Abstract
Aims: The first 26 weeks of the 2GO-CGM trial assessed the efficacy and safety of real-time continuous glucose monitoring (rtCGM) use within a supported specialist model of care in a cohort of community-based adults with insulin-requiring type 2 diabetes in New Zealand.
Methods: A 26-week randomised one-way crossover 'waitlist-controlled' trial comparing rtCGM (Dexcom G6) with self-monitoring of blood glucose (SMBG). All participants completed 2 weeks of SMBG before being randomised to 12 weeks (phase 1) use of SMBG followed by 12 weeks (phase 2) use of rtCGM (Group A) or 24 weeks of rtCGM (Group B). A time-adjusted within-subject analysis was conducted to estimate the overall treatment effect of rtCGM versus SMBG.
Results: Sixty-seven participants were randomised to Group A or B, and all were included in the analysis (53% indigenous Māori, 57% female, median age 53 [range 16-69] years). Baseline-adjusted mean time in range (3.9-10.0 mmol/L) was 15% (95% CI 10-20; p = <0.001) higher with rtCGM use versus SMBG use. There was no evidence of a difference in Hba1c between rtCGM and SMBG use (-3.4 mmol/mol [0.31%], 95% CI -9.4 to 2.7 mmol/mol [-0.86 to 0.24%], p = 0.27). One participant withdrew in phase 2 due to unmanageable skin reactions to the CGM device. There were no severe hypoglycaemia or ketoacidosis events in either group during the study.
Conclusions: Use of rtCGM demonstrates safe and sustained glycaemic improvement in rtCGM use with insulin-requiring type 2 diabetes during the first 26 weeks of the 2GO-CGM study.