統(tǒng)、互聯(lián)網(wǎng)和部件及功能實(shí)現(xiàn)并和其 一起利用。
[0227] 圖12示出可使用網(wǎng)絡(luò)、或網(wǎng)絡(luò)或計(jì)算機(jī)的部分實(shí)現(xiàn)本發(fā)明的一個(gè)或多個(gè)實(shí)施例 的系統(tǒng)。但本發(fā)明葡萄糖裝置可在無(wú)網(wǎng)絡(luò)的情況下操作。
[0228] 圖12概略地示出可在其中實(shí)現(xiàn)本發(fā)明實(shí)例的示例性系統(tǒng)。在一個(gè)實(shí)施例中,葡萄 糖監(jiān)測(cè)器可由本地在家或其他所需位置的受檢者(或患者)實(shí)現(xiàn)。然而,在另選的實(shí)施例 中,葡萄糖監(jiān)測(cè)器可在診所環(huán)境或輔助環(huán)境中實(shí)現(xiàn)。例如,參考圖12,診所機(jī)構(gòu)158提供用 于醫(yī)生(例如164)或臨床醫(yī)生/助手診斷患有與葡萄糖相關(guān)的疾病和相關(guān)疾病與病癥的 患者(例如159)的地方。葡萄糖監(jiān)測(cè)裝置10可用于監(jiān)測(cè)和/或測(cè)試患者的葡萄糖水平一 作為獨(dú)立式裝置。應(yīng)理解,盡管圖中僅示出葡萄糖監(jiān)測(cè)器裝置10,但本發(fā)明的系統(tǒng)和其任 何部件可以圖12中描繪的方式使用。該系統(tǒng)或部件可按需要或按要求附連到患者,或與患 者通信。例如,該系統(tǒng)或其部件的組合一包括葡萄糖監(jiān)測(cè)器裝置10 (或其他相關(guān)裝置或系 統(tǒng),諸如控制器,和/或胰島素栗,或任何其他所需要或要求的裝置或部件)一可通過(guò)帶材 或管材(或其他醫(yī)療器械或部件)接觸、通信或附連到患者,或可通過(guò)有線或無(wú)線連接進(jìn)行 通信。此類(lèi)監(jiān)測(cè)和/或測(cè)試可以是短期的(例如臨床訪視)或長(zhǎng)期的(例如臨床住院或在 家)。葡萄糖監(jiān)測(cè)裝置輸出可由醫(yī)生(臨床醫(yī)生或助手)使用而采取適當(dāng)動(dòng)作,諸如對(duì)患者 進(jìn)行胰島素注射或喂食,或其他適當(dāng)動(dòng)作或建模。另選地,葡萄糖監(jiān)測(cè)裝置輸出可傳送到計(jì) 算機(jī)終端168,用于即時(shí)或未來(lái)分析。該傳送可通過(guò)纜線或無(wú)線或任何其他合適的介質(zhì)進(jìn) 行。來(lái)自患者的葡萄糖監(jiān)測(cè)裝置輸出還可傳送到便攜式裝置,諸如PDA 166。具有改善的準(zhǔn) 確度的葡萄糖監(jiān)測(cè)裝置輸出可傳送到葡萄糖監(jiān)測(cè)中心172,用于處理和/或分析。此類(lèi)傳送 可以通過(guò)許多方式完成,諸如網(wǎng)絡(luò)連接170,該網(wǎng)絡(luò)連接可以是有線的或無(wú)線的。
[0229] 除葡萄糖監(jiān)測(cè)裝置輸出之外,誤差、用于準(zhǔn)確度改善的參數(shù)和任何準(zhǔn)確度相關(guān)信 息都可傳送到例如計(jì)算機(jī)168和/或葡萄糖監(jiān)測(cè)中心172,用于執(zhí)行誤差分析。這樣可為葡 萄糖中心提供集中化的準(zhǔn)確度監(jiān)測(cè)、建模和/或準(zhǔn)確度增強(qiáng),這歸因于葡萄糖傳感器的重 要性。
[0230] 本發(fā)明的實(shí)例還可在與目標(biāo)葡萄糖監(jiān)測(cè)裝置相關(guān)聯(lián)的獨(dú)立式計(jì)算裝置中實(shí)現(xiàn)。圖 IOA中示意性地示出可在其中實(shí)現(xiàn)本發(fā)明的實(shí)例的一種示例性計(jì)算裝置(或其部分)。
[0231] 參考f獻(xiàn)
[0232] 如以下所列舉并貫穿本文檔的以下專(zhuān)利、申請(qǐng)和出版物據(jù)此全文以引用方式并 入,并且不因?yàn)樗鼈儼ㄔ诒竟?jié)中而認(rèn)為是關(guān)于本發(fā)明的現(xiàn)有技術(shù)。
[0233] I. Rahbar S,Blumenfeld 0, Ranney HM. Studies of an unusual hemoglobin in patients with diabetes mellitus. Biochem Biophys Res Commun. 1969 ;36:838-43.
[0234] 2.The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 ;329:977-86.
[0235] 3. UK Prospective Diabetes Study (UKPDS)Group.Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type2 diabetes(UKPDS 33). The Lancet. 1998 ;352:837-53.
[0236] 4. Manley, Susan. Haemoglobin Ale-A marker for complications of type2 diabetes:The experience from the UK Prospective Diabetes Study(UKPDS), Clinical Chemistry and Laboratory Medicine 200341:9(1182-1190).
[0237] 5.Rohlfing CL,Wiedmeyer H,Little RR,England JD American Diabetes Association:Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 2010 ;33(Suppl. I) :S62-S69.
[0238] 6. ADA Standards of Care 2011 ;Diabetes Care, Volume 34, SupplementI,January 2011,S11-S6L
[0239] 7. Nathan, D M. , Kuenenj Jj Borg, Rj Zheng, Hj Schoenfeldj Dj Heine, R J. , Lor The Ale-Derived Average Glucose (ADAG) Study Group. Translating the AlC Assay Into Estimated Average Glucose Values Diabetes Care 31:1473-1478,2008.
[0240] 8. Makrisj Konstantinos ;Spanou, L. ;Rambaouni-Antoneli, A.; Koniari,Katerina ;Drakopoulos,Ioannis ;Rizos,Demetrios A. ;Haliassos, Alexander. Relationship between mean blood glucose and glycated hemoglobin in Type 2 diabetic patients Diabetic Medicine 200825:2(174-178).
[0241] 9. Temschj Wilhelm; Lugerj Anton F. ;Riedl,Michaela. HbAlc values calculated from blood glucose levels using truncated Fourier series and implementation in standard SQL database language. Methods of Information in Medicine 200847:4(346-355).
[0242] 10. Polneauj S. V. ;Lasserre,V. ;Fonfrede, M. ;Delattre, J. ;Benazeth, S. A different approach to analyzing age-related HbAlc values in non-diabetic subjects. Clinical Chemistry and Laboratory Medicine 200442:4 (423-428).
[0243] 11. Nowickaj Paulina ;Santoro, Nicola ;Liu, Haibei ;Lartaud, Derek ; Shaw, Melissa M. ;Goldberg, Rachel ;Guandalini, Cindy ;Savoye, Mary ;Rose, Paulina ; Caprioj Sonia. Utility of hemoglobin Ale for diagnosing prediabetes and diabetes in obese Children and adolescents. Diabetes Care 201134:6 (1306-1311).
[0244] 12. Hamren,Bengt ;Bjork,E. ;Sunzel,M. ;Karlsson,Mats 0· Models for plasma glucose, HbAlcj and hemoglobin interrelationships in patients with type 2diabetes following tesaglitazar treatment. Clinical Pharmacology and Therapeutics 200884:2 (228-235).
[0245] 13. Heislerj Michele M. ;Piette, John D. ;Spencer, Michael S. ;Kieffer, Edie ; Vijanj Sandeep.The relationship between knowledge of recent HbAlc values and diabetes care understanding and self-management.Diabetes Care 200528:4(816-822).
[0246] 14. Landgrafj Rudiger. The relationship of postprandial glucose to HbAlc. Diabetes Metab Res Rev 200420:SUPPL 2(S9-S12).
[0247] 15. Yamamoto-Hondaj Ritsuko ;Kitazato, Hiroji ;Hashimoto, Shinij ; TakahashijYoshihiko ;YoshidajYoko ;Hasegawa, Chiyoko ;Akanuma,Yasuo ; Noda,Mitsuhiko. Distribution of blood glucose and the correlation between blood glucose and hemoglobin Ale levels in diabetic outpatients. Endocrine Journal 200855:5(913-923).
[0248] 16. Goldstein DE,Little RR,Lorenz RA等人,Tests of glycemia in diabetes. Diabetes Care. 2004 ;27:1761-73.
[0249] 17.Trevino, G. On Ale and its dependence on PG level. Diabetes Research and Clinical Practice 200673:1(111-112).
[0250] 18. Trevino,G.On the weighted-average relationship between plasma glucose and HbAlc. Diabetes Care 200618:2(466-467).
[0251] 19. Trevino, G. A nonlinear relation between glucose and Ale. Diabetes Research and Clinical Practice 200879:3 (el4).
[0252] 20. Zielkej Roland ;Henrichs, H. R. Use of the HbAlc determination as long-term parameter in diabetes control. Klinisches Labor 199339:12 (988-990).
[0253] 21. Ollertonj R. L. ;Luzio, S. D. ;0wens, D. R. Contribution of fasting and postprandial plasma glucose to HbA(Ic)Diabetic Medicine 200522:7 (954-955.
[0254] 22. Osterman-Golkarj S. M. ;Vesper, H. ff. Assessment of the relationship between glucose and Ale using kinetic modelling. Journal of Diabetes and its Complications 200620:5 (285-294).
[0255] 23.Kahromj M. An innovative mathematical model: A key to the riddle of HbAlc. International Journal of Endocrinology 2010Article Number481326.
[0256] 24. Kovatchevj B. P. ;Cox, D. J. ;Straume, M. ;Farhy, L. S. Association of selfmonitoring blood glucose profiles with glycolysated hemoglobin in patients with insulin-dependent diabetes. Methods in Enzymology 2000321 (410-417)
[0257] 25. Kovatchev BPjStraume MjCox DJjFarhy LS. Risk analysis of blood glucose data:A quantitative approach to optimizing the control of insulin dependent diabetes. J of Theoretical Medicine, 3:1-10, 2001.
[0258] 26. Kovatchev BPj Cox DJ. Numerical Estimation of HbAic from Routine Self-Monitoring Data in People With Type land Type 2Diabetes Mellitus(2004). In:Methods in Enzymology,384:Numerical Computer Methods. Part E:94-106. M Johnson 和 L Brand 編輯,Academic Press,NY. ISBN: 978-0-12-182789-2.
[0259] 27. Kovatchev BPj Cox DJj Kumar A, Gonder-Frederick LA, Clarke WL (2003). Algorithmic Evaluation of Metabolic Control and Risk of Severe Hypoglycemia in Type land Type 2Diabetes Using Self-Monitoring Blood Glucose (SMBG) Data. Diabetes Technology and Therapeutics. 5(5):817-828.
[0260] 28. Kovatchev BPjOtto EjCox DjGonder-Frederick LjClarke ff. Evaluation of a new measure of blood glucose variability in diabetes. Diabetes Care. 2006年 11 月;29(11) :2433-8.
[0261] 29. Kovatchev BPjMendosa PjAnderson SjHawley JSjRitterband LMj Gonder-Frederick L.Effect of automated bio-behavioral feedback on the control of type ldiabetes. Diabetes Care.2011 年 2 月;34(2):302-7. Epub 2011 年 I 月7日。
[0262] 30. Clarke WLj Cox Dj Gonder-Frederick LA, Carter Wj Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987 ; 10 (5) :622-8.
[0263] 31. Parkes JL,Slatin SL,Pardo Sj Ginsberg BH. A new consensus error grid to evaluate the clinical signifcance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000 ;23 (8):1143-8.
[0264] 32. Kovatchev BPjGonder-Frederick LAjCox DJjClarke WL. Evaluating the accuracy of continuous glucose-monitoring sensors:continuous gluc