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临床试验 NCT05849428 针对1型糖尿病，2型糖尿病目前状态未知。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes 10
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临床试验NCT05849428是一项针对1型糖尿病，2型糖尿病的干预性研究试验，目前试验状态为状态未知。试验始于2023年5月1日，计划招募10名患者。该研究由University of the Pacific主导，预计于2024年3月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2023年5月8日。
简要概括
There are multiple CGMs that are FDA approved. However, there are few studies looking at the variability of measurements between the left and right arm, and none looking at this effect in diabetic patients. This study may identify if glucose differences exist in the left and right arm in patients with Type 1 or Type 2 Diabetes. Furthermore, it may point to future directions for research to standardize methods of gluc...显示更多
详细描述
The goal of this clinical trial is to determine the time-matched difference in glucose levels between the left arm and right arm in patients with Type 1 or Type 2 diabetes. The main objective aims to answer:
• Is there a difference in time-matched controlled glucose monitoring (CGM) - derived blood glucose between left and right arm in patients with Type 1 or Type 2 diabetes in target range (<70 mg/dL; 70-180 mg/dL...
显示更多官方标题
Blood Glucose Differences Between Left Arm and Right Arm in Patients With Type 1 or Type 2 Diabetes Using a Continuous Glucose Monitor
疾病
1型糖尿病2型糖尿病出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- IRB2023-25
主要目的
其他
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
其他Measuring Arm Participants will wear 2 Freestyle Libre 3 sensors on each arm, 1 on the left and 1 on the right for 2 consecutive weeks (total of 14 days). | Freestyle Libre 3 Freestyle Libre 3 consists of a sensor that is applied to the back of the upper arm. The sensor is a penny-sized flexible filament placed beneath the skin surface to measure interstitial fluid. This sensor is applied utilizing a sensor applicator provided in the packaging. The sensor will continuously read interstitial glucose readings every minute and syncs with the Freestyle View app. At the completion of the study...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients with Type 1 or Type 2 Diabetes below target range (<70 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis below the target range (\<70 mg/dL). | 14 days |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (70-180 mg/dL). | 14 days |
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (\>180180 mg/dL). | 14 days |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Adults 18-65 years of age
- Diagnosed with Type 1 or Type 2 Diabetes
- Willing to wear CGMs for 2 weeks on both arms
- Willing to attend 3 virtual calls meetings over the course of the trial
- Have active health insurance
- Willing to refrain from any heat therapy for the duration of the study
- Willing to refrain from consuming ascorbic acid and salicylic acid for the duration of the study due to known interaction with CGMs
- Have access to 2 compatible mobile devices for the Freestyle Libre 3 CGMs
- Not currently using any Freestyle Libre CGM
- Willing to provide HbA1c readings within 3 months of the trial
- Have a baseline HbA1c equal or above 6.5
- Any active dermatologic condition on the upper arms
- Implanted medical devices including another continuous glucose monitoring device (i.e.
pacemaker)
- Critically ill or dialysis patients
- Planned magnetic resonance imaging screening, computed tomography scan, X-ray imaging or high-frequency electrical heat treatment during study period
- Current systemic infections
- Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
- Refusal to sign the informed consent document
- Pregnant, planned pregnancy during study period, or currently breast-feeding
- Fear of needles to the point where patients cannot self-administer the sensors
- History of allergic reactions or hypersensitivity from adhesives
University of the Pacific研究责任方
Sachin Shah, 主要研究者, Professor of Pharmacy, University of the Pacific
研究中心联系人
联系人: Sarika Mujumdar, PharmD, 209-946-7754, [email protected]
联系人: Allen Lat, PharmD, 209-946-7754, [email protected]
1 位于 1 个国家/地区的研究中心
California
University of the Pacific, Stockton, California, 95211, United States
Sachin Shah, 联系人, [email protected]
招募中