Advanced Diabetes Management System

描述(申请人提供)：对于美国1000万患有2型糖尿病的人来说，严格遵守饮食、体重、锻炼、眼睛护理和足部护理是必不可少的。处方疗法促进血糖控制，这与更好的健康相关。许多人提出的干预措施要么是时间/劳动密集型和昂贵的(护士定期打电话)，要么是高科技(互联网网站)。这项研究的目标是确定高级糖尿病管理(ADMS)系统的可行性，该系统非常易于所有患者使用，并以非常经济高效的方式将技术掌握在医疗保健提供者手中。 ADMS在预定时间以友好、非机器人的声音向患者发出自动交互电话，以鼓励患者、强化目标和收集数据。先进的语音识别和互联网技术使供应商能够快速输入方案、收集实时数据和审查例外报告。 我们的试验数据表明，ADMS概念具有优点，老年患者易于使用，并且具有巨大的商业潜力-如果我们进行两项重大修改(在我们的申请中描述)。在第一阶段，我们将修改ADMS的试点原型，并在INOVA糖尿病中心对20名患者进行为期6个月的测试。这些数据将与对照组中20名受试者的数据进行比较。我们计划评估系统的接受度、系统功能的价值、商业潜力和易用性。如果第一阶段成功，第二阶段将吸收第一阶段的经验教训，并对160名受试者进行为期12个月的随机对照试验。将在第一和第二阶段作出重大努力，以实现ADA认可和第三方报销，为ADMS商业化铺平道路。

DESCRIPTION (provided by applicant): For the 10 million people in the U.S. with Type 2 diabetes, it is essential to follow strict regimens that include diet, weight, exercise, eye care and foot care. The prescribed regimen promotes glycemic control, which is correlated with better health. Many have proposed interventions that are either time/labor intensive and costly (regular phone calls from nurse), or high tech (Internet web sites). The goal of this research is to determine the feasibility of an advanced diabetes management (ADMS) system that is extremely easy for all patients to use and puts the technology in the hands of the healthcare provider - in a very cost-effective manner. The ADMS places automated interactive telephone calls to patients at scheduled times in a friendly, non-robotic voice to encourage the patient, reinforce goals, and collect data. Advanced speech recognition and Internet technology allow the provider to rapidly input regimens, collect real-time data and review exception reports. Our pilot data suggest that the ADMS concept has merit, is easy for older patients to use, and has significant commercial potential - if we make two significant modifications (described in our application). In phase 1, we will modify the pilot ADMS prototype and conduct a 6-month test with 20 patients at the INOVA Diabetes Center. These data will be compared with data from 20 subjects in a control group. We plan to evaluate system acceptance, value of system features, commercial potential, and ease of use. If Phase 1 is successful, Phase 2 will incorporate lessons from Phase 1 and conduct a 12-month RCT with 160 subjects. A major effort will be made in Phases 1 and 2 to achieve ADA recognition and third-party reimbursement to pave the way for ADMS commercialization.