Exploring the Utility of a Novel Adaptive Device for Commercially Available Insulin Pens in Patients With Arthritis or Hand Deformities
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Visual analog scale for ease of use
研究概览
简要总结
Approximately 34 subjects will be enrolled in an unblinded cross-over design. For one week, they will use the adaptive pen device and for the next week, they will use just the insulin (or other medication) pen. This will be repeated for another one week period each. At the end of each week, the subjects will fill out a questionnaire regarding their experiences and any suggestions for improvements for the design of the pen device.
详细描述
This study is of an unblinded crossover design. Each patient will be randomly assigned to initiate a one week observation period with either the pen alone or the pen with the device. The following week, the patient will switch to the other assignment. This will be repeated one more time for a total of two weeks with the device and two weeks without it.
At the end of every week, the patients will be given a questionnaire to fill out. Questions will include a measurement of their satisfaction with their insulin (or other medication) delivery system for that week. Patients will be instructed to continue their usual dosage of medication as prescribed by their physician. If the patients have any problems with the device or feel uncomfortable with it, they are instructed to discontinue use of the device and continue using their pen as usual.
The patients may keep the device at the end of the study. The questionnaires that the patients fill out will be the primary source documents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently using a pen to administer medication at least once a week
- •Currently are having some difficulty (self reported) using their pens because of dexterity issues
排除标准
- •Woman of child-bearing age who are known to be pregnant
- •People who are unable or unwilling to sign the informed consent document
- •Patients who do not understand the proper use of the device after sufficient instruction
- •Anyone in the Principal Investigator's judgment who cannot properly use the device
研究组 & 干预措施
Intervention (pen device)
Subjects will use the pen device when using their commercially available insulin pens
干预措施: Pen device (Device)
Control
Subjects will use the commercially available insulin pens only (no adaptive pen device).
结局指标
主要结局
Visual analog scale for ease of use
时间窗: one month
Questionnaires re: efficacy and ease of use
次要结局
未报告次要终点
研究者
David I. Levenson, MD
PI
Levenson, David I., M.D.