The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in A1c
研究概览
简要总结
The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
详细描述
The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
- •Absence of orders for deployment or permanent change of station
- •Willingness to recruit up to 19 patients prior to randomization
- •Willingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.
排除标准
- •Specialist physicians
- •Orders for deployment or permanent change of station
- •Unwillingness to recruit up to 19 patients prior to randomization
- •No prior experience with management of type 2 diabetes in adults
- •Unwillingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.
结局指标
主要结局
Change in A1c
时间窗: baseline, 12, 24, 36, and 48 months
Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".
次要结局
- Patient satisfaction with treatment(basline and 48 months)
- Quality of life(baseline and 48 months)
- Other DM-related events(ongoing)
- Glucose measures(baseline, 12, 24, 36, 48 months)
- Blood pressure(baseline, 12, 24, 36, and 48 months)
- Major events(ongoing)
- Lipids(baseline, 12, 24, 36, and 48 months)
- Degree of Acceptance(baseline and 48 months)
- Acceptance of uploading data(baseline, 12, 24, 36, and 48 months)
- Demographic variables(baseline and 48 months)
研究者
Alicia L. Warnock
Director, Diabetes Institute
Walter Reed National Military Medical Center