Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for the Care of Patients With Type 2 Diabetes Not Using Insulin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in Average Glucose Levels as Measured by Continuous Glucose Monitor
研究概览
简要总结
The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.
详细描述
The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.
During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate.
All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The device is used in blinded mode where both patient and provider are blinded to the data only during Phase 1.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes of any duration
- •Hb A1c ≥ 7% (no upper limit)
- •BMI ≥ 30 kg/m2
- •Ability to wear CGM (e.g. no dermatological issue precluding device insertion)
- •Access to a smartphone device
排除标准
- •Any insulin use in the past 3 months
- •Planned use of insulin in the next 6 months
- •Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate
- •Current use of a weight loss medication
- •Unable or uncomfortable with wearing a CGM device
结局指标
主要结局
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor
时间窗: 0, 30, 60, 90 days
Average glucose on CGM
Change in Glucose Variability as Measured by Continuous Glucose Monitor
时间窗: 0, 30, 60, 90 days
Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.
Change in Time in Range as Measured by Continuous Glucose Monitor
时间窗: 0, 30, 60, 90 days
Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.
次要结局
- Change in Total Cholesterol From Blood Test(0 and 90 days)
- Change in Low Density Lipoprotein Cholesterol From Blood Test(0 and 90 days)
- Change in High Density Lipoprotein Cholesterol From Blood Test(0 and 90 days)
- Change in Hemoglobin A1c From Blood Test(0 and 90 days)
- Change in Body Mass Index From Height and Weight(0 and 90 days)
- Change in Systolic Blood Pressure From Automated Cuff(0 and 90 days)
- Change in Diastolic Blood Pressure From Automated Cuff(0 and 90 days)
- Type 2 Diabetes Distress Screening Scale (T2-DDAS)(0, 90 days)
- International Physical Activity Questionnaire (IPAQ)(0, 90 days)
- Change in Triglycerides From Blood Test(0 and 90 days)
- Picture Your Plate Dietary Assessment Questionnaire(0, 90 days)
- Glucose Monitoring Satisfaction Survey(90 days)
研究者
Ian J. Neeland, MD
Director, UH Center for Cardiovascular Prevention
University Hospitals Cleveland Medical Center