{"id":709319,"date":"2026-10-20T10:03:27","date_gmt":"2026-10-20T01:03:27","guid":{"rendered":"https:\/\/www.globalresearch.jp\/jp\/inbx26b1692"},"modified":"2026-10-20T10:03:27","modified_gmt":"2026-10-20T01:03:27","slug":"inbx26b1692","status":"publish","type":"post","link":"https:\/\/www.globalresearch.jp\/jp\/inbx26b1692","title":{"rendered":"\u65e5\u672c\u306e\u6301\u7d9a\u7684\u30b0\u30eb\u30b3\u30fc\u30b9\u30e2\u30cb\u30bf\u30fc\uff08CGM\uff09\u30bb\u30f3\u30b5\u30fc\u5e02\u5834\uff1a\u5206\u6790\u3001\u4e88\u6e2c\u3001\u898f\u6a21\u3001\u30c8\u30ec\u30f3\u30c9\uff06\u30a4\u30f3\u30b5\u30a4\u30c8"},"content":{"rendered":"<p>1. \u306f\u3058\u3081\u306b<br \/>\n1.1 \u5831\u544a\u66f8\u306e\u8aac\u660e<br \/>\n1.2 \u7814\u7a76\u65b9\u6cd5\u8ad6\u3068\u5206\u6790\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af<br \/>\n1.3 \u30d3\u30b8\u30cd\u30b9\u306e\u305f\u3081\u306e\u30c7\u30fc\u30bf\u99c6\u52d5\u578b\u610f\u601d\u6c7a\u5b9a<br \/>\n1.4 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\u88fd\u54c1\u306e\u7bc4\u56f2\u3068\u5b9a\u7fa9<br \/>\n4.1 \u542b\u307e\u308c\u308b\u3082\u306e\u3068\u5e02\u5834\u306e\u5b9a\u7fa9<br \/>\n4.2 \u5e02\u5834\u306e\u5305\u542b\u57fa\u6e96<br \/>\n4.3 \u96fb\u5b50\/\u96fb\u6c17\u88fd\u54c1\u306e\u5b9a\u7fa9<br \/>\n4.4 \u9664\u5916\u4e8b\u9805\u3068\u5883\u754c<br \/>\n4.5 \u6a19\u6e96\u3068\u5206\u985e\u306e\u7bc4\u56f2<br \/>\n4.6 \u5bfe\u8c61\u3068\u306a\u308b\u30b3\u30a2\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u3001\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u304a\u3088\u3073\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30ec\u30a4\u30e4\u30fc<br \/>\n4.7 \u96a3\u63a5\u30e2\u30b8\u30e5\u30fc\u30eb\u3001\u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u5b8c\u6210\u54c1\u3068\u306e\u533a\u5225<br \/>\n5. \u30bb\u30b0\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3<br \/>\n5.1 \u88fd\u54c1\/\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u30bf\u30a4\u30d7\u5225<br \/>\n5.2 \u6700\u7d42\u7528\u9014\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u5225<br \/>\n5.3 \u6700\u7d42\u7528\u9014\u7523\u696d\u5225<br \/>\n5.4 \u5f62\u72b6\/\u7d71\u5408\u30ec\u30d9\u30eb\u5225<br \/>\n5.5 \u6280\u8853\/\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\/\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30af\u30e9\u30b9\u5225<br \/>\n5.6 \u54c1\u8cea\/\u8cc7\u683c\u30c6\u30a3\u30a2\u5225<br \/>\n5.7 \u30c1\u30e3\u30f3\u30cd\u30eb\/\u5546\u696d\u30e2\u30c7\u30eb\u5225<br \/>\n6. \u9700\u8981\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3<br \/>\n6.1 \u6700\u7d42\u7528\u9014\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u5225\u306e\u9700\u8981<br \/>\n6.2 OEM\/\u30d0\u30a4\u30e4\u30fc\u30bf\u30a4\u30d7\u5225\u306e\u9700\u8981<br \/>\n6.3 \u8a2d\u8a08\u30a4\u30f3\u307e\u305f\u306f\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u30b5\u30a4\u30af\u30eb\u306b\u3088\u308b\u9700\u8981<br \/>\n6.4 \u9700\u8981\u306e\u63a8\u9032\u8981\u56e0<br \/>\n6.5 \u4ee3\u66ff\u3001\u518d\u8a2d\u8a08\u304a\u3088\u3073\u4ed5\u69d8\u79fb\u884c\u30ed\u30b8\u30c3\u30af<br \/>\n6.6 \u5c06\u6765\u306e\u9700\u8981\u898b\u901a\u3057<br \/>\n7. \u4f9b\u7d66\u3068\u30d0\u30ea\u30e5\u30fc\u30c1\u30a7\u30fc\u30f3<br \/>\n7.1 \u4e0a\u6d41\u6750\u6599\u3001\u30a6\u30a7\u30fc\u30cf\u304a\u3088\u3073\u91cd\u8981\u306a\u6295\u5165\u7269<br \/>\n7.2 \u88fd\u9020\u3001\u7d44\u7acb\u304a\u3088\u3073\u30c6\u30b9\u30c8\u6bb5\u968e<br \/>\n7.3 \u8a8d\u5b9a\u3001\u4fe1\u983c\u6027\u304a\u3088\u3073\u30ea\u30ea\u30fc\u30b9<br \/>\n7.4 \u6d41\u901a\u3001\u8a2d\u8a08\u30a4\u30f3\u30b5\u30dd\u30fc\u30c8\u304a\u3088\u3073\u30c1\u30e3\u30cd\u30eb\u7ba1\u7406<br \/>\n7.5 \u4f9b\u7d66\u30dc\u30c8\u30eb\u30cd\u30c3\u30af<br \/>\n7.6 \u5951\u7d04\u88fd\u9020\u304a\u3088\u3073\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u30ed\u30b8\u30c3\u30af<br \/>\n8. \u4fa1\u683c\u8a2d\u5b9a\u3001\u5358\u4f4d\u7d4c\u6e08\u304a\u3088\u3073\u5546\u696d\u30e2\u30c7\u30eb<br \/>\n8.1 \u4fa1\u683c\u8a2d\u5b9a\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3<br \/>\n8.2 \u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u4fa1\u683c\u5e2f<br \/>\n8.3 \u30b3\u30b9\u30c8\u30c9\u30e9\u30a4\u30d0\u30fc\u304a\u3088\u3073\u6b69\u7559\u307e\u308a\u30c9\u30e9\u30a4\u30d0\u30fc<br \/>\n8.4 \u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u30de\u30fc\u30b8\u30f3\u30ed\u30b8\u30c3\u30af<br \/>\n8.5 \u30e1\u30fc\u30ab\u30fc\u5bfe\u8cfc\u5165\u306e\u8003\u616e\u4e8b\u9805<br \/>\n8.6 \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u5207\u308a\u66ff\u3048\u30b3\u30b9\u30c8<br \/>\n9. \u7af6\u4e89\u74b0\u5883<br \/>\n9.1 \u6280\u8853\u304a\u3088\u3073\u6027\u80fd\u306e\u30dd\u30b8\u30b7\u30e7\u30f3<br \/>\n9.2 \u91cd\u8981\u306a\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3001\u77e5\u7684\u8ca1\u7523\u304a\u3088\u3073BOM\u30ed\u30b8\u30c3\u30af\u306b\u5bfe\u3059\u308b\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<br \/>\n9.3 \u8a8d\u5b9a\u3001\u4fe1\u983c\u6027\u304a\u3088\u3073\u57fa\u6e96\u306b\u57fa\u3065\u304f\u5229\u70b9<br \/>\n9.4 \u8a2d\u8a08\u30a4\u30f3\u3001\u6d41\u901a\u304a\u3088\u3073\u30c1\u30e3\u30cd\u30eb\u306e\u30ea\u30fc\u30c1<br \/>\n9.5 \u88fd\u9020\u898f\u6a21\u3001\u7d0d\u54c1\u306e\u4fe1\u983c\u6027\u304a\u3088\u3073\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0\u7ba1\u7406<br \/>\n9.6 \u62e1\u5f35\u304a\u3088\u3073\u7d71\u5408\u306e\u30b7\u30b0\u30ca\u30eb<br \/>\n10. \u30e1\u30fc\u30ab\u30fc\u306e\u53c2\u5165\u6226\u7565<br \/>\n10.1 \u3069\u3053\u3067\u30d7\u30ec\u30a4\u3059\u308b\u304b<br \/>\n10.2 \u3069\u306e\u3088\u3046\u306b\u52dd\u3064\u304b<br \/>\n10.3 \u53c2\u5165\u30e2\u30fc\u30c9\u306e\u9078\u629e\u80a2\uff1a\u69cb\u7bc9\u5bfe\u8cfc\u5165\u5bfe\u30d1\u30fc\u30c8\u30ca\u30fc<br \/>\n10.4 \u6700\u4f4e\u9650\u306e\u80fd\u529b\u8981\u4ef6<br \/>\n10.5 \u8a8d\u5b9a\u304a\u3088\u3073\u53ce\u76ca\u5316\u307e\u3067\u306e\u6642\u9593\u30ed\u30b8\u30c3\u30af<br \/>\n10.6 \u521d\u56de\u9867\u5ba2\u6226\u7565<br \/>\n10.7 \u53c2\u5165\u30ea\u30b9\u30af\u304a\u3088\u3073\u8efd\u6e1b\u7b56<br \/>\n11. \u5730\u7406\u7684\u666f\u89b3<br \/>\n11.1 \u9700\u8981\u306e\u30cf\u30d6<br \/>\n11.2 \u30b5\u30d7\u30e9\u30a4\u30cf\u30d6<br \/>\n11.3 \u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u30cf\u30d6<br \/>\n11.4 \u8f38\u5165\u4f9d\u5b58\u5e02\u5834<br \/>\n11.5 \u65b0\u8208\u6a5f\u4f1a\u5e02\u5834<br \/>\n11.6 \u56fd\u306e\u30a2\u30fc\u30ad\u30bf\u30a4\u30d7<br \/>\n12. \u6700\u3082\u9b45\u529b\u7684\u306a\u6210\u9577\u6a5f\u4f1a<br \/>\n12.1 \u6700\u3082\u9b45\u529b\u7684\u306a\u88fd\u54c1\u30cb\u30c3\u30c1<br \/>\n12.2 \u6700\u3082\u9b45\u529b\u7684\u306a\u9867\u5ba2\u30bb\u30b0\u30e1\u30f3\u30c8<br \/>\n12.3 \u88fd\u9020\u306b\u6700\u3082\u9b45\u529b\u7684\u306a\u56fd<br \/>\n12.4 \u8abf\u9054\u306b\u6700\u3082\u9b45\u529b\u7684\u306a\u56fd<br \/>\n12.5 \u5546\u696d\u62e1\u5927\u306b\u6700\u3082\u9b45\u529b\u7684\u306a\u5e02\u5834<br \/>\n12.6 \u30db\u30ef\u30a4\u30c8\u30b9\u30da\u30fc\u30b9\u3068\u672a\u958b\u62d3\u306e\u6a5f\u4f1a<br \/>\n13. \u4e3b\u8981\u4f01\u696d\u306e\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb<br \/>\n\u30a8\u30ec\u30af\u30c8\u30ed\u30cb\u30af\u30b9\u5e02\u5834\u306e\u69cb\u9020\u3068\u4f01\u696d\u30a2\u30fc\u30ad\u30bf\u30a4\u30d7<br \/>\n13.1 \u7d71\u5408\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u304a\u3088\u3073\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u30ea\u30fc\u30c0\u30fc<br \/>\n13.2 \u30d4\u30e5\u30a2\u30d7\u30ec\u30a4CGM\u30bb\u30f3\u30b5\u30fc\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc<br \/>\n13.3 \u5f93\u6765\u578b\u8840\u7cd6\u6e2c\u5b9a\u5668\uff08BGM\uff09\u306e\u591a\u69d8\u5316\u4f01\u696d<br \/>\n13.4 \u88fd\u85ac\/\u533b\u7642\u6280\u8853\u30b3\u30f3\u30b0\u30ed\u30de\u30ea\u30c3\u30c8\u90e8\u9580<br \/>\n13.5 \u5951\u7d04\u96fb\u5b50\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc<br \/>\n13.6 \u534a\u5c0e\u4f53\u304a\u3088\u3073\u5148\u9032\u6750\u6599\u306e\u5c02\u9580\u5bb6<br \/>\n13.7 \u30e2\u30b8\u30e5\u30fc\u30eb\u3001\u76f8\u4e92\u63a5\u7d9a\u304a\u3088\u3073\u30b5\u30d6\u30b7\u30b9\u30c6\u30e0\u306e\u5c02\u9580\u5bb6<br \/>\n14. \u65b9\u6cd5\u8ad6\u3001\u60c5\u5831\u6e90\u304a\u3088\u3073\u514d\u8cac\u4e8b\u9805<br \/>\n14.1 \u30e2\u30c7\u30ea\u30f3\u30b0\u30ed\u30b8\u30c3\u30af<br \/>\n14.2 \u60c5\u5831\u6e90\u767b\u9332<br \/>\n14.3 \u51fa\u7248\u7269\u304a\u3088\u3073\u898f\u5236\u53c2\u7167<br \/>\n14.4 \u5206\u6790\u30ce\u30fc\u30c8<br \/>\n14.5 \u514d\u8cac\u4e8b\u9805<\/p>\n","protected":false},"excerpt":{"rendered":"<p>## \u65e5\u672c\u306e\u6301\u7d9a\u7684\u30b0\u30eb\u30b3\u30fc\u30b9\u30e2\u30cb\u30bf\u30fc\uff08CGM\uff09\u30bb\u30f3\u30b5\u30fc\u5e02\u5834 2026\u5e74\u5206\u6790\u30682035\u5e74\u307e\u3067\u306e\u4e88\u6e2c<br \/>\n## \u30a8\u30b0\u30bc\u30af\u30c6\u30a3\u30d6\u30b5\u30de\u30ea\u30fc<br \/>\n### \u4e3b\u306a\u767a\u898b<br \/>\n&#8211; \u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u5e02\u5834\u306f\u30012026\u5e74\u306b\u7d042\u51048000\u4e07\uff5e3\u51045000\u4e07\u7c73\u30c9\u30eb\u3068\u8a55\u4fa1\u3055\u308c\u3066\u304a\u308a\u3001\u9ad8\u9f62\u5316\u793e\u4f1a\u30682\u578b\u7cd6\u5c3f\u75c5\u306e\u5897\u52a0\u304c\u8981\u56e0\u3067\u3059\u3002\u3053\u306e\u5e02\u5834\u306f2035\u5e74\u307e\u3067\u306b\u5e74\u5e73\u5747\u6210\u9577\u7387\uff08CAGR\uff0911\uff5e14%\u3067\u6210\u9577\u3057\u30018\u51045000\u4e07\uff5e11\u5104\u7c73\u30c9\u30eb\u306b\u9054\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u30ea\u30a2\u30eb\u30bf\u30a4\u30e0CGM\uff08rtCGM\uff09\u30bb\u30f3\u30b5\u30fc\u306f\u3001\u65e5\u672c\u306e\u30e6\u30cb\u30c3\u30c8\u30dc\u30ea\u30e5\u30fc\u30e0\u306e\u7d0460\uff5e65%\u3092\u5360\u3081\u3066\u304a\u308a\u3001\u30d5\u30e9\u30c3\u30b7\u30e5\u30b0\u30eb\u30b3\u30fc\u30b9\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\uff08FGM\uff09\u304c25\uff5e30%\u3001\u57cb\u3081\u8fbc\u307f\u578b\u9577\u671f\u30bb\u30f3\u30b5\u30fc\u306f\u5c0f\u898f\u6a21\u306a\u304c\u3089\u6025\u6210\u9577\u3057\u3066\u3044\u308b\u30cb\u30c3\u30c1\u5e02\u5834\u3092\u4ee3\u8868\u3057\u3066\u3044\u307e\u3059\u3002\u30a4\u30f3\u30b9\u30ea\u30f3\u6cbb\u7642\u3092\u53d7\u3051\u3066\u3044\u308b\u60a3\u8005\u3078\u306e\u511f\u9084\u304c\u62e1\u5927\u3059\u308b\u4e2d\u3067\u3001rtCGM\u3078\u306e\u79fb\u884c\u304c\u52a0\u901f\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u65e5\u672c\u306f\u5b8c\u6210\u3057\u305fCGM\u30bb\u30f3\u30b5\u30fc\u306e\u30e6\u30cb\u30c3\u30c8\u306e80%\u4ee5\u4e0a\u3092\u8f38\u5165\u3057\u3066\u304a\u308a\u3001\u4e3b\u306b\u30a2\u30e1\u30ea\u30ab\u3001\u30c9\u30a4\u30c4\u3001\u6771\u5357\u30a2\u30b8\u30a2\u306e\u5951\u7d04\u88fd\u9020\u62e0\u70b9\u304b\u3089\u4f9b\u7d66\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u56fd\u5185\u3067\u306e\u7d44\u307f\u7acb\u3066\u306f\u3001\u6570\u793e\u306e\u591a\u56fd\u7c4d\u5b50\u4f1a\u793e\u306b\u3088\u308b\u6700\u7d42\u30d1\u30c3\u30b1\u30fc\u30b8\u30f3\u30b0\u3068\u54c1\u8cea\u30c6\u30b9\u30c8\u306b\u9650\u3089\u308c\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u65e5\u672c\u306b\u304a\u3051\u308b\u30bb\u30f3\u30b5\u30fc\u30ad\u30c3\u30c8\u306e\u4fa1\u683c\uff08\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u306e\u5e0c\u671b\u5c0f\u58f2\u4fa1\u683c\uff09\u306f\u30011\u30e6\u30cb\u30c3\u30c8\u3042\u305f\u308a8,000\uff5e15,000\u5186\u3067\u3001\u4f7f\u3044\u6368\u3066\u30bb\u30f3\u30b5\u30fc\u306e\u6708\u984d\u30b5\u30d6\u30b9\u30af\u30ea\u30d7\u30b7\u30e7\u30f3\u30b3\u30b9\u30c8\u306f6,000\uff5e12,000\u5186\u3067\u3059\u3002\u65e5\u672c\u306e\u516c\u7684\u533b\u7642\u4fdd\u967a\u306b\u3088\u308b\u511f\u9084\u306f\u3001\u5bfe\u8c61\u60a3\u8005\u306e\u30bb\u30f3\u30b5\u30fc\u30b3\u30b9\u30c8\u306e\u7d0470\uff5e80%\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u30a2\u30dc\u30c3\u30c8\u3001\u30c7\u30af\u30b9\u30b3\u30e0\u3001\u30e1\u30c9\u30c8\u30ed\u30cb\u30c3\u30af\u306e3\u793e\u304c\u3001\u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u4f9b\u7d66\u306e85%\u4ee5\u4e0a\u3092\u5360\u3081\u3066\u3044\u307e\u3059\u3002\u56fd\u5185\u306e\u96fb\u5b50\u6a5f\u5668\u4f01\u696d\u306f\u3001\u7279\u306bASIC\u3084\u30ef\u30a4\u30e4\u30ec\u30b9\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u4f9b\u7d66\u30c1\u30a7\u30fc\u30f3\u306b\u53c2\u5165\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u65e5\u672c\u306e\u898f\u5236\u7d4c\u8def\u306f\u3001\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u306b\u3088\u3063\u3066\u7ba1\u7406\u3055\u308c\u3066\u304a\u308a\u3001\u65b0\u3057\u3044\u30bb\u30f3\u30b5\u30fc\u30bf\u30a4\u30d7\u306b\u306f\u56fd\u5185\u81e8\u5e8a\u8a66\u9a13\u304c\u5fc5\u8981\u3067\u3001\u30a2\u30e1\u30ea\u30ab\u306e\u627f\u8a8d\u306b\u5bfe\u3057\u306612\uff5e18\u30f6\u6708\u306e\u9045\u308c\u3092\u751f\u3058\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u57cb\u3081\u8fbc\u307f\u578b\u30bb\u30f3\u30b5\u30fc\u306e\u63a1\u7528\u304c\u9045\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>### \u5e02\u5834\u52d5\u5411<br \/>\n\u4e0a\u6d41\u306e\u6295\u5165\u7269\u304b\u3089\u88fd\u9020\u3001\u8a8d\u8a3c\u3001\u30c1\u30e3\u30cd\u30eb\u914d\u4fe1\u3092\u901a\u3058\u3066\u4fa1\u5024\u304c\u69cb\u7bc9\u3055\u308c\u308b\u65b9\u6cd5\u3002<br \/>\n&#8211; \u30b0\u30eb\u30b3\u30fc\u30b9\u30aa\u30ad\u30b7\u30c0\u30fc\u30bc\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u9175\u7d20<br \/>\n&#8211; \u5a92\u4ecb\u3055\u308c\u305f\u30ec\u30c9\u30c3\u30af\u30b9\u5316\u5b66<br \/>\n&#8211; \u30d5\u30ec\u30ad\u30b7\u30d6\u30eb\u30d7\u30ea\u30f3\u30c8\u56de\u8def\u57fa\u677f\uff08FPCB\uff09<br \/>\n&#8211; \u533b\u7642\u7528\u63a5\u7740\u5264<br \/>\n&#8211; \u751f\u4f53\u9069\u5408\u6027\u819c\u30fb\u30dd\u30ea\u30de\u30fc<br \/>\n&#8211; \u30bb\u30f3\u30b5\u30fc\/\u30c8\u30e9\u30f3\u30b9\u30df\u30c3\u30bf\u30fcOEM<br \/>\n&#8211; \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30a2\u30d7\u30ea\u958b\u767a\u8005<br \/>\n&#8211; \u30c7\u30fc\u30bf\u5206\u6790\u30fb\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u63d0\u4f9b\u8005<br \/>\n&#8211; \u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u30fb\u8010\u4e45\u533b\u7642\u6a5f\u5668\uff08DME\uff09\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc<br \/>\n&#8211; FDA 510(k)\u307e\u305f\u306fPMA\uff08\u7c73\u56fd\uff09<br \/>\n&#8211; MDR\u306b\u57fa\u3065\u304fCE\u30de\u30fc\u30ad\u30f3\u30b0\uff08EU\uff09<br \/>\n&#8211; ISO 13485\u54c1\u8cea\u7ba1\u7406<br \/>\n&#8211; \u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u533b\u7642\u6a5f\u5668\u30e9\u30a4\u30bb\u30f3\u30b9<br \/>\n&#8211; \u7cd6\u5c3f\u75c5\u7ba1\u7406<br \/>\n&#8211; \u4f4e\u8840\u7cd6\u4e88\u9632<br \/>\n&#8211; \u8840\u7cd6\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u6700\u9069\u5316<br \/>\n&#8211; \u9060\u9694\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<br \/>\n&#8211; \u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u53ce\u96c6<br \/>\n&#8211; \u81ea\u52d5\u30a4\u30f3\u30b9\u30ea\u30f3\u6295\u4e0e\uff08AID\uff09\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u7d71\u5408\u304c\u4e3b\u8981\u306a\u6280\u8853\u30c8\u30ec\u30f3\u30c9\u3067\u3059\u3002\u65e5\u672c\u306e\u539a\u751f\u52b4\u50cd\u7701\uff08MHLW\uff09\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u30af\u30ed\u30fc\u30ba\u30c9\u30eb\u30fc\u30d7\u30b7\u30b9\u30c6\u30e0\u3092\u627f\u8a8d\u3057\u3066\u304a\u308a\u3001Bluetooth\/NFC\u4f1d\u9001\u306b\u5bfe\u5fdc\u3057\u305frtCGM\u30bb\u30f3\u30b5\u30fc\u306e\u9700\u8981\u3092\u9ad8\u3081\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u30a4\u30f3\u30b9\u30ea\u30f3\u6cbb\u7642\u3092\u53d7\u3051\u3066\u3044\u306a\u30442\u578b\u7cd6\u5c3f\u75c5\u60a3\u8005\u3078\u306e\u511f\u9084\u62e1\u5927\u304c\u9032\u884c\u4e2d\u3067\u3059\u30022025\u5e74\u306b\u306f\u3001\u91cd\u5ea6\u306e\u4f4e\u8840\u7cd6\u30ea\u30b9\u30af\u3092\u6301\u306450,000\u4eba\u306e\u60a3\u8005\u3092\u5bfe\u8c61\u3068\u3057\u305fCGM\u30bb\u30f3\u30b5\u30fc\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30d7\u30ed\u30b0\u30e9\u30e0\u304c\u30012028\u5e74\u307e\u3067\u306b20\u4e07\u4eba\u4ee5\u4e0a\u306b\u62e1\u5927\u3059\u308b\u898b\u8fbc\u307f\u3067\u3059\u3002<br \/>\n&#8211; \u5c0f\u578b\u5316\u3068\u9577\u671f\u9593\u306e\u88c5\u7740\uff08\u30bb\u30f3\u30b5\u30fc\u3042\u305f\u308a14\uff5e15\u65e5\uff09\u304c\u4ea4\u63db\u30b5\u30a4\u30af\u30eb\u3092\u4fc3\u9032\u3057\u3066\u3044\u307e\u3059\u3002\u65e5\u672c\u306e\u9ad8\u9f62\u5316\u793e\u4f1a\u306f\u3001\u63a5\u7740\u5264\u306b\u3088\u308b\u523a\u6fc0\u304c\u5c11\u306a\u304f\u3001\u3088\u308a\u5c0f\u578b\u306e\u30bb\u30f3\u30b5\u30fc\u3092\u597d\u3080\u305f\u3081\u3001\u7814\u7a76\u958b\u767a\u306f\u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30eb\u30d9\u30fc\u30b9MEMS\u30bb\u30f3\u30b5\u30fc\u306b\u5411\u304b\u3063\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u75c5\u9662\u30fb\u81e8\u5e8a\u3067\u306e\u4f7f\u7528\u306f\u5e74\u738715\uff5e18%\u3067\u6210\u9577\u3057\u3066\u304a\u308a\u3001\u5468\u8853\u671f\u306e\u8840\u7cd6\u7ba1\u7406\u3084\u96c6\u4e2d\u6cbb\u7642\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u63a8\u9032\u8981\u56e0\u3067\u3059\u3002\u65e5\u672c\u306e\u75c5\u9662\u30bb\u30af\u30bf\u30fc\u306f\u30bb\u30f3\u30b5\u30fc\u306e\u30dc\u30ea\u30e5\u30fc\u30e0\u306e20\uff5e25%\u3092\u5360\u3081\u3066\u304a\u308a\u3001\u898f\u5236\u9075\u5b88\u30b3\u30b9\u30c8\u306e\u305f\u3081\u306b\u5358\u4fa1\u304c\u9ad8\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u30c7\u30fc\u30bf\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u6599\u91d1\u3084\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b5\u30d6\u30b9\u30af\u30ea\u30d7\u30b7\u30e7\u30f3\u304c\u65b0\u305f\u306a\u53ce\u76ca\u6e90\u3068\u3057\u3066\u6d6e\u4e0a\u3057\u3066\u3044\u307e\u3059\u3002\u65e5\u672c\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306f\u30af\u30e9\u30a6\u30c9\u30d9\u30fc\u30b9\u30b0\u30eb\u30b3\u30fc\u30b9\u5206\u6790\u3092\u63a1\u7528\u3057\u3066\u304a\u308a\u3001\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u6599\u91d1\u306f\u60a3\u80051\u4eba\u3042\u305f\u308a\u67082,000\uff5e4,000\u5186\u3092\u8ffd\u52a0\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>### \u4e3b\u306a\u8ab2\u984c<br \/>\n&#8211; \u9175\u7d20\u30d9\u30fc\u30b9\u30bb\u30f3\u30b5\u30fc\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3084\u533b\u7642\u7528\u63a5\u7740\u5264\u306e\u4f9b\u7d66\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u304c\u3001\u56fd\u5185\u7d44\u307f\u7acb\u3066\u3092\u5236\u7d04\u3057\u3066\u3044\u307e\u3059\u3002\u65e5\u672c\u306f\u3001\u30a2\u30e1\u30ea\u30ab\u30fb\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u7279\u6b8a\u5316\u5b66\u54c1\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u8f38\u5165\u3057\u305f\u9175\u7d20\u88fd\u5264\u306b\u4f9d\u5b58\u3057\u3066\u304a\u308a\u3001\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0\u306f8\uff5e12\u9031\u9593\u3067\u3059\u3002<br \/>\n&#8211; \u30dd\u30c6\u30f3\u30b7\u30e7\u30b9\u30bf\u30c3\u30c8\u56de\u8def\u7528\u306eASIC\u306e\u5165\u624b\u53ef\u80fd\u6027\u304c\u91cd\u8981\u306a\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u3067\u3059\u3002\u4e16\u754c\u7684\u306a\u534a\u5c0e\u4f53\u4e0d\u8db3\u306b\u3088\u308a\u3001\u65b0\u898f\u53c2\u5165\u8005\u304c\u30d5\u30a1\u30d6\u5bb9\u91cf\u3092\u6c42\u3081\u308b\u4e2d\u3067\u3001\u30bb\u30f3\u30b5\u30fc\u306e\u767a\u58f2\u304c6\uff5e9\u30f6\u6708\u9045\u308c\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u65e5\u672c\u306e\u975e\u30a4\u30f3\u30b9\u30ea\u30f3\u6cbb\u7642\u3092\u53d7\u3051\u3066\u3044\u308b2\u578b\u7cd6\u5c3f\u75c5\u60a3\u8005\u306e\u4fa1\u683c\u611f\u5ea6\u304c\u5e02\u5834\u6d78\u900f\u3092\u5236\u9650\u3057\u3066\u3044\u307e\u3059\u3002\u5b8c\u5168\u511f\u9084\u304c\u306a\u3044\u60a3\u8005\u306e\u81ea\u5df1\u8ca0\u62c5\u30b3\u30b9\u30c8\u306f\u670810,000\uff5e15,000\u5186\u306b\u9054\u3059\u308b\u3053\u3068\u304c\u3042\u308a\u3001\u63a1\u7528\u3092\u59a8\u3052\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; PMDA\u3068FDA\/CE\u306e\u9593\u306e\u898f\u5236\u306e\u9055\u3044\u304c\u91cd\u8907\u30b3\u30b9\u30c8\u3092\u751f\u3058\u3066\u3044\u307e\u3059\u3002\u65e5\u672c\u3067\u306f\u3001\u6771\u30a2\u30b8\u30a2\u306e\u4eba\u53e3\u306b\u304a\u3051\u308b\u30bb\u30f3\u30b5\u30fc\u306e\u7cbe\u5ea6\u306b\u5bfe\u3057\u3066\u5225\u9014\u81e8\u5e8a\u691c\u8a3c\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u88fd\u54c1\u3054\u3068\u306b12\uff5e18\u30f6\u6708\u30fb500\u4e07\uff5e1000\u4e07\u7c73\u30c9\u30eb\u306e\u958b\u767a\u30b3\u30b9\u30c8\u304c\u8ffd\u52a0\u3055\u308c\u307e\u3059\u3002<br \/>\n&#8211; \u4f7f\u3044\u6368\u3066\u30bb\u30f3\u30b5\u30fc\u306e\u6ec5\u83cc\u80fd\u529b\u306f\u56fd\u5185\u306e2\u3064\u306e\u65bd\u8a2d\u306b\u96c6\u4e2d\u3057\u3066\u304a\u308a\u3001\u8106\u5f31\u6027\u3092\u751f\u3058\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5de5\u5834\u3067\u306e\u4f55\u3089\u304b\u306e\u6df7\u4e71\u304c\u767a\u751f\u3059\u308b\u3068\u3001\u65e5\u672c\u306e\u30bb\u30f3\u30b5\u30fc\u4f9b\u7d66\u306e\u6700\u592730%\u304c3\uff5e6\u30f6\u6708\u505c\u6b62\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>## \u5e02\u5834\u6982\u8981<\/p>\n<p>\u5bfe\u8c61: \u4e3b\u8981\u7d71\u8a08<\/p>\n<p>\u3053\u306e\u88fd\u54c1\u304c\u4ed5\u69d8\u3001\u8a8d\u8a3c\u3001\u7d71\u5408\u3001\u4ea4\u63db\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u901a\u5e38\u3069\u306e\u3088\u3046\u306b\u4fa1\u5024\u3092\u5275\u51fa\u3059\u308b\u304b\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002\u65e5\u672c\u306e\u6301\u7d9a\u7684\u8840\u7cd6\u30e2\u30cb\u30bf\u30fc\uff08CGM\uff09\u30bb\u30f3\u30b5\u30fc\u5e02\u5834\u306f\u3001PMDA\u306e\u76e3\u8996\u4e0b\u3067\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u5206\u985e\u3055\u308c\u308b\u30bb\u30f3\u30b5\u30fc\u6280\u8853\u3092\u6301\u3064\u898f\u5236\u3055\u308c\u305f\u533b\u7642\u6280\u8853\u30a8\u30b3\u30b7\u30b9\u30c6\u30e0\u5185\u3067\u904b\u55b6\u3055\u308c\u3066\u3044\u307e\u3059\u30022026\u5e74\u306b\u306f\u3001\u63a8\u5b9a1100\u4e07\u304b\u30891200\u4e07\u4eba\u306e\u6210\u4eba\u304c\u7cd6\u5c3f\u75c5\u3092\u62b1\u3048\u308b\u65e5\u672c\u3067\u306f\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30fb\u30d5\u30e9\u30c3\u30b7\u30e5\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30bb\u30f3\u30b5\u30fc\u306e\u9700\u8981\u304c\u9ad8\u307e\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>### \u5e02\u5834\u69cb\u9020<br \/>\n&#8211; \u5e02\u5834\u306f\u69cb\u9020\u7684\u306b\u8f38\u5165\u4f9d\u5b58\u3067\u3042\u308a\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30ea\u30fc\u30c0\u30fc\u304c\u73fe\u5730\u306e\u5b50\u4f1a\u793e\u3092\u901a\u3058\u3066\u5b8c\u6210\u3057\u305f\u30bb\u30f3\u30b5\u30fc\u3092\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u65e5\u672c\u306e\u96fb\u5b50\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306f\u3001\u30dd\u30c6\u30f3\u30b7\u30e7\u30b9\u30bf\u30c3\u30c8ASIC\u3001Bluetooth\u30e2\u30b8\u30e5\u30fc\u30eb\u3001MEMS\u30d9\u30fc\u30b9\u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30eb\u306a\u3069\u306e\u91cd\u8981\u306a\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u6700\u7d42\u7684\u306a\u30bb\u30f3\u30b5\u30fc\u306e\u7d44\u307f\u7acb\u3066\u306f\u30a2\u30e1\u30ea\u30ab\u5408\u8846\u56fd\u3068\u6771\u5357\u30a2\u30b8\u30a2\u306b\u96c6\u4e2d\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u65e5\u672c\u306e\u56fd\u6c11\u5065\u5eb7\u4fdd\u967a\u5236\u5ea6\u306b\u3088\u308b\u511f\u9084\u304c\u4e3b\u8981\u306a\u9700\u8981\u306e\u8981\u56e0\u3067\u3042\u308a\u3001\u30a4\u30f3\u30b9\u30ea\u30f3\u4f9d\u5b58\u60a3\u8005\u304b\u3089\u3088\u308a\u5e83\u7bc4\u306a2\u578b\u7cd6\u5c3f\u75c5\u60a3\u8005\u3078\u306e\u30ab\u30d0\u30ec\u30c3\u30b8\u304c\u62e1\u5927\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>## \u5e02\u5834\u898f\u6a21\u3068\u6210\u9577<br \/>\n\u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u5e02\u5834\u306f\u30012026\u5e74\u306b420\u5104\u304b\u3089520\u5104\u5186\uff082\u51048000\u4e07\u304b\u30893\u51045000\u4e07\u30c9\u30eb\uff09\u3068\u63a8\u5b9a\u3055\u308c\u3001\u5e74\u9593350\u4e07\u304b\u3089450\u4e07\u30bb\u30f3\u30b5\u30fc\u306e\u30e6\u30cb\u30c3\u30c8\u30dc\u30ea\u30e5\u30fc\u30e0\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u6210\u9577\u7387\u306f2035\u5e74\u307e\u3067\u306b\u5e74\u5e73\u5747\u6210\u9577\u7387\uff08CAGR\uff0911%\u304b\u308914%\u304c\u4e88\u6e2c\u3055\u308c\u3066\u304a\u308a\u3001\u511f\u9084\u306e\u62e1\u5927\u3001\u9ad8\u9f62\u5316\u3059\u308b\u4eba\u53e3\u3001\u30a4\u30f3\u30b9\u30ea\u30f3\u30dd\u30f3\u30d7\u3068\u306e\u7d71\u5408\u304c\u63a8\u9032\u8981\u56e0\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>### \u4e3b\u8981\u306a\u30b7\u30b0\u30ca\u30eb<br \/>\n&#8211; 2030\u5e74\u307e\u3067\u306b\u5e02\u5834\u306f700\u5104\u304b\u3089850\u5104\u5186\uff084\u51047000\u4e07\u304b\u30895\u51047000\u4e07\u30c9\u30eb\uff09\u306b\u9054\u3057\u3001\u30e6\u30cb\u30c3\u30c8\u30dc\u30ea\u30e5\u30fc\u30e0\u306f700\u4e07\u30bb\u30f3\u30b5\u30fc\u3092\u8d85\u3048\u308b\u3068\u4e88\u60f3\u3055\u308c\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u57cb\u3081\u8fbc\u307f\u578b\u9577\u671f\u30bb\u30f3\u30b5\u30fc\u30bb\u30b0\u30e1\u30f3\u30c8\u306f\u3001\u73fe\u5728\u306e\u30dc\u30ea\u30e5\u30fc\u30e0\u306e5%\u672a\u6e80\u3067\u3059\u304c\u300190\u65e5\u30fb180\u65e5\u30bb\u30f3\u30b5\u30fc\u306ePMDA\u627f\u8a8d\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u3001CAGR20%\u304b\u308925%\u3067\u6210\u9577\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<br \/>\n&#8211; \u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u5e02\u5834\u306e\u4e16\u754c\u5e02\u5834\u30b7\u30a7\u30a2\u306f\u7d048%\u304b\u308910%\u3067\u3042\u308a\u3001\u6210\u719f\u3057\u305f\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u3068\u9069\u683c\u60a3\u8005\u306e\u9ad8\u3044\u4e00\u4eba\u5f53\u305f\u308a\u306e\u63a1\u7528\u7387\u3092\u53cd\u6620\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>## \u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u30fb\u6700\u7d42\u7528\u9014\u5225\u306e\u9700\u8981<br \/>\n\u30bf\u30a4\u30d7\u5225\u3067\u306f\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0CGM\uff08rtCGM\uff09\u30bb\u30f3\u30b5\u30fc\u304c\u65e5\u672c\u306e\u30bb\u30f3\u30b5\u30fc\u306e60%\u304b\u308965%\u3092\u5360\u3081\u3001\u30d5\u30e9\u30c3\u30b7\u30e5\u30b0\u30eb\u30b3\u30fc\u30b9\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\uff08FGM\uff09\u304c25%\u304b\u308930%\u3001\u57cb\u3081\u8fbc\u307f\u578b\u9577\u671f\u30bb\u30f3\u30b5\u30fc\u304c3%\u304b\u30895%\u3092\u5360\u3081\u3066\u3044\u307e\u3059\u3002\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u5225\u3067\u306f\u30011\u578b\u7cd6\u5c3f\u75c5\u7ba1\u7406\u304c\u30bb\u30f3\u30b5\u30fc\u4f7f\u7528\u306e45%\u304b\u308950%\u3001\u30a4\u30f3\u30b9\u30ea\u30f3\u6cbb\u7642\u3092\u53d7\u3051\u3066\u3044\u308b2\u578b\u7cd6\u5c3f\u75c5\u304c30%\u304b\u308935%\u3001\u975e\u30a4\u30f3\u30b9\u30ea\u30f3\u578b2\u578b\u7cd6\u5c3f\u75c5\u304c10%\u304b\u308912%\u3001\u598a\u5a20\u7cd6\u5c3f\u75c5\u304c3%\u304b\u30895%\u3001\u75c5\u9662\/\u81e8\u5e8a\u4f7f\u7528\u304c8%\u304b\u308910%\u3092\u5360\u3081\u3066\u3044\u307e\u3059\u3002\u5bb6\u5ead\u533b\u7642\u306f\u30bb\u30f3\u30b5\u30fc\u306e\u30dc\u30ea\u30e5\u30fc\u30e0\u306e70%\u304b\u308975%\u3092\u5360\u3081\u308b\u4e3b\u8981\u306a\u6700\u7d42\u7528\u9014\u30bb\u30af\u30bf\u30fc\u3067\u3042\u308a\u3001\u6b21\u3044\u3067\u75c5\u9662\u3068\u30af\u30ea\u30cb\u30c3\u30af\u304c20%\u304b\u308925%\u3001\u81e8\u5e8a\u7814\u7a76\u6a5f\u95a2\u304c3%\u304b\u30895%\u3067\u3059\u3002\u7cbe\u5ea6\u304c\u5411\u4e0a\u3057\u305f\u75c5\u9662\u7528\u30bb\u30f3\u30b5\u30fc\uff08MARD <8%\uff09\u306e\u9700\u8981\u306f\u3001\u5468\u8853\u671f\u30fbICU\u306e\u30b0\u30eb\u30b3\u30fc\u30b9\u7ba1\u7406\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u3088\u308a\u3001\u5e74\u959315%\u304b\u308918%\u3067\u6210\u9577\u3057\u3066\u3044\u307e\u3059\u3002\n\n## \u4fa1\u683c\u3068\u30b3\u30b9\u30c8\u8981\u56e0\n\u65e5\u672c\u306b\u304a\u3051\u308b\u30bb\u30f3\u30b5\u30fc\u30ad\u30c3\u30c8\u306e\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u306e\u5e0c\u671b\u5c0f\u58f2\u4fa1\u683c\uff08MSRP\uff09\u306f\u30011\u30e6\u30cb\u30c3\u30c8\u3042\u305f\u308a8000\u5186\u304b\u308915000\u5186\u306e\u7bc4\u56f2\u3067\u3001\u4f7f\u3044\u6368\u3066\u30bb\u30f3\u30b5\u30fc\u306e\u6708\u984d\u30b5\u30d6\u30b9\u30af\u30ea\u30d7\u30b7\u30e7\u30f3\u30b3\u30b9\u30c8\u306f6000\u5186\u304b\u308912000\u5186\u3067\u3059\u3002\u65e5\u672c\u306e\u516c\u7684\u5065\u5eb7\u4fdd\u967a\u306b\u3088\u308b\u511f\u9084\u306f\u3001\u30a4\u30f3\u30b9\u30ea\u30f3\u6cbb\u7642\u3092\u53d7\u3051\u3066\u3044\u308b\u60a3\u8005\u306e\u30bb\u30f3\u30b5\u30fc\u30b3\u30b9\u30c8\u306e70%\u304b\u308980%\u3092\u30ab\u30d0\u30fc\u3057\u3001\u81ea\u5df1\u8ca0\u62c5\u984d\u3092\u67082000\u5186\u304b\u30894000\u5186\u306b\u6291\u3048\u3066\u3044\u307e\u3059\u3002\n\n### \u4fa1\u683c\u30b7\u30b0\u30ca\u30eb\n- \u4e3b\u8981\u306a\u30b3\u30b9\u30c8\u8981\u56e0\u306b\u306f\u3001\u9175\u7d20\u306e\u8abf\u9054\u3068\u5b89\u5b9a\u5316\uff08\u30bb\u30f3\u30b5\u30fc\u306e\u6750\u6599\u8cbb\u306e15%\u304b\u308920%\uff09\u3001\u533b\u7642\u7528\u63a5\u7740\u5264\u306e\u914d\u5408\uff0810%\u304b\u308915%\uff09\u3001ASIC\u30fb\u30ef\u30a4\u30e4\u30ec\u30b9\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u30b3\u30b9\u30c8\uff0820%\u304b\u308925%\uff09\u3001\u6ec5\u83cc\u30fb\u5305\u88c5\uff088%\u304b\u308912%\uff09\u304c\u542b\u307e\u308c\u307e\u3059\u3002\n- \u65e5\u672c\u306e\u5b8c\u6210\u3057\u305fCGM\u30bb\u30f3\u30b5\u30fc\u306b\u5bfe\u3059\u308b\u8f38\u5165\u95a2\u7a0e\u306fWTO\u306e\u7d04\u675f\u306b\u57fa\u3065\u304d0%\u304b\u30892.5%\u3067\u3059\u304c\u3001\u898f\u5236\u9075\u5b88\u30b3\u30b9\u30c8\u304c\u4e0a\u4e57\u305b\u3055\u308c\u3001\u4e0a\u9678\u4fa1\u683c\u306b10%\u304b\u308915%\u3092\u8ffd\u52a0\u3057\u307e\u3059\u3002\n- rtCGM\u30bb\u30f3\u30b5\u30fc\u306e\u4fa1\u683c\u306f\u3001\u7af6\u4e89\u3068\u65e5\u672c\u306e\u5730\u57df\u5065\u5eb7\u4fdd\u967a\u5354\u4f1a\u306b\u3088\u308b\u30dc\u30ea\u30e5\u30fc\u30e0\u30d9\u30fc\u30b9\u8abf\u9054\u306b\u3088\u308a\u3001\u5e74\u95933%\u304b\u30895%\u306e\u4fa1\u683c\u4e0b\u843d\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002\n\n## \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u88fd\u9020\u696d\u8005\u30fb\u7af6\u4e89\n3\u3064\u306e\u591a\u56fd\u7c4d\u4f01\u696d\u2014\u30a2\u30dc\u30c3\u30c8\u30fb\u30e9\u30dc\u30e9\u30c8\u30ea\u30fc\u30ba\uff08FreeStyle Libre\uff09\u3001\u30c7\u30af\u30b9\u30b3\u30e0\uff08G7\u30b7\u30ea\u30fc\u30ba\uff09\u3001\u30e1\u30c9\u30c8\u30ed\u30cb\u30c3\u30af\uff08Guardian\u30b7\u30ea\u30fc\u30ba\uff09\u2014\u304c\u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u306e\u30dc\u30ea\u30e5\u30fc\u30e0\u306e85%\u4ee5\u4e0a\u3092\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002\u30a2\u30dc\u30c3\u30c8\u306fFGM\u30bb\u30b0\u30e1\u30f3\u30c8\u3067\u65e5\u672c\u306e\u30e6\u30cb\u30c3\u30c8\u30b7\u30a7\u30a2\u306e\u7d0450%\u304b\u308955%\u3092\u5360\u3081\u3066\u304a\u308a\u3001\u30c7\u30af\u30b9\u30b3\u30e0\u306frtCGM\u306730%\u304b\u308935%\u3092\u5360\u3081\u3066\u3044\u307e\u3059\u3002\n\n### \u7af6\u4e89\u30b7\u30b0\u30ca\u30eb\n- \u30e1\u30c9\u30c8\u30ed\u30cb\u30c3\u30af\u306f10%\u304b\u308915%\u3092\u4fdd\u6301\u3057\u3066\u304a\u308a\u3001\u4e3b\u306b\u7d71\u5408\u578bAID\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\n- \u56fd\u5185\u306e\u96fb\u5b50\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u3042\u308b\u6751\u7530\u88fd\u4f5c\u6240\u3084TDK\u306f\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30bb\u30f3\u30b5\u30fc\u88fd\u9020\u696d\u8005\u306b\u30dd\u30c6\u30f3\u30b7\u30e7\u30b9\u30bf\u30c3\u30c8ASIC\u3084\u30ef\u30a4\u30e4\u30ec\u30b9\u30e2\u30b8\u30e5\u30fc\u30eb\u3092\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002\n- \u65e5\u672c\u306e2\u3064\u306e\u5951\u7d04\u96fb\u5b50\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u2014\u30cb\u30c7\u30c3\u30af\u3068\u30db\u30b7\u30c7\u30f3\u2014\u306f\u3001\u30a2\u30b8\u30a2\u5e02\u5834\u5411\u3051\u306e\u30bb\u30f3\u30b5\u30fc\u7d44\u307f\u7acb\u3066\u306b\u53c2\u5165\u3057\u3066\u304a\u308a\u3001\u5e74\u959350\u4e07\u304b\u308970\u4e07\u30e6\u30cb\u30c3\u30c8\u306e\u5408\u8a08\u751f\u7523\u80fd\u529b\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002\n- \u7af6\u4e89\u306f\u6fc0\u5316\u3057\u3066\u304a\u308a\u3001\u30ed\u30b7\u30e5\u3068\u30a2\u30bb\u30f3\u30b7\u30a2\u30fb\u30c0\u30a4\u30a2\u30d3\u30fc\u30c6\u30a3\u30b9\u30fb\u30b1\u30a2\u304c2027\u5e74\u304b\u30892028\u5e74\u306b\u304b\u3051\u3066\u65e5\u672c\u3067CGM\u30bb\u30f3\u30b5\u30fc\u3092\u767a\u58f2\u3059\u308b\u6e96\u5099\u3092\u9032\u3081\u3066\u304a\u308a\u3001\u975e\u30a4\u30f3\u30b9\u30ea\u30f3\u578b2\u578b\u7cd6\u5c3f\u75c5\u30bb\u30b0\u30e1\u30f3\u30c8\u3092\u30bf\u30fc\u30b2\u30c3\u30c8\u306b\u3057\u3066\u3044\u307e\u3059\u3002\n\n## \u56fd\u5185\u751f\u7523\u3068\u4f9b\u7d66\n\u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u306e\u56fd\u5185\u751f\u7523\u306f\u3001\u591a\u56fd\u7c4d\u4f01\u696d\u306e\u6771\u4eac\u30fb\u5927\u962a\u5e9c\u306e\u5b50\u4f1a\u793e\u306b\u3088\u308b\u6700\u7d42\u7d44\u307f\u7acb\u3066\u3001\u54c1\u8cea\u30c6\u30b9\u30c8\u3001\u5305\u88c5\u306b\u9650\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u65bd\u8a2d\u306f\u65e5\u672c\u306e\u30bb\u30f3\u30b5\u30fc\u306e\u30dc\u30ea\u30e5\u30fc\u30e0\u306e\u7d0415%\u304b\u308920%\u3092\u6271\u3063\u3066\u304a\u308a\u3001\u6b8b\u308a\u306f\u5b8c\u6210\u54c1\u3068\u3057\u3066\u8f38\u5165\u3055\u308c\u3066\u3044\u307e\u3059\u3002\n\n### \u30b5\u30d7\u30e9\u30a4\u30b7\u30b0\u30ca\u30eb\n\n## \u4e3b\u8981\u7d71\u8a08\n\n- \u56fd\u5185\u306e\u751f\u7523\u80fd\u529b\u306f\u5e74\u959370\u4e07\uff5e100\u4e07\u30bb\u30f3\u30b5\u30fc\u3068\u63a8\u5b9a\u3055\u308c\u3066\u304a\u308a\u3001\u8f38\u5165\u3055\u308c\u305f\u9175\u7d20\u88fd\u5264\u3068\u533b\u7642\u7528\u63a5\u7740\u5264\u3078\u306e\u4f9d\u5b58\u304c\u5236\u7d04\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\n- \u65e5\u672c\u306e\u96fb\u5b50\u6a5f\u5668\u30bb\u30af\u30bf\u30fc\u306f\u91cd\u8981\u306a\u90e8\u54c1\u3092\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002\u6751\u7530\u88fd\u4f5c\u6240\u306f3\u3064\u306e\u4e3b\u8981\u30bb\u30f3\u30b5\u30fc\u30d6\u30e9\u30f3\u30c9\u306e\u3046\u30612\u3064\u306b\u5bfe\u3057\u3066\u30dd\u30c6\u30f3\u30b7\u30e7\u30b9\u30bf\u30c3\u30c8ASIC\u3092\u88fd\u9020\u3057\u3001TDK\u306fBluetooth\/NFC\u30e2\u30b8\u30e5\u30fc\u30eb\u3092\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002\n- \u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30eb\u30a2\u30ec\u30a4\u306eMEMS\u88fd\u9020\u304c\u56fd\u5185\u306e\u30d5\u30a1\u30a6\u30f3\u30c9\u30ea\u3067\u9032\u5c55\u3057\u3066\u304a\u308a\u30012027\u5e74\u307e\u3067\u306b\u5e74\u959320\u4e07\uff5e30\u4e07\u306e\u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30eb\u30bb\u30f3\u30b5\u30fc\u3092\u751f\u7523\u3067\u304d\u308b\u30d1\u30a4\u30ed\u30c3\u30c8\u751f\u7523\u30e9\u30a4\u30f3\u304c\u6574\u5099\u3055\u308c\u3066\u3044\u307e\u3059\u3002\n- \u6ec5\u83cc\u80fd\u529b\u306f\u95a2\u6771\u3068\u95a2\u897f\u306e2\u3064\u306e\u65bd\u8a2d\u306b\u96c6\u4e2d\u3057\u3066\u304a\u308a\u3001\u56fd\u5185\u7d44\u7acb\u3068\u8f38\u5165\u30bb\u30f3\u30b5\u30fc\u306e\u518d\u5305\u88c5\u306e\u4e21\u65b9\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002\n\n## \u8f38\u5165\u3001\u8f38\u51fa\u30fb\u8cbf\u6613\n\u65e5\u672c\u306fCGM\u30bb\u30f3\u30b5\u30fc\u306e\u30e6\u30cb\u30c3\u30c8\u306e80%\u4ee5\u4e0a\u3092\u8f38\u5165\u3057\u3066\u304a\u308a\u3001\u30a2\u30e1\u30ea\u30ab\u304c55\uff5e60%\u3001\u30c9\u30a4\u30c4\u304c15\uff5e20%\u3001\u30de\u30ec\u30fc\u30b7\u30a2\u3068\u30d5\u30a3\u30ea\u30d4\u30f3\u306e\u5951\u7d04\u88fd\u9020\u62e0\u70b9\u304c10\uff5e15%\u3092\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002\u5b8c\u6210\u3057\u305f\u30bb\u30f3\u30b5\u30fc\u306fHS\u30b3\u30fc\u30c9901890\uff08\u533b\u7642\u7528\u5668\u5177\u30fb\u6a5f\u5668\uff09\u306b\u5206\u985e\u3055\u308c\u3001\u65e5\u672c\u306eWTO\u306e\u7fa9\u52d9\u306b\u57fa\u3065\u304d\u30bc\u30ed\u307e\u305f\u306f\u6700\u5c0f\u9650\u306e\u95a2\u7a0e\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\n\n### \u8cbf\u6613\u4fe1\u53f7\n- \u8f38\u5165\u306f2026\u5e74\u306b2\u51044000\u4e07\uff5e3\u5104\u30c9\u30eb\u306e\u4fa1\u5024\u304c\u3042\u308a\u3001\u5e74\u959312\uff5e15%\u306e\u6210\u9577\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002\n- \u65e5\u672c\u306fCGM\u30bb\u30f3\u30b5\u30fc\u306e\u8f38\u51fa\u91cf\u304c\u975e\u5e38\u306b\u5c11\u306a\u304f\u3001\u5e74\u9593500\u4e07\u30c9\u30eb\u672a\u6e80\u3067\u3001\u4e3b\u306b\u97d3\u56fd\u3068\u53f0\u6e7e\u306b\u81e8\u5e8a\u8a66\u9a13\u7528\u3068\u3057\u3066\u8f38\u51fa\u3055\u308c\u3066\u3044\u307e\u3059\u3002\n- \u8cbf\u6613\u30d5\u30ed\u30fc\u306f\u793e\u5185\u79fb\u8ee2\u304c\u4e3b\u5c0e\u3057\u3066\u304a\u308a\u3001\u30a2\u30dc\u30c3\u30c8\u3001\u30c7\u30af\u30b9\u30b3\u30e0\u3001\u30e1\u30c9\u30c8\u30ed\u30cb\u30c3\u30af\u306f\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u88fd\u9020\u62e0\u70b9\u304b\u3089\u65e5\u672c\u306e\u5b50\u4f1a\u793e\u306b\u5b8c\u6210\u3057\u305f\u30bb\u30f3\u30b5\u30fc\u3092\u51fa\u8377\u3057\u3066\u3044\u307e\u3059\u3002\n- \u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u306b\u95a2\u9023\u3059\u308b\u96fb\u5b50\u90e8\u54c1\u306e\u8f38\u51fa\uff08ASIC\u3084\u30ef\u30a4\u30e4\u30ec\u30b9\u30e2\u30b8\u30e5\u30fc\u30eb\u3092\u542b\u3080\uff09\u306f\u3001\u5e74\u95934000\u4e07\uff5e6000\u4e07\u30c9\u30eb\u306e\u4fa1\u5024\u304c\u3042\u308a\u3001\u4e3b\u306a\u8f38\u51fa\u5148\u306f\u30a2\u30e1\u30ea\u30ab\u3068\u30c9\u30a4\u30c4\u3067\u3059\u3002\n\n## \u6d41\u901a\u30c1\u30e3\u30cd\u30eb\u3068\u30d0\u30a4\u30e4\u30fc\n\u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u306e\u6d41\u901a\u306f\u30de\u30eb\u30c1\u30c1\u30e3\u30cd\u30eb\u30e2\u30c7\u30eb\u306b\u5f93\u3063\u3066\u3044\u307e\u3059\u3002\u8010\u4e45\u533b\u7642\u6a5f\u5668\uff08DME\uff09\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306f\u30bb\u30f3\u30b5\u30fc\u306e55\uff5e60%\u3092\u6271\u3044\u3001\u75c5\u9662\u3001\u30af\u30ea\u30cb\u30c3\u30af\u3001\u5728\u5b85\u533b\u7642\u63d0\u4f9b\u8005\u306b\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002\n\n### \u9700\u8981\u306e\u63a8\u9032\u8981\u56e0\n- \u85ac\u5c40\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\uff08PBM\uff09\u3068\u5c0f\u58f2\u85ac\u5c40\u30c1\u30a7\u30fc\u30f3\u306f25\uff5e30%\u3092\u5360\u3081\u3001\u4e3b\u306b\u60a3\u8005\u76f4\u63a5\u8ca9\u58f2\u306b\u304a\u3044\u3066\u511f\u9084\u306e\u4e0b\u3067\u884c\u308f\u308c\u307e\u3059\u3002\n- \u75c5\u9662\u306e\u30b0\u30eb\u30fc\u30d7\u8cfc\u8cb7\u6a5f\u95a2\uff08GPO\uff09\u306f\u3001\u4e2d\u592e\u5165\u672d\u3092\u901a\u3058\u306610\uff5e15%\u306e\u30dc\u30ea\u30e5\u30fc\u30e0\u3092\u7ba1\u7406\u3057\u3066\u3044\u307e\u3059\u3002\n- \u30d0\u30a4\u30e4\u30fc\u30b0\u30eb\u30fc\u30d7\u306b\u306f\u3001\u30bb\u30f3\u30b5\u30fc\u306e\u9078\u629e\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u533b\u7642\u63d0\u4f9b\u8005\uff08\u51e6\u65b9\u8005\uff09\u3001\u81ea\u5df1\u8ca0\u62c5\u8cbb\u7528\u3068\u5229\u4fbf\u6027\u306b\u57fa\u3065\u3044\u3066\u9078\u629e\u3059\u308b\u60a3\u8005\/\u6d88\u8cbb\u8005\u3001\u511f\u9084\u7387\u3092\u4ea4\u6e09\u3059\u308b\u5065\u5eb7\u4fdd\u967a\u5354\u4f1a\u304c\u542b\u307e\u308c\u307e\u3059\u3002\n- \u65e5\u672c\u306e47\u90fd\u9053\u5e9c\u770c\u306e\u5065\u5eb7\u4fdd\u967a\u5354\u4f1a\u306f\u3001\u4eba\u53e3\u306e85\uff5e90%\u3092\u30ab\u30d0\u30fc\u3057\u3066\u304a\u308a\u3001\u30bb\u30f3\u30b5\u30fc\u306e\u511f\u9084\u30dd\u30ea\u30b7\u30fc\u306b\u306f\u5730\u57df\u5dee\u304c\u3042\u308a\u307e\u3059\u3002\n\u4f7f\u3044\u6368\u3066\u30bb\u30f3\u30b5\u30fc\u306e\u5e73\u5747\u4ea4\u63db\u30b5\u30a4\u30af\u30eb\u306f10\uff5e14\u65e5\u3067\u3001\u60a3\u8005\u306f\u5e74\u959324\uff5e36\u30bb\u30f3\u30b5\u30fc\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002\n\n## \u898f\u5236\u3068\u57fa\u6e96\n\u5546\u696d\u7684\u8ca0\u62c5\u304c\u6280\u8853\u7684\u9069\u5408\u304b\u3089\u627f\u8a8d\u30d9\u30f3\u30c0\u30fc\u306e\u5730\u4f4d\u3001\u751f\u7523\u306e\u7d99\u7d9a\u6027\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30b5\u30dd\u30fc\u30c8\u3078\u3068\u3069\u306e\u3088\u3046\u306b\u4e0a\u6607\u3059\u308b\u304b\u3002\n- \u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\n- \u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306e\u4e92\u63db\u6027\n- \u71b1\u7684\/\u4fe1\u983c\u6027\u306e\u9069\u5408\n- FDA 510(k)\u307e\u305f\u306fPMA\uff08\u7c73\u56fd\uff09\n- MDR\u306b\u57fa\u3065\u304fCE\u30de\u30fc\u30ad\u30f3\u30b0\uff08EU\uff09\n- ISO 13485\u54c1\u8cea\u7ba1\u7406\n- \u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u533b\u7642\u6a5f\u5668\u30e9\u30a4\u30bb\u30f3\u30b9\n- \u8a2d\u8a08\u691c\u8a3c\n- AVL\u30b9\u30c6\u30fc\u30bf\u30b9\n- \u751f\u7523\u6e96\u5099\n- \u30ea\u30fc\u30c9\u30bf\u30a4\u30e0\u306e\u5b89\u5b9a\u6027\n- \u5728\u5eab\u30b5\u30dd\u30fc\u30c8\n- \u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30b5\u30dd\u30fc\u30c8\n\u65e5\u672c\u306e\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u306fCGM\u30bb\u30f3\u30b5\u30fc\u3092\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u5206\u985e\u3057\u3066\u304a\u308a\u3001\u56fd\u5185\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u4f34\u3046\u5e02\u5834\u524d\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3059\u3002\u627f\u8a8d\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306f\u63d0\u51fa\u304b\u3089\u5e73\u574712\uff5e18\u30f6\u6708\u3067\u3001FDA 510(k)\u306e\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u306f6\uff5e9\u30f6\u6708\u3067\u3059\u3002\n\n### \u653f\u7b56\u4fe1\u53f7\n- \u65e5\u672c\u306e\u511f\u9084\u5236\u5ea6\u306f\u539a\u751f\u52b4\u50cd\u7701\uff08MHLW\uff09\u306b\u3088\u3063\u3066\u7ba1\u7406\u3055\u308c\u3066\u304a\u308a\u3001\u56fd\u6c11\u5065\u5eb7\u4fdd\u967a\uff08NHI\uff09\u4fa1\u683c\u30ea\u30b9\u30c8\u306e\u4e0b\u3067CGM\u30bb\u30f3\u30b5\u30fc\u306b\u7279\u5b9a\u306e\u511f\u9084\u30b3\u30fc\u30c9\u304c\u5272\u308a\u5f53\u3066\u3089\u308c\u3066\u3044\u307e\u3059\u3002\n- \u73fe\u5728\u306eNHI\u306e\u511f\u9084\u306f\u3001\u30a4\u30f3\u30b9\u30ea\u30f3\u6cbb\u7642\u3092\u53d7\u3051\u3066\u3044\u308b1\u578b\u30fb2\u578b\u7cd6\u5c3f\u75c5\u60a3\u8005\u306e\u305f\u3081\u306ertCGM\u30fbFGM\u30bb\u30f3\u30b5\u30fc\u3092\u30ab\u30d0\u30fc\u3057\u3066\u304a\u308a\u30012025\u5e74\u306b\u306f\u975e\u30a4\u30f3\u30b9\u30ea\u30f3\u60a3\u8005\u5411\u3051\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30d7\u30ed\u30b0\u30e9\u30e0\u304c\u958b\u59cb\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3059\u3002\n- ISO 13485\u54c1\u8cea\u7ba1\u7406\u8a8d\u8a3c\u306f\u56fd\u5185\u7d44\u7acb\u65bd\u8a2d\u306b\u3068\u3063\u3066\u5fc5\u9808\u3067\u3042\u308a\u3001\u65e5\u672c\u306e\u826f\u597d\u306a\u88fd\u9020\u6163\u884c\uff08GMP\uff09\u57fa\u6e96\u306f\u30bb\u30f3\u30b5\u30fc\u751f\u7523\u306b\u5bfe\u3057\u3066\u5225\u3005\u306e\u76e3\u67fb\u3092\u8981\u6c42\u3057\u3066\u3044\u307e\u3059\u3002\n- \u65e5\u672c\u306e\u500b\u4eba\u60c5\u5831\u4fdd\u8b77\u6cd5\uff08APPI\uff09\u306b\u57fa\u3065\u304f\u30c7\u30fc\u30bf\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u898f\u5236\u306f\u3001\u30af\u30e9\u30a6\u30c9\u30d9\u30fc\u30b9\u30b0\u30eb\u30b3\u30fc\u30b9\u30c7\u30fc\u30bf\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u7ba1\u7406\u3057\u3001\u60a3\u8005\u60c5\u5831\u306e\u30ed\u30fc\u30ab\u30eb\u30c7\u30fc\u30bf\u30b9\u30c8\u30ec\u30fc\u30b8\u3092\u8981\u6c42\u3057\u3066\u3044\u307e\u3059\u3002\n\n## 2035\u5e74\u307e\u3067\u306e\u5e02\u5834\u4e88\u6e2c\n\u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u5e02\u5834\u306f2035\u5e74\u307e\u3067\u306b1,300\uff5e1,650\u5104\u5186\uff088\u51045,000\u4e07\uff5e11\u5104\u30c9\u30eb\uff09\u306b\u9054\u3057\u3001\u5e74\u95931,200\u4e07\uff5e1,600\u4e07\u30bb\u30f3\u30b5\u30fc\u306e\u30e6\u30cb\u30c3\u30c8\u30dc\u30ea\u30e5\u30fc\u30e0\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u6210\u9577\u7387\u306f2026\u5e74\u304b\u30892030\u5e74\u306e14%\u306eCAGR\u304b\u3089\u30012031\u5e74\u304b\u30892035\u5e74\u306e8\uff5e10%\u306eCAGR\u306b\u6e1b\u901f\u3057\u3001\u5e02\u5834\u6d78\u900f\u7387\u306f\u5bfe\u8c61\u3068\u306a\u308b\u7cd6\u5c3f\u75c5\u60a3\u8005\u306e40\uff5e50%\u306b\u9054\u3059\u308b\u898b\u8fbc\u307f\u3067\u3059\u3002\n\n### \u6210\u9577\u306e\u898b\u901a\u3057\n- rtCGM\u30bb\u30b0\u30e1\u30f3\u30c8\u306f\u30ea\u30fc\u30c9\u3092\u7dad\u6301\u3057\u30012035\u5e74\u307e\u3067\u306b\u30dc\u30ea\u30e5\u30fc\u30e0\u306e70\uff5e75%\u306b\u6210\u9577\u3059\u308b\u4e00\u65b9\u3067\u3001\u57cb\u3081\u8fbc\u307f\u578b\u9577\u671f\u30bb\u30f3\u30b5\u30fc\u306fPMDA\u306e\u627f\u8a8d\u304c\u62e1\u5927\u3059\u308b\u306b\u3064\u308c\u306610\uff5e12%\u3092\u5360\u3081\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059\u3002\n- \u75c5\u9662\u30fb\u81e8\u5e8a\u3067\u306e\u4f7f\u7528\u306f\u3001\u5468\u8853\u671f\u30d7\u30ed\u30c8\u30b3\u30eb\u3084ICU\u306e\u81ea\u52d5\u5316\u306b\u3088\u308a\u3001\u30bb\u30f3\u30b5\u30fc\u306e\u30dc\u30ea\u30e5\u30fc\u30e0\u306e15\uff5e18%\u306b\u6210\u9577\u3059\u308b\u898b\u8fbc\u307f\u3067\u3059\u3002\n\n## \u4e3b\u8981\u7d71\u8a08\n\n- \u65e5\u672c\u306e\u9ad8\u9f62\u5316\u793e\u4f1a\u306b\u3088\u308a\u30012035\u5e74\u307e\u3067\u306b65\u6b73\u4ee5\u4e0a\u306e\u5e02\u6c11\u304c30%\u306b\u9054\u3059\u308b\u3053\u3068\u304b\u3089\u3001\u9700\u8981\u306e\u6210\u9577\u304c\u6301\u7d9a\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u5e74\u95933\uff5e4%\u306e\u4fa1\u683c\u4e0b\u843d\u304c\u4fa1\u5024\u6210\u9577\u3092\u6291\u5236\u3059\u308b\u3067\u3057\u3087\u3046\u3002\n- \u56fd\u5185\u306e\u7d44\u7acb\u80fd\u529b\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u5bfe\u3059\u308b\u653f\u5e9c\u306e\u30a4\u30f3\u30bb\u30f3\u30c6\u30a3\u30d6\u306b\u652f\u3048\u3089\u308c\u30012035\u5e74\u307e\u3067\u306b\u5e74\u9593200\u4e07\uff5e300\u4e07\u30bb\u30f3\u30b5\u30fc\u306b\u500d\u5897\u3059\u308b\u898b\u8fbc\u307f\u3067\u3059\u3002\n\n## \u5e02\u5834\u6a5f\u4f1a\n\u65e5\u672c\u306eCGM\u30bb\u30f3\u30b5\u30fc\u5e02\u5834\u306f\u30013\u3064\u306e\u5206\u91ce\u3067\u6a5f\u4f1a\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305a\u3001\u975e\u30a4\u30f3\u30b9\u30ea\u30f3\u578b2\u578b\u7cd6\u5c3f\u75c5\u60a3\u8005\u3078\u306e\u511f\u9084\u306e\u62e1\u5927\u304c\u3042\u308a\u30012030\u5e74\u307e\u3067\u306b\u8ffd\u52a0\u3067300\u4e07\uff5e500\u4e07\u4eba\u3092\u30ab\u30d0\u30fc\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u3001\u3053\u308c\u306b\u3088\u308a2\u5104\uff5e3\u5104\u7c73\u30c9\u30eb\u306e\u53ce\u76ca\u6a5f\u4f1a\u304c\u751f\u307e\u308c\u307e\u3059\u3002\n\n### \u6226\u7565\u7684\u512a\u5148\u4e8b\u9805\n- \u6b21\u306b\u3001\u30bb\u30f3\u30b5\u30fc\u7528ASIC\u30fb\u30ef\u30a4\u30e4\u30ec\u30b9\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u56fd\u5185\u4f9b\u7d66\u306f\u672a\u958b\u62d3\u3067\u3042\u308a\u3001\u65e5\u672c\u306e\u96fb\u5b50\u6a5f\u5668\u4f01\u696d\u306f\u4e16\u754c\u306eCGM\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u5e02\u5834\u306e20%\u672a\u6e80\u3092\u5360\u3081\u3066\u3044\u307e\u3059\u3002\n- \u7b2c\u4e09\u306b\u3001\u5468\u8853\u671f\u30fb\u91cd\u75c7\u30b1\u30a2\u306b\u304a\u3051\u308b\u75c5\u9662\u30d9\u30fc\u30b9CGM\u30bb\u30f3\u30b5\u30fc\u306e\u63a1\u7528\u306f\u5e74\u959315\uff5e18%\u306e\u6210\u9577\u3092\u898b\u305b\u3066\u304a\u308a\u3001\u30bb\u30f3\u30b5\u30fc\u7d71\u5408\u578b\u306e\u81e8\u5e8a\u610f\u601d\u6c7a\u5b9a\u652f\u63f4\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306b\u6a5f\u4f1a\u304c\u3042\u308a\u307e\u3059\u3002\n- \u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u578b\u306e\u9577\u671f\u30bb\u30f3\u30b5\u30fc\u30bb\u30b0\u30e1\u30f3\u30c8\u306f\u5c0f\u898f\u6a21\u3067\u3059\u304c\u3001\u30d7\u30ec\u30df\u30a2\u30e0\u4fa1\u683c\uff08\u30bb\u30f3\u30b5\u30fc1\u500b\u3042\u305f\u308a3\u4e07\uff5e5\u4e07\u5186\uff09\u3068\u9577\u3044\u4ea4\u63db\u30b5\u30a4\u30af\u30eb\u3092\u63d0\u4f9b\u3057\u3001\u65e5\u672c\u306e\u5229\u4fbf\u6027\u91cd\u8996\u306e\u60a3\u8005\u5c64\u306b\u30a2\u30d4\u30fc\u30eb\u3057\u3066\u3044\u307e\u3059\u3002\n- 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\u8a2d\u8a08\u652f\u63f4 | \u30c1\u30e3\u30cd\u30eb\u30ea\u30fc\u30c1 |\n|--------------|----------|----------|------|----------|----------------|\n| \u7d71\u5408\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u30fb\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u30ea\u30fc\u30c0\u30fc | \u9ad8 | \u9ad8 | \u9ad8 | \u9ad8 | \u9ad8 |\n| \u30d4\u30e5\u30a2\u30d7\u30ec\u30a4CGM\u30bb\u30f3\u30b5\u30fc\u30a4\u30ce\u30d9\u30fc\u30bf\u30fc | \u9078\u629e\u7684 | \u9ad8 | \u4e2d | \u4e2d | \u9ad8 |\n| \u5f93\u6765\u306e\u8840\u7cd6\u6e2c\u5b9a\u5668\uff08BGM\uff09\u591a\u69d8\u5316\u4f01\u696d | \u9078\u629e\u7684 | \u9ad8 | \u4e2d | \u4e2d | \u9ad8 |\n| \u88fd\u85ac\/\u30e1\u30c9\u30c6\u30c3\u30af\u30b3\u30f3\u30b0\u30ed\u30de\u30ea\u30c3\u30c8\u90e8\u9580 | \u9078\u629e\u7684 | \u9ad8 | \u4e2d | \u4e2d | \u9ad8 |\n| \u5951\u7d04\u96fb\u5b50\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc | \u9078\u629e\u7684 | \u9ad8 | \u4e2d | \u4e2d | \u9ad8 |\n| 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content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u65e5\u672c\u306e\u6301\u7d9a\u7684\u30b0\u30eb\u30b3\u30fc\u30b9\u30e2\u30cb\u30bf\u30fc\uff08CGM\uff09\u30bb\u30f3\u30b5\u30fc\u5e02\u5834\uff1a\u5206\u6790\u3001\u4e88\u6e2c\u3001\u898f\u6a21\u3001\u30c8\u30ec\u30f3\u30c9\uff06\u30a4\u30f3\u30b5\u30a4\u30c8\" \/>\n<meta property=\"og:description\" content=\"## \u65e5\u672c\u306e\u6301\u7d9a\u7684\u30b0\u30eb\u30b3\u30fc\u30b9\u30e2\u30cb\u30bf\u30fc\uff08CGM\uff09\u30bb\u30f3\u30b5\u30fc\u5e02\u5834 2026\u5e74\u5206\u6790\u30682035\u5e74\u307e\u3067\u306e\u4e88\u6e2c ## \u30a8\u30b0\u30bc\u30af\u30c6\u30a3\u30d6\u30b5\u30de\u30ea\u30fc ### \u4e3b\u306a\u767a\u898b - 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\u65e5\u672c\u306e\u898f\u5236\u7d4c\u8def\u306f\u3001\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u306b\u3088\u3063\u3066\u7ba1\u7406\u3055\u308c\u3066\u304a\u308a\u3001\u65b0\u3057\u3044\u30bb\u30f3\u30b5\u30fc\u30bf\u30a4\u30d7\u306b\u306f\u56fd\u5185\u81e8\u5e8a\u8a66\u9a13\u304c\u5fc5\u8981\u3067\u3001\u30a2\u30e1\u30ea\u30ab\u306e\u627f\u8a8d\u306b\u5bfe\u3057\u306612\uff5e18\u30f6\u6708\u306e\u9045\u308c\u3092\u751f\u3058\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u57cb\u3081\u8fbc\u307f\u578b\u30bb\u30f3\u30b5\u30fc\u306e\u63a1\u7528\u304c\u9045\u308c\u3066\u3044\u307e\u3059\u3002 ### \u5e02\u5834\u52d5\u5411 \u4e0a\u6d41\u306e\u6295\u5165\u7269\u304b\u3089\u88fd\u9020\u3001\u8a8d\u8a3c\u3001\u30c1\u30e3\u30cd\u30eb\u914d\u4fe1\u3092\u901a\u3058\u3066\u4fa1\u5024\u304c\u69cb\u7bc9\u3055\u308c\u308b\u65b9\u6cd5\u3002 - 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\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u533b\u7642\u6a5f\u5668\u30e9\u30a4\u30bb\u30f3\u30b9 - \u7cd6\u5c3f\u75c5\u7ba1\u7406 - \u4f4e\u8840\u7cd6\u4e88\u9632 - \u8840\u7cd6\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u6700\u9069\u5316 - \u9060\u9694\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0 - \u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u53ce\u96c6 - \u81ea\u52d5\u30a4\u30f3\u30b9\u30ea\u30f3\u6295\u4e0e\uff08AID\uff09\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u7d71\u5408\u304c\u4e3b\u8981\u306a\u6280\u8853\u30c8\u30ec\u30f3\u30c9\u3067\u3059\u3002\u65e5\u672c\u306e\u539a\u751f\u52b4\u50cd\u7701\uff08MHLW\uff09\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u30af\u30ed\u30fc\u30ba\u30c9\u30eb\u30fc\u30d7\u30b7\u30b9\u30c6\u30e0\u3092\u627f\u8a8d\u3057\u3066\u304a\u308a\u3001Bluetooth\/NFC\u4f1d\u9001\u306b\u5bfe\u5fdc\u3057\u305frtCGM\u30bb\u30f3\u30b5\u30fc\u306e\u9700\u8981\u3092\u9ad8\u3081\u3066\u3044\u307e\u3059\u3002 - 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PMDA\u3068FDA\/CE\u306e\u9593\u306e\u898f\u5236\u306e\u9055\u3044\u304c\u91cd\u8907\u30b3\u30b9\u30c8\u3092\u751f\u3058\u3066\u3044\u307e\u3059\u3002\u65e5\u672c\u3067\u306f\u3001\u6771\u30a2\u30b8\u30a2\u306e\u4eba\u53e3\u306b\u304a\u3051\u308b\u30bb\u30f3\u30b5\u30fc\u306e\u7cbe\u5ea6\u306b\u5bfe\u3057\u3066\u5225\u9014\u81e8\u5e8a\u691c\u8a3c\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u88fd\u54c1\u3054\u3068\u306b12\uff5e18\u30f6\u6708\u30fb500\u4e07\uff5e1000\u4e07\u7c73\u30c9\u30eb\u306e\u958b\u767a\u30b3\u30b9\u30c8\u304c\u8ffd\u52a0\u3055\u308c\u307e\u3059\u3002 - 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### \u5e02\u5834\u69cb\u9020 - \u5e02\u5834\u306f\u69cb\u9020\u7684\u306b\u8f38\u5165\u4f9d\u5b58\u3067\u3042\u308a\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30ea\u30fc\u30c0\u30fc\u304c\u73fe\u5730\u306e\u5b50\u4f1a\u793e\u3092\u901a\u3058\u3066\u5b8c\u6210\u3057\u305f\u30bb\u30f3\u30b5\u30fc\u3092\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002 - \u65e5\u672c\u306e\u96fb\u5b50\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306f\u3001\u30dd\u30c6\u30f3\u30b7\u30e7\u30b9\u30bf\u30c3\u30c8ASIC\u3001Bluetooth\u30e2\u30b8\u30e5\u30fc\u30eb\u3001MEMS\u30d9\u30fc\u30b9\u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30eb\u306a\u3069\u306e\u91cd\u8981\u306a\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u6700\u7d42\u7684\u306a\u30bb\u30f3\u30b5\u30fc\u306e\u7d44\u307f\u7acb\u3066\u306f\u30a2\u30e1\u30ea\u30ab\u5408\u8846\u56fd\u3068\u6771\u5357\u30a2\u30b8\u30a2\u306b\u96c6\u4e2d\u3057\u3066\u3044\u307e\u3059\u3002 - 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### \u5e02\u5834\u69cb\u9020 - \u5e02\u5834\u306f\u69cb\u9020\u7684\u306b\u8f38\u5165\u4f9d\u5b58\u3067\u3042\u308a\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30ea\u30fc\u30c0\u30fc\u304c\u73fe\u5730\u306e\u5b50\u4f1a\u793e\u3092\u901a\u3058\u3066\u5b8c\u6210\u3057\u305f\u30bb\u30f3\u30b5\u30fc\u3092\u4f9b\u7d66\u3057\u3066\u3044\u307e\u3059\u3002 - \u65e5\u672c\u306e\u96fb\u5b50\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306f\u3001\u30dd\u30c6\u30f3\u30b7\u30e7\u30b9\u30bf\u30c3\u30c8ASIC\u3001Bluetooth\u30e2\u30b8\u30e5\u30fc\u30eb\u3001MEMS\u30d9\u30fc\u30b9\u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30eb\u306a\u3069\u306e\u91cd\u8981\u306a\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u6700\u7d42\u7684\u306a\u30bb\u30f3\u30b5\u30fc\u306e\u7d44\u307f\u7acb\u3066\u306f\u30a2\u30e1\u30ea\u30ab\u5408\u8846\u56fd\u3068\u6771\u5357\u30a2\u30b8\u30a2\u306b\u96c6\u4e2d\u3057\u3066\u3044\u307e\u3059\u3002 - 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