Study Objective
The 2GO-CGM trial was designed to assess the efficacy and safety of real-time continuous glucose monitoring (rtCGM) in adults with insulin-requiring type 2 diabetes. Conducted by the University of Otago, the trial aimed to compare rtCGM with traditional self-monitoring of blood glucose (SMBG) in improving glycemic control.
Trial Design and Methodology
This study followed a 26-week, randomized, one-way crossover, waitlist-controlled trial format. Sixty-seven participants were enrolled and randomly assigned to two groups. Initially, all participants underwent a 2-week period using SMBG. Following this, Group A continued with SMBG for 12 more weeks before switching to rtCGM for the next 12 weeks. Group B used rtCGM continuously for the entire 24-week period. A time-adjusted within-subject analysis was used to determine the overall treatment effect between rtCGM and SMBG.
Inclusion Criteria
Participants were eligible if they met the following criteria: diagnosed with type 2 diabetes, had an HbA1c level above 8.0%, required at least 0.2 units of insulin per kilogram of body weight per day for at least three months prior to the study, were aged 16 years or older, and were willing and able to comply with the study protocol.
Results
All 67 participants were included in the final analysis. Of these, 53% identified as Indigenous Māori, 57% were female, and the median age was 53 years (ranging from 16 to 69 years). The use of rtCGM improved glycemic control, as evidenced by a 15% higher baseline-adjusted mean time in the target glucose range (3.9–10.0 mmol/L) compared to SMBG (95% CI: 10–20; p < 0.001). However, no statistically significant difference was observed in HbA1c levels between the two monitoring methods. The mean difference in HbA1c was –3.4 mmol/mol (–0.31%), with a 95% confidence interval ranging from –9.4 to 2.7 mmol/mol (–0.86% to 0.24%) and a p-value of 0.27. One participant withdrew during the second phase of the study due to skin reactions, but no episodes of severe hypoglycemia or ketoacidosis were reported.
Conclusion
The findings from the 2GO-CGM trial demonstrate that real-time continuous glucose monitoring is a safe and effective method for improving glycemic control in adults with insulin-requiring type 2 diabetes. The rtCGM system showed sustained benefits over SMBG without significant safety concerns.