OBJECTIVE Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.

中文翻译：

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移动闭环控制的随机对照试验。


目标 评估移动闭环控制 (CLC) 系统 inControl AP 的功效。研究设计和方法 该方案 NCT02985866 是一项为期 3 个月的平行组、多中心、随机非盲试验，旨在比较移动 CLC 与传感器增强泵 (SAP) 疗法。资格标准为患有 1 型糖尿病至少 1 年、使用胰岛素泵至少 6 个月、年龄≥14 岁、基线 HbA1c <10.5% (91 mmol/mol)。该研究旨在评估两个共同主要结果：在连续血糖监测仪 (CGM) 测量时间低于 3.9 mmol/L 方面，CLC 优于 SAP；在 CGM 测量时间高于 10 mmol/L 方面，CLC 相对于 SAP 具有非劣效性。结果 2017 年 11 月至 2018 年 5 月期间，127 名参与者被随机分配至 CLC（n = 65）和 SAP（n = 62）； 125 名参与者完成了这项研究。 CLC 组中 CGM 时间低于 3.9 mmol/L 的比例在基线时为 5.0%，在随访期间为 2.4%，而 SAP 组中分别为 4.7% 和 4.0%（平均差 -1.7% [95% CI -2.4， -1.0]；P < 0.0001 为优越性）。 CLC 组 CGM 时间高于 10 mmol/L 的比例在基线时为 40%，在随访期间为 34%，而 SAP 组分别为 43% 和 39%（平均差 -3.0% [95% CI -6.1， 0.1]；P < 0.0001 为非劣效性）。 CLC 组发生了 1 例严重低血糖事件，与研究设备无关。结论 在满足其共同主要终点时，在 CGM 测量时间低于 3.9 mmol/L 时，CLC 优于 SAP，在 CGM 测量时间高于 10 mmol/L 时，CLC 优于 SAP，该研究证明移动 CLC 是可行的，并且可以提供一定的可用性相对于嵌入式系统的优势，前提是系统组件之间的连接稳定。