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The trial was the maker's own, a prospective study of 96 subjects at three clinical institutions, with venous glucose as the reference. The mean absolute relative difference (MARD) was 9.20% (95% CI 8.65% to 9.74%). Of the readings, 99.32% fell in Clarke error grid zones A and B. MARD rose from 7.22% on day 1 to 10.40% at about day 30. No adverse event was related to the device. In a report posted on 12 August 2026, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks). 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Undated report, posted on CMDE's website on 12 August 2026. Section 三、临床评价概述 (clinical evaluation).","title":"医疗器械产品注册技术审评报告：无创血糖仪（CQZ2500265）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1786495243657085501.pdf","date":"2026-08-12","written_by":"independent","quote":"平均绝对相对误差值（MARD%）结果及 95%CI 为 9.20%（8.65%，9.74%）"},{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：无创血糖仪 (technical review report for the registration of a non-invasive blood glucose meter), acceptance no. CQZ2500265, applicant 北京乐普诊断科技股份有限公司. Undated report, posted on CMDE's website on 12 August 2026. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：无创血糖仪（CQZ2500265）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1786495243657085501.pdf","date":"2026-08-12","written_by":"independent","quote":"经综合评价，在当前认知水平上，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"}],"replication":{"produced_by":["An LED on one side of the ring sent near-infrared light through the finger to an optical sensor on the other side.","An artificial-intelligence model in the apps and server predicted blood glucose from the light signals.","Each user first calibrated the ring with finger-stick readings while fasting and two hours after a meal."],"must_hold":["Users are adults with type 2 diabetes who do not use insulin.","Users repeat the finger-stick calibration at least every 30 days and keep testing finger-stick blood.","The estimates do not serve to screen for or diagnose diabetes or to decide on medication.","The ring is used for self-management outside medical institutions."],"echoes":[]},"paired_incident":null,"headline":"*GluRing* estimated blood glucose without a needle in China's review","metric":"differed from venous values by 9.20% on average","comparator":{"against":"Venous blood glucose of the same subjects, measured in pairs as the reference standard","before":null,"after":"MARD 9.20% (95% CI 8.65% to 9.74%)","basis":"measured","quote":"平均绝对相对误差值（MARD%）结果及 95%CI 为 9.20%（8.65%，9.74%）。主要评价指标的结果均达到了检验假设的要求。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1786495243657085501.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The accuracy was measured in the maker's pre-market trial, and the report gives no outcome of care, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration.","source":"https://www.cmde.org.cn/directory/web/cmde/images/1786495243657085501.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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CQZ2500265, applicant 北京乐普诊断科技股份有限公司. Undated report, posted on CMDE's website on 12 August 2026. Section 三、临床评价概述 (clinical evaluation).","title":"医疗器械产品注册技术审评报告：无创血糖仪（CQZ2500265）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1786495243657085501.pdf","date":"2026-08-12","written_by":"independent","quote":"平均绝对相对误差值（MARD%）结果及 95%CI 为 9.20%（8.65%，9.74%）"},{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：无创血糖仪 (technical review report for the registration of a non-invasive blood glucose meter), acceptance no. CQZ2500265, applicant 北京乐普诊断科技股份有限公司. Undated report, posted on CMDE's website on 12 August 2026. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：无创血糖仪（CQZ2500265）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1786495243657085501.pdf","date":"2026-08-12","written_by":"independent","quote":"经综合评价，在当前认知水平上，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-1159-source-0001","AIBD-1159-source-0002"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：无创血糖仪 (technical review report for the registration of a non-invasive blood glucose meter), acceptance no. 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The report says that an artificial-intelligence model predicts the glucose value and that the apps and server contain a deep learning algorithm. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the application for Class III registration. The trial was the maker's own, a prospective study of 96 subjects at three clinical institutions, with venous glucose as the reference. The mean absolute relative difference (MARD) was 9.20% (95% CI 8.65% to 9.74%). Of the readings, 99.32% fell in Clarke error grid zones A and B. MARD rose from 7.22% on day 1 to 10.40% at about day 30. No adverse event was related to the device. In a report posted on 12 August 2026, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks). 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