Demonstration Study of the Interest of the MEDTRUM A7+ TouchCare Insulin Patch Pump Versus INSULET Omnipod® Patch Pump
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks
研究概览
简要总结
Demonstration study of the interest of the MEDTRUM A7+ TouchCare insulin patch pump versus INSULET Omnipod® patch pump
详细描述
Compare the daily use of two single usage patch pumps and demonstrate the interest of use of the A7+TouchCare® (Medtrum) patch pump for type 1 & 2 diabetes management.
Main objective is an estimation of Patients A1C (Glycated Haemoglobin) based on the average blood glucose (obtained from a Flash glucose monitoring) and to compare it in both groups.
Secondary objectives:
- comparison of mean A1C (laboratory values) between the two groups at Baseline and study end. Comparison to be established in a non-inferiority
- Observe Skin & overall Tolerance, Technical incidents with the device (failure, disconnection, catheter obstruction…)
- Collection of Glucose metrics (minimum, maximum, average/median, standard deviation, out of range value, percentage of time in range, glucose variability)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patient with type 1 or 2 diabetes, 18 years of age and over
- •Patients already equipped with Omnipod® ® (INSULET) insulin patch pump and Abbott FreeStyleLibre sensor®.
- •A1C ranking from : >= 6,5% to <= 9.5%
- •Any type of rapid insulin except FIASP (which can be substituted if necessary) with 60 IU max per day (unauthorized use of insulin supplements by pen injector)
- •Patient able to receive and understand study information, give written informed consent, and easily participate to the trial
- •Patient affiliated to the French social security system
排除标准
- •- Patient already participating in another study
- •Patient under the protection of justice or under guardianship or curatorship
- •Type 2 diabetic patient requiring a daily insulin dose > 60 IU
- •Patients not suitable for suing insulin pump such as: severe psychiatric disorders, rapidly progressing ischemic or proliferative retinopathy before laser treatment, and exposure to high magnetic fields
- •Patients allergic to nickel and adhesive
- •Pregnant women, breastfeeding women
- •Or any other criteria as appreciated by the study investigator.
结局指标
主要结局
Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks
时间窗: Month 3
A1C will be estimated by a Continuous Glucose Measurement (FreeStyle Libre®) for all patients, at baseline and end of the study (12 weeks). The main objective is to demonstrate Non-inferiority efficacy (PP then ITT) of Medtrum A7+ insulin patch pump vs Insulet Omnipod® insulin patch pump (2 randomized groups). For the primary outcome, A1C will be estimated and appear in percentage based on assessment done by a Continuous Glucose Monitoring system. The A1C obtained in real life for the group using the comparator pump (Omnipod®) is estimated at 7.8%. Assuming that blood glucose level will be the same with Medtrum pump and based on a defined non-inferiority margin ∆ = + 0.4 (following FDA Guidance for Industry Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention).
次要结局
- Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months(Month 3)
- Compare The Time Spent in Range(Month 3)
- Compare Patients Pump Satisfaction(Month 3)
- Compare Patients PDM Satisfaction(Month 3)
- Number of Participants With at Least One Pump Occlusion(Month 3)