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AIMS/HYPOTHESIS: The aim of this work was to examine whether glycaemic control has improved in those with type 1 diabetes in Scotland between 2004 and 2016, and whether any trends differed by sociodemographic factors. METHODS: We analysed records from 30,717 people with type 1 diabetes, registered anytime between 2004 and 2016 in the national diabetes database, which contained repeated measures of HbA1c. An additive mixed regression model was used to estimate calendar time and other effects on HbA1c. RESULTS: Overall, median (IQR) HbA1c decreased from 72 (21) mmol/mol [8.7 (4.1)%] in 2004 to 68 (21) mmol/mol (8.4 [4.1]%) in 2016. However, all of the improvement across the period occurred in the latter 4 years: the regression model showed that the only period of significant change in HbA1c was 2012-2016 where there was a fall of 3 (95% CI 1.82, 3.43) mmol/mol. The largest reductions in HbA1c in this period were seen in children, from 69 (16) mmol/mol (8.5 [3.6]%) to 63 (14) mmol/mol (7.9 [3.4]%), and adolescents, from 75 (25) mmol/mol (9.0 [4.4]%) to 70 (23) mmol/mol (8.6 [4.3]%). Socioeconomic status (according to Scottish Index of Multiple Deprivation) affected the HbA1c values: from the regression model, the 20% of people living in the most-deprived areas had HbA1c levels on average 8.0 (95% CI 7.4, 8.9) mmol/mol higher than those of the 20% of people living in the least-deprived areas. However this difference did not change significantly over time. From the regression model HbA1c was on average 1.7 (95% CI 1.6, 1.8) mmol/mol higher in women than in men. This sex difference did not narrow over time. CONCLUSIONS/INTERPRETATION: In this high-income country, we identified a modest but important improvement in HbA1c since 2012 that was most marked in children and adolescents. These changes coincided with national initiatives to reduce HbA1c including an expansion of pump therapy. However, in most people, overall glycaemic control remains far from target levels and further improvement is badly needed, particularly in those from more-deprived areas.
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Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/epidemiología , Hemoglobina Glucada/análisis , Hiperglucemia/sangre , Hiperglucemia/epidemiología , Adolescente , Adulto , Glucemia/análisis , Femenino , Humanos , Sistemas de Infusión de Insulina , Masculino , Persona de Mediana Edad , Prevalencia , Análisis de Regresión , Escocia/epidemiología , Clase Social , Adulto JovenRESUMEN
CONTEXT: Type 1 diabetes (T1D) is associated with an increased fracture risk at all ages. OBJECTIVE: To understand the determinants of bone health and fractures in children with T1D. DESIGN: Case-control study of children with T1D on bone-turnover markers, dual-energy X-ray absorptiometry, and 3 Tesla-MRI of the proximal tibia to assess bone microarchitecture and vertebral marrow adiposity compared with age- and sex-matched healthy children. RESULTS: Thirty-two children with T1D at a median (range) age of 13.7 years (10.4, 16.7) and 26 controls, aged 13.8 years (10.2, 17.8), were recruited. In children with T1D, serum bone-specific alkaline phosphatase (BAP) SD score (SDS), C-terminal telopeptide of type I collagen SDS, and total body (TB) and lumbar spine bone mineral density (BMD) SDS were lower (all P < 0.05). Children with T1D also had lower trabecular volume [0.55 (0.47, 0.63) vs 0.59 (0.47, 0.63); P = 0.024], lower trabecular number [1.67 (1.56, 1.93) vs 1.82 (1.56, 1.99); P = 0.004], and higher trabecular separation [0.27 (0.21, 0.32) vs 0.24 (0.20, 0.33); P = 0.001] than controls. Marrow adiposity was similar in both groups (P = 0.25). Bone formation, as assessed by BAP, was lower in children with poorer glycemic control (P = 0.009) and who were acidotic at initial presentation (P = 0.017) but higher in children on continuous subcutaneous insulin infusion (P = 0.025). Fractures were more likely to be encountered in children with T1D compared with controls (31% vs 19%; P< 0.001). Compared with those without fractures, the T1D children with a fracture history had poorer glycemic control (P = 0.007) and lower TB BMD (P < 0.001) but no differences in bone microarchitecture. CONCLUSION: Children with T1D display a low bone-turnover state with reduced bone mineralization and poorer bone microarchitecture.
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Densidad Ósea , Remodelación Ósea , Diabetes Mellitus Tipo 1/fisiopatología , Fracturas Óseas/etiología , Osteoporosis/etiología , Absorciometría de Fotón , Adiposidad , Adolescente , Médula Ósea/diagnóstico por imagen , Médula Ósea/fisiopatología , Niño , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 1/diagnóstico por imagen , Femenino , Humanos , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/fisiopatología , Imagen por Resonancia Magnética/métodos , Masculino , Tibia/diagnóstico por imagen , Tibia/fisiopatologíaRESUMEN
Aniseikonia is a difference in the perceived size or shape of images between eyes, and can arise from a variety of physiological, neurological, retinal, and optical causes. Aniseikonia is associated with anisometropia, as both anisometropia itself and the optical correction for anisometropia can cause aniseikonia. Image size differences above one to three per cent can be clinically symptomatic. Common symptoms include asthenopia, headache and diplopia in vertical gaze. Size differences of three and more impair binocular visual functions such as binocular summation and stereopsis. Above five per cent of aniseikonia, binocular inhibition or suppression tend to occur to prevent diplopia and confusion. Aniseikonia can be measured using a range of techniques and can be corrected or reduced by prescribing contact lenses or specially designed spectacle lenses. Subjective testing of aniseikonia is the only way to accurately measure the overall perceived amount of aniseikonia. However, currently it is not routinely assessed in most clinical settings. At least two-thirds of patients with amblyopia have anisometropia, thus we may expect aniseikonia to be common in patients with anisometropic amblyopia. However, aniseikonia may not be experienced by the patient under normal binocular viewing conditions if the image from the amblyopic eye is of poor quality or is too strongly suppressed for image size differences to be recognised. This lack of binocular simultaneous perception in amblyopia may also prevent the measurement of aniseikonia, as most common techniques require direct comparisons of images seen by each eye. Current guidelines for the treatment of amblyopia advocate full correction of anisometropia to equalise image clarity, but do not address aniseikonia. Significant image size differences between eyes may lead to suppression and abnormal binocular adaptations. It is possible that correcting anisometropia and aniseikonia simultaneously, particularly at the initial diagnosis of anisometropia, would reduce the need to develop suppression and improve treatment outcomes for anisometropic amblyopia.
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Ambliopía/etiología , Ambliopía/terapia , Aniseiconia/etiología , Anisometropía/complicaciones , Ambliopía/diagnóstico , Aniseiconia/diagnóstico , Aniseiconia/terapia , Anisometropía/diagnóstico , Anisometropía/terapia , HumanosRESUMEN
BACKGROUND: Glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors improve glycaemic control and reduce bodyweight in patients with type 2 diabetes through different mechanisms. We assessed the safety and efficacy of the addition of the once-weekly GLP-1 receptor agonist dulaglutide to the ongoing treatment regimen in patients whose diabetes is inadequately controlled with SGLT2 inhibitors, with or without metformin. METHODS: AWARD-10 was a phase 3b, double-blind, parallel-arm, placebo-controlled, 24-week study done at 40 clinical sites in Austria, Czech Republic, Germany, Hungary, Israel, Mexico, Spain, and the USA. Eligible adult patients (≥18 years) with inadequately controlled type 2 diabetes (HbA1c concentration ≥7·0% [53 mmol/mol] and ≤9·5% [80 mmol/mol]), a BMI of 45 kg/m2 or less, and taking stable doses (>3 months) of an SGLT2 inhibitor (with or without metformin) were randomly assigned (1:1:1) via an interactive web-response system to subcutaneous injections of either dulaglutide 1·5 mg, dulaglutide 0·75 mg, or placebo once per week for 24 weeks. Patients and investigators were masked to dulaglutide and placebo assignment, and those assessing outcomes were masked to study drug assignment. The primary objective was to test for the superiority of dulaglutide (1·5 mg or 0·75 mg) versus placebo for change in HbA1c concentration from baseline at 24 weeks. All analyses were done in the intention-to-treat population, defined as all randomly assigned patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT02597049. FINDINGS: Between Dec 7, 2015, and Feb 3, 2017, 424 patients were randomly assigned to dulaglutide 1·5 mg (n=142), dulaglutide 0·75 mg (n=142), and placebo (n=140). One patient in the dulaglutide 0·75 mg group was excluded from the analysis because they did not receive any dose of the study drug. The reduction in HbA1c concentration at 24 weeks was larger in patients receiving dulaglutide (least squares mean [LSM] for dulaglutide 1·5 mg -1·34% [SE 0·06] or -14·7 mmol/mol [0·6]; dulaglutide 0·75 mg -1·21% [0·06] or -13·2 mmol/mol [0·6]) than in patients receiving placebo (-0·54% [0·06] or -5·9 mmol/mol [0·6]; p<0·0001 for both groups vs placebo). The LSM differences were -0·79% (95% CI -0·97 to -0·61) or -8·6 mmol/mol (-10·6 to -6·7) for dulaglutide 1·5 mg and -0·66% (-0·84 to -0·49) or -7·2 mmol/mol (-9·2 to -5·4) for dulaglutide 0·75 mg (p<0·0001 for both). Serious adverse events were reported for five (4%) patients in the dulaglutide 1·5 mg group, three (2%) patients in the dulaglutide 0·75 mg group, and five (4%) patients in the placebo group. Treatment-emergent adverse events were more common in patients treated with dulaglutide than in patients who received placebo, mainly because of an increased incidence of gastrointestinal adverse events. Nausea (21 [15%] patients in the dulaglutide 1·5 mg group vs seven [5%] in the dulaglutide 0·75 mg group vs five [4%] in the placebo group), diarrhoea (eight [6%] vs 14 [10%] vs four [3%]), and vomiting (five [4%] vs four [3%] vs one [1%]) were more common with dulaglutide than with placebo. One episode of severe hypoglycaemia was reported in the dulaglutide 0·75 mg group. Two (1%) patients receiving dulaglutide 1·5 mg died, but these deaths were not considered to be related to study drug; no deaths occurred in the other groups. INTERPRETATION: Dulaglutide as add-on treatment to SGLT2 inhibitors (with or without metformin) resulted in significant and clinically relevant improvements in glycaemic control, with acceptable tolerability that is consistent with the established safety profile of dulaglutide. FUNDING: Eli Lilly and Company.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Péptidos Similares al Glucagón/análogos & derivados , Hipoglucemiantes/uso terapéutico , Fragmentos Fc de Inmunoglobulinas/uso terapéutico , Proteínas Recombinantes de Fusión/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Diabetes Mellitus Tipo 2/sangre , Método Doble Ciego , Quimioterapia Combinada , Femenino , Péptidos Similares al Glucagón/uso terapéutico , Hemoglobina Glucada/análisis , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
BACKGROUND: Evidence suggests youth with type 1 diabetes (T1D) have lower levels of physical activity (PA) than the general population. The ActivPals intervention aimed to support youth with T1D to lead an active lifestyle. METHODS: Twenty youth aged 7 to 16 years with T1D were recruited to a pilot randomized controlled trial. PA and quality of life (QoL) were measured using Actigraph GT3X+ monitor and Pediatric QoL scales at baseline and 1-month follow-up. A two-way, mixed ANOVA showed indicative effects of the intervention. Qualitative interviews were carried out with 16 participants to explore perceptions of the intervention. RESULTS: An increase in moderate to vigorous PA was reported in intervention and control groups from baseline to follow-up (F(1, 14) = 5.83; P = .03), with no significance between group differences. Participants in both groups reported significantly less overall diabetes "problems" (F(1, 16) = 7.93; P = .012) and significantly less lifestyle "problems" (F(1, 16) = 7.39; P = .015) at follow-up. However, both groups also reported significant increases in "problems" with the day-to-day diabetes routine (F(1,16) = 6.48; P = .022) at follow-up. Parents reported significant increased worry about their child's diabetes at follow-up, in both groups (F(1, 14) = 5.83; P = .046). There was no significant increase in reported hypoglycemic occurrences despite increased PA. The qualitative data highlight that goal setting, self-monitoring, and social support were effective motivators for increasing PA. CONCLUSIONS: A larger trial with longer follow-up should be conducted to explore the effect of the intervention on PA in youth with T1D.
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Diabetes Mellitus Tipo 1/psicología , Diabetes Mellitus Tipo 1/terapia , Ejercicio Físico , Estilo de Vida , Actigrafía , Adolescente , Niño , Estudios de Factibilidad , Femenino , Humanos , Masculino , Proyectos Piloto , Calidad de Vida , Conducta de Reducción del Riesgo , Apoyo SocialRESUMEN
AIMS: To evaluate the efficacy and safety of dulaglutide 1.5 and 0.75 mg in patients with type 2 diabetes by subgroups of gender, duration of diabetes and baseline glycated haemoglobin (HbA1c) in the dulaglutide clinical development programme (AWARD-1 to -6 and -8 clinical trials). METHODS: Change in HbA1c was analysed by gender, duration of diabetes (<5, ≥5 years and <10, ≥10 years), and baseline HbA1c (<8.5%, ≥8.5%) in pooled and individual studies. Changes from baseline in weight, hypoglycaemia and gastrointestinal adverse events were evaluated for individual trials. RESULTS: In the pooled analysis of patients treated with dulaglutide 1.5 mg at 6 months, the reductions in HbA1c from baseline were similar across gender (men: least squares [LS] mean -1.26% [95% confidence interval {CI} -1.36, -1.16]; women: LS mean -1.33% [95% CI -1.43, -1.24]) and among duration of diabetes subgroups (<5 years: LS mean -1.32% [95% CI -1.43, -1.22]; ≥5 and <10 years: LS mean -1.33% [95% CI -1.43, -1.22]; ≥10 years: -1.24% [95% CI -1.35, -1.14]). Patients with baseline HbA1c ≥8.5% had greater HbA1c reductions than patients with baseline HbA1c <8.5%, (≥8.5%: LS mean -1.86% [95% CI -1.97, -1.75]; <8.5%: LS mean -1.02% [95% CI -1.12, -0.93]). Reductions in fasting blood glucose (FBG) were consistent with HbA1c changes. Similar results were observed with dulaglutide 0.75 mg. In general, body weight changes were similar among duration of diabetes and in baseline HbA1c subgroups, respectively; women had a numerically greater weight loss or less weight gain than men with both dulaglutide doses. There was no clinically meaningful difference in hypoglycaemia trends by gender or duration of diabetes. Hypoglycaemia incidence and rate were generally lower in patients with baseline HbA1c ≥8.5% than in those with <8.5%, except for the AWARD-4 study (combination with mealtime insulin). CONCLUSIONS: Across the AWARD studies, dulaglutide demonstrated significant improvements in glycaemic control irrespective of gender, duration of diabetes, or baseline HbA1c, with greater HbA1c and FBG reductions in patients with a higher baseline HbA1c. Dulaglutide was well tolerated, with a safety profile similar to other glucagon-like peptide-1 receptor agonists.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Receptor del Péptido 1 Similar al Glucagón/agonistas , Péptidos Similares al Glucagón/análogos & derivados , Hiperglucemia/prevención & control , Hipoglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Fragmentos Fc de Inmunoglobulinas/administración & dosificación , Proteínas Recombinantes de Fusión/administración & dosificación , Anciano , Glucemia/análisis , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/metabolismo , Diarrea/inducido químicamente , Esquema de Medicación , Quimioterapia Combinada/efectos adversos , Femenino , Receptor del Péptido 1 Similar al Glucagón/metabolismo , Péptidos Similares al Glucagón/administración & dosificación , Péptidos Similares al Glucagón/efectos adversos , Péptidos Similares al Glucagón/uso terapéutico , Hemoglobina Glucada/análisis , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Fragmentos Fc de Inmunoglobulinas/efectos adversos , Fragmentos Fc de Inmunoglobulinas/uso terapéutico , Insulina/administración & dosificación , Insulina/efectos adversos , Insulina/uso terapéutico , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Proteínas Recombinantes de Fusión/efectos adversos , Proteínas Recombinantes de Fusión/uso terapéutico , Caracteres Sexuales , Vómitos/inducido químicamente , Aumento de Peso/efectos de los fármacos , Pérdida de Peso/efectos de los fármacosAsunto(s)
Glucemia , Enfermedad Crítica , Niño , Cuidados Críticos , Humanos , Hipoglucemiantes , InsulinaAsunto(s)
Insulina , Metformina , Adolescente , Glucemia , Diabetes Mellitus Tipo 1 , Humanos , Hipoglucemiantes , ObesidadRESUMEN
BACKGROUND: The global incidence of type 1 diabetes is rising, and youths with type 1 diabetes continue to suffer poorer health than peers without diabetes. Evidence suggests youths with type 1 diabetes have physical activity (PA) levels well below the recommendations for health and have high levels of sedentary behaviour. An active lifestyle is therefore recommended to improve health. There is limited research showing effective lifestyle behaviour change in this population; therefore, an evidence gap exists between the need to promote physical activity in type 1 diabetes care and lack of understanding on how to do this. This protocol paper describes a feasibility and pilot study of the ActivPals programme-an intervention to support active lifestyles in youths with type 1 diabetes. METHODS/DESIGN: Key intervention components have been identified from preliminary work (individual and family focus, peer mentoring, technology integration and improved communication and understanding) and are being developed into a pragmatic randomised controlled trial (RCT) supported by recruitment pathways. A steering group of health care professionals and managers will refine the intervention to patient needs. A pilot trial is providing data on intervention implementation, acceptability and feasibility. Twenty youths with type 1 diabetes are being recruited and randomised into an intervention or control group. Physical activity is being measured objectively using the Actigraph GT3X+ monitor at baseline and 1-month follow-up. Contextual factors associated with intervention delivery are being explored. DISCUSSION: This study will contribute to the development of evidence-based, user-informed and pragmatic interventions leading to healthier lifestyles in youths with type 1 diabetes.
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OBJECTIVES: To determine whether the likelihood of readmission (adjusted for severity on first admission) for pediatric type 1 diabetes (T1D) differs between Medicaid managed care and non-managed care. STUDY DESIGN: De-identified patients were retrospectively selected from the Pediatric Health Information Systems database of the Children's Hospital Association (CHA). The cohort of 42 hospitals across 25 states included discharges between 2008 and 2011 for patients who were receiving Medicaid at the time of service and had T1D as their diagnosis. METHODS: Multiple factors and co-variants for readmission were analyzed by logistic regression, including age, race, gender, severity of illness, and state of admission. RESULTS: Of 14,544 T1D discharges with Medicaid, 4985 were readmitted, including 1792 readmitted for diabetic ketoacidosis (DKA). Despite similar rates of DKA between the managed care and non-managed care cohorts, overall 90-day readmission was 1.12 times more likely for Medicaid patients on non-managed care plans than those on managed care (odds ratio, 1.12; range = 1.04-1.20; both adjusted for severity of illness). Significant contributors were race, age, and gender; the relationship of location (state) and days between readmissions was also significant. The conservative estimate of cost reduction from Medicaid managed care related to lower readmission rate for pediatric T1D across CHA institutions between 2008 and 2011 was $2.6 million. CONCLUSIONS: From the largest, national, defined cohort available for contemporary study, youths with T1D on Medicaid managed care plans were less likely to be readmitted within 90 days of discharge.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hospitales Pediátricos , Programas Controlados de Atención en Salud/organización & administración , Medicaid/organización & administración , Readmisión del Paciente/estadística & datos numéricos , Factores de Edad , Estudios de Cohortes , Bases de Datos Factuales , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/epidemiología , Femenino , Estudios de Seguimiento , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Humanos , Modelos Logísticos , Masculino , Oportunidad Relativa , Readmisión del Paciente/economía , Mejoramiento de la Calidad , Estudios Retrospectivos , Medición de Riesgo , Factores Sexuales , Resultado del Tratamiento , Estados UnidosRESUMEN
A patient with hepatitis C infection and hepatocellular carcinoma developed significant hyperbilirubinemia and acute kidney injury after initiation of a simeprevir and sofosbuvir regimen.
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OBJECTIVE: To explore stakeholder's perceptions of physical activity (PA) and sedentary behaviour support in youth with type 1 diabetes (T1D), to aid intervention development. METHODS: Primary data were collected between February and September 2012. Patients (N = 16), parents (N = 16), and professionals (N = 9) were recruited from a diabetes clinic for a qualitative study. Semi-structured interviews (N = 33) and focus groups (N = 2), using broad open-ended questions, were conducted in patient's/parent's homes, and at the diabetes clinic. Data were analysed thematically. RESULTS: Based on participants' experiences and interpretations, parent and peer support were perceived as essential. Professionals identified they could do more to encourage PA. Technology and information on local opportunities, in addition to in-person support, and a combination of group and one-to-one support were perceived as useful. Important perceived components of support were: diabetes preparation, management and support; enjoyment; education; and incorporation of behaviour change techniques. The time of diagnosis was described as an appropriate point to initiate interventions. CONCLUSIONS: The findings will help the development of future PA and sedentary behaviour interventions for youth with T1D.
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Diabetes Mellitus Tipo 1/terapia , Conocimientos, Actitudes y Práctica en Salud , Actividad Motora , Percepción , Conducta Sedentaria , Apoyo Social , Adolescente , Adulto , Cuidadores/psicología , Niño , Diabetes Mellitus Tipo 1/epidemiología , Diabetes Mellitus Tipo 1/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Padres/psicología , Grupo de Atención al Paciente/estadística & datos numéricos , Encuestas y CuestionariosRESUMEN
BACKGROUND: In this review of the visual development of children with Down syndrome we were specifically interested in how refractive error, binocular alignment and accommodation are different in Down syndrome from the general population. The differences and their aetiology will help practitioners make informed decisions about the visual assessment and management of these children. METHODS: Articles found using searches through Scopus, Medline and Google Scholar were evaluated by examining sample sizes, appropriate use of controls, methods of measurement and statistical significance of findings. Where the strength of evidence in an article might be weak, this is reported in the review. CONCLUSION: The development of the visual and oculomotor systems is substantially different in Down syndrome compared with the general population. Assessment and optometric management of this special population need to be directed accordingly.
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Acomodación Ocular , Síndrome de Down/complicaciones , Errores de Refracción , Visión Binocular , Niño , Salud Global , Humanos , Incidencia , Errores de Refracción/complicaciones , Errores de Refracción/epidemiología , Errores de Refracción/fisiopatologíaAsunto(s)
Diabetes Mellitus Tipo 1/terapia , Medicina Basada en la Evidencia , Ejercicio Físico , Hipoglucemia/prevención & control , Educación del Paciente como Asunto , Medicina de Precisión , Autocuidado , Adolescente , Medicina del Adolescente/tendencias , Niño , Preescolar , Ritmo Circadiano , Terapia Combinada , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/dietoterapia , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/dietoterapia , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/terapia , Dieta para Diabéticos , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemia/epidemiología , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/uso terapéutico , Lactante , Insulina/administración & dosificación , Insulina/uso terapéutico , Agencias Internacionales , Pediatría/tendencias , Sociedades CientíficasRESUMEN
Glucagon-like peptide-1 receptor agonists, used to treat type 2 diabetes mellitus, are associated with small reductions in systolic blood pressure (SBP) and increases in heart rate. However, findings based on clinic measurements do not adequately assess a drug's 24-hour pharmacodynamic profile. The effects of dulaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, on BP and heart rate were investigated using ambulatory BP monitoring. Patients (n=755; 56±10 years; 81% white; 48% women), with type 2 diabetes mellitus, taking ≥1 oral antihyperglycemic medication, with a clinic BP between 90/60 and 140/90 mm Hg were randomized to dulaglutide (1.5 or 0.75 mg) or placebo subcutaneously for 26 weeks. Ambulatory BP monitoring was performed at baseline and at 4, 16, and 26 weeks. The primary end point was change from baseline to week 16 in mean 24-hour SBP, a tree gatekeeping strategy compared the effects of dulaglutide to placebo. Both doses of dulaglutide were noninferior to placebo for changes in 24-hour SBP and diastolic blood pressure, and dulaglutide 1.5 mg significantly reduced SBP (least squares mean difference [95% confidence interval]), -2.8 mm Hg [-4.6, -1.0]; P≤0.001). Dulaglutide 0.75 mg was noninferior to placebo (1.6 bpm; [0.3, 2.9]; P≤0.02) for 24-hour heart rate (least squares mean difference [95% confidence interval]), but dulaglutide 1.5 mg was not (2.8 bpm [1.5, 4.2]). Dulaglutide 1.5 mg was associated with a reduction in 24-hour SBP and an increase in 24-hour heart rate. The mechanisms responsible for the observed effects remain to be clarified.
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Presión Sanguínea/efectos de los fármacos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Péptidos Similares al Glucagón/análogos & derivados , Frecuencia Cardíaca/efectos de los fármacos , Fragmentos Fc de Inmunoglobulinas/uso terapéutico , Receptores de Glucagón/agonistas , Proteínas Recombinantes de Fusión/uso terapéutico , Anciano , Presión Sanguínea/fisiología , Monitoreo Ambulatorio de la Presión Arterial , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/fisiopatología , Diarrea/inducido químicamente , Método Doble Ciego , Esquema de Medicación , Femenino , Receptor del Péptido 1 Similar al Glucagón , Péptidos Similares al Glucagón/efectos adversos , Péptidos Similares al Glucagón/uso terapéutico , Hemoglobina Glucada/metabolismo , Frecuencia Cardíaca/fisiología , Humanos , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Fragmentos Fc de Inmunoglobulinas/efectos adversos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Proteínas Recombinantes de Fusión/efectos adversos , Resultado del Tratamiento , Vómitos/inducido químicamenteRESUMEN
OBJECTIVE: The aim of this study was to explore from parents' perspectives the circumstances and events which led to their child being diagnosed with type 1 diabetes (T1D). The objective was to understand reasons for delays in seeking treatment and parents' emotional reactions to diagnosis so others can be better informed and supported in future. METHODS: In-depth interviews with 54 parents of children (aged ≤12 yr) with T1D were conducted. Data analysis used an inductive, thematic approach. RESULTS: Parents described a 'prompt' and a 'delayed' pathway to their child being diagnosed. Parents who considered the diagnosis to be 'prompt' reported how they, or other people, had recognized their child had developed symptoms of T1D which resulted in a rapid presentation to health care professionals. In contrast, parents who perceived their child's diagnosis to be 'delayed' did not recognize signs of T1D and attributed their child's deteriorating health to other conditions, being out of routines and/or their stage of development. These parents often only sought medical help when symptoms became extreme. All parents were distressed by their child's diagnosis; however, parents in the 'delayed' pathway expressed unresolved feelings of guilt, particularly when their child was diagnosed with diabetic ketoacidosis. DISCUSSION: Parents' and other people's knowledge about T1D can affect the duration between onset of their child's symptoms and diagnosis. Campaigns to raise awareness should ensure that parents are made aware of symptoms and that T1D can develop during childhood. Health care professionals could discuss with parents the events preceding their child's diagnosis to better determine their emotional support needs.
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Diabetes Mellitus Tipo 1/psicología , Emociones , Relaciones Padres-Hijo , Padres/psicología , Adulto , Actitud , Concienciación , Niño , Preescolar , Diagnóstico Tardío/estadística & datos numéricos , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/epidemiología , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Persona de Mediana Edad , Percepción , Factores Socioeconómicos , Estrés Psicológico/epidemiologíaRESUMEN
OBJECTIVE: To systematically review physical activity and/or sedentary behavior intervention studies for youth with type 1 diabetes. METHODS: Several databases were searched for articles reporting on randomized-controlled trials (RCTs) in youth (<18 yr) with type 1 diabetes. Data was extracted and bias assessed to evaluate study characteristics, intervention design, and efficacy of interventions on physical activity and health. Where sufficient data were available meta-analyses of health outcomes [for hemoglobin A1c (HbA1c)] were performed. Weighted mean differences (WMD) were calculated using fixed and random effect models. RESULTS: The literature search identified 12/2397 full-text articles reporting on 11 studies. Two interventions were wholly unsupervised and only one was based on behavior change theory with no studies exploring changes in behavior processes. Nine interventions aimed to improve fitness or physical activity, two aimed to improve health, and none aimed at changing sedentary behavior. Eight interventions improved physical activity and/or fitness. At least one beneficial effect on health was found in each intervention group apart from two studies where no changes were found. Meta-analysis of 10 studies showed the interventions have a significant beneficial reduction of HbA1c (%), indicating an improvement in glycemic control [WMD, -0.85% (95% CI, -1.45 to -0.25%)]. There were insufficient data to pool other health outcome data. CONCLUSIONS: Few RCTs explored the efficacy of unsupervised theory-based physical activity and/or sedentary behavior interventions in youth with type 1 diabetes. Limited reporting made comparison of findings challenging. There was an overall significant beneficial effect of physical activity on HbA1c.
Asunto(s)
Conducta del Adolescente , Conducta Infantil , Diabetes Mellitus Tipo 1/terapia , Medicina Basada en la Evidencia , Estilo de Vida , Actividad Motora , Adolescente , Niño , Terapia Combinada , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/dietoterapia , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Dieta para Diabéticos , Hemoglobina Glucada/análisis , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Aptitud Física , Ensayos Clínicos Controlados Aleatorios como Asunto , Conducta SedentariaRESUMEN
OBJECTIVE: Proinsulin is a marker of beta-cell distress and dysfunction in type 2 diabetes and transplanted islets. Proinsulin levels are elevated in patients newly diagnosed with type 1 diabetes. Our aim was to assess the relationship between proinsulin, insulin dose-adjusted haemoglobin A1c (IDAA1C), glucagon-like peptide-1 (GLP-1), glucagon, and remission status the first year after diagnosis of type 1 diabetes. METHODS: Juvenile patients (n = 275) were followed 1, 6, and 12 months after diagnosis. At each visit, partial remission was defined as IDAA1C ≤ 9%. The patients had a liquid meal test at the 1-, 6-, and 12-month visits, which included measurement of C-peptide, proinsulin, GLP-1, glucagon, and insulin antibodies (IA). RESULTS: Patients in remission at 6 and 12 months had significantly higher levels of proinsulin compared to non-remitting patients (p < 0.0001, p = 0.0002). An inverse association between proinsulin and IDAA1C was found at 1 and 6 months (p = 0.0008, p = 0.0022). Proinsulin was positively associated with C-peptide (p < 0.0001) and IA (p = 0.0024, p = 0.0068, p < 0.0001) at 1, 6, and 12 months. Glucagon (p < 0.0001 and p < 0.02) as well as GLP-1 (p = 0.0001 and p = 0.002) were significantly lower in remitters than in non-remitters at 6 and 12 months. Proinsulin associated positively with GLP-1 at 1 month (p = 0.004) and negatively at 6 (p = 0.002) and 12 months (p = 0.0002). CONCLUSIONS: In type 1 diabetes, patients in partial remission have higher levels of proinsulin together with lower levels of GLP-1 and glucagon compared to patients not in remission. In new onset type 1 diabetes proinsulin level may be a sign of better residual beta-cell function.