PDF(Pubmed)
Abstract：
UNASSIGNED: The Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study is a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes (T2D). The study aims to test the efficacy of a personalized behavioral approach for dietary management of moderately-controlled T2D, versus a standardized behavioral intervention that uses one-size-fits-all dietary recommendations, versus a usual care control (UCC). The primary outcome will compare the impact of each intervention on the mean amplitude of glycemic excursions (MAGE).
UNASSIGNED: Eligible participants are between 21 to 80 years of age diagnosed with moderately-controlled T2D (HbA1c: 6.0-8.0%), and managed on lifestyle alone or lifestyle plus metformin. Participants must be willing and able to attend virtual counseling sessions and log meals into a dietary tracking smartphone application (DayTwo), and wear a continuous glucose monitor (CGM) for up to 12 days. Participants are randomized with equal allocation (n = 255, n = 85 per arm) to one of three arms: 1) Personalized, 2) Standardized, or 3) UCC. Measurements occur at 0 (baseline), 3, and 6 months. All participants receive isocaloric energy and macronutrients targets to meet Mediterranean diet guidelines plus 14 intervention contacts over 6 months (4 weekly then 10 biweekly) to cover diabetes self-management education. The first 4 UCC intervention contacts are delivered via synchronous videoconferences followed by educational video links. Participants in Standardized receive the same education content as UCC on the same schedule. However, all intervention contacts are conducted via synchronous videoconferences, paired with Social Cognitive Theory (SCT)-based behavioral counseling, plus dietary self-monitoring of planned meals using a mobile app that provides real-time feedback on calories and macronutrients. Participants in the Personalized arm receive all elements of the Standardized intervention, plus real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app.
UNASSIGNED: The DiaTeleMed study will address an important gap in the current landscape of precision nutrition by determining the contributions of behavioral counseling and personalized nutrition recommendations on glycemic control in individuals with T2D. The fully remote methodology of the study allows for scalability and innovative delivery of personalized dietary recommendations at a population level.
UNASSIGNED: The DiaTeleMed Study is registered with ClinicalTrials.gov (Identifier: NCT05046886).
UNASSIGNED: Eligible participants are between 21 to 80 years of age diagnosed with moderately-controlled T2D (HbA1c: 6.0-8.0%), and managed on lifestyle alone or lifestyle plus metformin. Participants must be willing and able to attend virtual counseling sessions and log meals into a dietary tracking smartphone application (DayTwo), and wear a continuous glucose monitor (CGM) for up to 12 days. Participants are randomized with equal allocation (n = 255, n = 85 per arm) to one of three arms: 1) Personalized, 2) Standardized, or 3) UCC. Measurements occur at 0 (baseline), 3, and 6 months. All participants receive isocaloric energy and macronutrients targets to meet Mediterranean diet guidelines plus 14 intervention contacts over 6 months (4 weekly then 10 biweekly) to cover diabetes self-management education. The first 4 UCC intervention contacts are delivered via synchronous videoconferences followed by educational video links. Participants in Standardized receive the same education content as UCC on the same schedule. However, all intervention contacts are conducted via synchronous videoconferences, paired with Social Cognitive Theory (SCT)-based behavioral counseling, plus dietary self-monitoring of planned meals using a mobile app that provides real-time feedback on calories and macronutrients. Participants in the Personalized arm receive all elements of the Standardized intervention, plus real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app.
UNASSIGNED: The DiaTeleMed study will address an important gap in the current landscape of precision nutrition by determining the contributions of behavioral counseling and personalized nutrition recommendations on glycemic control in individuals with T2D. The fully remote methodology of the study allows for scalability and innovative delivery of personalized dietary recommendations at a population level.
UNASSIGNED: The DiaTeleMed Study is registered with ClinicalTrials.gov (Identifier: NCT05046886).
摘要：
糖尿病远程医疗地中海饮食（DiaTeleMed）研究是一项完全远程随机临床试验，旨在评估2型糖尿病（T2D）患者的个性化饮食管理。该研究旨在测试个性化行为方法对中度控制的T2D饮食管理的有效性，与使用一刀切的饮食建议的标准化行为干预相比，与常规护理控制(UCC)相比。主要结果将比较每种干预对血糖波动平均幅度（MAGE）的影响。方法符合条件的参与者年龄在21至80岁之间，诊断为中度控制的T2D（HbA1c：6.0-8.0％），并管理单独的生活方式或生活方式加二甲双胍。参与者必须愿意并且能够参加虚拟咨询会议，并将膳食记录到饮食跟踪智能手机应用程序（DayTwo）中，并佩戴连续血糖监测仪（CGM）长达12天。参与者被随机分配（每个手臂n=255，n=85）到三个手臂之一：1）个性化，2）标准化，或3）UCC。测量发生在0（基线），3和6个月。所有参与者均接受等热量能量和常量营养素目标，以满足地中海饮食指南，并在6个月内（每周4次，然后每两周10次）进行14次干预接触，以覆盖糖尿病自我管理教育。前4个UCC干预联系人通过同步视频会议传递，然后是教育视频链接。标准化的参与者在相同的时间表上获得与UCC相同的教育内容。然而,所有干预联系都是通过同步视频会议进行的，与基于社会认知理论(SCT)的行为咨询相结合，再加上使用移动应用程序，提供对卡路里和大量营养素的实时反馈计划膳食的饮食自我监控。个性化手臂的参与者接受标准化干预的所有要素，再加上实时反馈预测餐后血糖反应（PPGR）的膳食和零食登录到移动应用程序。讨论DiaTeleMed研究将通过确定行为咨询和个性化营养建议对T2D患者血糖控制的贡献来解决当前精准营养领域的重要差距。该研究的完全远程方法允许在人群水平上的可扩展性和个性化饮食建议的创新交付。试验注册：DiaTeleMed研究已在ClinicalTrials.gov注册（标识符：NCT05046886）。
