Introduction: Clinical guidelines recommend weight loss for management of type 2 diabetes mellitus (T2DM) and the prevention of cardiovascular disease. Commercial weight loss programs are more cost-effective and accessible than clinic-based modalities, and have been shown to be effective for clinically significant weight loss in adults with additional improvements in glycemic control. Continuous glucose monitoring (CGM) has emerged as an effective and popular tool for patients to track their glucose levels in real time and provide feedback to support behavior change. Hypothesis: The integration of continuous glucose monitoring (CGM) into a behavioral weight management program tailored for T2DM will improve weight loss and cardiometabolic risk factors. Methods: We conducted a two-arm, three-site, randomized controlled trial of a commercial weight management program (INT, WeightWatchers Diabetes Program) integrated with CGM (Abbott FreeStyle Libre 2) compared to usual care (UC) in patients with T2DM. Outcomes included 6-month changes in HbA1c, weight, waist circumference, blood pressure, and diabetes stress. Randomization was stratified by GLP1-RA use. Results: The sample included 151 participants (67.6% female) with a mean (± SD) age of 54.7 ± 9.1 years, BMI of 35.2 ± 6.9 kg/m 2 , and HbA1c of and 8.6% ± 1.0%. diverse race and ethnicity (12% Hispanic, 19.3% Non-Hispanic Black, 23.3% Non-Hispanic Asian, 41.3% Non-Hispanic White, 4% Multiracial/Other). Repeated measures mixed models employing the intention-to-treat principle showed participants in INT reduced HbA1c (-0.90%; 95% confidence interval, -1.20 to -0.60%) more than participants in UC (−0.42%; −0.73 to -0.10%) with a mean difference of -0.49% (-0.92 to 0.05%) between the groups (P = 0.029). Percent change in weight after 6 months was also significantly greater in INT (-4.1%; -5.3 to -3.0%) compared to UC (-0.8%; -2.1 to 0.4%), with a mean difference of -3.3% (-5.0 to -1.6%) between groups. There were no significant differences in waist circumference or blood pressure between the two groups. Regimen-related diabetes stress significantly reduced in INT relative to UC (-0.8; -1.2 to -0.5); however, there were no differences in other diabetes stress sub-scores. Conclusions: A widely available digital, commercial weight management program paired with CGMs provided significantly greater improvements HbA1c, weight loss, and regimen-related diabetes stress than usual care in patients with T2DM.
Katzmarzyk et al. (Tue,) studied this question.