Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study

青少年 2 型糖尿病改善健康的合作伙伴：Buddy 研究

基本信息

批准号：
8349961
负责人：
Kristina Rother
金额：
$ 4.8万
依托单位：
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8349961
关键词：
18 year old 2,4-thiazolidinedione Acarbose Adherence Adolescent Adult Age American Behavior Therapy Behavioral Blood Glucose Blood Pressure Body Weight British Cardiovascular Diseases Caring Child Childhood Chronic Disease Clinic Visits Clinical Cognition Disorders Combined Modality Therapy Communication Communities Comorbidity Data Collection Databases Development Diabetes Mellitus Diagnosis Diet Disease Enrollment Environment Exclusion Criteria Eye diseases FDA approved Family Fasting Fostering Glucosidase Inhibitor Glycosylated hemoglobin A Goals Guidelines HIV Infections Health Health Professional Home environment Home visitation Hour House Call Immunization Individual Insulin Insulin-Dependent Diabetes Mellitus Intention Intervention Kidney Diseases Label Laboratories Libraries Maintenance Measurement Medical Medical History Mental disorders Metformin Methods Minority Nature Non-Insulin-Dependent Diabetes Mellitus Obesity Parents Participant Patients Personal Satisfaction Persons Pharmaceutical Preparations Pharmacotherapy Physical Examination Physicians Pilot Projects Population Pregnancy Quality of life Questionnaires Randomized Randomized Controlled Trials Recording of previous events Regimen Research Design Research Personnel Resources Schedule Schools Screening procedure Secure Sulfonylurea Compounds Suspension substance Suspensions System Telephone Testing Thiazolidinediones Time Training Treatment Protocols United States National Institutes of Health Violence Visit Weight Youth arm base cohort conventional therapy cost diabetes control diabetes mellitus therapy diet and exercise early onset follow-up glucose monitor ideation improved inclusion criteria insulin secretagogues insulin sensitizing drugs lifestyle factors lifestyle intervention medication compliance meetings meglitinide minimally invasive outreach pregnant psychologic psychosocial secondary outcome suicidal uptake volunteer

项目摘要

Traditionally considered a disease of adults, type 2 diabetes mellitus (T2DM) is increasingly diagnosed in children and adolescents in parallel to rising obesity rates. Currently, only insulin and metformin are approved as pharmacotherapy for type 2 diabetes in patients less than 18 years of age. It is well known that adolescent patients often have difficulty adhering to medication regimens, and may have trouble with the lifestyle interventions required to effectively treat T2DM. The consequences of early-onset diabetes and lack of adequate glycemia control have been demonstrated; i.e. nephropathy, cardiovascular disease, and ophthalmopathy may all occur early in these young patients. It has been shown that improved personalized support may be beneficial to patients with other chronic illnesses such as type 1 diabetes and in patients with HIV infection. The use of lay volunteers (without prior professional health care training) has been documented in several studies conducted in the USA as well as in the developing world, and has been systematically reviewed. In addition, British studies have suggested that using non-professional volunteers to support parents can be an effective strategy for improving the uptake of immunization in children younger than 2 years. A Seattle group has previously shown in a randomized controlled trial that enhanced tracking and outreach increased the proportion of persons with elevated blood pressure detected during community measurement who followed up with medical care. We have found no studies to date documenting the use of lay volunteers in the treatment of adolescent T2DM in the US or abroad. Thus, we would like to test whether a low-cost, simple, personal intervention (the buddy study), in which an individual volunteer partner is assigned to each participant) can be effective in improving hemoglobin A1c (HbA1c) levels, adherence to treatment regimens, and quality of life in adolescents with T2DM. Relevance of Existing Guidelines for Care The American Diabetes Association (ADA) recommends initial therapy of T2DM in youth with diet and exercise if patients present asymptomatically, and with insulin if they present with ketoacidosis. If glycemia goals (fasting blood glucose < 126 mg/dL and HbA1c < 7%) are not achieved with diet and exercise, monotherapy is begun with metformin. If monotherapy fails then combination therapy should be initiated with metformin plus a sulfonylurea or insulin. However, other insulin secretagogues such as meglitinide, insulin sensitizers (e.g. thiazolidinediones), and glucosidase inhibitors (acarbose) are acceptable alternatives. Insulin therapy may be initiated at any point, or as a final step after combination therapy fails. It is important, however, to note that all drugs with the exception of metformin and insulin are being used off-label in pediatric patients. In this study, since only patients with HbA1c > 7% will be included, treatment for all subjects will have been initiated or will be initiated with diet and metformin. If glycemia goals are not achieved on metformin, other medications will be added based on existing clinical guidelines for adults and children. Relevance of Study Results to Care Demonstration of a change in HbA1c levels, and secondarily, in weight, overall diabetes care (i.e., number of glucose monitor checks, medication compliance, and adherence to clinic visit schedule), and psychological well-being in this pilot study would be an important development in the approach to T2DM therapy in this often difficult-to-treat adolescent cohort. Given the limited number of FDA-approved therapies in the pediatric population, and the nature of T2DM as disease requiring significant lifestyle modifications, an approach using personalized follow-up from a lay volunteer would be particularly applicable in resource-poor and underserved settings. Study Objectives Primaryoutcome: To evaluate the effect of a minimally invasive intervention C the buddy system C on hemoglobin A1c levels in adolescents with T2DM. Secondary outcomes: To assess changes between groups in body weight, number of home glucose monitor checks, compliance with medications, adherence to visit schedule, and psychological well-being. Inclusion Criteria Any patient with type 2 diabetes mellitus as documented by his or her primary physician 1. Age 12-20 years at enrollment 2. Most recent HbA1c 7% Exclusion Criteria 1. Significant comorbidity that, in the opinion of the investigators, may limit adequate study participation 2. Significant psychiatric or cognitive disorder, or communication difficulty that will, in the opinion of the investigators, limit the subject's ability to interact with the patient assistant or may present a danger to the patient assistant; patients with current suicidal or homicidal ideation, history of arrest for violent behavior, or history of school suspension/expulsion for violent behavior will be excluded. 3. Pregnancy or intention to become pregnant within 6 months Study Design and Statistical Analysis Patients will be randomized to conventional treatment versus interventional group (buddy study). Patients will be followed for 6 months. During this period, all patients should undergo two follow-up visits including physical examination, detailed medical history, and laboratory testing (hemoglobin A1c) approximately 3 months apart. All patients will complete an initial screening questionnaire (Appendix A), and quality of life questionnaires (Appendix B) after the initial and 6 month clinic visits. Patients assigned to the interventional (buddy) group will also have a home visit conducted by the buddy once a month. This visit will last approximately 30 minutes to 1 hour. Its purpose is to assist with bonding of the buddy and the patient in his or her familiar environment and to further the understanding of the patients psychosocial situation. The home environment will not be systematically assessed but any observations about unsafe conditions will be disclosed by the buddy to the investigator(s). However, should a home visit be declined by the patient or his/her family, acceptable alternative buddy-patient meeting places include schools, cafes, or libraries chosen by both parties at a mutually acceptable time. If necessary, these additional face-to-face encounters may also take place at NIH or at CNMC if this is most convenient for the study participants. Current recruitment status: Eight adolescents with type 2 diabetes have been enrolled and randomized (4 to the conventional arm and 4 to the 'Buddy' arm.

传统上认为 2 型糖尿病 (T2DM) 是一种成人疾病，但随着肥胖率的上升，儿童和青少年也越来越多地诊断出 2 型糖尿病 (T2DM)。目前，只有胰岛素和二甲双胍被批准作为 18 岁以下患者 2 型糖尿病的药物治疗。众所周知，青少年患者往往难以坚持服药，并且可能难以采取有效治疗 T2DM 所需的生活方式干预措施。早发性糖尿病和缺乏足够血糖控制的后果已得到证实；即肾病、心血管疾病和眼病都可能在这些年轻患者的早期发生。研究表明，改进的个性化支持可能对患有其他慢性疾病（例如 1 型糖尿病）的患者和 HIV 感染患者有益。在美国和发展中国家进行的几项研究中记录了使用非专业志愿者（事先没有接受过专业医疗保健培训）的情况，并进行了系统审查。此外，英国的研究表明，利用非专业志愿者来支持父母可能是提高2岁以下儿童免疫接种率的有效策略。西雅图的一个小组此前在一项随机对照试验中表明，加强跟踪和外展活动增加了社区测量中发现的高血压患者接受医疗护理的比例。迄今为止，我们尚未发现任何研究记录美国或国外使用非专业志愿者治疗青少年 T2DM 的情况。因此，我们想测试一种低成本、简单的个人干预（伙伴研究）是否可以有效改善糖化血红蛋白 (HbA1c) 水平、治疗依从性。 T2DM 青少年的治疗方案和生活质量。现有护理指南的相关性美国糖尿病协会 (ADA) 建议，如果患者无症状，则对青少年 T2DM 进行初始治疗：饮食和运动；如果患者出现酮症酸中毒，则应使用胰岛素。如果通过饮食和运动未能达到血糖目标（空腹血糖 < 126 mg/dL 和 HbA1c < 7%），则开始使用二甲双胍单一疗法。如果单一疗法失败，则应开始二甲双胍加磺酰脲类或胰岛素的联合治疗。然而，其他胰岛素促分泌剂，例如美格列奈、胰岛素增敏剂（例如噻唑烷二酮类）和葡萄糖苷酶抑制剂（阿卡波糖）也是可接受的替代品。胰岛素治疗可以在任何时候开始，或者作为联合治疗失败后的最后一步。然而，值得注意的是，除二甲双胍和胰岛素外，所有药物都在儿科患者中超说明书使用。在这项研究中，由于仅纳入 HbA1c > 7% 的患者，因此所有受试者的治疗都将开始或将开始饮食和二甲双胍。如果二甲双胍未能达到血糖目标，将根据现有的成人和儿童临床指南添加其他药物。研究结果与护理的相关性在这项试点研究中，证明 HbA1c 水平的变化，其次是体重、整体糖尿病护理（即血糖监测仪检查次数、用药依从性和遵守就诊时间表）以及心理健康的变化将是一个重要的因素针对这一往往难以治疗的青少年群体，T2DM 治疗方法的发展。鉴于 FDA 批准的儿科治疗方法数量有限，以及 T2DM 作为需要重大生活方式改变的疾病的性质，使用非专业志愿者进行个性化随访的方法将特别适用于资源匮乏和服务不足的环境。学习目标主要结果：评估微创干预 C 伙伴系统 C 对患有 T2DM 的青少年血红蛋白 A1c 水平的影响。次要结果：评估各组之间的体重变化、家庭血糖监测仪检查次数、药物依从性、遵守就诊时间表和心理健康状况。纳入标准由其主治医生记录的任何患有 2 型糖尿病的患者 1. 入学年龄12-20岁 2. 最近的 HbA1c 7% 排除标准 1. 研究人员认为，严重的合并症可能会限制充分的研究参与 2. 研究者认为，受试者有明显的精神或认知障碍，或沟通困难，这些障碍会限制受试者与患者助理互动的能力，或可能对患者助理构成危险；当前有自杀或杀人意念、因暴力行为被捕历史或因暴力行为被学校停课/开除历史的患者将被排除。 3. 怀孕或6个月内打算怀孕研究设计和统计分析患者将被随机分配到常规治疗组与干预组（伙伴研究）。患者将被随访 6 个月。在此期间，所有患者均应接受两次随访，包括体检、详细病史和实验室检测（糖化血红蛋白），间隔约 3 个月。所有患者将在初次就诊和 6 个月就诊后填写初步筛查问卷（附录 A）和生活质量问卷（附录 B）。分配到介入（伙伴）组的患者还将接受伙伴每月一次的家访。此次参观将持续约 30 分钟至 1 小时。其目的是帮助好友和患者在熟悉的环境中建立联系，并进一步了解患者的心理社会状况。家庭环境不会被系统评估，但任何有关不安全条件的观察结果都会由好友向调查人员披露。然而，如果患者或其家人拒绝家访，可接受的替代伙伴患者会面地点包括双方在双方可接受的时间选择的学校、咖啡馆或图书馆。如有必要，如果对研究参与者来说最方便，这些额外的面对面交流也可能在 NIH 或 CNMC 进行。目前招聘情况： 8 名患有 2 型糖尿病的青少年已入组并被随机分组（4 名进入传统组，4 名进入“巴迪”组）。