Clinical Evaluation of Insulin Real-Time Advisor (IRTA©): a Decision Support Software for Insulin Therapy Combined With Freestyle Libre®, a Continuous Glucose Monitoring System: Glycemic Impact and Satisfaction in Type 1 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Percentage of time spent in 70-180mg/dl (time in range) in the last month of each period of the study (without and then with IRTA©)
研究概览
简要总结
A prospective monocentric " before and after " study, ruled in 2 periods of 3 months : during the first period, the patient will adjust insulin treatment as usual, during the second period, the patient will adjust insulin treatment with IRTA support
详细描述
Freestyle Libre® continuous glucose monitoring (CGM) system may improve glycemic control. However, this system contributes to the complexity of insulin adjustment by the diversity of the data delivered by CGM system.
Insulin Real-Time Advisor (IRTA©), a decision support software, has been developed in order to guide patients in the adaptation of their treatment according to CGM data. IRTA© provides advice applicable to thousand situations according to six parameters: glucose level, trend arrows, meals, physical activity, before bedtime, time since the previous bolus.
Type of advice :
- Insulin injection (carb and correction)
- To continue treatment without modification
- To lower the insulin dose (temporary basal rate)
- Sugar intake advice
- Glucose level control with CGM, self-monitor blood glucose, blood ketones monitor
- To change catheter for patients treated by insulin pump.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18 years of age
- •Patients with type 1 diabetes mellitus for more than 2 years
- •Treated by either insulin pump for more than 6 months or multiple daily insulin injections.
- •Using Freestyle Libre® for more than 3 months
- •Accepting IRTA use
- •Patient able to provide free and informed consent
- •Patient able to provide written non-disclosure agreement
排除标准
- •Pregnancy, breastfeeding or pregnancy project in the future 6 months
- •Patients with no smart phone or internet access
- •Patients legally protected (under judicial protection, guardianship or supervision)
- •Patients with acute illness (psychiatric, infection, cancer,...)
- •Patients using another CGM system (Enlite® or Dexcom G4®)
研究组 & 干预措施
Type 1 diabetes
干预措施: A decision support software (Other)
结局指标
主要结局
Percentage of time spent in 70-180mg/dl (time in range) in the last month of each period of the study (without and then with IRTA©)
时间窗: 6 months
Assessment of the metabolic impact of IRTA© on "time in range" (time spent in the standard glucose range between 70-180mg/dl, ie 3.9-10mmol/l) in type 1 diabetic patients, treated by either insulin pump or multiple daily insulin injections, and using Freestyle Libre®.
次要结局
- Glycemic variability(6 months)
- Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)(6 months)
- Time spent in glucose level higher than 250 mg/dl(6 months)
- Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction(6 months)
- Number of connections to the IRTA system(6 months)
- Time spent in glucose level lower than 54 mg/dl(6 months)
- Comparison of HbA1c level at the end of each period of the study (without / with IRTA©)(6 months)
- Time spent in glucose level higher than 180 mg/dl(6 months)
- Time spent in glucose level lower than 70 mg/dl(6 months)
- Percentage of time spent with or without CGM(6 months)
- Patients' satisfaction related to IRTA©(6 months)
- Number of advice given by the IRTA system(6 months)
- Type of advice given by the IRTA system that is more often asked(6 months)