NCT03758430已完成不适用
Technology-supported, Meal-centric, Insulin Dosing for Optimized Post-prandial Glucose Control
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)
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 diabetes (T1D). 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D by clinical diagnosis for > 3 years
- •Insulin pump use > 3 months: must use one of the following pump types: Animas Ping and Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex
- •Continuous Glucose Monitor (CGM) > 3 months and current use of Dexcom G5 at least 6 out of 7 days per week
- •HbA1c 7.0-9.5%
- •Must have iPhone (meal-tagging app has been built on iOS)
- •Personal computer for uploading of pump and CGM devices
- •Willingness to follow study protocol including tagging food data
- •Comfort speaking, reading, and writing English
排除标准
- •Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G)
- •Individuals planning to follow a specific diet plan for weight loss
- •Inability to consume "common meals"
- •Gastroparesis;
- •Eating disorder
- •Evidence of missed insulin meal-time insulin boluses on pump download
- •Use of medications that can affect blood glucose levels (such as SGLT inhibitors, steroid, beta agonists)
- •Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide)
- •Alcohol abuse
- •Pre-conception, pregnancy, or lactation
结局指标
主要结局
Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)
时间窗: Baseline to Week 16
Change from Baseline to Week 16 in HbA1c
次要结局
- Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals(Baseline to Week 16)
研究者
研究点 (1)
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