NCT01341067已完成不适用
Continuous Glucose Monitoring in Subjects With Type 2 Diabetes
Rocky Mountain Diabetes and Osteoporosis Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in HgbA1c
研究概览
简要总结
The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Have been diagnosed with type 2 diabetes mellitus
- •Have an HgbA1c value ≥ 7% and ≤17%.
- •Are on basal insulin, with or without oral agents
- •Are not on basal bolus insulin therapy.
- •Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional.
- •Have no known allergy to medical tape or sensors.
- •Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day.
- •Are willing to not use Acetaminophen while enrolled in the study.
- •Are willing not to undergo a MRI procedure while wearing the CGM sensor.
- •Are willing and capable of performing self insertions of the device sensor.
- •Women of child bearing potential must be willing to use an approved form of birth control while enrolled in the study.
- •Women of child bearing potential must be willing to perform pregnancy tests monthly while enrolled in the study.
- •Can understand and speak English fluently.
- •Exclusion Criteria
- •Have been on pump therapy in the 6 months prior to enrollment in the study.
- •Are receiving basal- bolus insulin therapy
- •Are taking any medication that is not approved to be taken with insulin.
- •Are pregnant or have intentions of becoming pregnant during the duration of the study.
- •Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc.
- •Have a hematocrit ≤30% or ≥55%
- •Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study.
- •Are employed by any company that manufactures or is developing a CGM device.
- •Are deemed incapable of participating in the study by the Primary Investigator for any reason.
排除标准
- 未提供
结局指标
主要结局
Change in HgbA1c
时间窗: Measured at 6 months
次要结局
- Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl(Measured at baseline and 6 months)
- Change in Basal Insulin Dose From Baseline Values(Assessed at baseline and 6 months)
- Percentage of Time Spent at Glycemic Levels <65 mg/dl(Measured at baseline and at 6 months)
研究者
David Liljenquist, M.D.
Primary Investigator
Rocky Mountain Diabetes and Osteoporosis Center
研究点 (1)
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