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.
Thesaurus Terms: automated health care system, biomedical equipment development, noninsulin dependent diabetes mellitus, patient care management, telecommunication patient monitoring device, therapy compliance clinical research, human subject
