NCT02130401终止不适用
Device: Investigational Study to Examine the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes
Scion NeuroStim2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Measurement of Glycosylated Hemoglobin (A1c)
研究概览
简要总结
This is an open-label, proof of concept study with a single active treatment arm designed to assess whether CVS-based stimulation has a beneficial effect on patients with type 2 diabetes. The primary outcome measure is a difference between pre and post-treatment A1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject is eligible for the study if all of the following criteria are met:
- •Provide written informed consent prior to enrollment.
- •Is male or female between 18-70 years old.
- •Has been diagnosed with type II diabetes for greater than 12 months.
- •Is currently either using lifestyle modification or taking one or two of the following oral antihyperglycemic agents and has been on stable doses for 90 days prior to screening:
- •metformin
- •DPP-4 inhibitors (sitagliptin, saxagliptin, alogliptin, linaglyptin)
- •Pioglitazone
- •Has an A l c between 7.5 - 9.0% based upon point of care testing performed at visit
- •Currently performs self-monitoring blood glucose checks at least 3 times per week.
- •Able to adhere to protocol requirements.
排除标准
- •A subject will be excluded if any of the following criteria are met:
- •Has Type 1 Diabetes or Gestational Diabetes.
- •Is pregnant or planning to become pregnant during the course of the study.
- •Current use OR use in the past 6 months of sulfonylureas.
- •Current use OR use in the past 6 months of insulin
- •History of cardiovascular disease or cerebrovascular disease.
- •Any planned surgery during the course of the study.
- •Current continuous renal replacement therapy.
- •Current oral or injectable steroid use or use within the previous 3 months.
- •Previous or current treatment with deep brain stimulation.
- •Any previous known disease, injury, or surgical intervention involving the brain or central nervous system.
- •Moderate or greater hearing loss.
- •Presence of a cochlear implant.
- •Diagnosed vestibular dysfunction.
- •Eye surgery within the previous three months.
- •Any history of previous ear surgery.
- •Active ear infections or a perforated tympanic membrane.
- •Presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
结局指标
主要结局
Measurement of Glycosylated Hemoglobin (A1c)
时间窗: after 84 days of device use
At the end of the 84 day period of device use, the patient's A1c value will be compared with the baseline value to assess any reduction.
次要结局
- Measurement of Lipid Panel(after 84 days of device use)
- Assessment of Quality of Life(after 84 days of device use)
- Assessment of Mood(after 84 days of device use)
- Assessment of Diabetes Related Self Care(after 84 days of device use)
- Feasibility of the Device as an Intervention for the Diabetes Population(after 84 days of device use)
研究者
研究点 (2)
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