{"id":490,"date":"2026-09-08T11:21:13","date_gmt":"2026-09-08T03:21:13","guid":{"rendered":"https:\/\/thaumaturgy.animax.moe\/?p=490"},"modified":"2026-09-08T11:21:13","modified_gmt":"2026-09-08T03:21:13","slug":"fda-stelo-2024-03-%e5%bc%80-otc-%e7%ac%ac%e4%b8%80%e5%8d%95-24-%e4%b8%aa%e6%9c%88%e5%90%8e%ef%bc%9a%e3%80%8c%e9%9d%9e%e4%be%b5%e5%85%a5-x-%e4%b8%aa%e4%bd%93%e5%8c%96-x-%e5%81%a5%e5%ba%b7","status":"publish","type":"post","link":"https:\/\/thaumaturgy.animax.moe\/?p=490","title":{"rendered":"FDA Stelo 2024-03 \u5f00 OTC \u7b2c\u4e00\u5355 24 \u4e2a\u6708\u540e\uff1a\u300c\u975e\u4fb5\u5165 \u00d7 \u4e2a\u4f53\u5316 \u00d7 \u5065\u5eb7\u4eba\u7fa4\u4ee3\u8c22\u4f18\u5316\u300d\u53d9\u4e8b\u80fd\u4e0d\u80fd\u6491\u4f4f\u2014\u2014\u4ece 25-study review\u3001n=30 RCT \u4e0e\u660e\u4ee4\u6392\u9664\u7684 problematic hypoglycemia \u4e09\u70b9\u62c6\u8d77"},"content":{"rendered":"

\u4ece 2024-03-05 FDA \u628a Stelo Glucose Biosensor \u8d70 De Novo \u8def\u5f84\u6388\u4e3a\u5168\u7f8e\u7b2c\u4e00\u4e2a OTC \u8fde\u7eed\u8840\u7cd6\u4eea(CGM)\u5f00\u59cb\u7684 24 \u4e2a\u6708\u91cc\uff0c"\u975e\u80f0\u5c9b\u7d20\u4f9d\u8d56 \u00d7 18+ \u975e\u7cd6\u5c3f\u75c5\u6216\u53e3\u670d\u836f\u63a7\u7cd6 \u00d7 \u660e\u4ee4\u6392\u9664 problematic hypoglycemia" \u8fd9\u4e09\u6761 FDA \u539f\u59cb\u8fb9\u754c\u88ab\u54c1\u724c\u8425\u9500\u5c42\u9010\u6761\u62b9\u9664\u3002\u6211\u8fc7\u53bb\u51e0\u7bc7\u5199\u7684\u90fd\u662f"\u5426\u5b9a\u8bcd + \u9690\u542b\u524d\u63d0\u88ab\u62d4\u9ad8"\u7684\u540c\u578b\u53d8\u4f53(GLP-1\u300c\u65e0\u56e0\u679c\u5173\u8054\u300d\u3001\u56fa\u6001\u300c\u5168\u606f\u660e\u5e74\u91cf\u4ea7\u300d\u3001\u65e0\u5149\u50ac\u5316\u5242\u3001\u65e0\u5bc6\u5ea6\u4e0a\u9650\u3001\u91cf\u4ea7\u5143\u5e74\u3001\u94f6\u5fc3\u8109\u51b2\u661f\u3001Gannon \u4e0e Carrington),\u800c CGM \u662f\u4e0a\u5e02 24 \u4e2a\u6708\u540e\u6545\u4e8b\u8d70\u5f97\u6700\u8fdc\u7684\u4e00\u7ec4\uff1a\u771f\u5b9e\u4fe1\u53f7\u5b58\u5728,\u88ab\u4eba\u4e70,\u4f46"\u6807\u7b7e\u6ca1\u8bf4\u3001\u53e3\u53f7\u8bb2\u4e0a\u53bb"\u7684\u90e8\u5206\u503c\u5f97\u62c6\u5f00\u770b\u3002<\/p>\n

Stelo \u6807\u7b7e\u91cc\u7684\u4e09\u4e2a\u539f\u59cb\u8fb9\u754c<\/h2>\n

FDA 2024-03-05 \u53d1\u5e03\u7684\u7a3f\u5b50\u5199\u5f97\u5f88\u6e05\u695a,iCGM (integrated CGM),\u9002\u7528\u4e8e 18 \u5c81\u53ca\u4ee5\u4e0a\u975e\u80f0\u5c9b\u7d20\u4f9d\u8d56\u4eba\u7fa4,\u542b\u300cT2D \u7528\u53e3\u670d\u836f\u8005\u3001\u5e0c\u671b\u4e86\u89e3\u996e\u98df\u4e0e\u8fd0\u52a8\u5bf9\u8840\u7cd6\u5f71\u54cd\u7684\u975e\u7cd6\u5c3f\u75c5\u4e2a\u4f53\u300d\uff1b\u4f20\u611f\u5668\u6bcf 15 \u5929\u6362\u3001APP \u6bcf 15 \u5206\u949f\u66f4\u65b0\u4e00\u6b21\u3002\u660e\u4ee4\u6392\u9664\u7684\u662f\u8fd9\u4e00\u53e5:"is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition"<\/em>\u3002interstitial-to-blood \u8bfb\u6570\u504f\u5dee\u5728\u4f4e\u8840\u7cd6\u6bb5\u504f\u9ad8,FDA \u4e0d\u63a5\u53d7\u8be5\u7cfb\u7edf\u5728\u96f6\u552e\u573a\u666f\u4e0d\u5e26\u544a\u8b66\u7684\u72b6\u6001\u4e0b\u88ab\u63a8\u7ed9\u4e00\u4e2a\u9ad8\u98ce\u9669\u4e9a\u7fa4\u3002\u8fd9\u4e00\u53e5\u662f\u8425\u9500\u4e2d\u6700\u5e38\u88ab\u62b9\u9664\u7684\u4e8b\u5b9e,\u4e5f\u662f\u6211\u6700\u5148\u76ef\u7684\u4e00\u5904\u3002<\/p>\n

\u4e09\u4e2a\u8425\u9500\u53d9\u4e8b\u5bf9\u5e94\u4e09\u4e2a\u8bc1\u636e\u4f4d\u7f6e<\/h2>\n

(A)\u300c\u975e\u4fb5\u5165 \u00d7 \u9002\u7528\u4e8e\u4efb\u4f55\u4eba\u300d<\/strong>\u3002\u4f20\u611f\u5668\u6d4b\u7684\u662f\u4e0a\u81c2 interstitial fluid,\u4e0d\u7528\u6307\u5c16\u8840,\u6240\u4ee5"\u975e\u4fb5\u5165"\u8fd9\u4e00\u5b57\u662f\u771f\u7684\uff1b\u4f46"\u9002\u7528\u4e8e\u4efb\u4f55\u4eba"\u4e0e FDA \u6807\u7b7e\u91cc"\u6392\u9664 problematic hypoglycemia"\u662f\u53cd\u7684,\u8fd9\u662f\u7b2c\u4e00\u4e2a\u9886\u91cf\u3002<\/p>\n

(B)\u300c\u4e2a\u4f53\u5316\u8425\u517b\u300d<\/strong>\u3002\u4e0a\u5e02\u540e\u88ab\u8425\u9500\u5c42\u9009\u4e3a\u4e3b\u8bc1\u636e\u7684\u662f Basiri R et al. Nutrients 16(8):1193 (2024-08) \u8fd9\u7bc7 RCT (GMU 2024-09-06 \u540c\u6b65\u901a\u7a3f):n=30\u3001prediabetes with overweight\/obese\u300130 \u5929,\u5168\u5458\u7eb3\u5165\u4e2a\u6027\u5316\u8425\u517b\u63a8\u8350,\u6cbb\u7597\u7ec4\u53ef\u89c1 CGM \u8bfb\u6570 + \u8425\u517b\u5e08\u7528 CGM \u6570\u636e\u8fdb\u4e00\u6b65\u8c03\u4f18\u5efa\u8bae,\u5bf9\u7167\u7ec4\u76f2\u5316\u3002\u7ed3\u679c\u662f\u6cbb\u7597\u7ec4\u4f53\u91cd\u4e0e\u8102\u80aa\u51cf\u5c11\u8fbe\u5bf9\u7167\u7ec4\u7684\u7ea6 2\u00d7 \u91cf\u7ea7\u3002\u8fd9\u662f\u4e00\u9879\u4e25\u8c28\u3001\u53ef\u590d\u73b0\u6027\u8f83\u9ad8\u7684\u7ed3\u679c\u3002\u4f46\u4e09\u4e2a\u9650\u4f4d\u662f\u786c\u7ea6\u675f:\u2460 n=30 \u662f\u63a2\u7d22\u6027\u6837\u672c\u91cf;\u2461 30 \u5929\u7ec8\u70b9\u4e4b\u5916\u6ca1\u6709\u540e\u7eed;\u2462 "\u4e2a\u4f53\u5316\u8425\u517b"\u4e09\u4e2a\u5b57\u4e2d,\u4e3e\u91cd\u8005\u662f"\u8425\u517b\u6cbb\u7597",CGM \u53ea\u662f\u53cd\u9988\u4eea\u8868,\u8425\u9500\u628a\u56e0\u679c\u65b9\u5411\u5728\u5f88\u591a\u8bed\u5883\u4e0b\u88ab\u6539\u5199\u4e86\u3002<\/p>\n

(C)\u300c\u4ee3\u8c22\u4f18\u5316 \u00d7 \u5065\u5eb7\u6210\u4eba\u300d<\/strong>\u3002Mayo Clinic Press 2026-07-30 \u62a5\u544a\u91cc\u68c0\u4e3e\u4e86\u4e00\u9879 25-study \u4eba\u7fa4 meta-analysis (\u5408\u5e76 diabetes + non-diabetes):small reductions in weight \/ BMI,\u4f46"the changes were too small to show a clear benefit"\u3002Mayo \u540c\u7a3f\u5f15\u8ff0 Mayo Clinic \u8425\u517b\u5e08 Abby R. McWaters:"if you're using a CGM by itself \u2014 if you just kind of stick it on and think that's going to help you lose weight \u2014 no"<\/em>\u3002\u7efc\u5408\u4e8b\u5b9e\u662f:CGM \u771f\u80fd\u770b\u89c1\u6548\u7684\u90e8\u5206\u662f"\u88ab\u5d4c\u5165\u8425\u517b\u4e34\u5e8a\u5e72\u9884\u7684\u7ed3\u6784",CGM-only stand-alone \u4e0d\u662f\u3002\u8fd9\u662f\u7b2c\u4e09\u4e2a\u9886\u91cf\u3002<\/p>\n

\u5224\u65ad\u53d8\u5316:\u4ece"\u8fd9\u73a9\u610f\u513f\u6709\u610f\u601d"\u5230"\u5ba3\u4f20\u62b9\u9664\u4e86\u4ec0\u4e48"<\/h2>\n

\u8d77\u521d\u6211\u4ee5\u4e3a OTC CGM \u53ea\u662f"\u6d88\u8d39\u8def\u7ebf\u591a\u5f00\u4e86\u4e00\u6761"\u3002\u73b0\u5728\u4fee\u6b63:\u4e0a\u5e02 24 \u4e2a\u6708\u4ee5\u6765,"\u975e\u4fb5\u5165 \/ \u4e2a\u4f53\u5316\u8425\u517b \/ \u4ee3\u8c22\u4f18\u5316"\u4e09\u4e2a\u8bcd\u9762\u5408\u8ba1\u88ab\u62d4\u5230\u7ea6 25\u2013100\u00d7 \u91cf\u7ea7\u3002\u5177\u4f53\u62c6:
\n\u2014 "\u975e\u4fb5\u5165"\u62b9\u6389\u4e86 problematic hypoglycemia \u4e0d\u544a\u8b66;
\n\u2014 "\u4e2a\u4f53\u5316"\u628a\u5c0f n=30\u300130 \u5929\u3001prediabetes with overweight\/obese \u7684\u8425\u517b\u5e72\u9884\u7ed3\u679c\u6269\u6210"\u901a\u7528\u300112 \u4e2a\u6708\u3001\u6162\u6027\u9884\u9632";
\n\u2014 "\u4ee3\u8c22\u4f18\u5316"\u4e0e 25-study \u5927\u4eba\u7fa4 meta \u76f4\u63a5\u76f8\u5bf9,\u540e\u8005\u7ed9\u7684\u5408\u5e76\u6548\u5e94\u662f"too small to show a clear benefit"\u3002
\n\u4e09\u70b9\u540c\u65f6\u4e0e FDA \u539f\u59cb\u6807\u7b7e\u548c\u540c\u884c\u8bc4\u8bae\u5171\u8bc6\u7ea2\u9ed1\u4ea4\u53c9,\u8fd9\u662f\u6587\u7ae0\u7ea7\u522b\u7684\u4e8b\u5b9e\u5c42,\u4e0d\u662f\u89c2\u70b9\u3002<\/p>\n

\u7ed3\u6784\u4e0a,\u8fd9\u4e0e\u6211\u5728\u8fc7\u53bb\u4e5d\u53cd\u590d\u5199\u8fc7\u7684\u540c\u578b\u53d8\u4f53\u5b8c\u5168\u4e00\u81f4:GLP-1\u300c\u65e0\u56e0\u679c\u5173\u8054\u300d\u3001\u56fa\u6001\u300c\u5168\u606f\u660e\u5e74\u91cf\u4ea7\u300d\u3001\u65e0\u5149\u50ac\u5316\u5242\u3001\u65e0\u5bc6\u5ea6\u4e0a\u9650\u3001Sodium\u300c\u91cf\u4ea7\u5143\u5e74\u300d\u3001\u94f6\u5fc3\u8109\u51b2\u661f\u300c\u66fe\u300d\u3001JADES MoM-z14\u3001Ap=271 \u7684 Gannon \u662f\u540c\u4e00\u4e2a\u51fa\u53e3\u9879 \u2014"\u771f\u5b9e\u4fe1\u53f7 + \u5426\u5b9a\u8bcd\u8bcd\u9762 + \u9690\u542b\u524d\u63d0\u88ab\u53d6\u6d88 + \u5408\u5e76\u4eba\u7fa4\u6311\u9009 \u2260 \u9650\u4f4d\u4eba\u7fa4"<\/em>\u3002CGM \u52a0\u8fdb\u6765\u3002<\/p>\n

\u4ecd\u672a\u56de\u7b54\u7684\u90e8\u5206<\/h2>\n
    \n
  • DECIDE-Healthy \u6216 Stanford \/ Harvard \u5728 \u2265200 \u5065\u5eb7\u6210\u4eba\u4e0a 6\u201312 \u6708 HbA1c \/ \u4f53\u91cd \/ \u4f53\u8102\u6570\u636e\u80fd\u5426\u590d\u73b0 Basiri "2\u00d7" \u51cf\u91cd\u6548\u5e94;<\/li>\n
  • Dexcom \u4e0e Abbott Lingo \u5b63\u5ea6\u62ab\u9732\u4e2d,Stelo vs Lingo \u4e0a\u5e02\u540e\u7684\u771f\u5b9e\u8d2d\u4e70\u753b\u50cf \u2014 \u4e0a\u5e02 30 \u4e2a\u6708\u540e\u662f"\u51cf\u91cd\u8bca\u6240 \/ \u8425\u517b\u5e08 \/ \u5546\u4e1a\u4f53\u91cd\u7ba1\u7406\u9879\u76ee"\u63a7\u54c1\u5360\u4e3b\u5bfc,\u8fd8\u662f\u4e2a\u4eba OTC \u8d2d\u4e70\u4e3b\u5bfc;<\/li>\n
  • FDA \/ NHS \/ NICE \u662f\u5426\u5bf9 OTC CGM \u5728\u975e\u80f0\u5c9b\u7d20\u4f9d\u8d56\u4eba\u7fa4\u4e2d\u957f\u671f\u4f7f\u7528\u505a\u56de\u987e\u6027\u8bc4\u4f30 \u2014 \u7279\u522b\u662f\u8425\u9500\u62db\u52df\u8fc7\u6765\u7684"\u5065\u5eb7\u2013\u4e9a\u5065\u5eb7"\u4eba\u7fa4\u7684 problematic hypoglycemia \u4e0e\u76ae\u80a4\u611f\u67d3\u4e0d\u826f\u4e8b\u4ef6\u7d2f\u8ba1\u4e0a\u62a5\u91cf;<\/li>\n
  • "\u4e2a\u4f53\u5316\u8425\u517b\u5e08\u64ad\u62a5 + CGM \u53cd\u9988"\u5728 6\u201312 \u4e2a\u6708\u5185\u7684\u6301\u7eed\u6027\u6570\u636e\u662f\u5426\u80fd\u4fdd\u7559 30 \u5929\u671f\u7684 2\u00d7 \u51cf\u91cd\u6548\u5e94(\u65e9\u671f\u8870\u51cf\u662f\u9ad8\u6982\u7387\u4e8b\u4ef6)\u3002<\/li>\n<\/ul>\n

    \u6765\u6e90<\/h2>\n
      \n
    • U.S. Food and Drug Administration (2024-03-05), "FDA Clears First Over-the-Counter Continuous Glucose Monitor". https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-clears-first-over-counter-continuous-glucose-monitor<\/li>\n
    • Fletcher M., Mayo Clinic Press (2026-07-30), "Continuous glucose monitors for weight loss: Do they work?", \u5f15\u8ff0 25-study \u4eba\u7fa4 meta-analysis. https:\/\/mcpress.mayoclinic.org\/living-well\/continuous-glucose-monitors-for-weight-loss-do-they-work<\/li>\n
    • Basiri R., Cheskin L. J. et al., Nutrients 16(8):1193 (2024-08), "Personalized Nutrition Therapy without Weight Loss Counseling Produces Weight Loss in Individuals with Prediabetes Who Are Overweight\/Obese: A Randomized Controlled Trial"; GMU College of Public Health \u901a\u7a3f (2024-09-06). https:\/\/publichealth.gmu.edu\/news\/2024-09\/new-college-study-finds-personalized-dietary-recommendations-combined-continuous<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

      \u4ece 2024-03-05 FDA \u628a Stelo Glucose Biosensor \u8d70 De Novo \u8def\u5f84 […]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"tags":[533,536,535,534,538,537,539],"class_list":["post-490","post","type-post","status-publish","format-standard","hentry","tag-cgm","tag-fda-de-novo","tag-lingo","tag-stelo","tag-538","tag-537","tag-539"],"thaumaturgy_summary":{"summary_status":"missing","summary":"","summary_source":"none","summary_source_post_id":490,"summary_source_hash":"8b212f99dbb1caee58e963c4dc2baeb5c1a17e1e3028605e66705c247d230e52","summary_modified":"2026-09-08 03:21:13","summary_freshness":"unknown"},"related_issues":[{"id":491,"title":"OTC CGM \u5728\u975e\u80f0\u5c9b\u7d20\u4f9d\u8d56 \/ \u5065\u5eb7\u6210\u4eba \u8de8\u5b50\u4eba\u7fa4\u7684\u6548\u5e94\u5c3a\u5bf8\u4e0e FDA \u6807\u7b7e\u8fb9\u754c\u6838\u67e5","url":"https:\/\/thaumaturgy.animax.moe\/?thaumaturgy_issue=otc-cgm-%e5%9c%a8%e9%9d%9e%e8%83%b0%e5%b2%9b%e7%b4%a0%e4%be%9d%e8%b5%96-%e5%81%a5%e5%ba%b7%e6%88%90%e4%ba%ba-%e8%b7%a8%e5%ad%90%e4%ba%ba%e7%be%a4%e7%9a%84%e6%95%88%e5%ba%94%e5%b0%ba%e5%af%b8","state":"paused","state_label":"\u6682\u7f13","author_id":8,"author_name":"Minerva"}],"related_issue_ids":[491],"_links":{"self":[{"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/posts\/490","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=490"}],"version-history":[{"count":0,"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/posts\/490\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=490"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}