ADA

IDF 2025微专辑扫描二维码可查看更多内容编者按：糖化血红蛋白（HbA1c）作为评估长期血糖控制的核心指标，在糖尿病诊疗中占据重要地位。4月10日，在IDF 2025大会“HbA1c的全球视角：糖尿病护理的桥梁”专题中，来自中国、印度、葡萄牙、泰国、卡塔尔等多地代表分享了HbA1c诊断与管理经验。IDF-西太平洋地区（WPR）执行委员、天津医科大学朱宪彝纪念医院陈莉明教授，以区域代表身份深度解读中国视角，见解独到且意义深远，吸引众多关注。《国际糖尿病》特别邀请陈教授做客IDF同步直播间，以更直观、深入的方式，为大家剖析中国在HbA1c诊断与管理上的特点、挑战及应对策略，助力推动糖尿病诊疗水平的提升。报道如下，邀君享阅。《国际糖尿病》我国HbA1c诊断管理与国际相比在阈值设定、适用人群、检测标准化程度、筛查覆盖率等方面存在哪些差异与不足？陈莉明教授阈值设定2010年，美国糖尿病协会（ADA）将HbA1c纳入糖尿病诊断标准，推荐以HbA1c≥6.5%作为糖尿病诊断标准，HbA1c 5.7%~6.4%作为糖尿病前期诊断标准，并针对不同群体设定不同控制目标。在我国，《中国2型糖尿病防治指南（2020年版）》推荐，在采用标准化检测方法且有严格质量控制的医疗机构，可将HbA1c≥6.5%作为糖尿病补充诊断标准，而《中国糖尿病防治指南（2024年版）》尚未将HbA1c纳入糖尿病前期诊断推荐。值得注意的是，贾伟平院士、纪立农教授等国内学者基于中国人群的多项研究表明，适合中国人群的HbA1c诊断糖尿病最佳切点为6.2%~6.4%，低于ADA标准，但更契合中国人群特点。适用人群HbA1c检测便捷，不受进餐时间限制。然而，当人体红细胞数量、质量和寿命发生变化时，检测结果会受到干扰。因此，以下情况下不能以HbA1c诊断糖尿病：如镰状细胞病、近期失血或输血、妊娠中晚期、血液透析患者和促红细胞生成素治疗等。检测标准化程度在HbA1c检测方面，国际上建立了严格的标准化体系。美国国家糖化血红蛋白标准化计划（NGSP）和国际临床化学联合会（IFCC）建立了全球统一的参考系统，以确保检测结果的可比性，并设定了严格的质控标准：要求室内不精密度<2%，室间不精密度<3.5%。我国积极推进HbA1c检测标准化工作，已在多个省份成立了“HbA1c标准化工作组”，有3家实验室被IFCC正式接受成为HbA1c一级参考实验室，还搭建了全国糖化血红蛋白室间质量评价计划工作平台。但当前我国各地区检测水平存在明显差异，而且参与室间质量评价（EQA）的实验室数量会对评价结果产生影响，标准化建设仍有提升空间。存在的不足我国HbA1c标准化起步较晚，自2009年启动“糖化血红蛋白教育计划”以来，始终致力于推动检测一致性，但仍面临诸多挑战：在部分基层医疗机构中，免疫分析法与高效液相色谱法等方法学差异，造成检测结果偏差；区域发展不平衡，一线城市三甲医院NGSP认证比例较高，而基层医院因设备落后、质控不足，导致检测结果参差不齐；基层及偏远地区的筛查力度不足，医疗资源有限，严重影响糖尿病早期发现与管理；针对孕妇、儿童等特殊人群，HbA1c诊断和管理的研究匮乏，规范体系亟待完善。《国际糖尿病》目前我国HbA1c检测技术与标准化工作进展如何？取得了哪些显著成果？又面临怎样的困境和挑战？陈莉明教授标准化工作进展中国糖化血红蛋白一致性计划（CGHSP，原名为：中国糖化血红蛋白教育计划）项目自2009年启动，已成功开展完成四期。目前，全国三级医疗机构均已设立糖化血红蛋白标准化实验室，参与国家卫生健康委临床检验中心EQA计划的机构数量达4651家，该计划规模为全球之最。未来，CGHSP项目五期将聚焦于在全国范围内建设HbA1c标准化中心、糖尿病达标中心及医学达标网，以全面提升相关工作质量。标准化工作成果检测质量提升：通过CGSP项目等推动，建立了标准化实验室，促进了检测结果在不同实验室间的可比性和准确性，使检测质量得到有效提升。人员培训与科普：在全国400多个大中城市开展了医师、技师、大众患者科普培训活动，邀请专家授课2300多人次，培训医务人员15万人、大众患者6万人，媒体宣传覆盖1亿多人，提高了相关人员对HbA1c检测标准化的认识和重视程度。困境和挑战基层推广不足：在部分基层医疗机构，由于检测设备和技术水平等限制，HbA1c检测标准化程度相对较低，难以保证检测结果的质量和可比性。特殊人群影响：如高原地区人群、贫血患者、孕妇等特殊人群，其生理状态会对HbA1c检测结果产生影响，需要进一步针对这类人群开展深入研究，并制定针对性的检测和判断标准，以确保检测结果的准确性和临床诊断的可靠性。《国际糖尿病》如何利用技术创新构建HbA1c智能化管理体系？HbA1c检测技术的未来发展趋势将呈现何种面貌？陈莉明教授构建HbA1c智能化管理体系的方法数据收集与整合：借助物联网技术，将血糖仪、HbA1c检测仪等设备与电子病历系统或专门的健康管理平台连接，自动收集患者的HbA1c检测数据以及其他相关健康数据，如血糖、血压、血脂等，实现数据的整合与共享。智能分析与预警：利用大数据分析和人工智能算法，对收集到的数据进行深度分析。根据患者的HbA1c水平、变化趋势以及其他健康指标，预测糖尿病并发症的发生风险，及时向医生和患者发出预警。个性化管理方案：基于人工智能（AI）和机器学习技术，根据患者的个体特征，如年龄、性别、病史、遗传因素等，结合HbA1c数据，为患者制定个性化的治疗方案和生活方式干预建议。HbA1c检测技术未来发展趋势更高的检测精度和准确性：随着技术的不断进步，HbA1c检测方法将不断优化，减少检测误差，提高检测结果的可靠性，为糖尿病的诊断和治疗提供更精准的数据支持。即时检测（POCT）技术的发展：POCT设备将更加小型化、便捷化，操作更加简单，可实现现场快速检测，使患者能够在基层医疗机构、社区甚至家庭中进行HbA1c检测，提高检测的及时性和便利性。无创化：从采血检测到光学/生物传感、光谱技术的突破：近红外光谱（NIRS）或拉曼光谱通过皮肤表面分析血红蛋白糖化状态；可穿戴生物传感器：柔性电子皮肤贴片通过汗液或组织液中的糖化蛋白标志物间接估算HbA1c。总之，未来HbA1c的智能化管理体系将深度融合AI、物联网与新型检测技术，推动糖尿病管理从“被动治疗”转向“主动预防”，而检测技术则向无创、动态、多维度方向发展。《国际糖尿病》请您分享我国与其他国家地区在糖尿病防控领域的具体合作案例及其最新进展？陈莉明教授2017年，贾伟平院士牵头举办“一带一路”国际糖尿病论坛，俄罗斯等8个国家和地区的专家参会，并联合发表“重庆宣言”：倡议“通过教育、研究和医疗来预防和根除糖尿病”。2019年ADA年会上，CDS-ADA国际学术交流项目正式启动。该项目由中华医学会糖尿病学分会（CDS）和ADA联合开展，围绕糖尿病诊疗前沿研究、临床实践等领域进行为期三年的学术交流，旨在促进糖尿病领域专业机构和人员的国际合作，提升中国糖尿病诊疗水平。南京大学医学院附属鼓楼医院、北京医院、复旦大学附属中山医院和天津医科大学朱宪彝纪念医院均为首批参加单位。同年12月，CDS-ADA iACP项目在天津启动，美国杜克大学Jennifer Green教授访问天津医科大学朱宪彝纪念医院。2021年，我们团队与Joslin糖尿病中心的Sylvia E. Rosas教授进行了在线交流，Rosas教授以高分引用的多个国际期刊上发表的数据库研究案例，为数据库的研究和设计提供了思路。2023年，作为IDF-WPR执委，我受邀参加IDF-WPR会议暨第15届AASD年会，并做了题为“IDF-WPR糖尿病管理的现况和挑战”报告，此次会议有147名中国专家学者参会，其中79人受邀口头发言，25人进行壁报交流。“EASD中国代谢疾病创新项目”已正式落地中国，由我和纪立农教授主持首场会议，开启了中欧在糖尿病代谢领域的合作新篇章。会议邀请了EASD教育委员会主席Julia Mader教授亲临现场，EASD官方旗舰期刊Diabetologia主编Hindrik Mulder教授和EASD知名专家和赫尔辛基大学内科学教授Per-Henrik Groop教授通过远程连线带来精彩的学术讲解。今后，还将举办EASD中国代谢疾病创新峰会等系列活动，通过分享学术前沿进展，助力健康中国建设。专家简介陈莉明 教授天津医科大学朱宪彝纪念医院主任医师、博士生导师，天津医科大学朱宪彝纪念医院党委书记、院长，天津市内分泌与代谢重点实验室主任，IDF-WPR执委，CDS学会副主任委员，天津糖尿病学分会主任委员，国务院政府特殊津贴专家，国家卫健委中青年突出贡献专家，海河医学学者，天津名医，天津市优秀科技工作者，天津市高校 “学科领军人才”，《国际内分泌代谢杂志》主编、《中华糖尿病杂志》副主编。大会现场声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

AIRNA is focused on genetic variations that cause disease, plus using precision editing tech to tweak RNA into more healthy variations.\n AIRNA, a transatlantic RNA editing biotech, is prepping to launch its lead asset into clinical trials with fuel from a $155 million series B fundraise.The round was led by Venrock Healthcare Capital Partners and Forbion Growth, AIRNA announced in an April 1 release. Forbion had previously led AIRNA’s $60 million financing in July 2024. Other investors in the most recent round include RTW Investments, Arch Venture Partners, Nextech Invest, Forbion Ventures, ND Capital and other unnamed investors.  The series B cash will go toward launching a phase 1/2 trial for AIR-001, AIRNA’s drug candidate for alpha-1 antitrypsin deficiency (AATD), and will also help bolster the company’s early pipeline of RNA editing therapeutics.AIRNA plans to ask for approval to enter AIR-001 into clinical trials in the second half of this year, the company’s CEO Kris Elverum told Fierce Biotech in an interview. Elverum declined to disclose more information about the trial’s design and timeline.The biotech is also working to advance other preclinical programs that stem from AIRNA’s proprietary platform, Elverum added, including one in cardiometabolic disease.The company, headquartered in Cambridge, Massachusetts, with a subsidiary in Tübingen, Germany, was founded in 2021 and is open to partnerships with larger companies, according to the CEO.“There\'s only so much we\'re able to do as a small company,” Elverum said. “There are other companies that have capabilities in certain areas that would be better suited for bringing novel medicines to patients.”That being said, AIRNA remains committed to “building a significant and distinctive biopharma company for the long term,” Elverum added. AIRNA\'s lead asset is designed to treat AATD, a lung and liver disease that is caused by a mutated copy of the SERPINA1 gene, which leads to low levels of the protective alpha-1 antitrypsin (AAT) protein in the blood. AAT is made in the liver but ultimately migrates to the lungs; without enough of the protein, patients with AATD experience lung symptoms like coughing and shortness of breath. Malfunctioning AAT can also build up in the liver and cause cirrhosis, and patients with AATD may ultimately need a lung or liver transplant.The most common causative mutation of AATD is called PiZ, which is when an adenosine occurs at a site in the gene’s DNA instead of a guanosine. AIR-001 aims to fix this glitch by swapping the errant adenosine for a nucleotide called inosine, which the body treats the same as a guanosine.“We\'re able to repair the mutation for alpha-1 antitrypsin deficiency through this approach to give patients what we believe will be a functional cure,” Elverum said.AIRNA’s platform takes advantage of an enzyme that can be found in all of our cells, called adenosine deaminase acting on RNA (ADAR). AIRNA cofounder Thorsten Stafforst, Ph.D., a biochemist at the University of Tübingen in Germany, published a paper in 2019 demonstrating that oligonucleotides can be used to recruit ADAR to make targeted adenosine-to-inosine edits in RNA.Though AIRNA’s founders have also studied other RNA editing mechanisms, AIRNA is focused solely on harnessing ADAR.“Our data would indicate that there\'s a wide swath of opportunities for making multiple medicines with that one A to I letter change,” Elverum said.With AATD and other genetic conditions, AIRNA is focused on genetic variations that cause disease. But the company is also interested in using its precision editing tech to tweak RNA into more healthy variations.“It\'s the 90-year-old smoker who doesn\'t develop heart disease. Why is that?” Elverum said. “As a team, we\'ve spent a lot of time identifying these healthy variants and our data would indicate that we can recapitulate the positive physiological effects of these healthy variants through a single RNA edit.” AIR-001 requires regular subcutaneous doses, because editing RNA is not permanent the way editing DNA is. Elverum sees the temporary nature of RNA editing as a distinct advantage to the approach over one-and-done DNA editing gene therapies. “People want to maintain control over their health,” Elverum said. With RNA editing therapies, patients can work with their physicians to adjust dosing and find what works best for them, he added, or stop taking the medicine entirely if they want.Elsewhere in the industry, a one-and-done gene therapy for AATD from Beam Therapeutics recently saw early success in a phase 1/2 trial, appearing to correct the PiZ mutation in nine patients, with no serious adverse events reported. Beam\'s trial is expected to enroll about 106 adult patients with AATD and is taking place in two parts. The first part includes patients with AATD and lung disease, while the second part will include patients with AATD, plus patients with AATD that also have mild to moderate liver disease.

Dive Brief:Airna, a biotechnology startup developing RNA editing treatments, said Tuesday it raised $155 million in a Series B round that will help propel its lead program in alpha-1 antitrypsin deficiency into the clinic later this year.That medicine, codenamed AIR-001, repairs faulty RNA transcribed by the gene thats mutated in alpha-1 antitrypsin deficiency, or AATD. When the RNA is edited, cells are able to produce functional copies of AAT protein, lowering the risk of associated lung and liver disease.Airnas raise comes nearly six months after Wave Life Sciences unveiled promising Phase 1 data for an RNA editing drug also aimed at AATD. Similar to Wave, Airnas drug uses a sugar molecule to take its medicine into the liver.Dive Insight:No cure currently exists for AATD, which in some patients is managed with weekly injections of AAT protein. Airna estimates approximately 100,000 people in the U.S. have AATD.Co-founded by professors Thorsten Stafforst at the University of Tubingen and Jin Billy Li at Stanford University, Airna hopes to fill that niche with technology that can recruit an enzyme known as adenosine deaminase acting on RNA, or ADAR, to modify RNA.Kris Elverum, Airnas CEO, said the appeal of a drug like AIR-001 is its resemblance to biologic drugs, rather than experimental gene therapies that permanently alter DNA and can be costly to manufacture. AIR-001 is administered via a subcutaneous injection and its developers are experimenting with how to maintain its potency at lower dosages.Patients and physicians want to be able to have options that can give them a functional cure while maintaining flexibility and control over their healthcare decisions, Elverum said.The company has not disclosed specific conditions its targeting outside of AATD, but co-founder Stafforst has published research on the applicability of RNA editing in cardiometabolic and neurodegenerative diseases.RNA editing is not going to be the solution for every disease and every target, but what our data suggests is that the physiological effects of healthy variants that we identify can be reproduced through a single RNA edit, Elverum said.The Series B round was co-led by Venrock and Forbion, and included investors such as RTW Investments, Arch Venture Partners and Nextech Invest. Airna previously raised $90 million after emerging from stealth in 2023.Startups such as Shape Therapeutics, Ascidian Therapeutics and ADARx Pharmaceuticals, as well as established biotechs such as Wave and Korro Bio, have turned to RNA editing for tough-to-treat diseases. While the field has drawn hundreds of millions of venture capital dollars and the attention of pharma partners such as Roche and Novo Nordisk, its unclear whether any drugs resulting from that investment will succeed in finding a treatment niche.Airnas innovative approach to RNA editing has the distinctive potential to improve health across large populations by introducing healthy genetic variants for many conditions, Derk Kersten, a managing partner at Forbion, said in a statement. '