Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- HgbA1c
研究概览
简要总结
Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •At least 18 years of age
- •Have a previous diagnosis of type 2 diabetes
- •HbA1c of 7.0 - 9.5%
- •Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.
排除标准
- •Type 1 diabetes
- •Treatment with insulin, sulfonylurea, or meglitinide
- •Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
- •BMI <25 kg/m2
- •Weight change >5 pounds in the 3 months prior to enrollment
- •Estimated glomerular filtration rate <60 ml/minute/1.73 m2
- •Pregnant or breastfeeding
- •Anemia (which affects HbA1c)
- •Presence of any disease that would make adherence to the protocol difficult
结局指标
主要结局
HgbA1c
时间窗: week 12
次要结局
- Glucose variability/coefficient of variation(week 12)
- mean glucose(week 12)
- time in range (glucose 70-180 mg/dl)(week 12)
- Intervention Acceptability Questionnaire(week 12)
- Weight(week 12)
- Fasting serum insulin(week 12)
- Serum lipid panel(week 12)
- time above range (glucose 70-180 mg/dl)(week 12)
- Fasting plasma glucose(week 12)
- Diet Satisfaction Questionnaire (DSat-28)(week 12)
- Diabetes Management Self-Efficacy Scale (DMSES)(week 12)
- Medication Effect Score(week 12)
- Diabetes Treatment Satisfaction Questionnaire (DTSQ)(week 12)