Use of Continuous Glucose Monitoring in Veterans With Uncontrolled Diabetes Managed Without Insulin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Glycemic Control
研究概览
简要总结
The U.S. Food and Drug Administration (FDA) has approved multiple Continuous Glucose Monitoring (CGM) devices from different manufacturers to be used as an aide in patients with type 1 and type 2 diabetes who require medications, and more recently, as over the counter versions for patients with and or without diabetes who want to better understand how diet and exercise may impact blood sugar levels. However robust evidence supporting that CGM is significantly superior to traditional home fingerstick blood glucose monitoring (FSBGM) in this population is lacking. Thus, Medicare and VHA only authorize use of CGM for patients with diabetes who require daily insulin therapy , unless they meet special criteria such as having hypoglycemia or inability to monitor glucose via traditional FSBGM.
Objectives Primary Study Aim: Among veterans with uncontrolled diabetes not requiring insulin therapy who are participating in an intensive multidisciplinary program to improve diabetes control (VDOP), to assess whether use of a CGM compared to use of traditional FSBGM results in greater change in hemoglobin A1c upon VDOP completion and up to 12 months.
Secondary study aims: To assess whether use of CGM in this population leads to greater improvement in diet, physical activity, and weight loss upon VDOP completion and up to 12 months.
Hypothesis
The use of a CGM by Veterans with T2DM who do not use insulin will help them improve their diabetes self - management (diet, physical activity, weight) and glycemic control more so than those using traditional fingerstick glucose monitoring.
Methods
This will be a prospective "open label" randomized controlled trial where participants will be randomly assigned to CGM (intervention group) or FSBGM (control group) during their participation in VDOP.
Relevance to Veterans and VA mission
Most Veterans with T2DM do not use insulin. It is important for both, these Veterans and the VA, to learn whether this more costly and somewhat burdensome technology supports improvement in diabetes self-management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Successfully enrolled and ready to begin the VDOP program not on insulin therapy
- •Type 2 diabetes by clinical history
- •HbA1C between 8.0-12.0% inclusive within 3 months of enrollment
- •Assessment by clinician that patient is willing to and able to wear a CGM device
- •Stable diabetes medication regimen during the 3 months prior to entry
排除标准
- •Patients already or planned on starting insulin therapy, already on CGM, or those who qualify for CGM under VA policy
- •Patients with gestational diabetes or pregnant at time of screening or are planning to become pregnant during the study
- •Patients with end stage renal disease (ESRD) on dialysis
- •Anticipated acute uses of glucocorticoids (oral, injectable, or IV)
- •Acute conditions that impact the HbA1c measurement stability such as GI blood loss, recent (within 3 months of study entry), anticipated red blood cell transfusion or erythropoietin administration
- •Known or suspected significant allergy to use the Dexcom sensors
- •Planning or currently enrolled on different weight program different from MOVE!
- •Participating other clinical trials
结局指标
主要结局
Glycemic Control
时间窗: 12 months
HbA1c
次要结局
- Weight loss(12 months)
研究者
Carlos Mendez
Director, Diabetes Program
Milwaukee VA Medical Center