ORLANDO – New research suggests it’s feasible for hospitals to use an automated closed-loop insulin delivery system – free of prandial boluses and carbohydrate counts – to improve glucose control in noncritical patients with type 2 diabetes mellitus (T2DM).

The findings, released at the annual scientific sessions of the American Diabetes Association and via simultaneous publication in The New England Journal of Medicine, don’t examine cost or clinical outcomes. However, “our results suggest this new technology might be another approach to manage in-patient hypoglycemia in a safe and effective way, lead author Lia Bally, MD, PhD, of the division of endocrinology, diabetes, and clinical nutrition, Bern (Switzerland ) University Hospital, said in an interview.

For the open-label trial, the researchers recruited 136 adults with T2DM under noncritical care at two hospitals (one in the England and the other in Switzerland). Some patients had undergone surgery, Dr. Bally said, and some others were being treated for systemic infections. Comorbidities were significantly more severe in the closed-loop group, and 43% had sepsis.

All of the subjects required subcutaneous insulin therapy.

From 2016 to 2017, patients were randomly assigned to receive normal subcutaneous insulin therapy (n = 70) or closed-loop insulin delivery (n = 66).

It took about 15 minutes to perform the procedure to implement the closed-loop insulin delivery system, Dr. Bally said. It featured a subcutaneous cannula inserted into the abdomen, a continuous glucose monitor (a device also used in the control group), and a trial insulin pump.

This was not a hybrid system, and it did not include prandial insulin boluses or input of the timing and carbohydrate content of meals. One reason behind the choice to adopt a fully automated system was to relieve the burden on both health care professionals and patients, coauthor Hood Thabit, PhD, of Wellcome Trust–MRC Institute of Metabolic Science, the Manchester Academic Health Science Center, and University of Manchester, said in an interview.

For up to 15 days or until discharge, researchers tracked how much of the time sensor glucose measurements were in a target range of 100 mg/dL to 180 mg/dL.

In the closed-loop group, glucose measurements were in the target range 66 mg/dL ± 17% of the time compared to 42 mg/dL ± 17% in the control group, a difference of 24 mg/dL ± 3% (95% confidence interval, 19-30; P less than .001).

For the closed-loop group, the average glucose level was 154 mg/dL, and it was 188 mg/dL in the control group (P less than .001).

The researchers didn’t find a statistically significant difference between the groups in duration of hypoglycemia or amount of insulin delivered.

None of the patients suffered from severe hypoglycemia or clinically significant hyperglycemia with ketonemia.

There were 18 incidents of clinically significant hyperglycemia events (capillary glucose levels of more than 360 mg/dL) in the closed-loop group, compared with 41 such events in the control group. (P = .03)

Three patients in each group had adverse trial-related device effects.

Of 62 patients in the closed-loop group who completed the trial, 87% reported being pleased by their glucose levels, and all but one reported being happy to have their levels monitored automatically. All 62 patients said they’d recommend the system to others.

Going forward, the researchers hope to launch a multicenter trial that will examine clinical outcomes such as postoperative complications, infections, mortality, and glucose control after hospital discharge, according to Dr. Bally.

The study was supported by Diabetes UK, the Swiss National Science Foundation, the European Foundation for the Study of Diabetes, the JDRF, the National Institute for Health Research Cambridge Biomedical Research Center, and a Wellcome Strategic Award. Abbott Diabetes Care supplied equipment and guidance regarding connectivity, and representatives reviewed the manuscript before submission.

Dr. Bally reported funding from the University Hospital Bern, University of Bern and the Swiss Diabetes Foundation. Dr. Thabit reported no disclosures. Other authors report no disclosures or various disclosures.

SOURCE: Bally L et al. ADA 2018 Abstract 350-OR. Published simultaneously in The New England Journal of Medicine. June 25, 2018

ORLANDO – New research suggests it’s feasible for hospitals to use an automated closed-loop insulin delivery system – free of prandial boluses and carbohydrate counts – to improve glucose control in noncritical patients with type 2 diabetes mellitus (T2DM).

The findings, released at the annual scientific sessions of the American Diabetes Association and via simultaneous publication in The New England Journal of Medicine, don’t examine cost or clinical outcomes. However, “our results suggest this new technology might be another approach to manage in-patient hypoglycemia in a safe and effective way, lead author Lia Bally, MD, PhD, of the division of endocrinology, diabetes, and clinical nutrition, Bern (Switzerland ) University Hospital, said in an interview.

For the open-label trial, the researchers recruited 136 adults with T2DM under noncritical care at two hospitals (one in the England and the other in Switzerland). Some patients had undergone surgery, Dr. Bally said, and some others were being treated for systemic infections. Comorbidities were significantly more severe in the closed-loop group, and 43% had sepsis.

All of the subjects required subcutaneous insulin therapy.

From 2016 to 2017, patients were randomly assigned to receive normal subcutaneous insulin therapy (n = 70) or closed-loop insulin delivery (n = 66).

It took about 15 minutes to perform the procedure to implement the closed-loop insulin delivery system, Dr. Bally said. It featured a subcutaneous cannula inserted into the abdomen, a continuous glucose monitor (a device also used in the control group), and a trial insulin pump.

This was not a hybrid system, and it did not include prandial insulin boluses or input of the timing and carbohydrate content of meals. One reason behind the choice to adopt a fully automated system was to relieve the burden on both health care professionals and patients, coauthor Hood Thabit, PhD, of Wellcome Trust–MRC Institute of Metabolic Science, the Manchester Academic Health Science Center, and University of Manchester, said in an interview.

For up to 15 days or until discharge, researchers tracked how much of the time sensor glucose measurements were in a target range of 100 mg/dL to 180 mg/dL.

In the closed-loop group, glucose measurements were in the target range 66 mg/dL ± 17% of the time compared to 42 mg/dL ± 17% in the control group, a difference of 24 mg/dL ± 3% (95% confidence interval, 19-30; P less than .001).

For the closed-loop group, the average glucose level was 154 mg/dL, and it was 188 mg/dL in the control group (P less than .001).

The researchers didn’t find a statistically significant difference between the groups in duration of hypoglycemia or amount of insulin delivered.

None of the patients suffered from severe hypoglycemia or clinically significant hyperglycemia with ketonemia.

There were 18 incidents of clinically significant hyperglycemia events (capillary glucose levels of more than 360 mg/dL) in the closed-loop group, compared with 41 such events in the control group. (P = .03)

Three patients in each group had adverse trial-related device effects.

Of 62 patients in the closed-loop group who completed the trial, 87% reported being pleased by their glucose levels, and all but one reported being happy to have their levels monitored automatically. All 62 patients said they’d recommend the system to others.

Going forward, the researchers hope to launch a multicenter trial that will examine clinical outcomes such as postoperative complications, infections, mortality, and glucose control after hospital discharge, according to Dr. Bally.

The study was supported by Diabetes UK, the Swiss National Science Foundation, the European Foundation for the Study of Diabetes, the JDRF, the National Institute for Health Research Cambridge Biomedical Research Center, and a Wellcome Strategic Award. Abbott Diabetes Care supplied equipment and guidance regarding connectivity, and representatives reviewed the manuscript before submission.

Dr. Bally reported funding from the University Hospital Bern, University of Bern and the Swiss Diabetes Foundation. Dr. Thabit reported no disclosures. Other authors report no disclosures or various disclosures.

SOURCE: Bally L et al. ADA 2018 Abstract 350-OR. Published simultaneously in The New England Journal of Medicine. June 25, 2018

ORLANDO – New research suggests it’s feasible for hospitals to use an automated closed-loop insulin delivery system – free of prandial boluses and carbohydrate counts – to improve glucose control in noncritical patients with type 2 diabetes mellitus (T2DM).

The findings, released at the annual scientific sessions of the American Diabetes Association and via simultaneous publication in The New England Journal of Medicine, don’t examine cost or clinical outcomes. However, “our results suggest this new technology might be another approach to manage in-patient hypoglycemia in a safe and effective way, lead author Lia Bally, MD, PhD, of the division of endocrinology, diabetes, and clinical nutrition, Bern (Switzerland ) University Hospital, said in an interview.

For the open-label trial, the researchers recruited 136 adults with T2DM under noncritical care at two hospitals (one in the England and the other in Switzerland). Some patients had undergone surgery, Dr. Bally said, and some others were being treated for systemic infections. Comorbidities were significantly more severe in the closed-loop group, and 43% had sepsis.

All of the subjects required subcutaneous insulin therapy.

From 2016 to 2017, patients were randomly assigned to receive normal subcutaneous insulin therapy (n = 70) or closed-loop insulin delivery (n = 66).

It took about 15 minutes to perform the procedure to implement the closed-loop insulin delivery system, Dr. Bally said. It featured a subcutaneous cannula inserted into the abdomen, a continuous glucose monitor (a device also used in the control group), and a trial insulin pump.

This was not a hybrid system, and it did not include prandial insulin boluses or input of the timing and carbohydrate content of meals. One reason behind the choice to adopt a fully automated system was to relieve the burden on both health care professionals and patients, coauthor Hood Thabit, PhD, of Wellcome Trust–MRC Institute of Metabolic Science, the Manchester Academic Health Science Center, and University of Manchester, said in an interview.

For up to 15 days or until discharge, researchers tracked how much of the time sensor glucose measurements were in a target range of 100 mg/dL to 180 mg/dL.

In the closed-loop group, glucose measurements were in the target range 66 mg/dL ± 17% of the time compared to 42 mg/dL ± 17% in the control group, a difference of 24 mg/dL ± 3% (95% confidence interval, 19-30; P less than .001).

For the closed-loop group, the average glucose level was 154 mg/dL, and it was 188 mg/dL in the control group (P less than .001).

The researchers didn’t find a statistically significant difference between the groups in duration of hypoglycemia or amount of insulin delivered.

None of the patients suffered from severe hypoglycemia or clinically significant hyperglycemia with ketonemia.

There were 18 incidents of clinically significant hyperglycemia events (capillary glucose levels of more than 360 mg/dL) in the closed-loop group, compared with 41 such events in the control group. (P = .03)

Three patients in each group had adverse trial-related device effects.

Of 62 patients in the closed-loop group who completed the trial, 87% reported being pleased by their glucose levels, and all but one reported being happy to have their levels monitored automatically. All 62 patients said they’d recommend the system to others.

Going forward, the researchers hope to launch a multicenter trial that will examine clinical outcomes such as postoperative complications, infections, mortality, and glucose control after hospital discharge, according to Dr. Bally.

The study was supported by Diabetes UK, the Swiss National Science Foundation, the European Foundation for the Study of Diabetes, the JDRF, the National Institute for Health Research Cambridge Biomedical Research Center, and a Wellcome Strategic Award. Abbott Diabetes Care supplied equipment and guidance regarding connectivity, and representatives reviewed the manuscript before submission.

Dr. Bally reported funding from the University Hospital Bern, University of Bern and the Swiss Diabetes Foundation. Dr. Thabit reported no disclosures. Other authors report no disclosures or various disclosures.

SOURCE: Bally L et al. ADA 2018 Abstract 350-OR. Published simultaneously in The New England Journal of Medicine. June 25, 2018

ORLANDO – Liana K. Billings, MD, an endocrinologist at the University of Chicago and the NorthShore University HealthSystem in Skokie, Ill., loves the thrill of letting patients know they have a rare kind of diabetes. “Once you do this once, you don’t want to stop,” she told colleagues in a presentation at the annual scientific sessions of the American Diabetes Association. “I hope you all have the experience of diagnosing someone with MODY. It’s phenomenal.”

Yes, it’s true: There’s a diabetes diagnosis that spawns good feelings like delight and relief. The cause for celebration is a condition known as monogenetic diabetes, also known as maturity-onset diabetes of the young (MODY) if it develops after the neonatal period.

“The reason that getting a diagnosis of MODY can be a ‘good’ diagnosis is because the three most common forms of MODY have gene-specific treatments that typically improve patients’ glycemic control and are less onerous than the treatments patients were previously receiving when they were thought to have type 1 or type 2 diabetes,” explained Miriam S. Udler, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, Boston, in an interview.

Dr. Udler and Dr. Billings spoke to colleagues about monogenetic diabetes in their presentation at the ADA meeting.

Research has suggested that 1%-4% of people with diabetes have the monogenetic form, in which the condition is caused by changes in a single gene. A 2017 British study of 1,407 patients with diabetes reported that “the minimum prevalence of monogenic diabetes is 3.6% of patients diagnosed at age 30 years or younger.”

The study, which tested a screening regimen, also turned up 17 new diagnoses of monogenetic diabetes among the 1,407 patients, doubling the total. The findings reflect an apparent fact about monogenetic diabetes: Physicians often don’t look for it, even though a diagnosis can be a godsend – especially for those who were previously diagnosed with type 1 or type 2 and placed on treatment regimens that are unnecessary at best and harmful at worst. (Diabetes Care. 2017 Aug;40[8]: 1017-25)

Patients with the MODY variant in the GCK gene, for example, “can generally stop all medications because they are not at risk for clinically significant complications of diabetes,” Dr. Udler said. “Patients with HNF1A and HNF4A variants can often be switched from insulin injections to ... a sulfonylurea, which is easier to take than insulin injections, and patients generally have better glycemic control after switching to pills.”

Unfortunately for doctors and patients, it can be complicated and costly to test for monogenetic diabetes. But screening tools are available to help physicians make choices about whether to launch testing in the first place, according to Dr. Udler and Dr. Billings.

There are two forms of monogenetic diabetes – neonatal diabetes, which is diagnosed by age 6-9 months, and MODY, which is typically diagnosed in those aged between 10 and 25 years, noted Dr. Billings.

Reasons to suspect MODY include early onset of diabetes (under 35 years), a family history of diabetes, a lack of obesity, and negative islet-cell antibodies, she said.

Obese patients may also have the condition: A 2017 American study of 488 overweight and obese children and adolescents diagnosed with type 2 diabetes found that 4.5% actually had monogenetic diabetes. (Genet Med. 2018 Jun;20[6]:583-90).

Once a physician suspects MODY, physicians may consult the University of Exeter’s risk calculator. It provides guidance about whether a test is a good idea. Dr. Billings cautioned, however, that the value of a calculator’s estimate of risk is not all-encompassing. “You should never use the calculator by itself as a reason to not pursue your intuition,” she said.

Dr. Udler noted that the University of Exeter calculator has important limitations, such as its reliance on specific genes, its lack of consideration of family history outside of parents, and its reliance on the experiences of white European patients.

As for tests, the University of Chicago and the University of Exeter both offer free genetic testing for neonatal diabetes, Dr. Billings said in her presentation.

Monogenetic diabetes tests in older children and adults are not free. However, Dr. Udler said the tests are often covered by insurance companies whether done for one or more genes.

At least one company offers a direct-to-consumer monogenetic diabetes test, according to Dr. Udler, but she recommended against it, especially in light of a curious online notice that says the test isn’t intended to be diagnostic. “I’m not sure what this would be useful for then,” she said.

For her part, Dr. Billings cautioned that test results may be inconclusive, and tests may offer different answers. She also recommended referring patients to genetic counseling.

Dr. Udler reported a board member/advisory panel relationship with Encompass Bioscience. Dr. Billings reported relationships with Novo Nordisk, Sanofi, and Dexcom.
 

ORLANDO – Liana K. Billings, MD, an endocrinologist at the University of Chicago and the NorthShore University HealthSystem in Skokie, Ill., loves the thrill of letting patients know they have a rare kind of diabetes. “Once you do this once, you don’t want to stop,” she told colleagues in a presentation at the annual scientific sessions of the American Diabetes Association. “I hope you all have the experience of diagnosing someone with MODY. It’s phenomenal.”

Yes, it’s true: There’s a diabetes diagnosis that spawns good feelings like delight and relief. The cause for celebration is a condition known as monogenetic diabetes, also known as maturity-onset diabetes of the young (MODY) if it develops after the neonatal period.

“The reason that getting a diagnosis of MODY can be a ‘good’ diagnosis is because the three most common forms of MODY have gene-specific treatments that typically improve patients’ glycemic control and are less onerous than the treatments patients were previously receiving when they were thought to have type 1 or type 2 diabetes,” explained Miriam S. Udler, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, Boston, in an interview.

Dr. Udler and Dr. Billings spoke to colleagues about monogenetic diabetes in their presentation at the ADA meeting.

Research has suggested that 1%-4% of people with diabetes have the monogenetic form, in which the condition is caused by changes in a single gene. A 2017 British study of 1,407 patients with diabetes reported that “the minimum prevalence of monogenic diabetes is 3.6% of patients diagnosed at age 30 years or younger.”

The study, which tested a screening regimen, also turned up 17 new diagnoses of monogenetic diabetes among the 1,407 patients, doubling the total. The findings reflect an apparent fact about monogenetic diabetes: Physicians often don’t look for it, even though a diagnosis can be a godsend – especially for those who were previously diagnosed with type 1 or type 2 and placed on treatment regimens that are unnecessary at best and harmful at worst. (Diabetes Care. 2017 Aug;40[8]: 1017-25)

Patients with the MODY variant in the GCK gene, for example, “can generally stop all medications because they are not at risk for clinically significant complications of diabetes,” Dr. Udler said. “Patients with HNF1A and HNF4A variants can often be switched from insulin injections to ... a sulfonylurea, which is easier to take than insulin injections, and patients generally have better glycemic control after switching to pills.”

Unfortunately for doctors and patients, it can be complicated and costly to test for monogenetic diabetes. But screening tools are available to help physicians make choices about whether to launch testing in the first place, according to Dr. Udler and Dr. Billings.

There are two forms of monogenetic diabetes – neonatal diabetes, which is diagnosed by age 6-9 months, and MODY, which is typically diagnosed in those aged between 10 and 25 years, noted Dr. Billings.

Reasons to suspect MODY include early onset of diabetes (under 35 years), a family history of diabetes, a lack of obesity, and negative islet-cell antibodies, she said.

Obese patients may also have the condition: A 2017 American study of 488 overweight and obese children and adolescents diagnosed with type 2 diabetes found that 4.5% actually had monogenetic diabetes. (Genet Med. 2018 Jun;20[6]:583-90).

Once a physician suspects MODY, physicians may consult the University of Exeter’s risk calculator. It provides guidance about whether a test is a good idea. Dr. Billings cautioned, however, that the value of a calculator’s estimate of risk is not all-encompassing. “You should never use the calculator by itself as a reason to not pursue your intuition,” she said.

Dr. Udler noted that the University of Exeter calculator has important limitations, such as its reliance on specific genes, its lack of consideration of family history outside of parents, and its reliance on the experiences of white European patients.

As for tests, the University of Chicago and the University of Exeter both offer free genetic testing for neonatal diabetes, Dr. Billings said in her presentation.

Monogenetic diabetes tests in older children and adults are not free. However, Dr. Udler said the tests are often covered by insurance companies whether done for one or more genes.

At least one company offers a direct-to-consumer monogenetic diabetes test, according to Dr. Udler, but she recommended against it, especially in light of a curious online notice that says the test isn’t intended to be diagnostic. “I’m not sure what this would be useful for then,” she said.

For her part, Dr. Billings cautioned that test results may be inconclusive, and tests may offer different answers. She also recommended referring patients to genetic counseling.

Dr. Udler reported a board member/advisory panel relationship with Encompass Bioscience. Dr. Billings reported relationships with Novo Nordisk, Sanofi, and Dexcom.
 

ORLANDO – Liana K. Billings, MD, an endocrinologist at the University of Chicago and the NorthShore University HealthSystem in Skokie, Ill., loves the thrill of letting patients know they have a rare kind of diabetes. “Once you do this once, you don’t want to stop,” she told colleagues in a presentation at the annual scientific sessions of the American Diabetes Association. “I hope you all have the experience of diagnosing someone with MODY. It’s phenomenal.”

Yes, it’s true: There’s a diabetes diagnosis that spawns good feelings like delight and relief. The cause for celebration is a condition known as monogenetic diabetes, also known as maturity-onset diabetes of the young (MODY) if it develops after the neonatal period.

“The reason that getting a diagnosis of MODY can be a ‘good’ diagnosis is because the three most common forms of MODY have gene-specific treatments that typically improve patients’ glycemic control and are less onerous than the treatments patients were previously receiving when they were thought to have type 1 or type 2 diabetes,” explained Miriam S. Udler, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, Boston, in an interview.

Dr. Udler and Dr. Billings spoke to colleagues about monogenetic diabetes in their presentation at the ADA meeting.

Research has suggested that 1%-4% of people with diabetes have the monogenetic form, in which the condition is caused by changes in a single gene. A 2017 British study of 1,407 patients with diabetes reported that “the minimum prevalence of monogenic diabetes is 3.6% of patients diagnosed at age 30 years or younger.”

The study, which tested a screening regimen, also turned up 17 new diagnoses of monogenetic diabetes among the 1,407 patients, doubling the total. The findings reflect an apparent fact about monogenetic diabetes: Physicians often don’t look for it, even though a diagnosis can be a godsend – especially for those who were previously diagnosed with type 1 or type 2 and placed on treatment regimens that are unnecessary at best and harmful at worst. (Diabetes Care. 2017 Aug;40[8]: 1017-25)

Patients with the MODY variant in the GCK gene, for example, “can generally stop all medications because they are not at risk for clinically significant complications of diabetes,” Dr. Udler said. “Patients with HNF1A and HNF4A variants can often be switched from insulin injections to ... a sulfonylurea, which is easier to take than insulin injections, and patients generally have better glycemic control after switching to pills.”

Unfortunately for doctors and patients, it can be complicated and costly to test for monogenetic diabetes. But screening tools are available to help physicians make choices about whether to launch testing in the first place, according to Dr. Udler and Dr. Billings.

There are two forms of monogenetic diabetes – neonatal diabetes, which is diagnosed by age 6-9 months, and MODY, which is typically diagnosed in those aged between 10 and 25 years, noted Dr. Billings.

Reasons to suspect MODY include early onset of diabetes (under 35 years), a family history of diabetes, a lack of obesity, and negative islet-cell antibodies, she said.

Obese patients may also have the condition: A 2017 American study of 488 overweight and obese children and adolescents diagnosed with type 2 diabetes found that 4.5% actually had monogenetic diabetes. (Genet Med. 2018 Jun;20[6]:583-90).

Once a physician suspects MODY, physicians may consult the University of Exeter’s risk calculator. It provides guidance about whether a test is a good idea. Dr. Billings cautioned, however, that the value of a calculator’s estimate of risk is not all-encompassing. “You should never use the calculator by itself as a reason to not pursue your intuition,” she said.

Dr. Udler noted that the University of Exeter calculator has important limitations, such as its reliance on specific genes, its lack of consideration of family history outside of parents, and its reliance on the experiences of white European patients.

As for tests, the University of Chicago and the University of Exeter both offer free genetic testing for neonatal diabetes, Dr. Billings said in her presentation.

Monogenetic diabetes tests in older children and adults are not free. However, Dr. Udler said the tests are often covered by insurance companies whether done for one or more genes.

At least one company offers a direct-to-consumer monogenetic diabetes test, according to Dr. Udler, but she recommended against it, especially in light of a curious online notice that says the test isn’t intended to be diagnostic. “I’m not sure what this would be useful for then,” she said.

For her part, Dr. Billings cautioned that test results may be inconclusive, and tests may offer different answers. She also recommended referring patients to genetic counseling.

Dr. Udler reported a board member/advisory panel relationship with Encompass Bioscience. Dr. Billings reported relationships with Novo Nordisk, Sanofi, and Dexcom.
 

As a physician you are the embodiment of delayed gratification. You spent more than 20 years in school before you earned a degree that then allowed you spend another 3-plus years in training before anyone would consider you a “real” doctor. Somewhere along that long and shallow trajectory someone may have said, “You must have done really well on the marshmallow test.”

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

As a physician you are the embodiment of delayed gratification. You spent more than 20 years in school before you earned a degree that then allowed you spend another 3-plus years in training before anyone would consider you a “real” doctor. Somewhere along that long and shallow trajectory someone may have said, “You must have done really well on the marshmallow test.”

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

As a physician you are the embodiment of delayed gratification. You spent more than 20 years in school before you earned a degree that then allowed you spend another 3-plus years in training before anyone would consider you a “real” doctor. Somewhere along that long and shallow trajectory someone may have said, “You must have done really well on the marshmallow test.”

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

The number of births in the United States has fallen for the second year in a row. Births in 2017 were down 2% from 2016, bringing the birth rate to a 30-year low at 60 births per 1,000 women aged 15-44 years. This decline spanned nearly all maternal age groups, including teenagers (Hamilton et al. NVSS Vital Statistics Rapid Release Report No 004, May 2018).

In the crudest terms, babies represent the raw material of pediatrics. Without children, we pediatricians would have to begin treating those whining adults. Most of us chose pediatrics because we enjoy being around children, and many of us were motivated to study medicine by a desire to help sick children. Is this decline in the supply stream of patients something we should be worrying about?

gpointstudio/Thinkstock

AleksandarNakic/E+/Getty Images

You can worry about job security if you like, but in a quirky kind of way pediatrics is following along its own rules of supply and demand. And, you should rest easy ... that is until the next panicked call from a parent wakes you in the middle of the night.


 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

The number of births in the United States has fallen for the second year in a row. Births in 2017 were down 2% from 2016, bringing the birth rate to a 30-year low at 60 births per 1,000 women aged 15-44 years. This decline spanned nearly all maternal age groups, including teenagers (Hamilton et al. NVSS Vital Statistics Rapid Release Report No 004, May 2018).

In the crudest terms, babies represent the raw material of pediatrics. Without children, we pediatricians would have to begin treating those whining adults. Most of us chose pediatrics because we enjoy being around children, and many of us were motivated to study medicine by a desire to help sick children. Is this decline in the supply stream of patients something we should be worrying about?

gpointstudio/Thinkstock

AleksandarNakic/E+/Getty Images

You can worry about job security if you like, but in a quirky kind of way pediatrics is following along its own rules of supply and demand. And, you should rest easy ... that is until the next panicked call from a parent wakes you in the middle of the night.


 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

The number of births in the United States has fallen for the second year in a row. Births in 2017 were down 2% from 2016, bringing the birth rate to a 30-year low at 60 births per 1,000 women aged 15-44 years. This decline spanned nearly all maternal age groups, including teenagers (Hamilton et al. NVSS Vital Statistics Rapid Release Report No 004, May 2018).

In the crudest terms, babies represent the raw material of pediatrics. Without children, we pediatricians would have to begin treating those whining adults. Most of us chose pediatrics because we enjoy being around children, and many of us were motivated to study medicine by a desire to help sick children. Is this decline in the supply stream of patients something we should be worrying about?

gpointstudio/Thinkstock

AleksandarNakic/E+/Getty Images

You can worry about job security if you like, but in a quirky kind of way pediatrics is following along its own rules of supply and demand. And, you should rest easy ... that is until the next panicked call from a parent wakes you in the middle of the night.


 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

Since the Food and Drug Administration first approved checkpoint blockade immunotherapy (CBI) and BRAF^V600-targeted therapy in 2011, survival times for patients with melanoma brain metastases (MBMs) have significantly improved, with a 91% increase in 4-year overall survival (OS) from 7.4% to 14.1%.

“The management of advanced melanoma has traditionally been tempered by limited responses to conventional therapies, resulting in a median overall survival (OS) of less than 1 year,” wrote J. Bryan Iorgulescu, MD, of Brigham and Women’s Hospital in Boston, and his colleagues. The report was published in Cancer Immunology Research. “The landscape of advanced melanoma treatment was revolutionized” by the approval of immunotherapy agents, beginning in 2011.

The current, retrospective study involved 2,753 patients with stage IV melanoma. Patient data were drawn from the National Cancer Database, with diagnoses made between 2010 and 2015. Patient management, overall survival, and disease characteristics were evaluated.

During initial review, the researchers found that 35.8% of patients with stage IV melanoma had brain involvement. These patients were further categorized by those with MBM only (39.7%) versus those with extracranial metastatic disease (60.3%), which included involvement of lung (82.9%), liver (8.1%), bone (6.0%), and lymph nodes or distant subcutaneous skin (3%). MBM-only disease was independently predicted by both younger age and geographic location.

Patients receiving first-line CBI therapy demonstrated improved 4-year OS (28.1% vs. 11.1%; P less than.001) and median OS (12.4 months vs. 5.2 months; P less than .001).

Improvements with CBI were most dramatic in patients with MBM-only disease. In these cases, 4-year OS improved from 16.9% to 51.5% (P less than .001), while median OS jumped from 7.7 months to 56.4 months (P less than .001).

Improved OS was also associated with fewer comorbidities, younger age, management at an academic cancer center, single-fraction stereotactic radiosurgery, and resection of the MBM.

“Our findings help bridge the gaps in early clinical trials of CBIs that largely excluded stage IV melanoma patients with MBMs, with checkpoint immunotherapy demonstrating a more than doubling of the median and 4-year OS of MBMs,” the authors concluded.

SOURCE: Iorgulescu et al. Cancer Immunol Res. 2018 July 12 doi: 10.1158/2326-6066.CIR-18-0067.

Since the Food and Drug Administration first approved checkpoint blockade immunotherapy (CBI) and BRAF^V600-targeted therapy in 2011, survival times for patients with melanoma brain metastases (MBMs) have significantly improved, with a 91% increase in 4-year overall survival (OS) from 7.4% to 14.1%.

“The management of advanced melanoma has traditionally been tempered by limited responses to conventional therapies, resulting in a median overall survival (OS) of less than 1 year,” wrote J. Bryan Iorgulescu, MD, of Brigham and Women’s Hospital in Boston, and his colleagues. The report was published in Cancer Immunology Research. “The landscape of advanced melanoma treatment was revolutionized” by the approval of immunotherapy agents, beginning in 2011.

The current, retrospective study involved 2,753 patients with stage IV melanoma. Patient data were drawn from the National Cancer Database, with diagnoses made between 2010 and 2015. Patient management, overall survival, and disease characteristics were evaluated.

During initial review, the researchers found that 35.8% of patients with stage IV melanoma had brain involvement. These patients were further categorized by those with MBM only (39.7%) versus those with extracranial metastatic disease (60.3%), which included involvement of lung (82.9%), liver (8.1%), bone (6.0%), and lymph nodes or distant subcutaneous skin (3%). MBM-only disease was independently predicted by both younger age and geographic location.

Patients receiving first-line CBI therapy demonstrated improved 4-year OS (28.1% vs. 11.1%; P less than.001) and median OS (12.4 months vs. 5.2 months; P less than .001).

Improvements with CBI were most dramatic in patients with MBM-only disease. In these cases, 4-year OS improved from 16.9% to 51.5% (P less than .001), while median OS jumped from 7.7 months to 56.4 months (P less than .001).

Improved OS was also associated with fewer comorbidities, younger age, management at an academic cancer center, single-fraction stereotactic radiosurgery, and resection of the MBM.

“Our findings help bridge the gaps in early clinical trials of CBIs that largely excluded stage IV melanoma patients with MBMs, with checkpoint immunotherapy demonstrating a more than doubling of the median and 4-year OS of MBMs,” the authors concluded.

SOURCE: Iorgulescu et al. Cancer Immunol Res. 2018 July 12 doi: 10.1158/2326-6066.CIR-18-0067.

Since the Food and Drug Administration first approved checkpoint blockade immunotherapy (CBI) and BRAF^V600-targeted therapy in 2011, survival times for patients with melanoma brain metastases (MBMs) have significantly improved, with a 91% increase in 4-year overall survival (OS) from 7.4% to 14.1%.

“The management of advanced melanoma has traditionally been tempered by limited responses to conventional therapies, resulting in a median overall survival (OS) of less than 1 year,” wrote J. Bryan Iorgulescu, MD, of Brigham and Women’s Hospital in Boston, and his colleagues. The report was published in Cancer Immunology Research. “The landscape of advanced melanoma treatment was revolutionized” by the approval of immunotherapy agents, beginning in 2011.

The current, retrospective study involved 2,753 patients with stage IV melanoma. Patient data were drawn from the National Cancer Database, with diagnoses made between 2010 and 2015. Patient management, overall survival, and disease characteristics were evaluated.

During initial review, the researchers found that 35.8% of patients with stage IV melanoma had brain involvement. These patients were further categorized by those with MBM only (39.7%) versus those with extracranial metastatic disease (60.3%), which included involvement of lung (82.9%), liver (8.1%), bone (6.0%), and lymph nodes or distant subcutaneous skin (3%). MBM-only disease was independently predicted by both younger age and geographic location.

Patients receiving first-line CBI therapy demonstrated improved 4-year OS (28.1% vs. 11.1%; P less than.001) and median OS (12.4 months vs. 5.2 months; P less than .001).

Improvements with CBI were most dramatic in patients with MBM-only disease. In these cases, 4-year OS improved from 16.9% to 51.5% (P less than .001), while median OS jumped from 7.7 months to 56.4 months (P less than .001).

Improved OS was also associated with fewer comorbidities, younger age, management at an academic cancer center, single-fraction stereotactic radiosurgery, and resection of the MBM.

“Our findings help bridge the gaps in early clinical trials of CBIs that largely excluded stage IV melanoma patients with MBMs, with checkpoint immunotherapy demonstrating a more than doubling of the median and 4-year OS of MBMs,” the authors concluded.

SOURCE: Iorgulescu et al. Cancer Immunol Res. 2018 July 12 doi: 10.1158/2326-6066.CIR-18-0067.

Depression screening among U.S. adults was 1.4% for the period from 2005 to 2015 despite a 2009 recommendation for routine screening from the U.S. Preventive Services Task Force, data from a cross-sectional study show.

FilmColoratStudio/iStock/Getty Images

SOURCE: Bhattacharjee S et al. Psychiatr Serv. 2018 Jul 9. doi: 10.1176/appi.ps.201700439.

Depression screening among U.S. adults was 1.4% for the period from 2005 to 2015 despite a 2009 recommendation for routine screening from the U.S. Preventive Services Task Force, data from a cross-sectional study show.

FilmColoratStudio/iStock/Getty Images

SOURCE: Bhattacharjee S et al. Psychiatr Serv. 2018 Jul 9. doi: 10.1176/appi.ps.201700439.

Depression screening among U.S. adults was 1.4% for the period from 2005 to 2015 despite a 2009 recommendation for routine screening from the U.S. Preventive Services Task Force, data from a cross-sectional study show.

FilmColoratStudio/iStock/Getty Images

SOURCE: Bhattacharjee S et al. Psychiatr Serv. 2018 Jul 9. doi: 10.1176/appi.ps.201700439.

Ado-trastuzumab emtansine (T-DM1) has met a predefined efficacy endpoint in what investigators say is the first positive clinical trial in patients with advanced HER2-mutant lung cancers.

The HER2-targeted therapy produced a 44% overall response rate among 18 patients enrolled in the phase 2, investigator-initiated basket trial reported in the Journal of Clinical Oncology.

The median progression-free survival (PFS) was 5 months in this heavily pretreated group of patients, according to first author Bob T. Li, MD, of Memorial Sloan Kettering Cancer Center, New York, and his coauthors.

“This is important therapeutic progress in the context of more than a decade of negative clinical trials targeting HER2 in lung cancer,” the researchers wrote.

The patients (median age, 64 years; 72% female) had metastatic lung adenocarcinomas treated in 2016 at Memorial Sloan Kettering Cancer Center. All patients had HER2-activating mutations identified by next-generation sequencing. They had received a median of two lines of prior therapy. Three of the 18 patients were treatment naive. Prior HER2-targeted therapy, including trastuzumab, was allowed.

All patients received intravenous infusions of T-DM1 at 3.6 mg/kg every 21 days until progression of disease or unacceptable toxicity.

Confirmed partial responses were seen in 8 patients (44%), while an additional 7 (39%) had stable disease, Dr. Li and his coauthors reported. Median PFS was 5 months overall and 6 months for responders, with the longest observed PFS being more than 11 months.

The treatment was well tolerated, with treatment-related adverse events mainly consisting of grade 1-2 infusion reactions, elevation of hepatic transaminases, and thrombocytopenia.

The rate of infusion reactions was higher than what was expected based on the experience with T-DM1 in breast cancer, though these reactions were generally mild and did not require discontinuation of the drug, which is approved for the treatment of HER2-amplified or –overexpressing metastatic breast cancer.

These findings have important implication for drug development in HER-2 mutant lung cancers, particularly as next-generation sequencing becomes more commonly used for initial tumor evaluation, Dr. Li and his coauthors noted.

“Just as the discovery of EGFR mutations eventually led to a plethora of approved oncogene-targeted therapies transforming the care of patients around the world, HER2-activating mutations similarly show promise as a therapeutic target,” they wrote.

Disappointing results were seen in previous studies looking at trastuzumab in lung cancer patients, and in those trials, patients were selected on the basis of HER2 protein expression by immunohistochemistry (IHC). “More recent studies have again confirmed that HER2 IHC is not the ideal biomarker in lung cancers,” the researchers wrote.

The 18-patient cohort in this study was part of a larger, investigator-initiated basket trial. Cohorts not reported at this time involved patients with other HER2-amplified solid tumors, including bladder.

The study was supported by the Conquer Cancer Foundation, Genentech, and a grant from the National Institutes of Health.

Dr. Li reported disclosures related to Roche, Biosceptre International, Thermo Fisher Scientific, Mersana, Guardant Health, Genentech, Illumina, BioMed Valley Discoveries, AstraZeneca, and GRAIL. Several co-authors reported disclosures, including employment, with NantOmics, a developer of molecular profiling tools.

SOURCE: Li BT et al. J Clin Oncol. 2018 July 10. doi: 10.1200/JCO.2018.77.9777.

Ado-trastuzumab emtansine (T-DM1) has met a predefined efficacy endpoint in what investigators say is the first positive clinical trial in patients with advanced HER2-mutant lung cancers.

The HER2-targeted therapy produced a 44% overall response rate among 18 patients enrolled in the phase 2, investigator-initiated basket trial reported in the Journal of Clinical Oncology.

The median progression-free survival (PFS) was 5 months in this heavily pretreated group of patients, according to first author Bob T. Li, MD, of Memorial Sloan Kettering Cancer Center, New York, and his coauthors.

“This is important therapeutic progress in the context of more than a decade of negative clinical trials targeting HER2 in lung cancer,” the researchers wrote.

The patients (median age, 64 years; 72% female) had metastatic lung adenocarcinomas treated in 2016 at Memorial Sloan Kettering Cancer Center. All patients had HER2-activating mutations identified by next-generation sequencing. They had received a median of two lines of prior therapy. Three of the 18 patients were treatment naive. Prior HER2-targeted therapy, including trastuzumab, was allowed.

All patients received intravenous infusions of T-DM1 at 3.6 mg/kg every 21 days until progression of disease or unacceptable toxicity.

Confirmed partial responses were seen in 8 patients (44%), while an additional 7 (39%) had stable disease, Dr. Li and his coauthors reported. Median PFS was 5 months overall and 6 months for responders, with the longest observed PFS being more than 11 months.

The treatment was well tolerated, with treatment-related adverse events mainly consisting of grade 1-2 infusion reactions, elevation of hepatic transaminases, and thrombocytopenia.

The rate of infusion reactions was higher than what was expected based on the experience with T-DM1 in breast cancer, though these reactions were generally mild and did not require discontinuation of the drug, which is approved for the treatment of HER2-amplified or –overexpressing metastatic breast cancer.

These findings have important implication for drug development in HER-2 mutant lung cancers, particularly as next-generation sequencing becomes more commonly used for initial tumor evaluation, Dr. Li and his coauthors noted.

“Just as the discovery of EGFR mutations eventually led to a plethora of approved oncogene-targeted therapies transforming the care of patients around the world, HER2-activating mutations similarly show promise as a therapeutic target,” they wrote.

Disappointing results were seen in previous studies looking at trastuzumab in lung cancer patients, and in those trials, patients were selected on the basis of HER2 protein expression by immunohistochemistry (IHC). “More recent studies have again confirmed that HER2 IHC is not the ideal biomarker in lung cancers,” the researchers wrote.

The 18-patient cohort in this study was part of a larger, investigator-initiated basket trial. Cohorts not reported at this time involved patients with other HER2-amplified solid tumors, including bladder.

The study was supported by the Conquer Cancer Foundation, Genentech, and a grant from the National Institutes of Health.

Dr. Li reported disclosures related to Roche, Biosceptre International, Thermo Fisher Scientific, Mersana, Guardant Health, Genentech, Illumina, BioMed Valley Discoveries, AstraZeneca, and GRAIL. Several co-authors reported disclosures, including employment, with NantOmics, a developer of molecular profiling tools.

SOURCE: Li BT et al. J Clin Oncol. 2018 July 10. doi: 10.1200/JCO.2018.77.9777.

Ado-trastuzumab emtansine (T-DM1) has met a predefined efficacy endpoint in what investigators say is the first positive clinical trial in patients with advanced HER2-mutant lung cancers.

The HER2-targeted therapy produced a 44% overall response rate among 18 patients enrolled in the phase 2, investigator-initiated basket trial reported in the Journal of Clinical Oncology.

The median progression-free survival (PFS) was 5 months in this heavily pretreated group of patients, according to first author Bob T. Li, MD, of Memorial Sloan Kettering Cancer Center, New York, and his coauthors.

“This is important therapeutic progress in the context of more than a decade of negative clinical trials targeting HER2 in lung cancer,” the researchers wrote.

The patients (median age, 64 years; 72% female) had metastatic lung adenocarcinomas treated in 2016 at Memorial Sloan Kettering Cancer Center. All patients had HER2-activating mutations identified by next-generation sequencing. They had received a median of two lines of prior therapy. Three of the 18 patients were treatment naive. Prior HER2-targeted therapy, including trastuzumab, was allowed.

All patients received intravenous infusions of T-DM1 at 3.6 mg/kg every 21 days until progression of disease or unacceptable toxicity.

Confirmed partial responses were seen in 8 patients (44%), while an additional 7 (39%) had stable disease, Dr. Li and his coauthors reported. Median PFS was 5 months overall and 6 months for responders, with the longest observed PFS being more than 11 months.

The treatment was well tolerated, with treatment-related adverse events mainly consisting of grade 1-2 infusion reactions, elevation of hepatic transaminases, and thrombocytopenia.

The rate of infusion reactions was higher than what was expected based on the experience with T-DM1 in breast cancer, though these reactions were generally mild and did not require discontinuation of the drug, which is approved for the treatment of HER2-amplified or –overexpressing metastatic breast cancer.

These findings have important implication for drug development in HER-2 mutant lung cancers, particularly as next-generation sequencing becomes more commonly used for initial tumor evaluation, Dr. Li and his coauthors noted.

“Just as the discovery of EGFR mutations eventually led to a plethora of approved oncogene-targeted therapies transforming the care of patients around the world, HER2-activating mutations similarly show promise as a therapeutic target,” they wrote.

Disappointing results were seen in previous studies looking at trastuzumab in lung cancer patients, and in those trials, patients were selected on the basis of HER2 protein expression by immunohistochemistry (IHC). “More recent studies have again confirmed that HER2 IHC is not the ideal biomarker in lung cancers,” the researchers wrote.

The 18-patient cohort in this study was part of a larger, investigator-initiated basket trial. Cohorts not reported at this time involved patients with other HER2-amplified solid tumors, including bladder.

The study was supported by the Conquer Cancer Foundation, Genentech, and a grant from the National Institutes of Health.

Dr. Li reported disclosures related to Roche, Biosceptre International, Thermo Fisher Scientific, Mersana, Guardant Health, Genentech, Illumina, BioMed Valley Discoveries, AstraZeneca, and GRAIL. Several co-authors reported disclosures, including employment, with NantOmics, a developer of molecular profiling tools.

SOURCE: Li BT et al. J Clin Oncol. 2018 July 10. doi: 10.1200/JCO.2018.77.9777.