OBJECTIVE To compare the 12-month effects of continuous glucose monitoring (CGM) versus blood glucose monitoring (BGM) in adults with insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS 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 healthcare 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. RESULTS 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), BMI (−1.1 kg/m2, −1.8; −0.3), and greater self-rated diabetes-related health, well-being, satisfaction, and health behavior. CONCLUSIONS 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.

中文翻译：

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比较连续血糖监测和血糖监测对控制不充分、胰岛素治疗的 2 型糖尿病成人的影响（Steno2tech 研究）：一项为期 12 个月的单中心随机对照试验

目的 比较连续血糖监测 (CGM) 与血糖监测 (BGM) 对接受胰岛素治疗的 2 型糖尿病成人的 12 个月效果。研究设计和方法 这是一项单中心、平行、开放标签、随机对照试验，受试者为丹麦哥本哈根 Steno 糖尿病中心门诊的 2 型糖尿病控制不充分且接受胰岛素治疗的成人。纳入标准为 ≥18 岁、接受胰岛素治疗的 2 型糖尿病、HbA1c ≥ 7.5% (58 mmol/mol)。参与者被随机分配 (1:1) 接受 12 个月的 CGM 或 BGM。所有参与者都接受了糖尿病自我管理教育课程，并由他们平时的医疗保健提供者进行跟踪。主要结局是组间时间变化范围 (TIR) 3.9–10.0 mmol/L 的差异，在基线、6 个月和 12 个月后通过盲法 CGM 进行评估。预先指定的次要结果是其他几种血糖、代谢和参与者报告的结果变化的差异。结果 76 名参与者的中位基线 HbA1c 为 8.3 (7.8, 9.1)% (67 [62–76] mmol/mol)，其中 61.8% 为男性。与 BGM 相比，CGM 的使用与 TIR（组间差异 15.2%，95% CI 4.6；25.9）、HbA1c（−0.9%，−1.4；−0.3 [−9.4 mmol/mol，−15.2] ；-3.5]），每日总胰岛素剂量（-10.6单位/天，-19.9；-1.3），体重（-3.3公斤，-5.5；-1.1），BMI（-1.1公斤/平方米，-1.8；-0.3） ），以及更好的自我评价糖尿病相关的健康、幸福感、满意度和健康行为。结论 对于胰岛素治疗效果不佳的 2 型糖尿病成人，CGM 在改善血糖控制和其他重要健康参数方面的 12 个月效果优于 BGM。研究结果支持在胰岛素治疗的 2 型糖尿病亚组中使用 CGM。