臺灣博碩士論文加值系統

現今市面上大多血糖機內部軟體都有撰寫溫度補償之方程式，其中一種補償方法是粗略的在環境溫度每降低或升高2℃時，對血糖濃度進行±1%的調整，雖然可以大略估算，但是可能還會受到許多外在因素影響，因此本研究旨在探討整個血糖監控系統受環境溫度所造成之影響，特別是包括血糖機、血糖試片、血液溫度及血液來源等因素。
本研究係以自製環境溫度手套箱作環境溫度下模擬血糖量測，血糖監控系統是以市售羅氏優勝血糖機與血糖試片進行血糖量測，並將整個量測實驗分為(1)血糖試片、血糖機、靜脈血皆保溫(2)血糖試片、靜脈血保溫，血糖機25℃常溫(3)血糖機、靜脈血保溫，血糖試片25℃常溫(4)血糖機、血糖試片、靜脈血皆25℃常溫等參數進行實驗，預保溫之裝置會置入手套箱內靜置待溫度平衡後(1hr)進行血糖量測，量測結束後取出箱內保溫血液樣本進行YSI 2300及YSI 2700第三方儀器血糖濃度確認，並依YSI所測得血糖濃度為基準與羅氏血糖監控系統測出讀值做比較。
研究結果發現當使用新鮮靜脈血進行血糖量測，全保溫偏離YSI之偏差百分比最大，且血糖試片受溫度影響大於血糖機，且在高溫時有最大誤差高達-20.1%的偏離YSI之偏差百分比，而當使用冷藏靜脈血量測時，也是在全保溫偏離YSI之偏差百分比最大，且一樣血糖試片受溫度影響大於血糖機，且在高溫時有最大誤差高達-33.3%的偏離YSI之偏差百分比，且冷藏靜脈血誤差皆大於新鮮靜脈血。
本論文已進一步探討血糖監控系統對環境溫度之相對影響，探討血糖機與血糖試片各別受環境溫度影響之相對關係，以及新鮮靜脈血測得讀值相較於冷藏靜脈血穩定，因此建議實驗時，應選用細胞還未死亡的新鮮靜脈血進行血糖監控系統實驗，且應在常溫下進行實驗，以免不完善的溫度補償系統導致實驗上的誤差。

Most glucose meters on the market now are equipped with software programmed for temperature compensation. One of the compensation mechanisms is to adjust the blood glucose level by ±1% when the ambient temperature decreases or increases by roughly 2℃. Despite the rough estimation, the result can be affected by numerous external factors. The purpose of the study is to investigate the impact of ambient temperature on the overall glucose monitoring system, especially glucose meters, glucose test strips, blood temperature and source of the blood.
The study utilized a custom-made ambient temperature glove compartment for simulation of glucose measurement under ambient temperatures. For the glucose meter system, we used commercial Accu-Check Performa (Roche) and glucose test strips. The entire experiment was divided into the following parameters: (1) glucose test strips, Accu-Check Performa, venous blood at warm temperature (2) glucose test strips, venous blood at warm temperature and Accu-Check Performa at 25℃ room temperature (3) Accu-Check Performa, venous blood at warm temperature, glucose test strips at 25℃ room temperature (4) glucose test strips, Accu-Check Performa, venous blood at 25℃ room temperature. Pre-warmed devices were placed in the glove compartment until reaching the desired temperature (1hr) before taking measurements. After the measurements have been taken, warm blood samples were removed from the compartment and glucose levels were measured by the third-party devices YSI 2300 and YSI 2700 for confirmation. Readings of YSI were compared with those of Accu-Check (Roche).
The study result showed when using fresh venous blood for the glucose measurement, the group with warm devices had the largest percent deviation from the YSI readings. The temperature impact was greater on glucose test strips than glucose meters. At higher temperatures, the maximum percent deviation from YSI was up to -20.1%. When using refrigerated venous blood for glucose measurement, the group with warm devices also had the largest percent deviation from the YSI readings with greater impact on the glucose test strips than glucose meter. At a higher temperature, the maximum YSI percent deviation was up to -33.3%. All deviations of refrigerated venous blood were greater than those of fresh blood.
The study further investigated the relative impact of glucose monitoring system on ambient temperature and the relative correlation between glucose meter vs. ambient temperature and glucose test strips vs. ambient temperature. As readings from fresh venous blood were more stable than those from refrigerated venous blood, it is advised to use fresh venous blood with live cells for experiments of the glucose monitoring system. The experiment should also be performed at room temperature to avoid experimental deviations due to incomplete temperature compensation system.

目 錄

摘 要 i
ABSTRACT iii
誌 謝 v
目 錄 vi
表目錄 ix
圖目錄 xi
第一章 緒論 1
1.1 研究背景 1
1.2 糖尿病 2
1.3 論文架構 4
第二章 文獻探討 5
2.1 文獻回顧 5
2.2 文獻總結 14
2.3 研究動機與目的 15
第三章 研究方法 16
3.1 實驗樣品與設備 16
3.1.1 靜脈血 16
3.1.2 YSI 2300葡萄糖檢測儀 16
3.1.3 血糖機 17
3.1.4 血糖試片 19
3.1.5滾氧機 19
3.1.6環境溫度手套箱 20
3.2 實驗流程與方法 21
3.2.1實驗流程圖 21
3.2.2 血液樣本配置 27
3.2.3 全保溫血糖量測 28
3.2.4單獨保溫血糖試片及血液量測 28
3.2.5單獨保溫血糖機及血液量測 29
第四章 研究結果與討論 30
4.1新鮮靜脈血 30
4.1.1新鮮靜脈血不同環境溫度量測結果 30
4.1.2 新鮮靜脈血各溫度血糖讀值偏離YSI之偏差百分比 38
4.1.3環境溫度對新鮮靜脈血血糖濃度之影響趨勢 40
4.1.4新鮮靜脈血探討 43
4.2冷藏靜脈血 44
4.2.1冷藏靜脈血不同環境溫度量測結果 44
4.2.2冷藏靜脈血各溫度血糖讀值偏離YSI之偏差百分比 51
4.2.3環境溫度對冷藏靜脈血血糖濃度之影響趨勢 54
4.2.4冷藏靜脈血探討 57
4.3新鮮靜脈血與冷藏靜脈血測量之差異結果 58
4.3.1新鮮靜脈血與冷藏靜脈血全保溫之比較 58
4.3.2新鮮靜脈血與冷藏靜脈血單獨保溫血糖試片及血液之比較 62
4.3.3新鮮靜脈血與冷藏靜脈血單獨保溫血糖機及血液之比較 67
4.3.4新鮮靜脈血與冷藏靜脈血測量之差異探討 72
第五章 結論與未來展望 74
5.1 結論 74
5.2 未來展望 75
參考文獻 76

參考文獻
[1] Y. Shi and F.B. Hu, “The global implications of diabetes and cancer,” The Lancet, vol. 383, 2014, pp. 1947-1948.
[2] J.D. Newman and A.P. Turner, “Home blood glucose biosensors: a commercial perspective,” Biosensors and Bioelectronics, 2005, pp. 2435-2453.
[3] A. Nassar, R. Childs, M. Boyle and K. jameson“Diabetes in the Desert: What Do Patients Know about the Heat?,” Journal of Diabetes Science and Technology, vol.4,2010 ,pp.1156-1163.
[4] G. Cembrowsk and B. Smith “Increases in Whole Blood Glucose Measurements Using Optically Based Self-Monitoring of Blood Glucose Analyzers Due to Extreme Canadian Winters,” Journal of Diabetes Science and Technology, vol.3,2009,pp.661-667.
[5] H. Ishii and H. Suzuki,“Seasonal Variation of Glycemic Control in Type 2 Diabetic Patients,” DIABETES CARE , vol. 24 , 2001,pp.1503.
[6] S. Deakin and D. Steele “Cook and Chill: Effect of Temperature on the Performance of Nonequilibrated Blood Glucose Meters,” Journal of Diabetes Science and Technology, Vol. 9 ,2015,pp.1260-1269.
[7] 楊旭平，糖尿病的認識與防治 (http://www.n.mart.com.tw/docs/a18.htm)
[8] 李佳欣，判定糖尿病的３個重要指標！
(http://www.commonhealth.com.tw/article/article.action?nid=68429)
[9] 蘇景傑、羅福松，年輕糖尿病的診斷、分類及流行病學趨勢
(https://www1.cgmh.org.tw/chldhos/intr/c4a60/index.files/pteducation%20files/DM/etiologydiag/Young%20DM%20patient.htm)
[10] Health 2 Sync，糖尿病的常見症狀與預防
(https://www.health2sync.com/blog/post/20180326/to.know.diabetes/)
[11] World Health Organization, “Definition, diagnosis and classification of diabetes mellitus and its complications Part 1 : diagnosis and classification of diabete mellitus,” Geneva, 1999.
[12] JM. King, CA. Eiqenmann and S. Colaqiuri, “Effect of ambient temperature and humidity on performance of blood glucose meters,” Diabetic Medicine : a Journal of the British Diabetic Association, vol. 12, 1995, pp. 337-340.
[13] Y. Gonzales, IS. Kampa, “The effect of various storage environments on reagent strips,” Laboratory Medicine, vol. 28, 1997, pp. 135-137.
[14] D. Öberg, CG. Östenson, “Performance of glucose dehydrogenase-and glucose oxidase-based blood glucose meters at high altitude and low temperature,”Diabetes Care, vol. 28, 2005, pp. 1261.
[15] MJ. Haller, JJ. Shuster, D. Schatz and RJ. Melker, “Adverse impact of temperature and humidity on blood glucose monitoring reliability : a pilot study,”Diabetes Technology & Therapeutics, vol. 9, 2007, pp. 1-9.
[16] RF. Louie, SL. Sumner, S. Belcher, R. Mathew, NK. Tran and GJ. Kost, “Thermal stress and point-of-care testing performance : suitability of glucose test strips and blood gas cartridges for disaster response,” Disaster Medicine and Public Health Preparedness, vol. 3, 2009, pp. 13-17.
[17] K. Nerhus, P. Rustad and S. Sandberg, “Effect of ambient temperature on analytical performance of self-monitoring blood glucose systems,” Diabete Technology & Therapeutics, vol. 13, 2011, pp. 883-892.
[18] S. Kinchiku,K. Kotani and S. Kajiya,“Influence of ambient temperature on the correlation between self-monitoring of blood glucose and plasma glucose values in diabetes management,”J PRIM HEALTH CARE,vol. 4,2012,pp.294-298.

[19] M. Lam, RF. Louie, CM. Curtis, WJ. Ferguson, JH. Vy, AT. Truong, SL. Sumner and GJ. Kost, “Short-term thermal.humidity shock affects point-of-care glucose testing : implications for health professionals and patients,” Journal of Diaberes Science and Technology, vol. 8, 2014, pp. 83-88.
[20] B. Pratumvinit ,N. Charoenkoop and S. Niwattisaiwong “The Effects of Temperature and Relative Humidity on Point-of-Care Glucose Measurements in Hospital Practice in a Tropical Clinical Setting,” Journal of Diabetes Science and Technology, vol .10,2016,pp.1094-1100.