Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.
Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.
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DOI：
10.2337/dc15-2716
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发表时间：
2016-07
期刊：
影响因子：
16.2
通讯作者：
Lum JW
中科院分区：
文献类型：
--
作者：
Maahs DM;Buckingham BA;Castle JR;Cinar A;Damiano ER;Dassau E;DeVries JH;Doyle FJ 3rd;Griffen SC;Haidar A;Heinemann L;Hovorka R;Jones TW;Kollman C;Kovatchev B;Levy BL;Nimri R;O'Neal DN;Philip M;Renard E;Russell SJ;Weinzimer SA;Zisser H;Lum JW
人工胰腺（AP）的研究和商业开发继续快速发展，AP有望成为临床护理的一部分。在本报告中，JDRF人工胰腺项目联盟的成员与更广泛的AP社区合作，1）倡导在AP试验中使用动态血糖监测血糖指标作为除HbA 1c外的结局指标，2）在可行的情况下确定AP研究中报告的一组简短的基本、易于解释的结局指标。就更广泛的衡量标准达成共识仍然具有挑战性;因此，鼓励酌情报告个别AP研究或研究组的其他指标。基本结果指标报告的更大一致性可能有助于研究者、监管机构、医疗保健提供者、付款人和患者自己对研究结果的解释，从而加速AP技术的广泛采用，以改善1型糖尿病患者的生活。
Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.