Glycemic control and quality of life in children, adolescents and young adults with type-1 diabetes mellitus described in a world-wide cross-sectional study in 2012: Impact of age-patient-related, treatment-related, behavior and structure of care-related variables.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5,000
- 试验地点
- 20
- 主要终点
- Evaluation of the percentage of type-1 diabetes mellitus (T1DM) patients with controlled glycemia reflected by HbA1c at targets according to guidelines in predefined age groups.
研究概览
简要总结
It is an observational non interventional disease registry to assess glycemic control and thee quality of life in type 1 diabetes mellitus aged between 8 and 25 and to evaluate the impact of age-patient related, treatment-related, behaviour and structure of the care related variables in this patient population.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary objective of this study Evaluation of the percentage of type-1 diabetes mellitus (T1DM) patients with controlled glycemia reflected by HbA1c at targets according to guidelines in predefined age groups. The parameters would be evaluated with the use of CRF and tools like quality of life questionare PedsQL and emotional status using Problem Areas in Diabetes (PAID) by patients and their parents.
This is a worldwide cross-sectional study 2012 expected to enroll globally 5000-7000 patients across 21 countries, India will enroll 400 patients across 20 sites.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 8.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged > 8 to < 25 years old, diagnosed at least 1 year prior to the study entry with type-1 diabetes mellitus.
- •Signed written informed consent obtained from the patient if applicable or from the parent(s)/guardian.
排除标准
- •T1DM diagnosed after 18 years of age for patients 18 years old.
- •Diabetes other than type-1 diabetes (e.g. type-2 diabetes, secondary diabetes mellitus (pancreatic history, drug- or chemical-induced diabetes), genetic defects in β-cell function or insulin action).
- •Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 7 consecutive days or more within the last 3 months.
- •Patients with known uncontrolled or inadequately controlled hyperthyroidism or hypothyroidism.
- •Change from pump regimen to multiple insulin injections regimen within the last 3 months.
- •Treatment with oral antidiabetic drugs (OAD) (except metformin which is permitted) at any time from the diagnosis.
- •Treatment with any investigational drug within the last 3 months.
- •Any known medical condition impacting red blood cells production or destruction such as hemoglobinopathy, polycythemia, splenectomy, iron deficiency anemia, hemorrhage, myelodysplastic disease or receipt or donation of blood or plasma products within the last 3 months.
- •Patient or parent/legally authorized representative(s) unable to understand the nature and scope of the study, unable to read and write or unlikely to comply with the protocol, e.g. inability and unwillingness to complete the questionnaires.
- •Children or relatives of the Investigators, research assistants, study coordinator or other staff directly involved in the conduct of the protocol, employee of the Sponsor or of Sponsor’s representatives.
结局指标
主要结局
Evaluation of the percentage of type-1 diabetes mellitus (T1DM) patients with controlled glycemia reflected by HbA1c at targets according to guidelines in predefined age groups.
时间窗: Evaluation of the percentage of type-1 diabetes mellitus (T1DM) patients with controlled glycemia reflected by HbA1c at targets according to guidelines in predefined age groups.
次要结局
- Quality of life (QOL) of T1DM patients evaluated with PedsQL questionnaires for patients and parents/guardian in the different predefined age classes (subgroup analysis with controlled and uncontrolled patients(at the time of visit)