Lever Claire S, Williman Jonathan A, Boucsein Alisa, Watson Antony, Sampson Rachael S, Sergel-Stringer Oscar T, Keesing Celeste, Wheeler Benjamin J, de Bock Martin I, Paul Ryan G
Te Huataki Waiora, School of Health, University of Waikato, Hamilton, New Zealand.
Waikato Regional Diabetes Service, Te Whatu Ora Health New Zealand Waikato, Hamilton, New Zealand.
Diabet Med. 2025 May;42(5):e70025. doi: 10.1111/dme.70025. Epub 2025 Mar 18.
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.
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 withinsubject analysis was conducted to estimate the overall treatment effect of rtCGM versus SMBG.
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.
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.
2GO-CGM试验的前26周评估了实时连续血糖监测（rtCGM）在新西兰一组需要胰岛素治疗的社区成年2型糖尿病患者的支持性专科护理模式中的疗效和安全性。
一项为期26周的随机单向交叉“等待名单对照”试验，比较rtCGM（德康G6）与自我血糖监测（SMBG）。所有参与者在随机分组前完成2周的SMBG，然后随机分为12周（第一阶段）使用SMBG，随后12周（第二阶段）使用rtCGM（A组）或24周使用rtCGM（B组）。进行了时间调整的受试者内分析，以估计rtCGM与SMBG的总体治疗效果。
67名参与者被随机分为A组或B组，所有参与者均纳入分析（53%为毛利原住民，57%为女性，中位年龄53岁[范围16 - 69岁]）。与使用SMBG相比，使用rtCGM时，经基线调整后的血糖在目标范围内（3.9 - 10.0毫摩尔/升）的平均时间高出15%（95%置信区间10 - 20；p = <0.001）。没有证据表明rtCGM与SMBG在糖化血红蛋白方面存在差异（-3.4毫摩尔/摩尔[0.31%]，95%置信区间-9.4至2.7毫摩尔/摩尔[-0.86至0.24%]，p = 0.27）。一名参与者在第二阶段因对CGM设备出现难以控制的皮肤反应而退出。研究期间两组均未发生严重低血糖或酮症酸中毒事件。
在2GO-CGM研究的前26周，使用rtCGM表明在需要胰岛素治疗的2型糖尿病患者中使用rtCGM可实现安全且持续的血糖改善。
