Impact of Therapeutic Education Consultations Conducted by Specialized Nurses on Glycemic Control and Quality of Life in Diabetic Patients Treated With Intensified Insulin Therapy: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Rate of glycated hemoglobin HBA1c
研究概览
简要总结
Diabetes is a chronic condition that affects around 8% of the French population, and is associated with severe complications. Maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.Insulin can be administered by injection via syringes or pens, or by insulin pumps and patients can perform self-monitoring of blood glucose.
All these actions can be the subject of therapeutic education, which involves a range of tools, including dedicated individual consultations carried out by state-qualified nurses.
The aim of the study is to evaluate the benefit of therapeutic education consultations conducted by nurses in addition to medical consultations, on the follow-up of diabetic patients, insulin pump carriers or treated with multiple injections, in terms of glycemic control, quality of life and medical complications. The objective of the study is to evaluate whether the therapeutic education consultations conducted by nurses can improve the care of the diabetic patient.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Woman or man aged 18 to 75
- •Diabetic patient type 1 or 2 insulin-dependent
- •Patient treated with multi-injections or insulin pump
- •Patient equipped with FreeStyle Libre flash glucose monitoring system
- •Glycemic imbalance with HBA1c > 8
- •Patient living at home
排除标准
- •Recent discovery (< 6 months) of diabetes
- •Major intellectual disability
- •Social isolation
- •IMC > 35
- •Pregnant women
研究组 & 干预措施
Therapeutic Education Group.
Medical follow-up every 6 months for 18 months (inclusion, M6, M12, M18) associated with therapeutic education consultations conducted by nurses in the month following inclusion (between D0 and M1), M3, M9 and M15
干预措施: Diabetes Therapeutic Education conducted by nurses (Other)
Standard
Medical follow-up every 6 months for 18 months (Inclusion, M6, M12, M18) :usual practice
结局指标
主要结局
Rate of glycated hemoglobin HBA1c
时间窗: 12 months
Difference in HBA1c between baseline and 12 months (M12)
次要结局
- Evaluation of patients' quality of life over 18 months(18 months)
- Evaluation of long-term complications over 18 months(18 months)
- Evaluation of glycemic control over 18 months(18 months)
- Evaluation of patients' satisfaction with diabetes treatment(18 months)