COntinuous Glucose Monitoring, Contingency Management, and Motivational InTerviewing for Patients With TypE 2 Diabetes in Kansas City
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time in target blood glucose range per CGM
研究概览
简要总结
This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management.
详细描述
A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM. Individuals will be randomized in a 1:1 ratio to the intervention group or the control group. Randomization will be blocked and stratified by long-acting insulin and GLP1 medication use. All participants will be given a Continuous Glucose Monitor (CGM) to assess real-time blood sugar levels and establish CM rewards for those assigned to the treatment group.
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
- Single (Care Provider)
盲法说明
Because this is a behavioral intervention, participant blinding is not possible. Randomization will occur after baseline assessment and participants will be instructed to not tell their provider their assigned condition.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes
- •Age 18 to 65
- •Hemoglobin A1c (blood draw or point-of-care) test available within the last 3 months
- •Most recent hemoglobin A1c result between 8.0 and 11.0
- •Currently receiving treatment for diabetes by a licensed healthcare provider.
- •Reliable access to a personal smart phone that is compatible with CGM
- •English speaking
排除标准
- •Type 1 diabetes
- •Secondary type 2 diabetes (diagnosis secondary to other medical conditions such as pancreatitis, Cystic Fibrosis, or Cushing disease)
- •Prescribed short-acting (mealtime) insulin as part of diabetes treatment plan
- •Known or acknowledged active substance use disorder or that would interfere or negatively impact participation in the study
- •Diagnosis of a medical/psychiatric condition that would prevent participation in the study (e.g., Intellectual Disability, Alzheimer's disease, Traumatic Brain Injury, Schizophrenia)
结局指标
主要结局
Time in target blood glucose range per CGM
时间窗: baseline to 14 weeks
Percent time with blood glucose between 70 to 180 mg/dL
Hemoglobin A1C
时间窗: baseline to 12 weeks
laboratory value
次要结局
- Diabetes Quality of Life Brief Inventory(baseline to 12 weeks)
- PROMIS Medication Adherence Scale(Baseline to 12 weeks)
- Perceived Dietary Adherence Questionnaire(Baseline to 12 weeks)
- Diabetes Distress Scale(Baseline to 12 weeks)
- Motivation and Confidence Ruler(Baseline to 12 weeks)