NCT01176149已完成3 期
Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin: a Pilot Study
Consorzio Mario Negri Sud2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Improvement of metabolic control
研究概览
简要总结
The aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, when needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
- •Patients on treatment with OHA monotherapy (i.e. metformin alone or sulphonylureas alone or TZDs alone);
- •No need for insulin treatment;
- •Male and female patients, aged between 45-75 years;
- •Hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
- •No experience of self monitoring of blood glucose in the previous 12 months (SMBG performed with a frequency of < 1 times/week)
- •Ability and willingness to comply with all study requirements
- •Signature of consent form
排除标准
- •Patients incapable to perform SMBG
- •Patients needing insulin or multiple OHA association therapy
- •Patients needing a regular use of SMBG (e.g. frequent hypoglycemic episodes)
- •Diabetes care not exclusively managed by diabetic clinics
- •Patients with serious underlying medical or psychiatric condition
结局指标
主要结局
Improvement of metabolic control
Aim of this study is to evaluate the efficacy of Self Monitoring Blood Glucose and Intensive Education in terms of improvement of metabolic control expressed as HbA1c levels after 6 months.
次要结局
- Reduction in prandial Blood Glucose excursions
- Percentage of patients needing therapy modifications
- Percentage of patients reaching target HbA1c (i.e. <7.0%)
研究者
研究点 (2)
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