A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Insulin Dosing Accuracy (in units)
研究概览
简要总结
This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay.
详细描述
This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay. Patients will have no prior experience using insulin or other self-administered injectable medicine. The study will examine which method of administering insulin reduces dosing errors, causes a lower incidence of low blood sugars, increases adherence to therapy and with which method patients are more satisfied.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult in hospital and diagnosed with diabetes; must have no prior experience using insulin or other self-administered injectable medicine. they must be able to prepare an injection and to self administer the insulin using either a pen device or syringe and vial. They must be willing to monitor their blood sugar three times per day and keep a diary of their sugar measurements and insulin doses.
排除标准
- •Previously treated with injectable medicine
结局指标
主要结局
Insulin Dosing Accuracy (in units)
时间窗: Approximately one year
Whether the method of administering insulin would: 1) reduce dosing errors as measured by direct observation of patient performance, 2) reduce the risk of hypoglycemia, 3) increase adherence to insulin, 4) improve patient satisfaction.Dosing accuracy was measured by direct observation of subject's performance at follow-up visits.
次要结局
- Adherence to prescribed dose of insulin (assess patient diaries and observation of used pens/vials)(3 months)
- Reduce the Risk of hypoglycemia (assessed by patient diary)(3 months)
- Patient satisfaction with method of insulin administration measured by questionnaire.(3 months)
研究者
Jeffrey Rothman
Endocrinology
Northwell Health