Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Difference between HbA1c at Month 12 and Month 0 > 0.5%
研究概览
简要总结
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.
详细描述
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study we plan to enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age between 18 and 70
- •Type 1 diabetes for more than 1 year
- •Treatment by basal/bolus insulin therapy and insulin pump for more than 6 months
- •HbA1c between 7.5 and 12%
- •Volunteer to be educated to Functional Insulin Therapy
- •Patient must be willing to undergo all study procedures
- •Patient must be affiliated or beneficiary of a social medical insurance
- •Patient has signed informed consent form prior to study entry
排除标准
- •Type 2 diabetes
- •Difficulties with mathematics calculation (simple algebra)
- •Patient is pregnant, or breast feeding during the period of the study
- •Manifest psychological disorders
- •Patient with eating behaviour desorder
- •Alcohol or drug addiction, as identified by investigator during screening visit
- •Persons deprived of freedom, adults protected by law or vulnerable persons
研究组 & 干预措施
Type 1 diabetes patient
Type 1 diabetes patient are included in this study to have an education to Functional Insulin Therapy (intervention)
干预措施: Education to Functional Insulin Therapy (Behavioral)
结局指标
主要结局
Difference between HbA1c at Month 12 and Month 0 > 0.5%
时间窗: at baseline et at Month 12
次要结局
- Difference between HbA1c at Month 3 and Month 0 > 0.3%(at baseline et at Month 3)
- Difference between HbA1c at Month 6 and Month 0 > 0.5%(at baseline and at Month 6)
- Difference between HbA1c at Month 9 and Month 0 > 0.5%(at baseline and at Month 9)
- Reduction of 50% of hypoglycemia < 60mg/dl(at Month 12)
- Reduction of 30% of hypoglycemia between 60 and 80mg/dl(at Month 12)
- Reduction of number of patients who have severe hypoglycemia(at MONTH 12)
- Better score at surveys of quality of life (SF-6D, DQOL) and auto-management(at baseline, at Month 6 and at Month 12)