RESUMO
Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.
Assuntos
Diabetes Mellitus Tipo 1/terapia , Avaliação de Resultados em Cuidados de Saúde/métodos , Pâncreas Artificial , Glicemia/metabolismo , Ensaios Clínicos como Assunto , Consenso , Diabetes Mellitus Tipo 1/sangue , Hemoglobinas Glicadas/análise , HumanosRESUMO
OBJECTIVE: We assessed the effect of type 2 diabetes mellitus and obesity on flow-mediated dilation (FMD) and endothelial-dependent vasodilation and carotid intima-medial thickness (cIMT) in young people. STUDY DESIGN: Adolescents were recruited in 3 groups: subjects with type 2 diabetes mellitus (n = 15), subjects who were obese and non-insulin resistant (n = 13), and lean control subjects (n = 13). Body mass index was similar in subjects with obesity and subjects with type 2 diabetes mellitus, but higher compared with that of lean control subjects (both P < .001). Brachial artery FMD and cIMT were assessed by using Duplex ultrasound scanning imaging. RESULTS: There were no significant differences in brachial or common carotid arterial diameters in the groups. cIMT was significantly greater in the group with type 2 diabetes mellitus (0.54 ± 0.01mm) compared with both the lean control (0.46 ± 0.02 mm, P < .001) and obese control (0.46 ± 0.02 mm, P < .01) groups. FMD was significantly decreased in the group with type 2 diabetes mellitus (7.98% ± 0.54%) compared with the lean group (10.40% ± 1.00%, P < .05). CONCLUSIONS: Measures of vascular health were impaired in adolescents with type 2 diabetes mellitus compared with lean and obese adolescents who were not insulin resistant. Measures of arterial function and structure may provide pre-clinical measures of cardiovascular disease in young people at elevated risk.
Assuntos
Espessura Intima-Media Carotídea , Diabetes Mellitus Tipo 2/patologia , Diabetes Mellitus Tipo 2/fisiopatologia , Endotélio Vascular/fisiopatologia , Obesidade/patologia , Obesidade/fisiopatologia , Adolescente , Feminino , Humanos , MasculinoRESUMO
OBJECTIVES: To investigate the relationships between cardiorespiratory fitness and adiposity among young children, and their influence on a comprehensive cardiovascular risk profile. STUDY DESIGN: The sample included 95 healthy weight, 54 overweight, and 31 obese children (n=180, 10.9+/-2.1 years). All children had a medical assessment that included a physical examination and fasting investigations including glycated hemoglobin, total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, insulin and glucose levels. Body mass index and waist circumference z-scores were calculated. Children's fitness level was measured with the Queens College step test. RESULTS: Although low fitness was independently associated with cardiovascular risk, multi-level analysis demonstrated that waist circumference z-score was the only significant predictor of cardiovascular risk factors including SBP (beta=3.29, P<.001), DBP (beta=1.88, P<.005), high-density lipoprotein (beta=-0.12, P<.001), and triglyceride levels (beta=0.14, p<.001), fasting insulin (beta=2.83, P<.001), C-peptide (beta=0.11, P<.001), and HOMA-IR (beta=0.34, P<.001), with increasing waist circumference z-score associated with increasing cardiovascular risk. Within the healthy weight children, high fitness was associated with significantly reduced triglyceride levels, and lower fasting glucose, insulin and HOMA-IR. CONCLUSIONS: Young children's health may be influenced more by body fatness, and in particular, the distribution of body fat than by cardiorespiratory fitness. However, within the healthy weight children, high fitness was associated with a favorable metabolic profile, suggesting that cardiorespiratory fitness may exert a protective effect on metabolic risk in children whose risk is not confounded by fatness.
Assuntos
Tecido Adiposo/metabolismo , Doenças Cardiovasculares/etiologia , Obesidade , Aptidão Física , Índice de Massa Corporal , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Obesidade/complicações , Obesidade/metabolismo , Obesidade/fisiopatologia , Fatores de Risco , Circunferência da CinturaRESUMO
OBJECTIVE: To characterize the effects of severe hypoglycemia on the developing brain in children with early-onset type 1 diabetes mellitus (T1DM). STUDY DESIGN: Children diagnosed with T1DM before age 6 years were studied. Those with prospectively monitored severe hypoglycemia (coma/seizure; n = 32) were compared with age-matched peers (n = 30) with no history of such events using magnetic resonance imaging. Glycemic control (evaluated based on glycated hemoglobin [HbA(lc)] level), episodes of diabetic ketoacidosis (DKA), and clinical variables were monitored continuously since diagnosis in all subjects. RESULTS: Mean HbA(lc) from diagnosis and the duration of T1DM were similar in those with and without a history of severe hypoglycemia (9.0% +/- 0.9% vs 8.8% +/- 0.9%; 7.2 +/- 2.7 years vs 6.7 +/- 2.3 years). A high prevalence of central nervous system (CNS) structural abnormalities was detected (29%), and mesial temporal sclerosis (MTS) was detected in 16% of the total sample (n = 62). The presence of MTS was not associated with a history of severe hypoglycemia or DKA. Analysis of brain matter volumes suggested relatively less gray matter density in those subjects with a history of severe hypoglycemia. CONCLUSIONS: Early age of onset of T1DM per se is associated with a high incidence of CNS abnormalities, particularly MTS, suggesting hippocampal damage. Early-onset severe hypoglycemia may have an effect on gray matter volume.
Assuntos
Doenças do Sistema Nervoso Central/epidemiologia , Diabetes Mellitus Tipo 1/complicações , Idade de Início , Doenças do Sistema Nervoso Central/diagnóstico , Doenças do Sistema Nervoso Central/etiologia , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Feminino , Seguimentos , Hemoglobinas Glicadas/metabolismo , Humanos , Imageamento por Ressonância Magnética , Masculino , Prevalência , Prognóstico , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Austrália Ocidental/epidemiologiaRESUMO
OBJECTIVE: To investigate whether severe hypoglycemia in young children with early-onset type 1 diabetes (T1DM) is associated with subsequent abnormalities in cognitive status. STUDY DESIGN: Recruitment was from a large population-based database of children and adolescents with T1DM. Children and adolescents with early-onset T1DM (<6 years) were eligible for the study. Diabetic individuals (n = 41) with a prospectively documented history of seizure or coma were compared with peers with no history of severe hypoglycemic events (n = 43). A comprehensive test battery of learning and memory was used together with intellectual and behavioral measures. RESULTS: No significant group differences were revealed on the intellectual, memory, or behavioral measures. Similarly, those participants with a history of early first seizure did not differ from their peers with no seizures. There were no significant group differences on the memory subtests that were examined given their potential sensitivity to compromised hippocampal function. CONCLUSIONS: There was no clear evidence from this cohort that episodes of seizure or coma, even those occurring in very early childhood, resulted in broad cognitive dysfunction, nor was there evidence of specific memory difficulties at the time of testing in children and adolescents with early-onset T1DM.
Assuntos
Transtornos Cognitivos/epidemiologia , Diabetes Mellitus Tipo 1/epidemiologia , Hipoglicemia/complicações , Idade de Início , Estudos de Casos e Controles , Criança , Comportamento Infantil , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Coma Insulínico/complicações , Inteligência , Masculino , Memória , Convulsões/complicações , Austrália Ocidental/epidemiologiaRESUMO
OBJECTIVES: Atherosclerosis is a disease that begins in childhood; endothelial dysfunction is its earliest detectable manifestation, and primary prevention strategies are likely to be most effective if instituted early. The aim of this study was to characterize the impact of obesity on vascular function in young children and to determine whether an exercise program improves abnormalities in vascular function. STUDY DESIGN: The influence of 8 weeks of exercise training was examined in 14 obese subjects, 8.9 +/- 0.4 years of age, with the use of a randomized crossover protocol. Conduit vessel endothelial function was assessed by means of high-resolution ultrasound and flow-mediated dilation of the brachial artery (FMD). RESULTS: Exercise training did not change subcutaneous fat mass, body weight, or body mass index. FMD in the obese group was significantly impaired relative to matched control subjects at entry (6.00% +/- 0.69% to 12.32% +/- 3.14%, P <.0001). FMD significantly improved with exercise training (7.35% +/- 0.99%, P <.05) in the obese group. CONCLUSIONS: Conduit vessel FMD, a validated surrogate measure of early atherosclerosis, was impaired in obese children but improved as a result of exercise training. This study supports the value of an exercise program in the treatment of obese children in a primary prevention setting.