NCT06999356招募中不适用
Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring In Predominantly Hispanic/Latino Adults With Non-Insulin Treated Type 2 Diabetes And An HbA1c > 9%
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in HbA1c at 18 weeks compared to baseline
研究概览
简要总结
The aim of this proposal is to determine the impact of a produce prescription program in predominantly Hispanic/Latino adults with established non-insulin treated T2D and an HbA1c at or above 9%.
详细描述
The aim of this proposal is to determine the impact of a produce prescription program in predominantly Hispanic/Latino adults with established non-insulin treated T2D and an HbA1c at or above 9%. For individuals not responding to the produce prescription program, they will be randomized to the addition of real-time continuous glucose monitoring (rtCGM) or continue with the produce prescription program only for a further 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (aged>18 years) with established T2D and HbA1c of 9% or higher per most recent test result within the last 6 months.
- •Agreement to only track glucose levels via study-provided CGM -
排除标准
- •Type 1 diabetes, Insulin use, Pregnancy, Use of steroids or medications that impact glucose levels
- •Medications Include:
- •Atypical antipsychotics Clozapine Olanzapine Paliperidone Quietiapine Risperidone Corticosteroids Calcineurin inhibitors Cyclosporine Sirolimus Tacrolimus Protease Inhibitors Atazanavir Darunavir Fosamprenavir Indinavir Nelfinavir Ritonivir Saquinavir Tipranivir
- •Life expectancy less than 6 months Diagnosis of stage 5 kidney disease or at risk of needing dialysis per Investigator discretion Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.
- •Inability to follow study procedures per Investigator discretion
结局指标
主要结局
Change in HbA1c at 18 weeks compared to baseline
时间窗: 18 weeks
Change in HbA1c at 18 weeks compared to baseline
次要结局
- Change in Body Weight(6 weeks and 3 months)
- Waist Circumference(6 weeks and 3 months)
- Blood Pressure(6 weeks and 3 months)
- Depression and anxiety are measured using DASS-21 (Depression Anxiety Stress Scale - 21)(6 weeks and 3 months)
- Height(6 weeks and 3 months.)
研究者
研究点 (2)
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