Claire S. Lever, Jonathan A. Williman, Alisa Boucsein, Antony Watson, Rachael S. Sampson, Oscar T. Sergel-Stringer, Celeste Keesing, Benjamin J. Wheeler, Martin I. de Bock, Ryan G. Paul
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引用次数: 0
摘要
目的：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的社区成人2型糖尿病患者的支持专科护理模式中使用的有效性和安全性。方法：一项为期26周的随机单向交叉“候补对照”试验，比较rtCGM （Dexcom G6）与自我监测血糖（SMBG）。所有参与者完成了2周的SMBG治疗，然后随机分配到12周（第一阶段）使用SMBG，随后使用12周（第二阶段）rtCGM （A组）或24周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。结果：67名参与者被随机分为A组或B组，所有参与者都被纳入分析（53%土著Māori， 57%女性，中位年龄53岁[范围16-69岁]）。基线调整后的平均时间范围（3.9-10.0 mmol/L）为15% (95% CI 10-20；结论：在2GO-CGM研究的前26周，使用rtCGM治疗需要胰岛素的2型糖尿病患者显示出安全且持续的血糖改善。
Extended use of real-time continuous glucose monitoring in adults with insulin-requiring type 2 diabetes: Results from the first 26 weeks of the 2GO-CGM trial
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.
期刊介绍：
Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions.
The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed.
We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services.
Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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