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1.
Postgrad Med ; 128(8): 731-739, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27690710

RESUMO

OBJECTIVE: This study aims to compare the effectiveness of insulin glargine 300 U/mL (Gla-300) with its accompanying patient support program with that of other basal insulin and available patient support programs in patients with type 2 diabetes (T2D) in a real-world setting in terms of achieving HEDIS (Healthcare Effectiveness Data and Information Set) individualized glycemic targets without documented symptomatic hypoglycemia. METHODS: Achieve Control is a US-based, multicenter, randomized, open-label, active-controlled, parallel group pragmatic Phase IV trial in insulin-naïve patients with T2D uncontrolled on ≥2 oral antidiabetes drugs (OAD) and/or glucagon-like peptide-1 receptor antagonists (GLP-1 RA). Inclusion criteria include a diagnosis of T2D, age ≥18 years, and glycated hemoglobin (HbA1c) between 8.0% and 11.0%. Patients will be assigned to either the Gla-300 or other basal insulin group. The primary end point is the proportion of patients achieving HEDIS HbA1c targets (<8.0% [64 mmol/mol] in patients with comorbidities or aged ≥65 years; <7.0% [58 mmol/mol] in all other patients) without occurrence of symptomatic hypoglycemia (blood glucose ≤70 mg/dL) from baseline to 6 months. Secondary end points include rates of documented symptomatic nocturnal hypoglycemia and severe hypoglycemia; change from baseline in HbA1c, fasting glucose, and body weight; treatment persistence; patient-reported outcomes; and healthcare resource utilization. Planned enrollment is 3270 patients across approximately 400 clinical sites. CONCLUSION: Pragmatic clinical trials offer the potential to assess comparative effectiveness in broadly based patient populations receiving care (with or without a corresponding educational support program) in real-world clinical settings. The results of Achieve Control should elucidate the benefits of management of T2D with Gla-300 versus other basal insulins in terms of patient outcomes, experiences, and perceptions, and its impact on healthcare resource utilization and cost. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT02451137.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina Detemir/uso terapêutico , Insulina Glargina/uso terapêutico , Idoso , Glicemia , Peso Corporal , Comorbidade , Relação Dose-Resposta a Droga , Esquema de Medicação , Quimioterapia Combinada , Feminino , Receptor do Peptídeo Semelhante ao Glucagon 1/antagonistas & inibidores , Hemoglobinas Glicadas , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Hipoglicemia , Hipoglicemiantes/administração & dosagem , Insulina Detemir/administração & dosagem , Insulina Glargina/administração & dosagem , Masculino , Medidas de Resultados Relatados pelo Paciente , Estados Unidos
2.
J Clin Sleep Med ; 10(7): 787-92, 2014 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-25024657

RESUMO

PURPOSE: To determine the feasibility and pilot a sleep education program in New Zealand high school students. METHODS: A parallel, two-arm randomized controlled pilot trial was conducted. High school students (13 to 16 years) were randomly allocated to either a classroom-based sleep education program intervention (n = 15) or to a usual curriculum control group (n = 14). The sleep education program involved four 50-minute classroom-based education sessions with interactive groups. Students completed a 7-day sleep diary, a sleep questionnaire (including sleep hygiene, knowledge and problems) at baseline, post-intervention (4 weeks) and 10 weeks follow-up. RESULTS: An overall treatment effect was observed for weekend sleep duration (F 1,24 = 5.21, p = 0.03). Participants in the intervention group slept longer during weekend nights at 5 weeks (1:37 h:min, p = 0.01) and 10 weeks: (1:32 h:min, p = 0.03) compared to those in the control group. No differences were found between groups for sleep duration on weekday nights. No significant differences were observed between groups for any of the secondary outcomes (sleep hygiene, sleep problems, or sleep knowledge). CONCLUSIONS: A sleep education program appears to increase weekend sleep duration in the short term. Although this program was feasible, most schools are under time and resource pressure, thus alternative methods of delivery should be assessed for feasibility and efficacy. Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes. COMMENTARY: A commentary on this article appears in this issue on page 793.


Assuntos
Educação em Saúde/métodos , Desenvolvimento de Programas/métodos , Avaliação de Programas e Projetos de Saúde/métodos , Sono , Adolescente , Currículo , Estudos de Viabilidade , Feminino , Educação em Saúde/estatística & dados numéricos , Humanos , Masculino , Nova Zelândia , Projetos Piloto , Desenvolvimento de Programas/estatística & dados numéricos , Avaliação de Programas e Projetos de Saúde/estatística & dados numéricos , Estudantes , Inquéritos e Questionários , Fatores de Tempo
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