Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.
J Diabetes. 2023 Jun;15(6):474-487. doi: 10.1111/1753-0407.13392. Epub 2023 Apr 23.
The objective of this study was to provide recommendations regarding effectiveness, safety, optimal starting dose, optimal maintenance dose range, and target fasting plasma glucose of five basal insulins (glargine U-300, degludec U-100, glargine U-100, detemir, and insulin protamine Hagedorn) in insulin-naïve adult patients with type 2 diabetes in the Asia-Pacific region. Based on evidence from a systematic review, we developed an Asia-Pacific clinical practice guideline through comprehensive internal review and external review processes. We set up and used clinical thresholds of trivial, small, moderate, and large effects for different critical and important outcomes in the overall certainty of evidence assessment and balancing the magnitude of intervention effects when making recommendations, following GRADE methods (Grading of Recommendations, Assessment, Development, and Evaluation). The AGREE (Appraisal of Guidelines, Research and Evaluation) and RIGHT (Reporting Items for practice Guidelines in HealThcare) guideline reporting checklists were complied with. After the second-round vote by the working group members, all the recommendations and qualifying statements reached over 75% agreement rates. Among 44 contacted external reviewers, we received 33 clinicians' and one patient's comments. The overall response rate was 77%. To solve the four research questions, we made two strong recommendations, six conditional recommendations, and two qualifying statements. Although the intended users of this guideline focused on clinicians in the Asia-Pacific region, the eligible evidence was based on recent English publications. We believe that the recommendations and the clinical thresholds set up in the guideline can be references for clinicians who take care of patients with type 2 diabetes worldwide.
本研究旨在为亚太地区新诊断 2 型糖尿病成人患者提供五种基础胰岛素（甘精胰岛素 U-300、地特胰岛素 U-100、甘精胰岛素 U-100、德谷胰岛素和精蛋白锌胰岛素）在有效性、安全性、起始最佳剂量、最佳维持剂量范围和目标空腹血糖方面的推荐意见。基于系统评价证据，我们通过全面的内部审查和外部审查程序制定了亚太临床实践指南。我们根据 GRADE 方法（推荐分级的评估、制定与评价），在整体证据评估中设定了不同关键和重要结局的轻微、小、中、大影响的临床阈值，并在制定推荐意见时平衡干预效果的大小。我们还遵循了 AGREE（评估、制定与评价指南）和 RIGHT（医疗保健实践指南报告条目）指南报告清单。在工作组第二轮投票后，所有推荐意见和限定性陈述的同意率均超过 75%。在联系的 44 位外部审查者中，我们收到了 33 位临床医生和一位患者的意见。总体回复率为 77%。为了解决四个研究问题，我们提出了两项强推荐、六项有条件推荐和两项限定性陈述。尽管该指南的目标用户主要是亚太地区的临床医生，但合格证据基于最近的英文出版物。我们相信，该指南中的推荐意见和设定的临床阈值可以为全球范围内治疗 2 型糖尿病患者的临床医生提供参考。
