Crowley Matthew J, Edelman David, Voils Corrine I, Maciejewski Matthew L, Coffman Cynthia J, Jeffreys Amy S, Turner Marsha J, Gaillard Leslie A, Hinton Teresa A, Strawbridge Elizabeth, Zervakis Jennifer, Barton Anna Beth, Yancy William S
Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, United States; Department of Medicine, Division of Endocrinology, Duke University Medical Center, Durham, NC, United States.
Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, United States; Department of Medicine, Division of General Internal Medicine, Duke University Medical Center, Durham, NC, United States.
Contemp Clin Trials. 2017 Jul;58:1-12. doi: 10.1016/j.cct.2017.04.004. Epub 2017 Apr 23.
Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management.
Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index≥27kg/m) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs.
Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes.
全国范围内血糖控制率仍未达到最佳水平。糖尿病药物强化治疗可能会产生不良副作用（体重增加、低血糖），从而抵消血糖控制的益处。一种强调体重管理的糖尿病共享医疗预约（SMA）干预措施可能会改善血糖结果、减轻体重，同时降低糖尿病药物需求，减少低血糖发生并提高生活质量。我们描述了一项研究的基本原理和设计，该研究评估一种主要强调以低碳水化合物饮食为重点的体重管理的新型糖尿病SMA干预措施。
“通过体重管理启动糖尿病共享医疗预约”（Jump Start）是一项随机对照试验，将超重的2型糖尿病退伍军人（体重指数≥27kg/m²）分为两组：1）专注于药物管理和自我管理咨询的传统SMA组；或2）将以低碳水化合物饮食为重点的体重管理（WM/SMA）与药物管理相结合的SMA组。48周时糖化血红蛋白的降低是主要结局。次要结局包括低血糖事件、糖尿病药物使用、体重、药物依从性、糖尿病相关生活质量和成本效益。我们假设WM/SMA在血糖控制方面不劣于标准SMA，并且相对于标准SMA将减少低血糖、糖尿病药物使用和体重，同时还能改善生活质量和成本。
Jump Start针对两个密切相关但很少同时管理的常见问题：糖尿病和肥胖症。通过将饮食和体重减轻作为控制糖尿病的主要手段，这种干预措施可能会改善与糖尿病相关的几个有意义的以患者为中心的结局。
