Eligibility for clinical trials is limited for youth with type 2 diabetes: Insights from the Pediatric Diabetes Consortium T2D Clinic Registry.

Abstract:

BACKGROUND/OBJECTIVE:Restrictive eligibility criteria have hampered enrollment into trials for new drugs for youth with type 2 diabetes (T2D). We utilized Pediatric Diabetes Consortium (PDC) T2D Registry enrollment data to estimate the percentage of patients who would be excluded from current T2D trials based on out-of-range HbA1c levels. We also examined whether well-controlled patients could be included because baseline HbA1c would rise during a 6 to 12-month study if assigned to control group. METHODS:Clinical characteristics and HbA1c levels were collected from 956 T2D patients aged 10 to <18 years upon Registry enrollment. HbA1c levels were also analyzed in 6-month intervals during the first 30 months of T2D duration. RESULTS:There was an approximately 2:1 ratio of females to males; the majority were obese and from economically disadvantaged minority families. On enrollment in the Registry, 53% of patients would be excluded from current trials because HbA1c levels were either <6.5% (<48 mmol/mol) (37%) or >10.5% (>91 mmol/mol) (16%). Furthermore, in patients with HbA1c levels <6.5% (<48 mmol/mol) and T2D duration between 6 and 30 months, mean HbA1c levels increased by 0.6% (6 mmol/mol) and 0.9% (10 mmol/mol) over the subsequent 6 and 12 months, respectively. CONCLUSIONS:Eligibility criteria for current clinical trials still exclude a large proportion of pediatric T2D patients because of HbA1c levels. Including patients with HbA1c <6.5% (<48 mmol/mol) would enhance recruitment and allow comparisons of the investigational treatment with placebo-assigned subjects in whom HbA1c levels would on average increase during the 6 to 12 months of the trial.

journal_name

Pediatr Diabetes

journal_title

Pediatric diabetes

authors

Tamborlane WV,Chang P,Kollman C,Klingensmith GJ,Ruedy K,Gal RL,Van Name M,Bacha F,Willi S,Beck RW,Pediatric Diabetes Consortium.

doi

10.1111/pedi.12763

subject

Has Abstract

pub_date

2018-12-01 00:00:00

pages

1379-1384

issue

8

eissn

1399-543X

issn

1399-5448

journal_volume

19

pub_type

杂志文章
  • Diabetes knowledge in adolescents with type 1 diabetes and their parents and glycemic control.

    abstract:OBJECTIVE:To evaluate diabetes knowledge and skills (DKS) in adolescents (>10 year) with type 1 diabetes (T1D) and their parents, and its effect on glycemic control. METHODS:A ready-to-use program and a standardized questionnaire comprising 50 true-false questions based on this program, were elaborated by a National C...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,多中心研究

    doi:10.1111/pedi.12458

    authors: Martin D,Elie C,Dossier C,Godot C,Gagnayre R,Choleau C,Cahané M,Robert JJ,AJD Study Group.

    更新日期:2017-11-01 00:00:00

  • Long-chain polyunsaturated fatty acids in a diabetic teenager during and after nine repeated episodes of diabetic ketoacidosis.

    abstract::Type 1 diabetes is often accompanied with acute hypoinsulinemia that may theoretically inhibit the conversion of essential fatty acids to their longer-chain metabolites. Previously, we found significant reduction in plasma arachidonic (C20:4n-6) and docosahexaenoic (C22:6n-3) acid values in a group of diabetic childre...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2008.00487.x

    authors: Szabó E,Marosvölgyi T,Kozári A,Erhardt E,Soltész G,Decsi T

    更新日期:2009-05-01 00:00:00

  • Renal Doppler indices in diabetic children with insulin resistance syndrome.

    abstract::End-stage renal failure is still a leading cause of mortality among type 1 diabetes patients. Insulin resistance plays a larger role in type 1 diabetes disease process than is commonly recognized. Detection of diabetic nephropathy as early as possible currently offers the best chance of delaying or possibly preventing...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2009.00628.x

    authors: Abd El Ghaffar S,El Kaffas K,Hegazy R,Mostafa M

    更新日期:2010-11-01 00:00:00

  • Clinical picture of childhood type 1 diabetes mellitus in the Eastern Province of Saudi Arabia.

    abstract:AIM:Study of the clinical presentation and laboratory data of type 1 diabetes in the Eastern Province of Saudi Arabia. METHODS:The medical records of all affected children during the period 1986-1997 were reviewed for the analysis of clinical and laboratory data. RESULTS:Type 1 diabetes was diagnosed in 46 children, ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1046/j.1399-543x.2001.00000.x

    authors: Kulaylat NA,Narchi H

    更新日期:2001-03-01 00:00:00

  • Intramyocellular lipid, adiposity, and muscle oxygen supply in prepubertal type 1 diabetes.

    abstract:BACKGROUND:In the non-diabetic population, intramyocellular lipid (IMCL) accumulation is associated with obesity and poor muscle oxygen supply. IMCL levels are increased in type 1 diabetes, but their significance is less clear. METHODS:We studied a group of 16 prepubertal boys (age 6.4-9.9 yr) with type 1 diabetes and...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1034/j.1399-5448.2003.00021.x

    authors: Ling AH,Donaghue KC,Howard NJ,Arrowsmith FE,Ward JA,Baur LA,Thompson CH

    更新日期:2003-09-01 00:00:00

  • Treatment options for type 2 diabetes in adolescents and youth: a study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes.

    abstract::Despite the increased prevalence of type 2 diabetes mellitus (T2DM) in the pediatric population, there is limited information about the relative effectiveness of treatment approaches. This article describes the rationale and design of a National Institutes of Health-sponsored multi-site, randomized, parallel group cli...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1111/j.1399-5448.2007.00237.x

    authors: TODAY Study Group.,Zeitler P,Epstein L,Grey M,Hirst K,Kaufman F,Tamborlane W,Wilfley D

    更新日期:2007-04-01 00:00:00

  • A Swedish approach to the prevention of type 1 diabetes.

    abstract:BACKGROUND:The autoimmune destruction of beta cells, resulting in clinical type 1 diabetes, may start early in life and last for several months or years. During this period of time, we have an opportunity to try to prevent or delay further beta-cell destruction and clinical onset of type 1 diabetes. OBJECTIVES:Ongoing...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,评审

    doi:10.1111/pedi.12325

    authors: Elding Larsson H

    更新日期:2016-07-01 00:00:00

  • Permanent neonatal diabetes with arthrogryposis multiplex congenita and neurogenic bladder - a new syndrome?

    abstract::Neonatal diabetes mellitus is a rare (1/400 000 newborns) but potentially devastating condition, which may be transient or permanent; typical symptoms occur within the first 4 wk of life. The transient form is a developmental insulin production disorder that resolves postnatally. Fifty to 60% of cases can be seen as t...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2006.00201.x

    authors: Goksen D,Darcan S,Coker M,Aksu G,Yildiz B,Kara S,Kültürsay N

    更新日期:2006-10-01 00:00:00

  • Daily vegetable intake during pregnancy negatively associated to islet autoimmunity in the offspring--the ABIS study.

    abstract:OBJECTIVE:To investigate if maternal diet during pregnancy is associated with occurrence of islet autoimmunity (IA) in the offspring. METHODS:Of 21 700 infants invited to the All Babies in South-east Sweden (ABIS) study, 16 004 screening questionnaires, including a 22-item food frequency questionnaire (FFQ) regarding ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2009.00563.x

    authors: Brekke HK,Ludvigsson J

    更新日期:2010-06-01 00:00:00

  • Youth and parent education about diabetes complications: health professional survey.

    abstract:OBJECTIVE:Avoiding complications is paramount in diabetes management, but little is known about how, when, and what diabetes professionals disclose to parents and youths about this topic. RESEARCH DESIGN AND METHOD:Pediatric diabetes experts (n = 534) were surveyed about their practices and attitudes regarding informi...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2008.00438.x

    authors: Lochrie AS,Wysocki T,Burnett J,Buckloh LM,Antal H

    更新日期:2009-02-01 00:00:00

  • Metformin treatment to reduce central adiposity after prenatal growth restraint: a placebo-controlled pilot study in prepubertal children.

    abstract:BACKGROUND:Children born small-for-gestational-age (SGA) who experience rapid postnatal catch-up in weight are at risk for central adiposity and hyperinsulinemia. OBJECTIVES:To study the effects of prepubertal metformin intervention over 24 months on the body composition and endocrine-metabolic profile of catch-up SGA...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1111/pedi.12220

    authors: Díaz M,Bassols J,López-Bermejo A,de Zegher F,Ibáñez L

    更新日期:2015-11-01 00:00:00

  • Comparison of the effectiveness of simple carbohydrates on hypoglycemic episodes in children and adolescents with type 1 diabetes mellitus: A randomized study in a diabetes camp.

    abstract:BACKGROUND:Hypoglycemia is the most common and severe complication of insulin treatment during the management of type 1 diabetes mellitus (T1DM). Despite its importance, there is a lack of data about the efficacy and superiority of the carbohydrate sources used in hypoglycemia management in children and adolescents. O...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.13077

    authors: Erbas IM,Abaci A,Anik A,Simsek E,Tuhan HU,Kocyigit C,Yıldız M,Dundar BN,Bober E,Catli G

    更新日期:2020-07-13 00:00:00

  • Screening for cystic fibrosis-related diabetes and prediabetes: Evaluating 1,5-anhydroglucitol, fructosamine, glycated albumin, and hemoglobin A1c.

    abstract:OBJECTIVE:Dysglycemia is prevalent in cystic fibrosis (CF) but screening with annual oral glucose tolerance tests (OGTT) can be burdensome. We investigated alternate glycemic markers-hemoglobin A1c (HbA1c), 1,5-anhydroglucitol (1,5AG), fructosamine (FA), and glycated albumin (GA)-as screening tests for CF-related diabe...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12914

    authors: Tommerdahl KL,Brinton JT,Vigers T,Nadeau KJ,Zeitler PS,Chan CL

    更新日期:2019-12-01 00:00:00

  • Glycemic extremes in youth with T1DM: the structural and functional integrity of the developing brain.

    abstract::The adult brain accounts for a disproportionally large percentage of the body’s total energy consumption (1). However, during brain development,energy demand is even higher, reaching the adult rate by age 2 and increasing to nearly twice the adult rate by age 10, followed by gradual reduction toward adult levels in th...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,评审

    doi:10.1111/pedi.12088

    authors: Arbelaez AM,Semenkovich K,Hershey T

    更新日期:2013-12-01 00:00:00

  • Gender differences in the relationship between parental report of self-regulation skills and adolescents' management of type 1 diabetes.

    abstract:OBJECTIVE:To examine the extent to which self-regulation skills of adolescents with type 1 diabetes (T1D), including executive functioning and emotion regulation, relate to treatment adherence and glycemic control. METHOD:Participants were 109 adolescents aged 12-18 yr with TID and their primary caregiver who attended...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2010.00692.x

    authors: Graziano PA,Geffken GR,Williams LB,Lewin AB,Duke DC,Storch EA,Silverstein JH

    更新日期:2011-06-01 00:00:00

  • Partial ABCC8 gene deletion mutations causing diazoxide-unresponsive hyperinsulinaemic hypoglycaemia.

    abstract::Inactivating mutations in the pancreatic beta cell ATP-sensitive potassium (K(ATP) ) channel genes are identified by sequencing in approximately 80% of patients with diazoxide-unresponsive hyperinsulinaemic hypoglycaemia (HH). Genetic testing is clinically important as the mode of inheritance of a K(ATP) channel mutat...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2011.00821.x

    authors: Flanagan S,Damhuis A,Banerjee I,Rokicki D,Jefferies C,Kapoor R,Hussain K,Ellard S

    更新日期:2012-05-01 00:00:00

  • Inflammatory cytokine, growth factor and counterregulatory responses to exercise in children with type 1 diabetes and healthy controls.

    abstract::In children with type 1 diabetes (T1DM), altered adaptive responses to exercise (secretion of growth factors, inflammatory cytokines, and glucoregulatory mediators) may have potential implications in growth and development, early onset of disease complications, and incidence of hypoglycemia. We therefore measured a br...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-543X.2006.00140.x

    authors: Galassetti PR,Iwanaga K,Crisostomo M,Zaldivar FP,Larson J,Pescatello A

    更新日期:2006-02-01 00:00:00

  • Longitudinal assessment of hippocampus structure in children with type 1 diabetes.

    abstract::The extant literature finds that children with type 1 diabetes mellitus (T1D) experience mild cognitive alterations compared to healthy age-matched controls. The neural basis of these cognitive differences is unclear but may relate in part to the effects of dysglycemia on the developing brain. We investigated longitud...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12683

    authors: Foland-Ross LC,Reiss AL,Mazaika PK,Mauras N,Weinzimer SA,Aye T,Tansey MJ,White NH,Diabetes Research in Children Network (DirecNet).

    更新日期:2018-04-19 00:00:00

  • Measurement properties of Patient Reported Outcomes Measurement Information System domains for children with type 1 diabetes.

    abstract:OBJECTIVE:Patient Reported Outcomes Measurement Information System (PROMIS) includes numerous domains to assess functioning among the pediatric population. These domains, however, have not been evaluated for use in children with type 1 diabetes (T1D). The objective of this study was to determine the measurement propert...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.13134

    authors: Singh A,Dasgupta M,Retherford D,Fiallo-Scharer R,Simpson PM,Panepinto JA

    更新日期:2020-10-07 00:00:00

  • Twenty-one years of prospective incidence of childhood type 1 diabetes in Hungary--the rising trend continues (or peaks and highlands?).

    abstract::The aim of this study was to examine secular trends in the incidence of type 1 diabetes in children aged 0-14 yr in Hungary over the period 1989-2009. Newly diagnosed children with type 1 diabetes aged 0-14 yr in Hungary were prospectively registered from 1989 to 2009. Primary ascertainment of cases was by prospective...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2011.00826.x

    authors: Gyurus EK,Patterson C,Soltesz G,Hungarian Childhood Diabetes Epidemiology Group.

    更新日期:2012-02-01 00:00:00

  • Islet/pancreas transplantation: challenges for pediatrics.

    abstract::Beta cell replacement is a valid alternative to exogenous insulin injections to treat type 1 diabetic patients. The rate of success obtained after whole-pancreas transplantation, performed alone or in combination with kidney, and, as shown recently, by islet transplantation, justifies optimism and sets the stage for a...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1034/j.1399-5448.2002.30408.x

    authors: Bottino R,Balamurugan AN,Giannoukakis N,Trucco M

    更新日期:2002-12-01 00:00:00

  • School-aged children with type 1 diabetes benefit more from a coping skills training program than adolescents in China: 12-month outcomes of a randomized clinical trial.

    abstract:BACKGROUND:Managing type 1 diabetes can be challenging, especially for youth, so there is a need for effective interventions to help youth live with diabetes. OBJECTIVE:To determine the efficacy of a coping skills training (CST) program for Chinese youth with type 1 diabetes and to explore whether the efficacy of the ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12975

    authors: Guo J,Luo J,Yang J,Huang L,Wiley J,Liu F,Li X,Zhou Z,Whittemore R

    更新日期:2020-05-01 00:00:00

  • Faster-acting insulin aspart provides faster onset and greater early exposure vs insulin aspart in children and adolescents with type 1 diabetes mellitus.

    abstract:BACKGROUND:Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with additional excipients (L-arginine and niacinamide). In adults, faster aspart provides faster onset and greater early exposure and action vs IAsp. AIM:This randomized, double-blind, 2-period crossover trial invest...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/pedi.12506

    authors: Fath M,Danne T,Biester T,Erichsen L,Kordonouri O,Haahr H

    更新日期:2017-12-01 00:00:00

  • Glucose metabolism in children and adolescents: Population-based reference values and comparisons to children and adolescents enrolled in obesity treatment.

    abstract:BACKGROUND:Alterations in glucose metabolism that lead to the development of metabolic and cardiovascular disease may begin already in childhood. OBJECTIVE:This study aims to generate pediatric age and sex-specific reference values for fasting concentrations of glucose, hemoglobin A1c (HbA1c), insulin, C-peptide, and ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12859

    authors: Frithioff-Bøjsøe C,Lund MAV,Kloppenborg JT,Nielsen TTH,Fonvig CE,Lausten-Thomsen U,Hedley PL,Hansen T,Pedersen OB,Christiansen M,Baker JL,Hansen T,Holm JC

    更新日期:2019-08-01 00:00:00

  • Influence of initial insulin dosage on blood glucose dynamics of children and adolescents with newly diagnosed type 1 diabetes mellitus.

    abstract:OBJECTIVE:To investigate the effect of initial insulin dosage on blood glucose (BG) dynamics, β-cell protection, and oxidative stress in type 1 diabetes mellitus. METHODS:Sixty newly diagnosed type 1 diabetes mellitus patients were randomly assigned to continuous subcutaneous insulin infusions of 0.6 ± 0.2 IU/kg/d (gr...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/pedi.12374

    authors: Wang Y,Gong C,Cao B,Meng X,Wei L,Wu D,Liang X,Li W,Liu M,Gu Y,Su C

    更新日期:2017-05-01 00:00:00

  • Worldwide childhood type 1 diabetes incidence--what can we learn from epidemiology?

    abstract::Type 1 diabetes is the most common form of diabetes in most part of the world, although reliable data are still unavailable in several countries. Wide variations exist between the incidence rates of different populations, incidence is lowest in China and Venezuela (0.1 per 100,000 per year) and highest in Finland and ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2007.00280.x

    authors: Soltesz G,Patterson CC,Dahlquist G,EURODIAB Study Group.

    更新日期:2007-10-01 00:00:00

  • Participant and parent experiences in the oral insulin study of the Diabetes Prevention Trial for Type 1 Diabetes.

    abstract:OBJECTIVE:To assess the experiences of participants and parents of children in the oral insulin study of the Diabetes Prevention Trial - Type 1. METHOD:Before trial results were publicized, surveys were completed by 124 participants and 219 parents of children in the oral trial. RESULTS:Although most of those surveye...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/j.1399-5448.2008.00463.x

    authors: Johnson SB,Baughcum AE,Rafkin-Mervis LE,Schatz DA,DPT-1 Study Group.

    更新日期:2009-05-01 00:00:00

  • Oxidant/antioxidant status in obese children compared to pediatric patients with type 1 diabetes mellitus.

    abstract:BACKGROUND:Type 1 diabetes (T1D) mellitus and obesity are recognized risk factors for cardiovascular disease (CVD). A common mechanism underlying an increased risk for endothelial dysfunction in these two metabolic diseases is oxidative stress. OBJECTIVE:To evaluate and compare the oxidant/antioxidant defense systems ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2009.00565.x

    authors: Codoñer-Franch P,Pons-Morales S,Boix-García L,Valls-Bellés V

    更新日期:2010-06-01 00:00:00

  • Plasma insulin levels in childhood are related to maternal factors--results of the Ulm Birth Cohort Study.

    abstract:AIMS:The cardiovascular risk factor profile of a child as well as the development of body weight are influenced by genetic and childhood factors. Circulating insulin concentrations reflect the metabolic cardiovascular risk and may trigger weight gain. We aimed at identifying parental and childhood factors which may inf...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12109

    authors: Brandt S,Moß A,Lennerz B,Koenig W,Weyermann M,Rothenbacher D,Brenner H,Wabitsch M

    更新日期:2014-09-01 00:00:00

  • Relationship of adiponectin and leptin with autoimmunity in children with new-onset type 1 diabetes: a pilot study.

    abstract:AIM:To explore racial differences in adiponectin, and leptin and their relationship with islet autoimmunity in children with new-onset type 1 diabetes (T1D). METHODS:Medical records were reviewed from a cohort of new-onset clinically diagnosed T1D subjects matched by race, age, gender, and year of diagnosis. Sera were...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12267

    authors: Hecht Baldauff N,Tfayli H,Dong W,Arena VC,Gurtunca N,Pietropaolo M,Becker DJ,Libman IM

    更新日期:2016-06-01 00:00:00