NCT06784375招募中不适用
Individualized Diabetes Education Assisted by CGM (IDEA-CGM)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
This project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type 2 diabetes mellitus (T2DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •at least 18 years of age
- •previous diagnosis of T2DM
- •HbA1c of 6.8-8.5%
排除标准
- •type 1 diabetes mellitus
- •treatment with insulin, sulfonylurea, or meglitinide
- •use of nondiabetic medications that affect blood glucose control (such as corticosteroids)
- •BMI <25 kg/m2 or <23 kg/m2 for participants who self-identify as Asian
- •weight change >5 pounds in the 3 months prior to study enrollment
- •estimated glomerular filtration rate <60 ml/minute/1.73 m2
- •pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of HbA1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."
研究组 & 干预措施
Blinded CGM/No Nutrition Therapy
Experimental
干预措施: Blinded CGM/No Nutrition Therapy (Behavioral)
Unblinded CGM/No Nutrition Therapy
Experimental
干预措施: Unblinded CGM/No Nutrition Therapy (Behavioral)
Unblinded CGM/Nutrition Therapy
Experimental
干预措施: Unblinded CGM/Nutrition Therapy (Behavioral)
Blinded CGM/Nutrition Therapy
Experimental
干预措施: Blinded CGM/Nutrition Therapy (Behavioral)
结局指标
主要结局
Hemoglobin A1c
时间窗: 12 weeks
Measure of blood glucose control
次要结局
未报告次要终点
研究者
研究点 (2)
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