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1
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7 NEDO 1
8 2 QOL 50mg/dl m
9 3
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12 政府経済産業省 暦年 法律 政府 技術評価をめぐる国内動向 科学技術基本法 中央省庁等改革基本法 施行 施行 公布 9511 科学技術基本計画 閣議決定 大網的指針 9708 総理大臣決定 9806 各省庁設置法 0101 施行 平成 14 年 4 月現在 科学技術基本計画 ( 第 2 期 ) 政策評価法 0103 閣議決定 大網的指針 0204 施行 0111 総理大臣決定 政策評価広報課 技術評価調査課 評価指針 9708 告示 政策立案 評価指針 評価指針 ( 改定 ) 9912 告示 0005 告示 評価指針 ( 改定 ) 0105 告示 評価指針 ( 改定 ) 0204 告示 N E D O 技術評価部 技術評価実施要領 技術評価実施要領 ( 改定 ) NEDO 技術評価部作成 1 1-1
13
14
15 NEDO NEDO
16
17 3 4 JIS
18 1-7
19 1-8
20
21
22
23 0 Closed Loop 690 1,370 1 H12fy H13fy H14fy H15fy H16fy (H12.4) () () ()
24 ( ()() ())
25 1. 2-1
26 2-2
27 (1) (2) WHO 1,150 (3) Continuous Subcutaneous Insulin Infusion ,500 5 (4) (5) 30 1,500 (6) (7)
28 / , , (8) 350, , , (9) (10) (11) ,
29 1) nm 1992 Robinson glucose oxidase 19.8mg/dl nm Heise 2-5
30 ,ISFISF 2001 FDA, Diabetes Technology Meeting Bios 14 2) open-loop control International Society for Artificial Organs International Study Group on Diabetes Treatment with Implantable Insulin Delivery Devices (ISGIID) randomized prospective study 2-6
31 , MEMSMicro-Electro Machine System
32 (1) 1 (A) 20500mg/dl (B) Closed Loop 2-8
33 Closed Loop 10% (2) (A)
34 20500mg/dl (B) Closed Loop Closed Loop 3 10% ) 2-10
35 ) (1)
36 2 in vitro (2) Closed Loop
37 3) H12fy H13fy H14fy H15fy H16fy (H12.4) () 182 () 19 ()
38 1) 800nm2500nm 1100nm 1100nm 1100nm 1100nm 1300nm mm 1mm CT 1mm S/N in vitro 2) () STG
39 () STG mm
40 5 (1) (2) 15mL (3) 2-16
41 2 (4) 3V 2-17
42 1) (1) () () () () () ()() () (2) NEDO NEDO () 2-18
43 () R&D M () CNT () 2-19
44 2) () R&D M R&D M R&D M R&D M R&D M R&D M R&D M R&D CNT 2-20
45 () () 2-21
46 2-22
47 4) () R&D TEL FAX () TEL FAX () TEL FAX () Closed Loop double lumen catheter ml/hr 1996 MPC () 2-23
48 () 2-24
49 690 長期動物実験実用化開発臨床医による評価製品化設計 ( 小型化 ) 臨床試験医療機器認定製品化 平成 17 平成 18 平成 19 平成 20 平成 (1)
50 14 2 in vitro mg/dl in vivo mg/dl L/min L/min L/min (2) In Vivo Study for Noninvasive Measurement of Blood Glucose Based on Near-Infrared Spectroscopy (submitted) Applied Spectroscopy Katsuhiko Maruo, Mituhiro Tsurugi, Mamoru Tamura, Masataka Ishii 2-26
51 (BOG) p.p Monte Carlo simulation of NIR spectra induced by varying the glucose concentration (accepted)bios2002(spie), San Jose (CA, USA), ( )Conference 4624 M.Tarumi, M.Shimada, T.Murakami, M.Tamura, M.Shimada, Y.Yamada ( ) 42 ( ) Noninvasive Optical Monitoring of Blood Glucose by Novel Fiber ProbeDiabetes Technology Meeting, 2nd Nov
52 K. Maruo, J. Chin, M. Tamura Noninvasive Blood Glucose Monitoring by Novel Optical Fiber ProbeBiOS2002(SPIE), San Jose (CA, USA), ( ) Conference 4624 K. Maruo, J. Chin, M. Tamura. Noninvasive Blood Glucose Monitoring by Newly Developed Near-infrared Spectroscopic System (submitted) American Diabetes Association 62nd Annual Meeting and Scientific Sessions, San Francisco (CA, USA), June 2002 K. Maruo, M. Tsurugi, M. Tamura, M. Ishii
53 (1) (in vitro) (in vivo) mg/dl in vitro A-b B B-b A B-a A-a A/D mg/dl 2-29
54 SN Lambert-Beer (2) 2-30
55 液の流れ MEMSMicro-Electro-Mechanical Systems L/min 3L/min (3 L/min ) ダイアフラム 閉 開 圧電素子 シリコン ガラス 2-31
56 14 駆動電圧に対する流量特性 8.0 駆動周波数に対する流量特性 流量 [ul/m in] 流量 [ul/m in] 使用領域駆動電圧 60V 駆動電圧 [V] 周波数 [Hz]
57 L/min 0.3mm 3 L/min MHz 10MHz 30MHz ASKAmplitude Shift KeyingFSK Frequency Shift KeyingPSKPhase Shift Keying STG
58 0.1U/kg mg/kg/160min mg/kg/160min dx(t)/dt=iir(t)-fdx(t) IRI(t)=X(t)/θ IRI(t)=e -FD t / θ IIR X(t)mU/kg IRI(t)U/mL IIR(t)mU/kg/min FD(/min) (L/kg) X FD Insulin space: θ
59 In vitro 10025mm 250g 13kPa(100mmHg) 15mL 100U/mL mm 150g mm 5060mm 100kHz AC100V50/60Hz 2-35
60 78mm88mm21mm 86 78mm88mm21mm a. in vitro M 136 b
61 8.3.1 () 1993 DCCT(The Diabetes Control and Complications Trial)DCCT HbA1c DCCT HbA1c HbA1c 58 closed-loop QOL 0pen-loop HbA1c 2-37
62 HbA1c, 1 30 () () () 4 () () () mg () 2-38
63 () () 4 4 () () () () 2-39
64 () () () () output 2-40
65
66 2-42
67 2-43
68 Quality of Life Closed-Loop 2-44
69 Closed-Loop Closed-Loop 2-45
70 2-46
71
72 1 QOL QOL NEDO 1 3-1
73 1 S/N 3-2
74 20500mg/dl 500mg/dl 3-3
75 NEDO 1 QOL 3-4
76 NEDO CSII 3-5
77 QOL NEDO 3-6
78 QOL DDS NEDO 2 3-7
79 50mg/dl
80 50mg/dl
81 1.6m
82 22.5m 3-11
83 3-12
84 3-13
85 2.1 (1).m S/N 3-14
86 22.5m 3-15
87 (2) 1 S/N l S/N QOL 3-16
88 3-17
89 (3) QOL
90 2.2 (1) CSII MiniMed 3-19
91 3-20
92 (2) 3-21
93 (3)
94
95 (1) 4-1
96 4-2
97 2.7 B B A A A A A 1.1 C C C C C C B 1.1 D C C C C B B 0.4 D D D D C C C 4-3
98 1 2 3 (4) 4-4
99 評価項目 評点 評価に当たっての考慮事項 評価 ( 委員限り ) 事業の目的 政策的位置付け [ A B C D ] 非常に重要 A NEDO の事業としての妥当性 [ a b c d ] 重要 B 事業目的 政策的位置付けの妥当性 [ a b c d ] 概ね妥当 C 妥当性がない又は失われた D 研究開発マネージメント [ A B C D ] 非常によい A 研究開発目標の妥当性 [ a b c d ] よい B 研究開発計画の妥当性 [ a b c d ] 概ね適切 C 研究開発実施者の事業体制の妥当性 [ a b c d ] 適切とはいえない D 研究開発実施者の運営の妥当性 [ a b c d ] 研究開発成果 [ A B C D ] 情勢変化への運営の妥当性 [ a b c d ] 非常によい A 計画と比較した目標の達成度 [ a b c d ] よい B 要素技術から見た成果の意義 [ a b c d ] 概ね妥当 C 成果の普及広報 [ a b c d ] 妥当とはいえない D 成果の公共性 [ a b c d ] 実用化 事業化の見通し [ A B C D ] 明確に実用可能なプランあり A 成果の実用化可能性 [ a b c d ] 実現可能なプランあり B 波及効果 [ a b c d ] 概ね実現可能なプランあり C 事業化までのシナリオ [ a b c d ] 見通しが不明 D 4-5
100
101 NEDO 1 2
102 3 NEDO 4
103 5 6
104
105 9 10
106 11 NEDO H H 12
107 < > (11:0012:00)
108 ( )
109 CSII DCCT Study) ( Study)
110 NEDO mg/dl ( ) ( ) 14 10%
111 NEDO H14 NEDO H12fy H13fy H14fy H15fy H16fy (H12.4) ( ( ) ( ) ) IIR FD X
112
113 3 ID0.2mm OD0.9mm X X SUS (QCM,agitate ) in vitro
114 - 2010)
115
116 . NEDO. NEDO 10% /36)
117 mg/dL 5 200mg/dL. NEDO 100mg/dL 20mg/dL NEDO NEDO 10mg/dL. NEDO
118 1 Study (The Diabetes Control and Complications Trial) : 27 HbA1c (%) %
119 HbA c DCCT
120 (mu/ml) (mg/100ml) (0.05U/kg) (0.05U/kg) (0.05U/kg) (0.05U/kg) QOL
121 (%) HbA1c 5.8 (4.35.8%) 4.3 (C Lalli, et al. Diabetes Care 22(3): , 1999) open-loop
122 1 Open-loop 1 Closed-loopOpen-loop Open-loop Closed-loop
123 Closed-loop QOL 1
124
125 < > < >
126 . QOL Medtronic MiniMed 2007 Basal Bolus BasalBolus 12 Bolus - (/1100U ) - /1100 Basal /h** BasalBolus /h* * 400U/mL) ** 100U/mL STG mL/h 0900mL/h
127 ( ) ( ) (. (CSII) MEMS 16 Pjt IC
128 MEMS 40 MEMS IC ( 70x18 100x25
129 STG-22 STG-22 QOL H
130 .
131 . MEMS
132 STG-22
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140 1 2
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143 7 CSII
144 9 10 p
145 11 or 12
146 Long-Term Glucose Sensor 2000mg/dl Long-Term Glucose Sensor 13 Long-Term Implantable Optical Blood Glucose Monitor Web 14
147 15 (
148 DIASENSOR DIASENSOR mg/dl 17 closed-loop ADICOL ADvanced Insulin Infusion using a COntrol Loop) EC closed-loop or 18
149 Medtronic MiniMed 2007Medtronic MiniMed (Aventis InfusaidModel 100 SiemensPromedos ID3 100U,50U 19 EVADIAC ( Diabetes Care Mar;18(3): MiniMed( Infusaid( Promedos( 20
150 21 open-loop MiniMed Medical Research Group(MRG) open loop Long-Term Glucose Sensor (LTGS) MiniMed closed-loop p
151 CGMS; GlucoWatch DIASENSOR LTGS; Animas MiniMed closed-loop ADICOL 23
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1 6-1 ... 1......................... 4.1.......................................... -ii- 0 概要 制度名 産業科学技術研究開発制度 事業名 医療福祉機器技術研究開発 事業の概要 連続的に測定された血糖値をもとに Closed Loop 制御 でインスリンを門脈に注入することで 厳格な血糖値管 理を行いうる体内埋込み型人工膵臓の実現をめざし
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