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临床试验/NCT01475422
NCT01475422Unknown不适用

Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home in Metabolic Control of People With Diabetes Mellitus

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
91
试验地点
1
主要终点
HbA1c

研究概览

简要总结

The self-monitoring of capillary blood glucose is part of the package of interventions in diabetes mellitus and an effective therapeutic strategy for the adequate control of the disease; and the continuing education of people with DM is recognized as one of the goals to delay the complications arising from chronic disease and alleviate the symptoms of hypoglycemia and hyperglycemia.

详细描述

This study aims to evaluate the effects of educational intervention on self-monitoring of capillary blood glucose in metabolic control, knowledge and attitude in two groups of patients with diabetes mellitus: a group of diabetic patients who participate in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive educational interventions (Intervention Group - G1) and a group of diabetic patients who participle in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive conventional treatment (Control Group - G2). As an educational tool in diabetes will be used Conversation Maps which is considered an interactive program of diabetes education.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 Years and older;
  • Diagnosis of type 1 and 2 diabetes mellitus;
  • In follow-up in the Self-Monitoring of Capillary Blood Glucose at Home Program;
  • Have cognitive conditions that enable participation (minimum ability of users to understand issues of data collection instruments, observation of the researcher and/or of the caregivers).

排除标准

  • Patients with gestational DM;
  • Patients with DM who are not located;
  • Those who die in the proposed period for the research;
  • Those who dropout the Self-Monitoring of Capillary Blood Glucose at Home Program;
  • Those who report difficulties to participate of the study due to work and those with amaurosis;
  • Used Conversation Maps as an educational tool.

结局指标

主要结局

HbA1c

时间窗: baseline, 3 and 6 months post intervention

Change from baseline in HbA1c at 6 months to less than 7%

次要结局

  • Diabetes Knowledge Questionnaire - DKN-A(baseline, 3 and 6 months post intervention)
  • Diabetes Attitude Questionnaire - ATT-19(baseline, 3 and 6 months post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vívian Saraiva Veras

PhD Student

University of Sao Paulo

研究点 (1)

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