The Effect of Insulin Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Time to Maximum Glucose Infusion Rate
研究概览
简要总结
Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.
详细描述
The investigators hypothesize that RAI absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate during the clamp study will be significantly faster when insulin bolus is delivered using the "Quick Bolus" feature as compared to the "Standard Bolus".
Outcomes were updated at time of results entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
single blinded
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 30 (inclusive)
- •Clinical diagnosis of T1D of at least one year's duration
- •On Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least three months
- •HbA1c <10%
- •Minimum weight requirement of at least 37.9 kg
- •Ability to comprehend written and spoken English
- •Total daily requirement of insulin between 0.6 and1.2 U/kg/day
- •Not have any other medical condition or disease known to affect insulin action and glucose control aside from T1D or treated hypothyroidism
排除标准
- •Medication besides insulin known to alter blood glucose or insulin action
- •Female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception.
- •Inability to comprehend written and spoken English
- •Any other condition, which in the judgment of the investigators, would interfere with the subject's ability to provide informed consent or the investigator's ability to perform the study
- •Hematocrit less than 35% or a serum potassium less than 3.4 mmol/L
研究组 & 干预措施
Individuals given Standard Bolus first, then quick bolus
Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
干预措施: Quick Bolus (Device)
Individuals given Standard Bolus first, then quick bolus
Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
干预措施: Standard Bolus (Device)
Individuals given Quick bolus first, then standard bolus
Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
干预措施: Quick Bolus (Device)
Individuals given Quick bolus first, then standard bolus
Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
干预措施: Standard Bolus (Device)
结局指标
主要结局
Time to Maximum Glucose Infusion Rate
时间窗: 300 minutes
time to maximum glucose infusion rate (GIR) in minutes
次要结局
- Area Under the Curve for the Glucose Infusion Rate(300 minutes)
- Earlier Clearance of Exogenous Insulin.(up to 5 hours)
- Maximum Glucose Infusion Rate(300 minutes)