Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study
Background: Initiating continuous glucose monitoring (CGM) can affect hemoglobin A1c (HbA1c) levels and patients' relationship with their diabetes. We used real-world HbA1c data to quantify short-term changes in glycemia and validated psychosocial questionnaires to assess changes in quality-of-life indicators in people during their first few months of CGM use. Methods: Eligibility was assessed during calls to Dexcom sales regarding its G6 CGM System. Eligibility criteria included ages 25–65 years, type 1 (T1D) or type 2 diabetes (T2D) on intensive insulin therapy (IIT), and no prior CGM use. Participants used a web-based portal to complete the 17-item Diabetes Distress Scale (DDS) and the 14-item Hypoglycemia Attitudes and Behavior Scale (HABS); provided validated HbA1c measurements; and shared their CGM data pre- and 3–5 months post-CGM initiation. Satisfaction and ease of use with the G6 System were also assessed. Results: Data were available from 248 patients (182 with T1D, 66 with T2D; 57% male, 88% non-Hispanic white). Mean (standard deviation) HbA1c fell significantly from 8.2% (1.9%) at baseline to 7.1% (1.1%) at the end of the study ( P < 0.001); more than half (54.4%) of those with initial HbA1c values >7% experienced absolute HbA1c reductions of >1%. Significant reductions in diabetes distress (DDS) and hypoglycemic concerns (HABS) were observed ( P < 0.001). Most (93%) participants were satisfied or very satisfied with the G6 System and 73% found it very easy to use. Conclusions: The first 3 months of CGM use was correlated with improvements in psychosocial outcomes and improved HbA1c levels for people with T1D or T2D who use IIT.