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New clinical guidelines on type 2 diabetes mellitus in children and adolescents from the American Academy of Pediatrics advise physicians to start metformin in newly diagnosed patients with moderate hyperglycemia, while also promoting diet and exercise changes.
The guidelines are addressed to the primary care physician, as children and adolescents with diabetes are most likely to be treated in primary care and not by an endocrinologist, according to the authors of the guidelines, led by pediatric endocrinologist Dr. Kenneth C. Copeland, of the University of Oklahoma (Pediatrics 2013;131:364-82,e648-e664).
The guidelines note that the sharp rise in incidence of type 2 diabetes among children and adolescents in recent decades has occurred alongside a severe shortage of pediatric endocrinologists in the United States. The scarcity of specialists, added to the fact that children with type 2 diabetes are disproportionately ethnic minorities living in poverty, means that access to pediatric endocrinologists will be "difficult or, in some cases, impossible." The guidelines, then, are intended to help primary care physicians who find themselves "unequipped to treat adult diseases encountered in children," according to the authors of the technical report that accompanies the guidelines, led by epidemiologist and neonatologist Dr. Shelley C. Springer of Big Lake, Minn. (Pediatrics 2013 Jan. 28 [doi: 10.1542/peds.2012-3496]).
An earlier guideline on type 2 diabetes in children and adolescents, issued by the International Society for Pediatric and Adolescent Diabetes (Pediatr. Diabetes 2009;10:17-32), had recommended initiation of metformin for youth with moderate hyperglycemia only after diet and exercise had failed.
The new American Academy of Pediatrics (AAP) guidelines recommend starting metformin as first-line therapy for children and adolescents aged 10-18 years with HbA1c of 6.5% or higher, citing observational and randomized controlled trial evidence that metformin is more effective than lifestyle interventions alone. Metformin should be started at 500 mg daily and increased by 500 mg every 1-2 weeks, up to 2,000 mg daily.
The guidelines note that while metformin is the only antidiabetic agent besides insulin that is currently approved for children, it may be of more limited benefit than previously believed. "Since the completion of these guidelines, results of the TODAY trial (N. Engl. J. Med. 2012;366:2247-56) have become available and reveal that metformin alone is inadequate in effecting sustained glycemic control in the majority of youth with diabetes," the authors wrote, noting that other agents are likely to become "reasonable options for initial pharmacologic management" of children and adolescents with type 2 diabetes in the near future.
"The writing group for these guidelines continues to recommend metformin as first-line therapy in this age group but with close monitoring for glycemic deterioration and the early addition of insulin or another pharmacologic agent if needed," Dr. Copeland and his associates wrote.
The guidelines recommend that clinicians incorporate the Academy of Nutrition and Dietetics’ pediatric weight management guidelines in nutrition counseling at diagnosis and during ongoing management. Clinicians also should prescribe 1 hour a day of moderate to vigorous exercise, and the limiting of nonacademic "screen time," or time before computers, televisions, gaming devices, and the like, to less than 2 hours daily.
HbA1c concentrations should be measured every 3 months, and treatment intensified if targets are not being met.
Physicians should initiate treatment with insulin for children and adolescents who are ketotic or present with diabetic ketoacidosis; children in whom the distinction between type 1 diabetes and type 2 diabetes is unclear; and those whose HbA1c is greater than 9% or plasma glucose concentration is 250 mg/dL or higher.
Up to a quarter of adolescents with type 2 diabetes will present with ketoacidosis, the guidelines’ authors noted, and these patients should immediately be referred to an inpatient setting for treatment with insulin and fluid replacement under the care of a physician experienced in treating this complication.
Finger-stick monitoring should be used to measure blood glucose concentrations in patients who are taking insulin or other medications and have a risk of hypoglycemia; who are initiating or changing their diabetes treatment regimens; who have not met treatment goals; or who have intercurrent illnesses, according to the guidelines.
The AAP guidelines were produced by systematic literature review, with 58 studies included, and with the support of the American Diabetes Association, the Pediatric Endocrine Society, the American Academy of Family Physicians, and the Academy of Nutrition and Dietetics.
The guidelines’ lead author, Dr. Copeland, disclosed financial relationships with Novo Nordisk, Genentech, and Endo. Coauthor Dr. Janet Silverstein disclosed support from Pfizer, Novo Nordisk, Lilly, and other companies, and coauthor Dr. Kelly Roberta Moore disclosed a relationship with the Merck Company Foundation.
Type 2 diabetes is a multidimensional disorder that requires a multidimensional management approach. The new AAP guidelines on type 2 diabetes in children and adolescents codify the current practice of nearly all pediatric endocrinologists, which is to start metformin in addition to initiating critically important nutrition and exercise changes.
However, as the TODAY study has shown [N. Engl. J. Med.2012;366:2247-56], metformin is less effective in children than adults. Metabolically, the young patient with type 2 diabetes is the toughest to treat.
Dr. Jay Cohen |
Endocrinologists need an enhanced relationship with the Food and Drug Administration and pharmaceutical companies to design clinical trials (some are already in progress) with medications currently approved for use in adults: dipeptidyl peptidase-4 inhibitor (DPP-4)-based therapies and glucagon-like peptide-1 receptor agonist (GLP-1)-based therapies. These two medication classes offer significant potential benefits to the adolescent and pediatric population, and desperately need to be looked at so that they may at some point become standard of care with or without metformin.
Many endocrinologists in the United States are already using these medicines for challenging adolescent and pediatric type 2 diabetes. The next challenge is in getting safety data for this population so that the drugs can become available to real-world patients and their parents. Understanding the family dynamics of each patient and communicating with families in a culturally sensitive manner, along with utilizing social, educational, and even faith-based resources, are all critical elements required for long-term success and prevention of premature complications.
Jay Cohen, M.D., is medical director of The Endocrine Clinic, Memphis, Tenn. Dr. Cohen has received research funding and/or speaking fees from Bristol-Myers Squibb, Novo Nordisk, Mannkind, Eli Lilly, and Sanofi-Aventis.
Type 2 diabetes is a multidimensional disorder that requires a multidimensional management approach. The new AAP guidelines on type 2 diabetes in children and adolescents codify the current practice of nearly all pediatric endocrinologists, which is to start metformin in addition to initiating critically important nutrition and exercise changes.
However, as the TODAY study has shown [N. Engl. J. Med.2012;366:2247-56], metformin is less effective in children than adults. Metabolically, the young patient with type 2 diabetes is the toughest to treat.
Dr. Jay Cohen |
Endocrinologists need an enhanced relationship with the Food and Drug Administration and pharmaceutical companies to design clinical trials (some are already in progress) with medications currently approved for use in adults: dipeptidyl peptidase-4 inhibitor (DPP-4)-based therapies and glucagon-like peptide-1 receptor agonist (GLP-1)-based therapies. These two medication classes offer significant potential benefits to the adolescent and pediatric population, and desperately need to be looked at so that they may at some point become standard of care with or without metformin.
Many endocrinologists in the United States are already using these medicines for challenging adolescent and pediatric type 2 diabetes. The next challenge is in getting safety data for this population so that the drugs can become available to real-world patients and their parents. Understanding the family dynamics of each patient and communicating with families in a culturally sensitive manner, along with utilizing social, educational, and even faith-based resources, are all critical elements required for long-term success and prevention of premature complications.
Jay Cohen, M.D., is medical director of The Endocrine Clinic, Memphis, Tenn. Dr. Cohen has received research funding and/or speaking fees from Bristol-Myers Squibb, Novo Nordisk, Mannkind, Eli Lilly, and Sanofi-Aventis.
Type 2 diabetes is a multidimensional disorder that requires a multidimensional management approach. The new AAP guidelines on type 2 diabetes in children and adolescents codify the current practice of nearly all pediatric endocrinologists, which is to start metformin in addition to initiating critically important nutrition and exercise changes.
However, as the TODAY study has shown [N. Engl. J. Med.2012;366:2247-56], metformin is less effective in children than adults. Metabolically, the young patient with type 2 diabetes is the toughest to treat.
Dr. Jay Cohen |
Endocrinologists need an enhanced relationship with the Food and Drug Administration and pharmaceutical companies to design clinical trials (some are already in progress) with medications currently approved for use in adults: dipeptidyl peptidase-4 inhibitor (DPP-4)-based therapies and glucagon-like peptide-1 receptor agonist (GLP-1)-based therapies. These two medication classes offer significant potential benefits to the adolescent and pediatric population, and desperately need to be looked at so that they may at some point become standard of care with or without metformin.
Many endocrinologists in the United States are already using these medicines for challenging adolescent and pediatric type 2 diabetes. The next challenge is in getting safety data for this population so that the drugs can become available to real-world patients and their parents. Understanding the family dynamics of each patient and communicating with families in a culturally sensitive manner, along with utilizing social, educational, and even faith-based resources, are all critical elements required for long-term success and prevention of premature complications.
Jay Cohen, M.D., is medical director of The Endocrine Clinic, Memphis, Tenn. Dr. Cohen has received research funding and/or speaking fees from Bristol-Myers Squibb, Novo Nordisk, Mannkind, Eli Lilly, and Sanofi-Aventis.
New clinical guidelines on type 2 diabetes mellitus in children and adolescents from the American Academy of Pediatrics advise physicians to start metformin in newly diagnosed patients with moderate hyperglycemia, while also promoting diet and exercise changes.
The guidelines are addressed to the primary care physician, as children and adolescents with diabetes are most likely to be treated in primary care and not by an endocrinologist, according to the authors of the guidelines, led by pediatric endocrinologist Dr. Kenneth C. Copeland, of the University of Oklahoma (Pediatrics 2013;131:364-82,e648-e664).
The guidelines note that the sharp rise in incidence of type 2 diabetes among children and adolescents in recent decades has occurred alongside a severe shortage of pediatric endocrinologists in the United States. The scarcity of specialists, added to the fact that children with type 2 diabetes are disproportionately ethnic minorities living in poverty, means that access to pediatric endocrinologists will be "difficult or, in some cases, impossible." The guidelines, then, are intended to help primary care physicians who find themselves "unequipped to treat adult diseases encountered in children," according to the authors of the technical report that accompanies the guidelines, led by epidemiologist and neonatologist Dr. Shelley C. Springer of Big Lake, Minn. (Pediatrics 2013 Jan. 28 [doi: 10.1542/peds.2012-3496]).
An earlier guideline on type 2 diabetes in children and adolescents, issued by the International Society for Pediatric and Adolescent Diabetes (Pediatr. Diabetes 2009;10:17-32), had recommended initiation of metformin for youth with moderate hyperglycemia only after diet and exercise had failed.
The new American Academy of Pediatrics (AAP) guidelines recommend starting metformin as first-line therapy for children and adolescents aged 10-18 years with HbA1c of 6.5% or higher, citing observational and randomized controlled trial evidence that metformin is more effective than lifestyle interventions alone. Metformin should be started at 500 mg daily and increased by 500 mg every 1-2 weeks, up to 2,000 mg daily.
The guidelines note that while metformin is the only antidiabetic agent besides insulin that is currently approved for children, it may be of more limited benefit than previously believed. "Since the completion of these guidelines, results of the TODAY trial (N. Engl. J. Med. 2012;366:2247-56) have become available and reveal that metformin alone is inadequate in effecting sustained glycemic control in the majority of youth with diabetes," the authors wrote, noting that other agents are likely to become "reasonable options for initial pharmacologic management" of children and adolescents with type 2 diabetes in the near future.
"The writing group for these guidelines continues to recommend metformin as first-line therapy in this age group but with close monitoring for glycemic deterioration and the early addition of insulin or another pharmacologic agent if needed," Dr. Copeland and his associates wrote.
The guidelines recommend that clinicians incorporate the Academy of Nutrition and Dietetics’ pediatric weight management guidelines in nutrition counseling at diagnosis and during ongoing management. Clinicians also should prescribe 1 hour a day of moderate to vigorous exercise, and the limiting of nonacademic "screen time," or time before computers, televisions, gaming devices, and the like, to less than 2 hours daily.
HbA1c concentrations should be measured every 3 months, and treatment intensified if targets are not being met.
Physicians should initiate treatment with insulin for children and adolescents who are ketotic or present with diabetic ketoacidosis; children in whom the distinction between type 1 diabetes and type 2 diabetes is unclear; and those whose HbA1c is greater than 9% or plasma glucose concentration is 250 mg/dL or higher.
Up to a quarter of adolescents with type 2 diabetes will present with ketoacidosis, the guidelines’ authors noted, and these patients should immediately be referred to an inpatient setting for treatment with insulin and fluid replacement under the care of a physician experienced in treating this complication.
Finger-stick monitoring should be used to measure blood glucose concentrations in patients who are taking insulin or other medications and have a risk of hypoglycemia; who are initiating or changing their diabetes treatment regimens; who have not met treatment goals; or who have intercurrent illnesses, according to the guidelines.
The AAP guidelines were produced by systematic literature review, with 58 studies included, and with the support of the American Diabetes Association, the Pediatric Endocrine Society, the American Academy of Family Physicians, and the Academy of Nutrition and Dietetics.
The guidelines’ lead author, Dr. Copeland, disclosed financial relationships with Novo Nordisk, Genentech, and Endo. Coauthor Dr. Janet Silverstein disclosed support from Pfizer, Novo Nordisk, Lilly, and other companies, and coauthor Dr. Kelly Roberta Moore disclosed a relationship with the Merck Company Foundation.
New clinical guidelines on type 2 diabetes mellitus in children and adolescents from the American Academy of Pediatrics advise physicians to start metformin in newly diagnosed patients with moderate hyperglycemia, while also promoting diet and exercise changes.
The guidelines are addressed to the primary care physician, as children and adolescents with diabetes are most likely to be treated in primary care and not by an endocrinologist, according to the authors of the guidelines, led by pediatric endocrinologist Dr. Kenneth C. Copeland, of the University of Oklahoma (Pediatrics 2013;131:364-82,e648-e664).
The guidelines note that the sharp rise in incidence of type 2 diabetes among children and adolescents in recent decades has occurred alongside a severe shortage of pediatric endocrinologists in the United States. The scarcity of specialists, added to the fact that children with type 2 diabetes are disproportionately ethnic minorities living in poverty, means that access to pediatric endocrinologists will be "difficult or, in some cases, impossible." The guidelines, then, are intended to help primary care physicians who find themselves "unequipped to treat adult diseases encountered in children," according to the authors of the technical report that accompanies the guidelines, led by epidemiologist and neonatologist Dr. Shelley C. Springer of Big Lake, Minn. (Pediatrics 2013 Jan. 28 [doi: 10.1542/peds.2012-3496]).
An earlier guideline on type 2 diabetes in children and adolescents, issued by the International Society for Pediatric and Adolescent Diabetes (Pediatr. Diabetes 2009;10:17-32), had recommended initiation of metformin for youth with moderate hyperglycemia only after diet and exercise had failed.
The new American Academy of Pediatrics (AAP) guidelines recommend starting metformin as first-line therapy for children and adolescents aged 10-18 years with HbA1c of 6.5% or higher, citing observational and randomized controlled trial evidence that metformin is more effective than lifestyle interventions alone. Metformin should be started at 500 mg daily and increased by 500 mg every 1-2 weeks, up to 2,000 mg daily.
The guidelines note that while metformin is the only antidiabetic agent besides insulin that is currently approved for children, it may be of more limited benefit than previously believed. "Since the completion of these guidelines, results of the TODAY trial (N. Engl. J. Med. 2012;366:2247-56) have become available and reveal that metformin alone is inadequate in effecting sustained glycemic control in the majority of youth with diabetes," the authors wrote, noting that other agents are likely to become "reasonable options for initial pharmacologic management" of children and adolescents with type 2 diabetes in the near future.
"The writing group for these guidelines continues to recommend metformin as first-line therapy in this age group but with close monitoring for glycemic deterioration and the early addition of insulin or another pharmacologic agent if needed," Dr. Copeland and his associates wrote.
The guidelines recommend that clinicians incorporate the Academy of Nutrition and Dietetics’ pediatric weight management guidelines in nutrition counseling at diagnosis and during ongoing management. Clinicians also should prescribe 1 hour a day of moderate to vigorous exercise, and the limiting of nonacademic "screen time," or time before computers, televisions, gaming devices, and the like, to less than 2 hours daily.
HbA1c concentrations should be measured every 3 months, and treatment intensified if targets are not being met.
Physicians should initiate treatment with insulin for children and adolescents who are ketotic or present with diabetic ketoacidosis; children in whom the distinction between type 1 diabetes and type 2 diabetes is unclear; and those whose HbA1c is greater than 9% or plasma glucose concentration is 250 mg/dL or higher.
Up to a quarter of adolescents with type 2 diabetes will present with ketoacidosis, the guidelines’ authors noted, and these patients should immediately be referred to an inpatient setting for treatment with insulin and fluid replacement under the care of a physician experienced in treating this complication.
Finger-stick monitoring should be used to measure blood glucose concentrations in patients who are taking insulin or other medications and have a risk of hypoglycemia; who are initiating or changing their diabetes treatment regimens; who have not met treatment goals; or who have intercurrent illnesses, according to the guidelines.
The AAP guidelines were produced by systematic literature review, with 58 studies included, and with the support of the American Diabetes Association, the Pediatric Endocrine Society, the American Academy of Family Physicians, and the Academy of Nutrition and Dietetics.
The guidelines’ lead author, Dr. Copeland, disclosed financial relationships with Novo Nordisk, Genentech, and Endo. Coauthor Dr. Janet Silverstein disclosed support from Pfizer, Novo Nordisk, Lilly, and other companies, and coauthor Dr. Kelly Roberta Moore disclosed a relationship with the Merck Company Foundation.