NCT01493388已完成不适用
Observational, Cross-sectional and Retrospective Study on Diabetes Mellitus Type 1 in Tunisian Children and Adolescents Under 15 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Percentage of children below 6 years with HbA1c less than 8.5%
研究概览
简要总结
This study is conducted in Africa. The aim of this study is to estimate the percentage of children and adolescents below or equal to 15 years in Tunisia with acceptably controlled diabetes mellitus type 1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol).
- •Child or adolescent below or equal to 15 years with diabetes mellitus type 1
- •Who has been undergoing treatment for diabetes for at least 6 months
排除标准
- •Previous participation in this study.
- •Current participation to a clinical trial
研究组 & 干预措施
A
干预措施: insulin (Drug)
结局指标
主要结局
Percentage of children below 6 years with HbA1c less than 8.5%
时间窗: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of children between 6-12 years with HbA1c less than 8%
时间窗: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
Percentage of adolescents between 13 and 15 years with HbA1c less than 7.5%
时间窗: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1)
次要结局
- Fasting plasma glucose (FPG) level(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Blood pressure level in children 12 years or older(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Total cholesterol and LDL-cholesterol levels in children 12 years or older(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Percentage of children with evaluation of thyroid function within the last 2 years(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Percentage of children with nephropathy(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Percentage of children with microalbuminuria(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Percentage of children with hypoglycemia event having led to hospitalization(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Percentage of children with self-monitoring of blood-glucose(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Percentage of parents and children having received at least one training and topic of the received training(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
- Type and dose of insulin treatment(one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-CSevere Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Multisystem Inflammatory Syndrome in Children (MIS-C)Coronavirus Disease 2019 (COVID-19)NCT04588363National Institute of Allergy and Infectious Diseases (NIAID)244
已完成
不适用
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Children With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01435642Novo Nordisk A/S349
已完成
不适用
Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®DiabetesDiabetes Mellitus, Type 2NCT00709683Novo Nordisk A/S216
已完成
不适用
Observational Study to Evaluate the Safety While Using Levemir®DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2NCT00701155Novo Nordisk A/S3,593
已完成
早期 1 期
A Study for the Identification of Biomarker Signatures for Diagnosis of Pulmonary Hypertension (PH) in Participants at Low or Intermediate Probability of PH Undergoing Cardiac Magnetic Resonance ImagingHypertension, PulmonaryNCT04480723Actelion86