Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in Type 2 Diabetes - The PRECISE-DIET Trial. -A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fidelity testing
研究概览
简要总结
The primary aim of this pilot study is to assess the feasibility of a 12-week dietary intervention combined with the use of CGM in adults with T2D. The results of the pilot study will provide insights into recruitment, design, and the effectiveness of the intervention for the future long-term (12-month) PRECISE-DIET STUDY
详细描述
In recent decades, there has been a significant rise in the development and use of glucose lowering drugs aimed at improving glycemic control in individuals with type 2 diabetes (T2D). Despite medical advancements, more than one-third of the danish population with T2D have a hemoglobin A1c (HbA1c) exceeding the recommended thresholds. One limiting factor in supporting individuals achieve their glycaemic target may be driven by substantial postprandial increases in plasma glucose levels, which is influenced by the quantity and type of carbohydrates in meals, underscoring the critical role of dietary interventions as an integral component of T2D management.
Recent studies have demonstrated that the use of continuous glucose monitors (CGMs), which allow individuals to track their glucose profiles continuously throughout the day, improves glycemic control in T2D patients. However, these studies often exclude dietary interventions, which could potentially yield greater improvements in blood glucose regulation.
Nutritional research in recent years has focused on dietary patterns such as low-fat diets, the paleo diet, and vegan diets. Nevertheless, these studies have not sufficiently addressed individualized dietary adjustments to mitigate postprandial glucose excursions, despite their substantial importance for glycemic control.
Several clinical studies have revealed significant inter-individual variations in glycemic responses to identical standardized meals, highlighting the necessity of a personalized approach to dietary recommendations, particularly with a focus on carbohydrate intake.
The primary aim of this pilot study is to assess the feasibility of a 12-week dietary intervention combined with the use of CGM in adults with T2D. The results of the pilot study will provide insights into recruitment, design, and the effectiveness of the intervention for the future long-term (12-month) PRECISE-DIET STUDY
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diabetes duration of ≥12 months
- •≥18 years of age
- •HbA1c ≥58 mmol/mol
- •Attending the SDCC outpatient clinic
- •Provided voluntary signed informed consent.
排除标准
- •Inability to understand the patient information.
- •Complications which do not permit to lowering HbA1c to <58 mmol/mol.
- •Treatment with insulin.
- •Low daily carbohydrate intake (defined as below 25 E% or 100 g/day) prior to study inclusion.
- •Systematic use of corticosteroids.
- •Using or requiring a specialized diet (e.g., kidney diet).
- •Circumstances that affect HbA1c (e.g., liver disease and anaemia).
- •Known or suspected drug or alcohol abuse (judged by the investigator).
- •Pregnancy or breastfeeding or plans of pregnancy within the study period.
- •Participation in other clinical trials.
研究组 & 干预措施
Precise diet intervention
The precise diet intervention for 12 weeks (n=20).
干预措施: The precise diet intervention (Other)
结局指标
主要结局
Fidelity testing
时间窗: 12 weeks after baseline
Participants will be invited to a workshop to evaluate the intervention and its components. Procedures from fidelity testing will be applied in the evaluation. These specific topics will be evaluated: * Study design o Is the design appropriate? E.g., number of visits, CGM use, dietetic feedback? * Sampling strategy o E.g., how many participated, recruitment methods, sample diversity? * Treatment receipt * "What is learned?" * Is the intervention relevant to and accepted by the participants? * Treatment enactment * What is actually used and done? * Do participants' "behavioural skills" improve?
次要结局
- Waist circumference (cm)(Measured at baseline and after 12 weeks)
- Hip circumference (cm)(Measured at baseline and after 12 weeks)
- Systolic blood pressure (mmHg)(Measured at baseline and after 12 weeks)
- Diastolic blood pressure (mmHg)(Measured at baseline and after 12 weeks)
- Self-reported diabetes distress(Measured at baseline and after 12 weeks)
- HbA1c (mmol/mol)(Measured at baseline and after 12 weeks)
- Time in range (TIR)(Measured at baseline and after 12 weeks)
- Time above range (TAR)(Measured at baseline and after 12 weeks)
- Time below range (TBR)(Measured at baseline and after 12 weeks)
- Coefficient of variation (CV)(Measured at baseline and after 12 weeks)
- Estimated HbA1c(Measured at baseline and after 12 weeks)
- Body mass index (kg/m^2)(Measured at baseline and after 12 weeks)
- Body weight (kg)(Measured at baseline and after 12 weeks)
- Self-reported treatment satisfaction(Measured at baseline and after 12 weeks)
- Dietary intake(Measured at baseline and after 12 weeks)
研究者
Bettina Ewers
Head of Nutrition and PhD
Steno Diabetes Center Copenhagen