NCT07063420招募中不适用
Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers: A Pilot Study
Daniel Chernavvsky, MD2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年10月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Clinical efficacy
研究概览
简要总结
Decision Support System (Software) for multi antidiabetic drug therapy use in type 2 diabetes (T2D).
详细描述
The purpose of this study is to test the safety and feasibility of using a patient centered decision support system (software) aim for healthcare providers to treat people with type 2 diabetes under multi antidiabetic drug therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥18.0 years old at time of consent.
- •Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months.
- •Hemoglobin A1c (HbA1c) ≥ 7.0%.
- •Currently using an approved long-acting insulin for at least 3 months (e.g., insulin glargine, insulin degludec).
- •Treated or about to be treated with multi-drug therapies for T2D.
- •If using a CGM, willingness to wear an additional study CGM during the duration of the study.
- •Access to the internet and willingness to upload data during the study as needed.
- •If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females who self-report that they are of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
排除标准
- •Currently using rapid insulin for at least three months (e.g., insulin aspart, insulin lispro, insulin regular).
- •Currently being treated for a seizure disorder.
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:
- •Seizure disease
- •Decompensated cardiac disease
- •Inpatient psychiatric treatment in the past 6 months
- •Presence of a known adrenal disorder
- •Currently pregnant or intent to become pregnant during the trial.
- •Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
结局指标
主要结局
Clinical efficacy
时间窗: 22 weeks
Measured by improved glycemic control (HbA1c change and CGM-derived metrics).
Clinical efficacy
时间窗: 22 weeks
Measured by improved glycemic control (HbA1c change and CGM-derived metrics).
次要结局
未报告次要终点
研究者
Daniel Chernavvsky, MD
Investigator
University of Virginia
研究点 (2)
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