Personalized Nutrition Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus - ABSTRACT Medical nutrition therapy can be an accessible, cost effective and powerful tool for treatment of type 2 diabetes mellitus (T2DM), but this potential has not been realized for all patients. A common shortcoming of dietary strategies is failure to provide personalization, despite increasing evidence showing interpersonal variability in blood glucose response to meals. This disconnect diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, diabetes self-efficacy, and long-term diet adherence. Continuous glucose monitoring (CGM) systems give real-time glucose data that could provide a solution; data from the literature support the efficacy of CGM use during lifestyle interventions for diabetes and suggest use of CGM can improve hemoglobin A1c (HbA1c), reduce glycemic variability, and increase diabetes self-efficacy. The overall objective of this proposal is to compare medical nutrition therapy personalized by CGM feedback to three control interventions in participants with T2DM. A 12-week randomized controlled trial will enroll 72 adult participants with T2DM and baseline hemoglobin A1c of 6.8-8.5% in a factorial design (18 per intervention group): 1) Unblinded CGM/Nutrition Therapy, 2) Blinded CGM/Nutrition Therapy, 3) Unblinded CGM/No Nutrition Therapy, or 4) Blinded CGM/No Nutrition Therapy. The central hypothesis is that CGM-informed personalized nutrition therapy is superior to improve glycemic control in T2DM compared to medical nutrition therapy alone or unblinded CGM use alone. A secondary hypothesis is that CGM-informed personalized nutrition will improve patient satisfaction and diabetes self-efficacy. Specific aims are 1) to determine if medical nutrition therapy with active adjustment based on CGM data is superior to control interventions for improvement of glycemic control of T2DM, and 2) to test if this new approach is acceptable to participants with T2DM, and if it improves treatment satisfaction, diet satisfaction, and diabetes self-efficacy scores measured by previously validated questionnaires. It is anticipated that this project will demonstrate feasibility and produce preliminary data for a future fully powered effectiveness trial testing our CGM-informed personalized nutrition approach. Potential benefits of this approach include improved glycemic control and increased diabetes self-efficacy for patients with T2DM. An additional advantage is that this strategy could be easily adapted to individual and cultural food preferences, making it broadly acceptable and readily adaptable to a wide range of patients with T2DM. This project is a critical next step to plan for a longer, larger multicenter trial to definitively test the effectiveness of this new and exciting approach.
