Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 9
- 主要终点
- Time in Range
研究概览
简要总结
To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by;
- regularly checking and understanding Continuous Glucose data & trend arrows at times other than the standard pre-meal bolus calculation test times and
- review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care Professional (HCP) and adjusting behaviours & therapy from interpretation of the Continuous Glucose profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18 years and over
- •Type 1 diabetes on MDI with bolus injections for >6 months prior to study enrolment or Type 2 diabetes treated with 2 or more insulin injections daily.
- •In the investigator's opinion, thought technically capable of using FreeStyle Navigator GM System device.
- •HbA1c between 7.5 and 12.0% (58 to 108 mmol/mol) for previous test obtained within 6 months prior to point of enrolment
排除标准
- •Concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any uncontrolled chronic medical condition
- •Female subject is pregnant or planning to become pregnant within the planned study duration. Subjects who become pregnant during the study will be discontinued from the study.
- •Currently using / has previously used a Continuous Glucose Monitoring System within the last 6 months.
- •Currently using Continuous Subcutaneous Insulin Infusion (CSII)
- •Currently using basal/long acting insulin only.
- •Participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
- •Known allergy to medical grade adhesives
- •In the investigators opinion is unsuitable to participate due to any other cause/reason.
研究组 & 干预措施
CGM - intervention arm
Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
干预措施: FreeStyle Navigator (Device)
SMBG - Control arm
Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
干预措施: Standard SMBG (Device)
结局指标
主要结局
Time in Range
时间窗: Day 86 to 100 compared to Day 1 to 15
Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.
次要结局
- Glucose Standard Deviation (SD)(Day 86 to 100 compared to day 1 to 15)
- HbA1c (mmol/Mol)(Day 100 compared to day 1)
- Time in Range(Days 86 to 100 intervention arm compared to control arm)
- HbA1c(Day 100 compared to day 1)