This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is a 5-year field outcomes study that will investigate the clinical utility of an intelligent feedback system assisting patients with type 1 diabetes (T1DM) in their natural environment. The proposed Integrated Biobehavioral Monitoring and Feedback (IBMF) system will integrate self-monitoring of blood glucose (SMBG) with behavioral monitoring and feedback, and will have two levels: 1. IBMF-1 will use SMBG data to estimate patients' HbA1c, acute risk for severe hypoglycemia and chronic risk for severe hypoglycemia, and will provide feedback of these biological parameters to patients.2. IBMF-2 will add to IBMF-1 monitoring of symptoms of hypoglycemia and hyperglycemia and self-treatment behavior, will assess idiosyncratic symptom significance and hypoglycemia awareness, and will provide feedback of these behavioral parameters to patients.One hundred and twenty adults with T1DM will participate in the study for approximately 1 year. We hypothesize that: IBMF-1 will:1.Reduce patients' risk of hypoglycemia (quantified by the SMBG-based Low BG Index, LBGI), without compromising their HbA1c; 2.Reduce patients' fear of hypoglycemia (quantified by the Fear of Hypoglycemia Scale); 3.Reduce the occurrence of severe hypoglycemia. 4. Improve the % of time patients spend within the BG target range of 70 to 180 mg/dl.IBMF-2 will improve:1. hypoglycemia awareness and recognition of hypoglycemic symptoms;2. overall accuracy in BG estimation (quantified by Error-Grid Analysis and Accuracy Index);3. Self-treatment behaviors; and4. BG stability.IBMF 1+2 will not result in higher HbA1c or higher risk for hyperglycemia (measured by the High BG Index, HBGI).
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