A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults With Type 1 Diabetes: Novel Pen With Memory Function (HumaPen Memoir) vs. Conventional Pen Without Memory Function (HumaPen Luxura)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint
研究概览
简要总结
The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus
- •receiving at least 3 prandial injections per day with short-acting or analogue insulin
排除标准
- •Insulin pump therapy
- •receiving pre-mixed insulin preparations
研究组 & 干预措施
HumaPen Luxura
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
干预措施: Insulin Lispro (Drug)
HumaPen Luxura
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
干预措施: Huminsulin Regular (Drug)
HumaPen Luxura
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
干预措施: HumaPen Luxura (Device)
HumaPen Memoir
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
干预措施: Insulin Lispro (Drug)
HumaPen Memoir
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
干预措施: Huminsulin Regular (Drug)
HumaPen Memoir
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
干预措施: HumaPen Memoir (Device)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint
时间窗: Baseline, Week 24
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment\*visit interaction, screening HbA1c (≤9% / \>9%), change of prandial insulin at baseline, and baseline HbA1c.
次要结局
- Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint(Week 24)
- Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint(Week 24)
- 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24(Baseline through Week 24)
- 30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24(Baseline through Week 24)