Use of a Bearable Continuous Interstitial Glucose Monitoring Device (GuardianR) During Teaching Sessions to Functional Insulin Therapy Concept in Patients Suffering From Type 1 Diabetes: Evaluation at 6 and 12 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- The HbA1c, the witness of the quality of the metabolic balance, in 6 and 12 months. We shall compare the deltae of HbA1c between the period of inclusion and 6 and 12 months following the training course in the "fonctional" insulin therapy
研究概览
简要总结
The objective of the project is to evaluate advantages from the use of a bearable continuous interstitial glucose monitoring device (GuardianR) during educative sessions of diabetic patients dedicated to functional insulin therapy teaching. This concept of intensified treatment is based on testing and explanation of simplified decision making algorithms to adapt insulin dose to every true life conditions. As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.
详细描述
Two groups of 60 patients (experimental and control groups) will be followed and evaluated at 6 and 12 months. We do think that this new tool would facilitate education of patients and lead further to a better glycemic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject major, from 18 to 70 years old
- •Diabetes of type 1 defined according to the criteria of American Diabetes Association
- •Insulinic treatment for at least 12 months
- •Understood HbA1C enters 6,5 and 9,5 %
排除标准
- •Minor subjects or under guardianship
- •Unbalance kétosis current or recent
- •Pregnancy
- •Incapacitated to participate weekly complete educational in the functional insulin-therapy,
- •Evolutionary severe general disease
- •Psychiatric confusions
- •Unbalance chronic (HbA1c > 9,5 %) connected to an absence of adapted coverage or to abnormal behaviors
- •Pathology making not interpretable the rate of HbA1c (hemoglobinopathy, anemia)
研究组 & 干预措施
1
This arm will benefit from the nonstop measure of the subcutaneous glucose during the hospitalization and the week on returning to the place of residence,
干预措施: GuardianR (Device)
结局指标
主要结局
The HbA1c, the witness of the quality of the metabolic balance, in 6 and 12 months. We shall compare the deltae of HbA1c between the period of inclusion and 6 and 12 months following the training course in the "fonctional" insulin therapy
时间窗: glycemia
次要结局
未报告次要终点