Glycated Albumin Guided Therapy in Newly Diagnosed Type 2 Diabetes A Randomized Controlled Trial

BACKGROUND: Glycated albumin (GA) has already been introduced in clinic for decades. However, it remains unclear whether routine measurement of GA could serve as a practical tool to improve the care of patients with type 2 diabetes (T2DM). METHODS: This multicenter, randomized controlled trial enrolled 200 patients with newly diagnosed, poorly controlled type 2 diabetes from seven sites in China. Participants were randomly assigned (1:1) to either GA-guided therapy (treatment intensification if GA > 16% at 4 weeks) or standard therapy, with a 12-weeks follow-up. The primary outcome was the proportion of patients achieving HbA1c < 7%; secondary outcomes included HbA1c < 6.5%, glycemic parameters, hypoglycemia, and β-cell function. RESULTS: A total of 200 patients were included in this study. Therapy compliances were 97.4% (SD, 5.3%) and 98.0% (SD, 8.2%) in the GA-guided therapy group and standard therapy group, respectively. There was no significant difference in the achievement rate of HbA1c (< 7%) between the GA-guided therapy group (64.3%) and the standard therapy group (64.4%) after the 12-week follow-up (p = 0.99). In the secondary outcome, the achievement rate of HbA1c (< 6.5%) was higher in the GA-guided therapy group than in the standard therapy group (40.5% vs. 25.3%, p = 0.034). Furthermore, the changes in HbA1c, HOMA-β, HOMA-IR, body weight reduction were all better in the GA guided therapy group than in standard therapy group. CONCLUSION: GA-guided therapy did not enhance HbA1c < 7% achievement; however, its potential benefits for more stringent glycemic targets and metabolic parameters in early diabetes management deserve further investigation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05227677.