaccines from age 12 up,” Dr. Baggish says. “The efficacy continues to look very durable and near complete, and the risk associated with vaccination is incredibly low, to the point where the risk-benefit ratio across the age spectrum, whether you’re athletic or not, strongly favors getting vaccinated. There is really no reason to hold off at this point.”

While outdoor activities are lower-risk for spreading COVID-19 and many people have been vaccinated, masks still should be worn in certain settings, the AAP notes.

“Indoor spaces that are crowded are still high-risk for COVID-19 transmission. And we recognize that not everyone in these settings may be vaccinated,” says Susannah Briskin, MD, lead author of the AAP guidance.

“So for indoor sporting events with spectators, in locker rooms or other small spaces such as a training room, and during shared car rides or school transportation to and from events, individuals should continue to mask,” adds Dr. Briskin, a pediatrician in the Division of Sports Medicine and fellowship director for the Primary Care Sports Medicine program at University Hospitals Rainbow Babies & Children’s Hospital.

For outdoor sports, athletes who are not fully vaccinated should be encouraged to wear masks on the sidelines and during group training and competition when they are within 3 feet of others for sustained amounts of time, according to the AAP.
 

Get back into exercise gradually

In general, athletes who have not been active for more than a month should resume exercise gradually, Dr. Briskin says. Starting at 25% of normal volume and increasing slowly over time – with 10% increases each week – is one rule of thumb.

“Those who have taken a prolonged break from sports are at a higher risk of injury when they return,” she notes. “Families should also be aware of an increased risk for heat-related illness if they are not acclimated.”

Caitlyn Mooney, MD, a team doctor for the University of Texas, San Antonio, has heard reports of doctors seeing more injuries like stress fractures. Some cases may relate to people going from “months of doing nothing to all of a sudden going back to sports,” says Dr. Mooney, who is also a clinical assistant professor of pediatrics and orthopedics at UT Health San Antonio.

“The coaches, the parents, and the athletes themselves really need to keep in mind that it’s not like a regular season,” Dr. Mooney says. She suggests gradually ramping up activity and paying attention to any pain. “That’s a good indicator that maybe you’re going too fast,” she adds.

Athletes should be mindful of other symptoms too when restarting exercise, especially after illness.

It is “very important that any athlete with recent COVID-19 monitor for new symptoms when they return to exercise,” says Jonathan Drezner, MD, a professor of family medicine at the University of Washington, Seattle. “A little fatigue from detraining may be expected, but exertional chest pain deserves more evaluation.”

Dr. Drezner – editor-in-chief of the British Journal of Sports Medicine and team doctor for the Seattle Seahawks – along with Dr. Baggish and colleagues, found a low prevalence of cardiac involvement in a study of more than 3,000 college athletes with prior SARS-CoV-2 infection.

“Any athlete, despite their initial symptom course, who has cardiopulmonary symptoms on return to exercise, particularly chest pain, should see their physician for a comprehensive cardiac evaluation,” Dr. Drezner says. “Cardiac MRI should be reserved for athletes with abnormal testing or when clinical suspicion of myocardial involvement is high.”

If an athlete had COVID-19 with moderate symptoms (such as fever, chills, or a flu-like syndrome) or cardiopulmonary symptoms (such as chest pain or shortness of breath), cardiac testing should be considered, he notes.

These symptoms “were associated with a higher prevalence of cardiac involvement,” Dr. Drezner said in an email. “Testing may include an ECG, echocardiogram (ultrasound), and troponin (blood test).”

For kids who test positive for SARS-CoV-2 but do not have symptoms, or their symptoms last less than 4 days, a phone call or telemedicine visit with their doctor may be enough to clear them to play, says Dr. Briskin, who’s also an assistant professor of pediatrics at Case Western Reserve University, Cleveland.

“This will allow the physician an opportunity to screen for any concerning cardiac signs or symptoms, update the patient’s electronic medical record with the recent COVID-19 infection, and provide appropriate guidance back to exercise,” she adds.

Dr. Baggish, Dr. Briskin, Dr. Mooney, and Dr. Drezner had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

As pandemic restrictions ease and young athletes once again take to fields, courts, tracks, and rinks, doctors are sharing ways to help them get back to sports safely.

That means taking steps to prevent COVID-19.

It also means trying to avoid sports-related injuries, which may be more likely if young athletes didn’t move around so much during the pandemic.

For adolescents who are eligible, getting a COVID-19 vaccine may be the most important thing they can do, according to the American Academy of Pediatrics.

“The AAP encourages all people who are eligible to receive the COVID-19 vaccine as soon as it is available,” the organization wrote in updated guidance on returning to sports and physical activity.

“I don’t think it can be overemphasized how important these vaccines are, both for the individual and at the community level,” says Aaron L. Baggish, MD, an associate professor of medicine at Harvard Medical School, Boston, and director of the Cardiovascular Performance Program at Massachusetts General Hospital in Boston.

Dr. Baggish, team cardiologist for the New England Patriots, the Boston Bruins, the New England Revolution, U.S. Men’s and Women’s Soccer, and U.S. Rowing, as well as medical director for the Boston Marathon, has studied the effects of COVID-19 on the heart in college athletes and written return-to-play recommendations for athletes of high school age and older.

“Millions of people have received these vaccines from age 12 up,” Dr. Baggish says. “The efficacy continues to look very durable and near complete, and the risk associated with vaccination is incredibly low, to the point where the risk-benefit ratio across the age spectrum, whether you’re athletic or not, strongly favors getting vaccinated. There is really no reason to hold off at this point.”

While outdoor activities are lower-risk for spreading COVID-19 and many people have been vaccinated, masks still should be worn in certain settings, the AAP notes.

“Indoor spaces that are crowded are still high-risk for COVID-19 transmission. And we recognize that not everyone in these settings may be vaccinated,” says Susannah Briskin, MD, lead author of the AAP guidance.

“So for indoor sporting events with spectators, in locker rooms or other small spaces such as a training room, and during shared car rides or school transportation to and from events, individuals should continue to mask,” adds Dr. Briskin, a pediatrician in the Division of Sports Medicine and fellowship director for the Primary Care Sports Medicine program at University Hospitals Rainbow Babies & Children’s Hospital.

For outdoor sports, athletes who are not fully vaccinated should be encouraged to wear masks on the sidelines and during group training and competition when they are within 3 feet of others for sustained amounts of time, according to the AAP.
 

Get back into exercise gradually

In general, athletes who have not been active for more than a month should resume exercise gradually, Dr. Briskin says. Starting at 25% of normal volume and increasing slowly over time – with 10% increases each week – is one rule of thumb.

“Those who have taken a prolonged break from sports are at a higher risk of injury when they return,” she notes. “Families should also be aware of an increased risk for heat-related illness if they are not acclimated.”

Caitlyn Mooney, MD, a team doctor for the University of Texas, San Antonio, has heard reports of doctors seeing more injuries like stress fractures. Some cases may relate to people going from “months of doing nothing to all of a sudden going back to sports,” says Dr. Mooney, who is also a clinical assistant professor of pediatrics and orthopedics at UT Health San Antonio.

“The coaches, the parents, and the athletes themselves really need to keep in mind that it’s not like a regular season,” Dr. Mooney says. She suggests gradually ramping up activity and paying attention to any pain. “That’s a good indicator that maybe you’re going too fast,” she adds.

Athletes should be mindful of other symptoms too when restarting exercise, especially after illness.

It is “very important that any athlete with recent COVID-19 monitor for new symptoms when they return to exercise,” says Jonathan Drezner, MD, a professor of family medicine at the University of Washington, Seattle. “A little fatigue from detraining may be expected, but exertional chest pain deserves more evaluation.”

Dr. Drezner – editor-in-chief of the British Journal of Sports Medicine and team doctor for the Seattle Seahawks – along with Dr. Baggish and colleagues, found a low prevalence of cardiac involvement in a study of more than 3,000 college athletes with prior SARS-CoV-2 infection.

“Any athlete, despite their initial symptom course, who has cardiopulmonary symptoms on return to exercise, particularly chest pain, should see their physician for a comprehensive cardiac evaluation,” Dr. Drezner says. “Cardiac MRI should be reserved for athletes with abnormal testing or when clinical suspicion of myocardial involvement is high.”

If an athlete had COVID-19 with moderate symptoms (such as fever, chills, or a flu-like syndrome) or cardiopulmonary symptoms (such as chest pain or shortness of breath), cardiac testing should be considered, he notes.

These symptoms “were associated with a higher prevalence of cardiac involvement,” Dr. Drezner said in an email. “Testing may include an ECG, echocardiogram (ultrasound), and troponin (blood test).”

For kids who test positive for SARS-CoV-2 but do not have symptoms, or their symptoms last less than 4 days, a phone call or telemedicine visit with their doctor may be enough to clear them to play, says Dr. Briskin, who’s also an assistant professor of pediatrics at Case Western Reserve University, Cleveland.

“This will allow the physician an opportunity to screen for any concerning cardiac signs or symptoms, update the patient’s electronic medical record with the recent COVID-19 infection, and provide appropriate guidance back to exercise,” she adds.

Dr. Baggish, Dr. Briskin, Dr. Mooney, and Dr. Drezner had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

As pandemic restrictions ease and young athletes once again take to fields, courts, tracks, and rinks, doctors are sharing ways to help them get back to sports safely.

That means taking steps to prevent COVID-19.

It also means trying to avoid sports-related injuries, which may be more likely if young athletes didn’t move around so much during the pandemic.

For adolescents who are eligible, getting a COVID-19 vaccine may be the most important thing they can do, according to the American Academy of Pediatrics.

“The AAP encourages all people who are eligible to receive the COVID-19 vaccine as soon as it is available,” the organization wrote in updated guidance on returning to sports and physical activity.

“I don’t think it can be overemphasized how important these vaccines are, both for the individual and at the community level,” says Aaron L. Baggish, MD, an associate professor of medicine at Harvard Medical School, Boston, and director of the Cardiovascular Performance Program at Massachusetts General Hospital in Boston.

Dr. Baggish, team cardiologist for the New England Patriots, the Boston Bruins, the New England Revolution, U.S. Men’s and Women’s Soccer, and U.S. Rowing, as well as medical director for the Boston Marathon, has studied the effects of COVID-19 on the heart in college athletes and written return-to-play recommendations for athletes of high school age and older.

“Millions of people have received these vaccines from age 12 up,” Dr. Baggish says. “The efficacy continues to look very durable and near complete, and the risk associated with vaccination is incredibly low, to the point where the risk-benefit ratio across the age spectrum, whether you’re athletic or not, strongly favors getting vaccinated. There is really no reason to hold off at this point.”

While outdoor activities are lower-risk for spreading COVID-19 and many people have been vaccinated, masks still should be worn in certain settings, the AAP notes.

“Indoor spaces that are crowded are still high-risk for COVID-19 transmission. And we recognize that not everyone in these settings may be vaccinated,” says Susannah Briskin, MD, lead author of the AAP guidance.

“So for indoor sporting events with spectators, in locker rooms or other small spaces such as a training room, and during shared car rides or school transportation to and from events, individuals should continue to mask,” adds Dr. Briskin, a pediatrician in the Division of Sports Medicine and fellowship director for the Primary Care Sports Medicine program at University Hospitals Rainbow Babies & Children’s Hospital.

For outdoor sports, athletes who are not fully vaccinated should be encouraged to wear masks on the sidelines and during group training and competition when they are within 3 feet of others for sustained amounts of time, according to the AAP.
 

Get back into exercise gradually

In general, athletes who have not been active for more than a month should resume exercise gradually, Dr. Briskin says. Starting at 25% of normal volume and increasing slowly over time – with 10% increases each week – is one rule of thumb.

“Those who have taken a prolonged break from sports are at a higher risk of injury when they return,” she notes. “Families should also be aware of an increased risk for heat-related illness if they are not acclimated.”

Caitlyn Mooney, MD, a team doctor for the University of Texas, San Antonio, has heard reports of doctors seeing more injuries like stress fractures. Some cases may relate to people going from “months of doing nothing to all of a sudden going back to sports,” says Dr. Mooney, who is also a clinical assistant professor of pediatrics and orthopedics at UT Health San Antonio.

“The coaches, the parents, and the athletes themselves really need to keep in mind that it’s not like a regular season,” Dr. Mooney says. She suggests gradually ramping up activity and paying attention to any pain. “That’s a good indicator that maybe you’re going too fast,” she adds.

Athletes should be mindful of other symptoms too when restarting exercise, especially after illness.

It is “very important that any athlete with recent COVID-19 monitor for new symptoms when they return to exercise,” says Jonathan Drezner, MD, a professor of family medicine at the University of Washington, Seattle. “A little fatigue from detraining may be expected, but exertional chest pain deserves more evaluation.”

Dr. Drezner – editor-in-chief of the British Journal of Sports Medicine and team doctor for the Seattle Seahawks – along with Dr. Baggish and colleagues, found a low prevalence of cardiac involvement in a study of more than 3,000 college athletes with prior SARS-CoV-2 infection.

“Any athlete, despite their initial symptom course, who has cardiopulmonary symptoms on return to exercise, particularly chest pain, should see their physician for a comprehensive cardiac evaluation,” Dr. Drezner says. “Cardiac MRI should be reserved for athletes with abnormal testing or when clinical suspicion of myocardial involvement is high.”

If an athlete had COVID-19 with moderate symptoms (such as fever, chills, or a flu-like syndrome) or cardiopulmonary symptoms (such as chest pain or shortness of breath), cardiac testing should be considered, he notes.

These symptoms “were associated with a higher prevalence of cardiac involvement,” Dr. Drezner said in an email. “Testing may include an ECG, echocardiogram (ultrasound), and troponin (blood test).”

For kids who test positive for SARS-CoV-2 but do not have symptoms, or their symptoms last less than 4 days, a phone call or telemedicine visit with their doctor may be enough to clear them to play, says Dr. Briskin, who’s also an assistant professor of pediatrics at Case Western Reserve University, Cleveland.

“This will allow the physician an opportunity to screen for any concerning cardiac signs or symptoms, update the patient’s electronic medical record with the recent COVID-19 infection, and provide appropriate guidance back to exercise,” she adds.

Dr. Baggish, Dr. Briskin, Dr. Mooney, and Dr. Drezner had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.