0 CGM S0120521080001 chentl S0120522100005 liuchuang 2023 11 19|1 CGM 2021 1.4 20002019 3%SMBG HbA1c GA CGM/CGM CGM+CGM CGM 3 3 505 G4 Platinum MARD 13%9%CGM CGM 2015 9.5%2020 21.4%2020 57+70%CGM 2020 80%2021 CGM CGM CGM 2030 100 CGM+CGM 4 Medicare 2 CGM/Medicare/CGM CGM CGM iCGM 50%YWEVwPtOpMoPqOsRqNoRnM8O9R6MmOpPmOtQlOnMoPiNsQoO7NpOnRxNpNsQuOtPoR2 CONTENTS CGM+CGM 3 1 2 BioNinja Mujeeb Z.Banday Pathophysiology of diabetes:An overview Yaqub Khan AReview on Diabetes and Its Management I t 10%II 90%II 1-14%ATP()1 10%2 90%T2DM 1-14%4 Naveed Sattar Age at Diagnosis of Type 2 Diabetes Mellitus and Associations With Cardiovascular and Mortality Risks Araz Rawshani Excess mortality and cardiovascular disease in young adults with type 1 diabetes in relation to age at onset:a nationwide,register-based cohort study 2000 2019 3%2019 150 5 1.4 IDF 1.373.72.316.9357.920.32.4114.22.220.7444.122.00.050.0100.0150.0200.0250.0300.0350.0400.0450.0500.0I 型 II 型 妊娠 I 型 II型 妊娠中国 全球2015 2019 2019 4.9 IDF 2021 5.4 20-79 2019 1.2 II I 2015-2019 Statista 2021 1.4 6 1 2021 2 IDF 1 4 2 3 3 4 8 3 00 2 4 7 3 1 2 2 4 3 7 1 4 2 24 4-7 7 CGM(2011)2021 SMBG 1.2.()3.1.2.3.4.HbA1c 1.2 3 2.3.4.GA 1.23 2.GA 3.HbA1c 4.HbA1c GA GA HbA1c 1.GA GA 2.GA CGM(1)(2)Somogyi(3)(4)(5)CGM CGM SMBG HbA1c GA CGM SMBG HbA1c GA SMBG HbA1c GA CGM 8 CGM CGM Federico Ribet Real-time intradermal continuous glucose monitoring using a minimally invasive microneedle-based system Sandeep Kumar Vashist Continuous Glucose Monitoring Systems:A Review mmol/L/CGM CGM/CGM 9 CGM BGM HbA1c Lori M Laffel Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes A Randomized Clinical Trial Robert J Tanenberg Use of the Continuous Glucose Monitoring System to Guide Therapy in Patients With Insulin-Treated Diabetes:A Randomized Controlled Trial CGM CGM HbA1c CGM 26 HbA1c HbA1c CGM CGM/CGM CGM HbA1c%BGM13 26 CGM 10 PM-6 AM 6 AM-10 PM 24 h CGM BGM CGM 10 CGM 2014.09 ISPAD 1.SMBG 2.(BG)3.(CGM)2015.01 2015 1.(SMBG)(POCT)2.HbA1c 3.CGM GA 2017.11 2017 1.SMBG)2.HbA1c)3.(CGM)2019.01 2019 1.(SMBG)2.CGM 2021.11 2021 1.2.HbA1e 2-3 3.GA CGM 4.CGM SMBG CGM CGM CGM 2021.12 ADA 2022 1.A1C TIR GMI 2.(MDI)CSII CGM(rtCGM)CGM(isCGM)2022.12ISPAD 2022 1.BG rtCGM CGM isCGM 2.6 10 3.RtCGM SMBG CGM Marian J Rewers Assessment and monitoring of glycemic control in children and adolescents with diabetes 2015 American Diabetes Association 2019 CGM CGM CGM 11 CGM CGM CGM 5 min 1 3d CGM CGM CGM“G7 FreeStyle Libre 3 FGM CGM 15 min 14 d FGM FGM FreeStyle Libre 2 CGM 3.5 mm 18.3 mm CGM Eversense CGM Senseonics CGM CoG CNOGA CGM TIR TAR TBR CGM CGM CGM FGM 1 CGM FGM TBR 180 2002 1,12 iCGM CGM CGM Control-IQ AID iCGM AID iCGM integrated continuous glucose monitoring CGM FDA II G6 2018 FDA iCGM FreeStyle Libre 2 FreeStyle Libre 3 2020 2023 FDA iCGM Medtronic 670G/770G Medtronic 780G CamAPS FX Diabeloop Control-IQ Omnipod 5 FDA/CE CE CE CE FDA/CE FDA670G 7+()770G 2+(FDA)7-80 1+12 18(DBL4T)18+(DBLG1)6+2+CGM Guardian 3 7 Guardian 3 7 Dexcom G6 10 Dexcom G6 10 Dexcom G6 10 Dexcom G6 10(4-6x/d)(2x/d)Guardian 4 CE 7 670G/770G 780G Dana RS,Dana I,mylife YpsoPumpKaleido patch pump Roche Accu-ChekTandem t:slim X2 Omnipod 5 ACE:120 mg/dL(6.7 mmol/L):100 mg/dL(5.6 mmol/L)(default);:104 mg/dL(5.8 mmol/L)(default);:110 mg/dL(6.1 mmol/L)();:112.5 160 mg/dL(6.2 8.9 mmol/L):110 mg/dL 150 mg/dL(6.1 mmol/L and 8.3 mmol/L)10 mg/dL:150 mg/dL(8.3 mmol/L):110 mg/dL(6.1 mmol/L)120 mg/dL(6.7 mmol/L)80 mg/dL 200 mg/dL(4.4 mmol/L 11.0 mmol/L)100 mg/dL(5.5 mmol/L)130 mg/dL(7.2 mmol/L)112.5 120 mg/dL(6.2 6.7 mmol/L):150 mg/dL(8.3 mmol/L):150 mg/dL(8.3 mmol/L):20 40 mg/dL 0.5 2.2 mmol/L 140 160 mg/dL(7.8 8.9 mmol/L)CGM 5-10 150mg/dL(8.3 mmol/L)120 mg/dL(6.7 mmol/L)180 mg/dL(10.0 mmol/L)110 mg/dL(6.1 mmol/L)B o o st”()AID Moshe Phillip Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice 13 CONTENTS CGM+CGM 14 CGM Guido Freckmann Jochen Mende Continuous glucose monitoring:data management and evaluation by patients and health care professionals current situation and developments CGM 1 2 3 4 CGM CGM+15 Santhisagar Vaddiraju Technologies for Continuous Glucose Monitoring:Current Problems and Future Promises 2023 GOx CGM GOx 1 H2O2 2 Heller 3 CGM 4 CGM CGM 1.2.3.1.2 3.1.2.1.2.16 CGM Audrey Sassolas Immobilization strategies to develop enzymatic biosensors ADAM HELLER BEN FELDMAN Electrochemistry in Diabetes Management Saroj Kumar Das Review Electrochemistry and Other Emerging Technologies for Continuous Glucose Monitoring Devices Freestyle Navigator CGM CGM 3 3 2 Ag/AgCl 17 B.Wayne Bequette Continuous Glucose Monitoring:Real-Time Algorithms for Calibration,Filtering,and Alarms Andrea Facchinetti Continuous Glucose Monitoring Sensors:PastPresent and Future Algorithmic Challenges Software 505 G4Platinum MARD 13%9%2014 CGM CGM CGM CGM CGM 1 CGM 2 CGM CGM 3/CGM mg/dl CGM CGM+18 CONTENTS CGM+CGM 19 CGM Irl B.Hirsch Introduction:History of Glucose Monitoring Olesya Didyuk Continuous Glucose Monitoring Devices:Past,Present,and Future Focus on the History and Evolution of Technological Innovation Alyson Blum FreestyleLibre Glucose Monitoring System Andrea Facchinetti Continuous Glucose Monitoring Sensors:Past,Present and Future Algorithmic Challenges CGM MiniMed CGM Cygnus Inc.GlucoWatch1999 2001 2006 2012 2015 2016 GuardianRT CGM MiniMed Paradigm REAL-Time G4 G5 SMBG 2005FDA FreeStyle Libre 2020 FreeStyle Libre22018 G6 Eversense2022 FreeStyle Libre3 Dexcom STS2008 FreeStyleNavigator2014 505 G4 MARD 2009 seven plus G7 Guardian 3 2005 TA-SG2010 CGMS-20092016 CGM FreeStyle Libre2019 MD-MY-0082021 CT2 GN-I G7 GS12023 i32015 2015 2017 2017 2021 2009 2009 2012 2012(2017)2013 RGMS-I CGM 1999 FDA CGM MiniMed CGM CGM 2005 TA-SG CGM CGM CGM CGM 2021 CGM 2023 CGM i3 CGM CGM 2021 20 CGM 2015 9.5%21.4%CGM 2015 17 2020 57 28.2%50%20%2015 878 2020 1 2%70%IDF CGM 9.50%21.40%90.50%78.60%0%20%40%60%80%100%2015 2020CGM 其他监测 系统1271217172025314401020304050602015 2016 2017 2018 2019 2020中国 美国 欧盟五国 其他 全球CGM 21 IDF Statista 2020 CGM CGM 2020 50%CGM 60 30%CGM 30%56%50%78%10%11%10%11%44%0%20%40%60%80%100%全球 中国 美国德康 雅培 美 敦力 其他 22 IDF CGM 2020 I II CGM 25.8%6.9%18.2%9.0%1.1%7.0%4.0%0.3%2.8%0.0%5.0%10.0%15.0%20.0%25.0%30.0%美国 中国 欧盟五国I 型 II 型 妊娠 2020 CGM 23 CGM CGM CGM 2021 CGM MARD iCAN GS1 iCGM ClinicalTrial FreeStyle 1 GS1 AIDEX G7 CT15 iCAN mm*mm*mm 35*5 20*33.5*5.3 35*22*8 39*30.1*6.4 32*5.7 4 18 18 18 18 4 2 14 14 14 14 15/60 60 60 60 120MARD 9.2%8.83%9.08%9.07%8.71%32.88 28.86 19.14 24.86 15.17 24 CGM 1 IDF 2030 1.64 1 5-10%1 2 2030 951 1.54 2 CGM 1000/2030 230/3 CGM 2030 30%10 4 2 10%CGM 2030 19%1.5%5 4 CGM IDF 2019 2020 2025E 2030E 1.16 1.20 1.51 1.64 464 696 874 951 1.08 1.13 1.42 1.54 CGM 1000 1000 311 230 5.0%6.9%15%30%3.0 3.6 6.6 10 I 7.0 17.3 26.9 66.3 44%46%57%67%10%10%10%10%0.5%1.1%5%19%1.0 1.4 3.0 5 II 0.24 0.80 3.78 22.61 0.05%0.10%0.5%1.5%0.5 0.8 2.3 4 II 0.11 0.38 2.65 12.98 II 0.3 1.2 6.4 35.6 7.3 18.5 33.3 101.9 25 CGM 1.23 CGM MARD MARD MARD i3 20/20%2.23 CGM CGM3.15 CGM+CGM i3 26 CONTENTS CGM+CGM 27 CGM 65+2022 61%Medicare Medicaid 39.5%8.4%65+0.6%65+95.2%Medicare Medicaid 4.243.754.312.22267.80.695.245.78.439.5610 20 40 60 80 100未参与保险公立保险商保整体 65岁+18-64 岁 0-17岁 2022%Robin A Health Insurance Coverage:Early Release of Estimates From the National Health Interview Survey,2022 Medicare Medicaid 28 CGM 2019 Medicare 65+1590 45-64 1550 2019 statista CDC 18-44 岁,5.645-64 岁,15.565 岁+,15.9 29 CGM Medicare CGM 4 Medicare 1 2 226/2023 80%20 Medicaid 4 16 Medicare 2 Medicare 300-350 60%+CGM CGM Medicare Part B Medicare Part B 2022 2023 Medicare CGM Dexcom Medicare Interactive diaTribe Change JDRF CMS Medicare 65+1 2 Medicare 80%20%Medigap Medicaid 44 CGM 15 1 27 CGM 1 2 2 0501001502002502016 2017 2018 2019 2020 2021 2022 2023 Medicare Part B 30 0%10%20%30%40%50%60%70%0246810121416德康医疗 雅培糖尿 病管理 雅培CGMyoy yoy yoy CGM Medicare CGM Medicare/Wind%2023.04Medicare FreeStyle Libre 3 Medicare 2017.03Medicare G5 2023.02Medicare G72018.10Medicare G6 FreeStyleLibre 14-Day2020.09Medicare FreeStyle Libre 22022.02Medicare CGM 31 CGM 40 Libre FreeStyle Libre 2 140 14 280 85%90%CGM SingleCare FreeStyle Libre 2 02040608010012014016018020022.11 22.12 23.01 23.02 23.03 23.04 23.05 23.06 23.07 23.08 23.09 23.10零售价 折扣网站 价格 32 CGM CGM 1 2 The Commonwealth Fund Dexcom David Reimbursement Pathways for New Diabetes Technologies in Europe:Top-Down Versus Bottom-Up Claudia Graham Continuous Glucose Monitoring and Global Reimbursement:An Update Germany Visa Medical Device InterNations Insee DiABETES UK MTRC Socialstyrelsen Diabeter Newsletter CGM GBA 88%1 2 2019 12.7%1/3 11%-HAS 1 2 NHS NICE 1 2 Piedmont Basilicata 1+1 1 HbA1c HbA1c 8%64 mmol/mol 1/385 33 CGM Almurashi Emerging Diabetes Technologies:Continuous Glucose Monitors/Artificial Pancreases CGM 3-5 G4 MARD 10%G5 CGM CGM G7 30 CGM STS SEVEN PLUS G4 G5 G6 G7FDA 2006 2007 2012 2015 2019 2022MARD 26%16%13%9%9%8.1%9.1%3 7 7 7 10 10+0.5 2 30 6-5 5 10 10 Tandem TandemTandemOmnipod 5-iCGM 20 3 G5 28%G6 60%2-6 APP G6 Seven Plus 30%59%60%CGM 34 SMBG CGM CGM 35/iCGM Dexcom G6 FDA iCGM/36 Libre 3 CGM CGM 70%Libre 3 iCGM c AID AID CGM Almurashi Emerging Diabetes Technologies:Continuous Glucose Monitors/Artificial Pancreases Freestyle libre Freestyle libre 2 Freestyle libre 3CGM$135 28$175$135 28$175$135 28$175 14 14 14 n/0 0 0 iCGM AID AID 2022 2023 MARD 9.2%9.2%7.9%15/15 mg/dL-86.3%89.1%20/20 mg/dL-93.2%94.7%4+4+4+1 1 1/37/OUS 70%2022 66%CGM CGM FreeStyle Libre 2 6 CGM 2022 3 FreeStyle Libre CGM 024681012141620Q1 20Q2 20Q3 20Q4 21Q1 21Q2 21Q3 21Q4 22Q1 22Q2 22Q3 22Q4 23Q1 23Q2 23Q3US OUS 38 Maiorino An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes Seley Continuous Glucose Monitoring:Interpreting the Data CGM vs G7 MARD-%15/15%20/20 CGM YSI 100mg/dL 15/20mg/dL YSI 100mg/dL 15/20%Senseonics G6 One G7 Freestyle libre Freestyle libre 2 Freestyle libre 3 Guardian sensor 3Guardian sensor 4Eversense E3CGM$300 90$420 30$380 34.9 90 39.9 10$170190 10$135 28$175$135 28$175$135 28$175$1100$450 35$1400$99+10 10 10+12 14 14 14 7 7 180 3 3 12 12 12 n/0 0 0 0 0 0 2 0 2 21 1 iCGM-MARD 9.0%8.2%9.2%9.2%7.9%9.1%10.6%8.5%15/15 mg/dL 83.3%89.6%-86.3%89.1%78.8%-85.6%20/20 mg/dL 93.9%95.3%-93.2%94.7%88.2%-92.9%2 17 2 17 2 17 2 17 MiniMed 780 G 2+2+2+4+4+4+2+2+18+2 2 30 1 1 1 2 2 24/39 8 MARD 7.9%MARD 8.2%MARD MARD FreeStyle Libre 3 MARD vs G7 8.5%9.1%6.6%7.1%0.0%2.0%4.0%6.0%8.0%10.0%12.0%14.0%days 1-3 days 7-8 days 9-12 days 13-1411.9%8.4%7.2%7.2%7.6%6.9%12.9%8.6%7.7%8.1%9.3%8.8%0.0%2.0%4.0%6.0%8.0%10.0%12.0%14.0%day 1 day 2 day 4 day 7 day 10 day 10.5手臂 腹部 G7 MARD Garg Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes KARINKA Performance of FreeStyle Libre 3 System 40 8%15/15%20/20 MARD 1%15/15%20/20/%15/15%20/20 Garg Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes KARINKA Performance of FreeStyle Libre 3 System vs G7 FreeStyle Libre 3%15/15%20/20 G7%15/15%20/20 85.6%84.4%92.2%89.3%92.3%90.8%95.8%94.5%0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%100.0%days 1-3 days 7-8 days 9-12 days 13-14%15/15%20/2076.9%89.4%91.8%93.7%92.4%93.2%87.4%95.5%97.2%97.5%96.4%97.4%0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%100.0%day 1 day 2 day 4 day 7 day 10 day 10.5%15/15%20/2073.0%86.5%90.9%89.5%84.5%86.4%84.5%94.9%96.6%95.3%92.9%93.1%0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%100.0%day 1 day 2 day 4 day 7 day 10 day 10.5%15/15%20/20 G7%15/15%20/20 41 CGM 54 mg/dL Libre 3 250 mg/dL Libre 3 180 mg/dL G7 FreeStyle Libre 3%15/15%20/20 Garg Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes Shridhara Alva Accuracy of the Third Generation of a 14-Day Continuous Glucose Monitoring System x mg/dL vs G7 66.7%88.6%85.2%92.4%98.2%100.0%90.0%95.2%91.5%96.8%100.0%100.0%0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%100.0%350%15/15%20/2085.1%92.6%86.2%90.3%96.8%91.9%96.5%93.6%96.0%99.1%0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%100.0%40-60 61-80 81-180 181-300 301-400%15/15%20/20 G7%15/15%20/20 42 CONTENTS CGM+CGM 43 BGM 2009 CGM CGM CGM precision wearable system PWS 2023 3 CGM i3 9 MDR CE MDR 2023+ClinicalTrials CGM BGM CGM 44 POCT 2021 5 CGM BGM CT15 2023 3 CT2 CGM CT2 CT3 CT2 CT15 2021.02 2023.03 mm*mm*mm 45*25*8 39*30.1*6.4-18 2 7 14/270 60MARD 9.6%9.1%-IP58 1.5 30min 45 Equil AiDEX G7 Equil 20 AiDEX G7 CGM+CGM+2023 5 2023 6 30 2023 46 CONTENTS CGM+CGM 47 CGM 48 48 2019 2018 2017 2016 2015 1.6 6 20%5%20%-5%+5%5%2.A 500 10%-10%10%10%49 49()50 600 N1 9+86 21 68761616+86 21 68767880400-8888-128