NCT04667182撤回不适用
Meal-centric Insulin Dosing for Optimized Post-Prandial Glucose Control in People Using Multiple Daily Injections
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from Baseline in Area Under the Curve (AUC) of CGM
研究概览
简要总结
The main purpose of this study is to determine whether combining meal, glucose and insulin data in a web-based system will improve management of type 1 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with type 1 or type 2 diabetes for >3 years by clinical diagnosis who use basal insulin, in addition to at least one injection of meal time insulin per day
- •Insulin pen use for at least 3 months
- •Current use of or willingness to use Dexcom G6 at least 6 out of 7 days per week
- •A1c 6.5-9.5%
排除标准
- •Currently using any form of insulin pump, including hybrid closed-loop system (e.g., Medtronic 670G)
- •Individuals requiring single insulin boluses of >40 units
- •Individuals planning to follow a specific diet plan for weight loss
- •Inability to consume regular, consistent meals
- •Individuals who have had severe hypoglycemia with seizure or coma within the past 6 months
- •Individuals who have been hospitalized for diabetic ketoacidosis (DKA) within the past 6 months
结局指标
主要结局
Change from Baseline in Area Under the Curve (AUC) of CGM
时间窗: Baseline, Week 17
Change from Baseline in AUC of CGM
次要结局
- Percent Time-in-Range (TIR)(Baseline through Week 17)
- Qualitative data from study investigators and participants(Baseline through Week 17)
- Time Above Range (TAR)(Baseline through Week 17)
- Postprandial TIR(Baseline through Week 17)
- Time Below Range (TBR) <70 mg/dL(Baseline through Week 17)
研究者
研究点 (2)
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