NCT01073566已完成2 期
The Effects of Finesse on Glycemic Control in Adults With Diabetes Using MDI: Finesse vs. Pen or Syringe and Vial as Bolus Prandial Insulin Device
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- Mean Daily Blood Glucose
研究概览
简要总结
The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its preference.
详细描述
The aim of this feasibility study is to compare efficacy, device satisfaction and quality of life (QOL) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel insulin bolus-patch (Finesse™; Calibra Medical, Inc., Redwood City, CA) versus current devices that deliver bolus insulin (pen/syringe). All subjects injected their basal insulin using their current pen/syringe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus on intensive insulin therapy
排除标准
- •Insulin pump therapy
- •Current use of NPH or regular insulin
- •Severe hypoglycemic episodes in prior 6 months
- •Unstable cardiac disease, hepatic, or renal function
结局指标
主要结局
Mean Daily Blood Glucose
时间窗: 6 weeks
Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
次要结局
- Glucose Profiles Per Day(6 weeks)
- Insulin Delivery System Rating(6 weeks)
- Self-reported Hypoglycemic Episodes(6 weeks)
研究者
研究点 (10)
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