NCT03805412已完成不适用
A Pilot Study on the Use of Real-Time Continuous Glucose Monitoring (RT-CGM) as an Educational Tool for Patients With Prediabetes and Diabetes
Nicole Ehrhardt, MD2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Percent Change in BMI From Baseline to 14 Weeks
研究概览
简要总结
Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM, nutrition and exercise education, participants will be able to monitor their blood sugar in real time for 2 sessions . Education on how to interpret CGM in the setting of food choices and exercise coupled with nutrition and exercise information should lead to improved weight and other nutritional and exercise changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10)
- •BMI ≥ 30 kg/m2
- •Willing to wear pedometer during study period
- •Able to walk 2 city blocks at baseline without assistance (self-reported)
- •Reading level at least 6th grade in English
- •Expected to remain in local community for at least 4 months
- •Either is not treated with or has been on a stable treatment regimen of any of the following medications for a minimum of 3 months prior to Visit 1 (Screening/Enrollment):
- •Sulfonylureas
- •Biguanidine
- •Thyroid replacement therapy
- •Glp-1 agonists
- •Sodium-glucose co-transporters
- •Basal insulin
- •Thiazolidinediones
- •Hormone replacement therapy (female subjects) estrogen/progesterone products
- •Oral contraceptives/birth control (female subjects)
- •Antidepressant agents (SSRIs, Paxil, Prozac, Celexa, Zoloft, etc.)
- •Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.
排除标准
- •Women who are pregnant, lactating, planning to become pregnant
- •Subjects who are taking amphetamines, anabolic, or weight-reducing agents
- •Contraindications to moderate exercise
- •Pre-prandial insulin
- •On any antipsychotic medication or history of schizophrenia or bipolar disorder
- •Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months
- •Active wounds or recent surgery within 3 months
- •Inflammatory disease, or chronic and current use of anti-inflammatory drugs or narcotics
- •Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study
- •Presence or history of severe congestive heart failure (New York Heart Association Class IV [CCNYHA 1994])
- •Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant
- •Enrolled in another weight loss program
- •Already receiving continuous glucose monitoring (CGM)
结局指标
主要结局
Percent Change in BMI From Baseline to 14 Weeks
时间窗: 14 weeks
weight and height will be combined to report % change BMI in kg/m\^2 at 14 weeks
Percent Body Fat Change at 14 Weeks
时间窗: 14 weeks
Percent by Tanita scale
次要结局
- Change in Minutes Walked Per Week at 14 Weeks(14 weeks)
- Mean Glucose Change at 14 Weeks(14 weeks)
- Food Frequency Change in Score at 14 Weeks(14 weeks)
- MAGE Mean Amplitude of Glycemic Excursion(14 weeks)
- Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes(14 weeks)
研究者
Nicole Ehrhardt, MD
Endocrinologist, Principal Investigator
George Washington University
研究点 (2)
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