Adaptive Device for Insulin Pens for Arthritic Patients
Exploring the Utility of a Novel Adaptive Device for Commercially Available Insulin Pens in Patients With Arthritis or Hand Deformities
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Boca Raton、Florida、美国、33433
- East Coast Medical Associates
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention (pen device)
Subjects will use the pen device when using their commercially available insulin pens
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Adaptive pen device
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无干预：Control
Subjects will use the commercially available insulin pens only (no adaptive pen device).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual analog scale for ease of use
大体时间：one month
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Questionnaires re: efficacy and ease of use
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one month
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
糖尿病的临床试验
Pen device的临床试验
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St. Louis UniversityLucerno Dynamics Limited Liability Company (LLC)完全的
-
University Hospital, Basel, SwitzerlandClinical Trial Unit, University Hospital Basel, Switzerland完全的
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Taipei Veterans General Hospital, TaiwanLotung Poh-Ai Hospital未知