Randomized trials have shown that self-monitoring of blood glucose (SMBG) improves glycemic control in T2DM, but is most effective combined with feedback on what SMBG levels mean. We have developed an Automated Self-Management Monitor (ASMM) that prompts patients to perform SMBG and take medication, as well as having the capability to provide user-friendly feedback about the results obtained from SMBG. A feasibility trial was conducted in a small population of older adults and those using the ASMM increased SMBG frequency and improved A1c during a 3-month period. This grant proposes to rigorously test the ASMM, expanding the quality and type of feedback provided. This may be particularly effective in changing behavior because it is timely, regular, and delivered at home, where the bulk of self-management must occur. Objectives: Our primary objective is to demonstrate that the ASMM supports improvements in self management behaviors and glycemic control.
Our specific aims i nclude: 1) To demonstrate that use of the ASMM improves glycemic control in T2DM over 12 months. 2) To determine whether use of the ASMM is associated with sustained improvement in glycemic control over an additional 12 months of follow up. 3) To determine whether self-management behaviors are improved when using the ASMM. Methods: 200 community-dwelling adults with poorly controlled T2DM (A1c >8%) will be recruited from low-income housing sites in Milwaukee, and through primary care clinics affiliated with MCW. Participants will be randomized to a usual care control group (UC) or to the ASMM intervention group. The ASMM will be installed 3 months after enrollment, and will provide audio reminders to perform SMBG and take medications, and feedback regarding whether individual readings are within target ranges. The system will also provide feedback about the participants'trends in glycemic control for readings taken at that time of day (e.g., when a fasting blood sugar is checked, the system will relate the trend in fasting glucose levels for the prior two weeks, and whether the current reading will keep the trend stable, decreasing or increasing). The ASMM will remain with participants for 12 months. We will collect data on patient characteristics, glycemic control, SMBG patterns and results, medication dosing, diet, and physical activity at home visits conducted at baseline, 3 months (when participants will be trained in use of the ASMM), 9 months and 15 months. We will use change in A1c as the primary outcome. Secondary outcomes include changes in self-management behaviors. We will also examine whether certain patient characteristics modify the impact of the ASMM on these outcomes.
