Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Glycemic Control as Determined by the Change in Absolute HbA1c Level
研究概览
简要总结
The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years or older
- •Has type 2 diabetes, starting on basal insulin therapy
- •Hemoglobin A1c between 9-14%
- •Has Wi-Fi internet connection at home
- •Is willing to monitor blood glucose at least once per day
- •Is willing to inject and self-titrate insulin dose
- •Able to read and communicate in English proficiently
排除标准
- •Has severe visual impairment impacting visual acuity
- •Has severe hearing impairment impacting communication
- •Has Type 1 diabetes
- •Pregnant or lactating women
- •Alcohol dependency
- •Require multiple daily insulin injections
研究组 & 干预措施
Intervention Group
The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.
干预措施: Tablet Computer (Device)
Control Group
The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
结局指标
主要结局
Glycemic Control as Determined by the Change in Absolute HbA1c Level
时间窗: 3 months
The primary outcome of interest is absolute decrease in A1c by end of 3 months.
次要结局
- Number of Participants Reaching Target of HbA1c ≤ 7%(3 months)
- Number of Participants With Hypoglycemia(3 months)
- Time Health Care Providers and Subjects Spend on Managing the Insulin Titration(3 months)
- Change in Average Participation Satisfaction(3 months)