Comparison of Effectiveness of Glulisine and Lispro in Decreasing Post-Prandial Hyperglycemia in a Real-World Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.
研究概览
简要总结
This study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.
详细描述
This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting. Children participating in the Florida Camp for Children and Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover carbohydrates after meals. The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 Diabetes
- •Children and Youth attending Florida Diabetes Camp in DeLand, FL
排除标准
- •only campers participating in sessions I and II are eligible to participate
研究组 & 干预措施
Humalog
Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
干预措施: Humalog (Drug)
Apidra
Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
干预措施: Apidra (Drug)
Novolog
Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
干预措施: Novolog (Drug)
结局指标
主要结局
The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.
时间窗: averaged over 5 days
Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona.
次要结局
- Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast(averaged over 5 days)
- Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner(averaged over 5 days)