IMpact of Flash Glucose Monitoring in pEople With Type 2 Diabetes Inadequately Controlled With Non-insulin Antihyperglycemic ThErapy - IMMEDIATE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 12
- 主要终点
- Time in Range (TIR)
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of a flash glucose monitor device in achieving optimal glycemic control among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy.
详细描述
The IMMEDIATE study is a multi-centre, randomized controlled, open-label, two-phase cross-over study evaluating the effectiveness of a flash glucose monitor device to increase the proportion of time spent in target glucose range (3.9 to 10.0 mmol/L) among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy compared to a control group not using a flash glucose monitor device. The study will consist of two phases; each 16 weeks long. In Phase 1, study participants who meet eligibility criteria will be randomized to receive a flash glucose monitor device combined with diabetes self-management education, or diabetes self-management education alone. In Phase 2, participants initially assigned to receive education alone will crossover to receive a flash glucose monitor device while participants initially using the flash glucose monitor will continue using their device. No diabetes self-management education will be provided during Phase 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study design is open-label in which neither investigator nor study participants will be blinded to study treatment. All study participants will wear a blinded continuous glucose monitoring device for two weeks at baseline and during the final two weeks of Phase 1, during which they will be blinded to the results of the blinded glucose monitoring device.
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
- •Eligible participants must be an adult aged 18 years or older and:
- •A clinical diagnosis of T2D, with diagnosis known for six months or more;
- •An HbA1c of > 7.5%;
- •Using one or more non-insulin antihyperglycemic therapy for a minimum of six months, with dose stability of 3 months; and
- •No previous history of using CGM or FGM devices.
排除标准
- •Participants will be excluded from the study if they:
- •Have a history of insulin use > 3 months
- •Are pregnant or breastfeeding
- •Have diabetic retinopathy
- •Have an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
- •Have unstable cardiovascular disease
- •Use other implanted medical devices, such as pacemakers
- •Have had more than one episode of severe hypoglycemia during the past 6 months or evidence of hypoglycemia unawareness
- •Anticipate or require regular magnetic resonance imaging, computed tomography scan, or high-frequency electrical heat (diathermy) treatment
结局指标
主要结局
Time in Range (TIR)
时间窗: 2-week period
The proportion of time within target glucose range (3.9 to 10.0 mmol/L) among adults with type 2 diabetes (T2D) inadequately controlled with non-insulin antihyperglycemic therapy compared to a control group not using an FGM device measured during the blinded continuous glucose monitor (CGM) period during the final last two-weeks of the Phase 1
次要结局
- Mean DSME goal achievement score during Phase 1(16-week period)
- Device satisfaction as measured by the Glucose Monitoring System Satisfaction Survey (GMSS)(2-week period)
- Participant self-efficacy as measured by the Skills, Confidence and Preparedness Index (SCPI)(2-week period)
- Diabetes self-management education (DSME) goals setting(16-week period)
- Glycemic control (a)(2-week period)
- Glycemic control (c)(2-week period)
- Glycemic variability(2-week period)
- Number of episodes of severe hypoglycemia(16-week period)
- Adherence to diabetes medications as measured by the Adherence to Refills and Medication-Diabetes (ARMS-D)(2-week period)
- Change in weight (kg)(16-week period)
- Change in waist circumference (cm)(16-week period)
- Glycemic control (b)(2-week period)
- Proportion of time spent in various glycemic ranges based on blinded CGM recordings(2-week period)
- Number of documented episodes of hypoglycemia episodes(2-week period)
- Psychological distress as measured by the Diabetes Distress Scale (DDS)(2-week period)
- Change in antihyperglycemic therapies(2-week period)
- Mean number of glucose checks(2-week period)