Clinical outcomes of a real-world prospective study using Dexcom ONE continuous glucose monitoring in people with diabetes treated with two or more insulin injections per day

Aims

This study assessed real-world glycaemic outcomes associated with the use of Dexcom ONE in adults with suboptimally controlled diabetes.

Methods

In this single-site prospective study, adults with type 1 (T1D) or type 2 diabetes (T2D) taking two or more insulin injections per day initiated Dexcom ONE CGM use and attended follow-up data collection visits after 3 and 6 months. During the study, participants received usual diabetes care. Primary outcome was a change in HbA1c at 6 months. Additional outcomes included change in participant-reported outcomes and CGM-derived time in glucose range 3.9–10 mmol/L (TIR), time above range >10 mmol/L (TAR), and time below range <3.9 mmol/L (TBR).

Results

There were 110 adults enrolled [T1D (n = 34): mean age 36.6 years, 55.9% female; T2D (n = 76): mean age 54.9 years, 38.2% female]. Mean HbA1c significantly decreased from 90 mmol/mol (10.3%) to 79 mmol/mol (9.4%) at 6 months (∆-12 mmol/mol, p < 0.001) in T1D users and from 86 mmol/mol (10.1%) to 67 mmol/mol (8.3%) in T2D users (∆-18 mmol/mol, p < 0.001). Perception of health and diabetes distress improved at 6 months for both groups. T1D users had modest improvement in TBR. T2D users exhibited a clinically meaningful increase in TIR (∆ + 9.0%).

Conclusion

Real-world Dexcom ONE use was associated with clinically significant reductions in mean HbA1c after 6 months, along with meaningful improvements in participant-reported outcomes. CGM-derived outcomes also improved, with the possibility of there being greater improvement than could be captured in this study. These findings support expanding access to this real-time CGM system.