Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 6
- 主要终点
- Difference in time in range (70-180 mg/dL) between the control and experimental group
研究概览
简要总结
The present study wants to compare the Dexcom G6® continuous glucose monitoring (CGM) system (experimental group) with the FreeStyle Libre flash glucose monitoring (FGM) system (control group).
The ALERTT1 trial will have three phases: a baseline, study, and extension phase.
During the baseline phase, eligible patients will be screened for in- and exclusion criteria, wear a blinded Dexcom G6® for 28 days, together with their FreeStyle Libre FGM system, and receive a uniform education moment.
In the study phase, patients will be randomized into two groups (1:1): the experimental group will use an unblinded Dexcom G6® CGM for 6 months, the control group will keep using the FreeStyle Libre FGM system for 6 months. Before the 6 month time point is reached, patients in the control group will wear a blinded Dexcom G6® CGM for 28 days, together with their FreeStyle Libre FGM.
In the extension phase, patients in the initial control group will start using unblinded Dexcom G6® for 30 months. The initial experimental group will keep using the unblinded Dexcom G6® for the next 30 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •signed ICF
- •diagnosis of type 1 diabetes ≥6 months
- •using FreeStyle Libre FGM system ≥6 months
- •intensified insulin therapy/insulin pump therapy
- •HbA1c ≤10%
- •willing to wear the glucose monitoring device >80% of the time
- •willing to download glucose monitoring data at regular intervals
排除标准
- •non-type 1 diabetes participants or diagnosis <6 months
- •participant with T1D not on insulin, or on non-intensified insulin therapy
- •pregnancy or planning pregnancy within next 6 months
- •severe cognitive dysfunction or other disease which makes sensor use difficult
- •current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- •abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo)
- •presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR <30 mL/min [stage ≥4])
- •beta-cell transplantation and c-peptide positive and/or under immunosuppressive therapy
研究组 & 干预措施
Dexcom G6
Use a Dexcom G6 CGM for 36 months
干预措施: Dexcom G6 CGM (Device)
FreeStyle Libre
Keep using their FreeStyle Libre for 6 months. Before the 6 month time point is reached, patients will wear a blinded Dexcom G6 for 28 days, together with their FreeStyle Libre.
Cross-over to Dexcom G6 for 30 months.
结局指标
主要结局
Difference in time in range (70-180 mg/dL) between the control and experimental group
时间窗: 6 months
measured by Dexcom G6
次要结局
- Between group difference in time in clinically important hypoglycemia (<54mg/dL)(6 months)
- Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire(6 months)
- Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey(6 months)
- Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)(6 months)
- Between group difference of HbA1c(6 months)
- Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey(6 months)
- Between group difference in time in hypoglycemia (<70 mg/dL)(6 months)
- Between group difference in time in target (70-140 mg/dL)(6 months)
- Between group difference in time in hyperglycemia (>180 mg/dL)(6 months)
- Between group difference in time in clinically important hyperglycemia (>250 mg/dL)(6 months)
- Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia(6 months)
- Between group difference in glycemic variability as measured by coefficient of variation [CV](6 months)
- Between group difference in glycemic variability as measured by standard deviation [SD](6 months)
- Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE](6 months)
- Between group difference in mean glucose concentration(6 months)
- Between group difference in number of low glucose events (LGE)(6 months)
- Between group difference in number of severe hypoglycemic episodes(6 months)
- Between group difference in general quality of life measured by the SF-36 questionnaire(6 months)
- Between group difference in number of patients having allergic reactions to the sensors(6 months)
研究者
prof dr Pieter Gillard
Prof Dr
Universitaire Ziekenhuizen KU Leuven