Department of Clinical Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Diabetes Care. 2024 May 1;47(5):881-889. doi: 10.2337/dc23-2194.
To compare the 12-month effects of continuous glucose monitoring (CGM) versus blood glucose monitoring (BGM) in adults with insulin-treated type 2 diabetes.
This is a single-center, parallel, open-label, randomized controlled trial including adults with inadequately controlled, insulin-treated type 2 diabetes from the outpatient clinic at Steno Diabetes Center Copenhagen, Denmark. Inclusion criteria were ≥18 years of age, insulin-treated type 2 diabetes, and HbA1c ≥7.5% (58 mmol/mol). Participants were randomly assigned (1:1) to 12 months of either CGM or BGM. All participants received a diabetes self-management education course and were followed by their usual health care providers. Primary outcome was between-group differences in change in time in range (TIR) 3.9-10.0 mmol/L, assessed at baseline, after 6 and 12 months by blinded CGM. The prespecified secondary outcomes were differences in change in several other glycemic, metabolic, and participant-reported outcomes.
The 76 participants had a median baseline HbA1c of 8.3 (7.8, 9.1)% (67 [62-76] mmol/mol), and 61.8% were male. Compared with BGM, CGM usage was associated with significantly greater improvements in TIR (between-group difference 15.2%, 95% CI 4.6; 25.9), HbA1c (-0.9%, -1.4; -0.3 [-9.4 mmol/mol, -15.2; -3.5]), total daily insulin dose (-10.6 units/day, -19.9; -1.3), weight (-3.3 kg, -5.5; -1.1), and BMI (-1.1 kg/m2, -1.8; -0.3) and greater self-rated diabetes-related health, well-being, satisfaction, and health behavior.
In adults with inadequately controlled insulin-treated type 2 diabetes, the 12-month impact of CGM was superior to BGM in improving glucose control and other crucial health parameters. The findings support the use of CGM in the insulin-treated subgroup of type 2 diabetes.
比较连续血糖监测（CGM）与血糖监测（BGM）在接受胰岛素治疗的 2 型糖尿病成人中的 12 个月效果。
这是一项单中心、平行、开放标签、随机对照试验，纳入了丹麦哥本哈根 Steno 糖尿病中心门诊治疗、血糖控制不佳的接受胰岛素治疗的 2 型糖尿病成人患者。纳入标准为年龄≥18 岁、接受胰岛素治疗的 2 型糖尿病患者、HbA1c≥7.5%（58mmol/mol）。参与者被随机分配（1:1）接受 12 个月的 CGM 或 BGM。所有参与者均接受糖尿病自我管理教育课程，并由其常规医疗保健提供者进行随访。主要结局是通过盲法 CGM 在基线、6 个月和 12 个月时评估的时间在目标范围内（TIR）3.9-10.0mmol/L 的组间差异。预设的次要结局是其他几个血糖、代谢和患者报告结局的变化差异。
76 名参与者的中位基线 HbA1c 为 8.3（7.8，9.1）%（67[62-76]mmol/mol），61.8%为男性。与 BGM 相比，CGM 治疗与 TIR（组间差异 15.2%，95%CI 4.6；25.9）、HbA1c（-0.9%，-1.4；-0.3[-9.4mmol/mol，-15.2；-3.5]）、总日胰岛素剂量（-10.6 单位/天，-19.9；-1.3）、体重（-3.3kg，-5.5；-1.1）和 BMI（-1.1kg/m2，-1.8；-0.3）的显著改善以及自我报告的糖尿病相关健康、幸福感、满意度和健康行为的显著改善相关。
在血糖控制不佳的接受胰岛素治疗的 2 型糖尿病成人中，CGM 的 12 个月影响优于 BGM，可改善血糖控制和其他关键健康参数。这些发现支持在 2 型糖尿病的胰岛素治疗亚组中使用 CGM。
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