Using Nutrition to Improve Time in rangE (UNITE): A Randomized Clinical Trial with Continuous Glucose Monitoring in People with Type 2 Diabetes Not Taking Insulin.

Abstract

Introduction: Preliminary research suggests that continuous glucose monitoring (CGM) can be used to guide food and lifestyle choices. The objective of the Using Nutrition to Improve Time in rangE (UNITE) study was to compare the glycemic and dietary impact of using either a nutrition-focused approach (NFA) or a self-directed approach (SDA) during CGM initiation in people with type 2 diabetes (T2D) not on insulin. Methods: UNITE was a 60-day, two-arm, randomized clinical trial. The NFA arm was designed to help participants use CGM data to guide evidenced-based food choices to improve percent time in range with glucose 70-180 mg/dL (TIR70-180) and diet quality, whereas the SDA arm was designed to guide participants to use CGM data in any way that felt useful to them. Changes in outcomes from baseline (Base) to postintervention (Post) were estimated by arm and compared between arms using difference-in-differences; analyses were limited to those with adequate CGM data at Base and Post. Results: Adults (NFA: N = 64, SDA: N = 60) with a mean (standard deviation) age of 65.0 (10.3) years, T2D duration of 10.7 (6.5) years, and HbA1c of 7.9% (0.7) participated. There was no differential change in TIR70-180 between arms (P = 0.14), but both arms improved from Base to Post (NFA: 46%-71%, SDA: 55%-71%; within-arm differences both P < 0.001). Time with glucose >250 mg/dL decreased more from Base to Post in the NFA versus the SDA (-14% versus -6%; differential change P = 0.047). NFA participants had several minor, but significant, within-arm changes in dietary intake, and the NFA arm reported significantly more confidence using CGM data than the SDA arm (P < 0.05). Conclusion: Changes in mean TIR70-180 did not differ between the NFA and SDA arms; however, both arms experienced significant within-arm improvements, which support the use of CGM to improve glycemia in people with T2D not on insulin.