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DF-201
是針對糖尿病所設計的一種全面性的綜合型配方，也是可以逆轉糖尿病與併發症的療法。結合了天然類胰島素與重建醣類代謝的機制，協助胰臟恢復正常功能，共同打造一個全新的身體環境。是透過減少、消耗血糖來恢復缺失的細胞能量（ATP）減少因高脂質代謝所造成的損害，讓人體自我更新和自我復原的 DNA 來進行自我療癒。在臨床實驗中，食用 DF-201 1 個月就可以得到驚人的效果，長期食用更可以逆轉糖尿病！
DF-201 is a comprehensive natural food designed for diabetes and a natural remedy for reversing diabetes and its complications. DF-201 combines natural insulin-like and carbohydrate metabolism mechanisms to help restore normal function of the pancreas and work together to create a new body environment.DF-201 reduces the damage caused by high lipid metabolism by lowering and depleting blood sugar to restore the missing (ATP), allowing the body's DNA to heal itself. Take DF-201 to see visible results in just one month and reverse diabetes after a recommended treatment period!
DF-201 逆轉糖尿病設計原理
一、阻止、減少腸道醣類分解與吸收，減輕胰臟負擔，讓胰島 β 細胞有時間修復。
二、可提升胰臟功能，增加胰島素含量、活性，增加敏感度和降低阻抗，能溫和、有效降低血糖值和糖化血色素。
三、完全取代糖尿病藥、胰島素注射劑，避免服藥的各種副作用。
四、有效減少糖尿病併發症產生，徹底改善糖尿病所衍生的各種相關症狀。
DF-201 recovery the design principle of diabetes
1 . Prevent and reduce the decomposition and absorption of intestinal carbohydrates, reduce the burden on the pancreas, and allow time for the islet β cells to repair.
2 . It can improve pancreatic function, increase insulin content, activity, increase sensitivity and reduce impedance. It can mildly and effectively lower blood sugar levels and HbA1c.
3 . It completely replaces diabetes medicines and insulin injections, avoiding various side effects.
4 . Effectively reduce diabetes complications and improve diabetes-related symptoms derived from diabetes.
該動畫描述了胰島素抵抗，這是 2 型糖尿病的根本原因
它解釋了葡萄糖和激素胰島素在我們體內的作用。 審查糖尿病的症狀，以及如果不及時治療 2 型糖尿病可能導致的各種健康並發症。
This animation describes insulin resistance, an underlying cause of type 2 diabetes
It explains the role of glucose and the hormone insulin in our bodies. It examines the symptoms of diabetes and the various health complications that can result if type 2 diabetes is left untreated.
DF-201 is a new type of medical food
with potential to treat diabetes
DF-201 為具潛力治療糖尿病的新型醫療食品
11/11 2021 DF-201 新聞發布會
三軍總醫院攜手基諾華生技共同合作進行人體臨床研究，以第2型糖尿病友為受試者，研究分析有效樣本人數共計42人，採隨機雙盲方式進行，糖化血色素（HbA1c）大於6.5，期中解盲報告證實本項研究運用在糖尿病患者血糖調控及降低糖化血色素（HbA1c）成效良好。
11/11 2021 DF-201 News Conference
The Tri-Service General Hospital and Geninova Biotech, Inc. conducted human clinical research. With type 2 diabetes patients as the subjects. The total number of effective samples for the study and analysis was 42 people. We used a randomized, double-blind method. The glycosylated hemoglobin (HbA1c) was more significant than 6.5. The blinding mid-term report confirmed that this study effectively regulated blood glucose and reduced glycosylated hemoglobin (HbA1c) in diabetic patients.
三軍總醫院人體試驗結案報告摘要
糖尿病位居台灣人民十大死因之一，每年近萬人因糖尿病死亡，根據人民健康署統計，全台灣約有200多萬名糖尿病的病友，且每年以25,000名的速度持續增加，糖尿病及其所引發的並發症影響人民健康不容小覷。
目前糖尿病患者主要以降糖西藥來控制血糖，然而藥物有諸多副作用，且血糖控制效果有個人差異，即便糖尿病患者血糖得到控制，長期服藥仍會引發一連串之並發症，包括視網膜病變、腎病變、糖尿病足、心血管疾病問題等。本次人體臨床試驗為針對確診糖尿病患者在未改變用藥情況並搭配深入衛教支持及輔助產品「DF-201」下， 觀察受試者之血糖調控、糖化血色素(HbA1c) 降低及糖尿病並發症相關症狀改善之效果評估。
臨床研究自2020年6月15日開始至2021年7月21日結束，探分梯次進行，一梯次進行七個月，共歷經一年多的時間，在與基諾華生物科技公司共同努力下，完美的畫上句點。
本次人體臨床試驗研究有效樣本人數共計40人，實驗、對照組各為20人，探隨機雙盲方式進行。年齡50歲以下4人; 50~59歲以上10人; 60~69歲以上17人; 70歲以上患者9人，病史5年以下11人，6~10年8人，11~20年10人，21年以上11人。收案標準為糖化血色素(HbA1c)大於6.5的第2型糖尿病個案。
期間，兩組全程皆接受衛教支持，實驗組在前3個月(調整期)及後3個月(平穩期)搭配食用輔助品「DF-201」，中間1個月(廓清期)僅衛教支持；對照組則是前3個月食用安慰劑，中間1個月(廓清期)僅衛教支持，後3個月期始食用輔助產品「DF-201」。
結論
大多數受試者在研究進行中，因糖化血色素(HbA1c)下降而遵從醫生囑咐減少西藥使用量，這些有力的數據，再再證明了糖尿病在搭配深入衛教支持及輔助食用「DF-201」，營養補充品及進行自主健康管理後，不僅對血糖及糖化血色素能有效地控制，進而對糖尿病所導致的並發症(如腎功能下降)亦能發揮改善效果。
何渭「雙盲測試」?
雙盲試驗中，受試者與研究人員均不知哪些對象分配在實驗組，哪些分配在對照組，只有在資料都經過收集完成及分析之後，研究人員才會知道受試者組別， 即解盲(unblind)。雙盲試驗的目的在於避免受試者與研究人員的主觀偏向影響實驗結果，通常得出的結果會更嚴謹。
Summary of Tri-Service General Hospital's Human Test Closing Report
Diabetes is one of the ten leading causes of death in Taiwan. Nearly 10,000 people die from diabetes each year. According to the statistics of the People’s Health Department, there are more than 2 million people with diabetes in Taiwan, and the number continues to increase at a rate of 25,000 per year. Diabetes and its The resulting complications that affect people’s health should not be underestimated.
At present, diabetic patients mainly use hypoglycemic western medicine to control blood sugar. However, the drugs have many side effects and the effect of blood sugar control varies among individuals. Even if the blood sugar of diabetic patients is controlled, long-term medication will still cause a series of complications, including retinopathy, nephropathy, and diabetes. Foot, cardiovascular disease, etc. This human clinical trial is aimed at observing the subjects’ blood glucose control, glycated hemoglobin (HbA1c) reduction and diabetic complications related symptoms under the condition of unchanged medication and in-depth health education support and auxiliary product "DF-201" for patients with diagnosed diabetes. Evaluation of the effect of improvement.
The clinical research started on June 15th, 2020 and ended on July 21st, 2021.It took seven months in one step, and after a total of more than a year, with the joint efforts of Geninova Biotech, Inc., the perfect ending was drawn.
The total number of valid samples in this human clinical trial study is 40 people, and the test group and control group are 20 people each. The exploration is carried out in a randomized double-blind manner. 4 persons under 50 years old; 10 persons over 50-59 years old; 17 persons over 60-69 years old; 9 persons over 70 years old, 11 persons under 5 years of medical history, 8 persons from 6 to 10 years, 10 persons from 11 to 20 years , 11 people over 21 years. The acceptance criteria are type 2 diabetes cases with glycosylated hemoglobin (HbA1c) greater than 6.5.
During this period, the two groups received health education support throughout the entire process. The experimental group was paired with the food supplement "DF-201" in the first 3 months (adjustment period) and the next 3 months (stationary period), and only health care in the middle 1 month (clearance period) Educational support; the control group took placebo for the first 3 months, only health education support for the middle 1 month (clearance period), and began to consume the supplementary product "DF-201" in the second 3 months.
Conclusion
In the study, most of the subjects followed the doctor's orders to reduce the consumption of western medicine due to the decline of HbA1c. These robust data prove that diabetes received mentoring support with in-depth health education, mental awareness, and supplementary DF-201. Nutritional supplements and independent health management can effectively control blood sugar and HbA1c and improve the complications caused by diabetes.
What is '' Double-blind test '' ?
Neither the subjects nor researchers knew which participant got assigned to the experimental or control group in a double-blind trial only after the researcher collected and analyzed all data. The purpose of double-blind trials is to avoid the subjectivity of participants and researchers that could affect experimental results. Results are usually rigorous in double-blind trials.
糖尿病收治个案糖化血色素控制成果
Results of（HbA1c）control in cases of diabetes
本次人體臨床試驗研究有效樣本人數共計40人，實驗、對照組各為20人，探隨機雙盲方式進行。年齡50歲以下4人; 50~59歲以上10人; 60~69歲以上17人; 70歲以上患者9人，病史5年以下11人，6~10年8人，11~20年10人，21年以上11人。收案標準為糖化血色素(HbA1c)大於6.5的第2型糖尿病個案。
The total number of valid samples in this human clinical trial study is 40 people. The test group and control group are 20 people each. In a double-blind manner. 4 persons under 50 years old; 10 persons over 50-59 years old; 17 persons over 60-69 years old; 9 persons over 70 years old, 11 persons under five years of medical history, eight persons from 6 to 10 years, ten persons from 11 to 20 years, 11 people over 21 years. The acceptance criteria are type 2 diabetes cases with glycosylated hemoglobin (HbA1c) greater than 6.5.
【圖-1】
臨床試驗期間個案糖化血色素比較圖(藍色為試驗組,紅色為對照組)
進行臨床試驗期間，可看出在糖化血色素(HbA1c)的下降趨勢方面，試驗組明顯優於對照組。試驗組在兩個月後，平均糖化血色素(HbA1c)便降低至6.0左右
Comparison chart of glycated hemoglobin of a case during the clinical trial (blue is the test group, red is the control group)
During the clinical trial, you can see that the test group is significantly better than the control group regarding the downward trend of glycated hemoglobin (HbA1c). After two months in the test group, the average glycosylated hemoglobin (HbA1c) decreased to about 6.0
【圖-2】
臨床試驗期間個案空腹血糖比較圖(藍色為試驗組，紅色為對照組)
進行臨床試驗期間，試驗組在1~6個月間的空腹血糖值明顯低於對照組，但在對照組於第5個月開始加入「DF-201」食用後，兩組於第7個月的飯前血糖值(AC)趨於相近。
Comparison chart of individual fasting blood glucose during the clinical trial (blue is the test group, red is the control group)
During the clinical trial, the fasting blood glucose level of the experimental group was significantly lower than that of the control during the 1 to 6 months Group. Still, after adding "DF-201" to the control group at the 5th month, the pre-meal blood glucose (AC) of the two groups at the 7th month tended to be similar.
【圖-3】
對照組的糖化血色素變化
對照組在第5個月開始食用「DF-201」3個月後同樣看到糖化血色(HbA1c)下降，且降低率也高達80%。
Changes of glycosylated hemoglobin in the control group
The control group started taking "DF-201" in the 5th month. After three months, the glycated blood color (HbA1c) also decreased, and the reduction rate was as high as 80%.
【圖-4】
全體受試者糖化血色素變化
兩組分別食用「DF-201」3個月後，高達90%的受試者糖化血色素(HbA1c)皆獲得改善。
Changes of glycosylated hemoglobin in all subjects
After taking "DF-201" for three months in the two groups, up to 90% of the subjects' glycated hemoglobin (HbA1c) improved.
【圖-5】
糖化血色素降低變化人數比對圖
本臨床研究收治個案皆為糖化血色素(HbAlc)>6.5的第2型糖尿病患者。從受試者糖化血色素(HbAlc)下降的趨勢中，可看到經臨床試驗後(HbAlc)<6.5的人數明顯增加；而(HbAlc)>6.5的人數明顯降低。
Comparison chart of the number of people with reduced glycated hemoglobin
The cases treated in this clinical study were all patients with type 2 diabetes (HbAlc)>6.5. From the downward trend of subjects' HbAlc, we can see that after clinical trials, the number of people with (HbAlc)<6.5 increased significantly, while the number of people with (HbAlc)>6.5 decreased significantly.
【圖-6】
腎絲球濾過率(eGFR)改善率
糖尿病患者每年應做「 糖尿病腎病變」的篩檢，腎絲球過濾率預估值(estimateGFR,eGFR)的數值可顯示出腎臟的功能，正常值在100-125 mL/min。參與本臨床試驗的全體受試者，eGFR.7個月的平均數值75%的受試者提升, 僅25%的人下降。
Glomerular filtration rate (eGFR) improvement rate
Diabetic patients should be screened for diabetic nephropathy every year. The estimated value of the glomerular filtration rate (estimateGFR, eGFR) can show the function of the kidney, and the average value is 100-125mL/min. For all subjects participating in this clinical trial, 75% had an average value of eGFR. Seven months increased, and only 25% decreased.
【圖-7】
空腹血糖(AC)下降比例圖
空腹血糖(Glucose AC, mg/dL)指檢測空腹情況下血糖中的葡萄糖含量。空腹血糖正常數值70~99mg/dL;100-125mg/dl之間，屬於糖尿病前期;>126mg/dl即確診糖尿病。參與本臨床試驗的全體受試者，發生空腹血糖(AC)下降的比例高達68%,僅32%未出現改善。
Fasting blood glucose (AC) reduction ratio chart
Fasting blood glucose (Glucose AC, mg/dL) refers to detecting the glucose content in blood sugar under fasting conditions. The typical value of fasting blood glucose is 70~99mg/dL; between 100-125mg/dl, it belongs to pre-diabetes; >126mg/dl is the diagnosis of diabetes. All subjects participating in this clinical trial occurred. The fasting blood glucose (AC) percentage decreased was as high as 68%, and only 32% showed no improvement.
【圖-8】
全體個案體重減輕比例圖
第2型糖尿病患者經常會合餅有肥胖或體重增加、減重不易等問題，因為胰島素阻抗或功能不佳，會讓身體分泌胰島素的數量增加，就容易促進脂肪的合成。參與本臨床試驗的全體受試者，體重減輕者比例高達93%。其中減重3kg以下佔27%;減重3.1~5 kg佔22%;減重5.1~10kg佔35%;減重10.1kg以上佔16%。
Weight loss ratio chart for all cases
Type 2 diabetic patients often suffer from obesity, weight gain, or difficulty in weight loss. Because insulin resistance or poor function will increase the amount of insulin secreted by the body, it is easy to promote fat synthesis. Of all the subjects participating in this clinical trial, the proportion of weight loss was as high as 93%. Among them, a weight loss of less than 3kg accounted for 27%; a weight loss of 3.1~5 kg accounted for 22%; a weight loss of 5.1~10kg accounted for 35%; a weight loss of 10.1kg or more accounted for 16%.
總結
在不影響患者初始治療和用藥的情況下，連續服用三個月的 DF-201 可以有效調節糖尿病患者的 HbA1c 和血糖。
服用 DF-201 三個月後，糖尿病患者的 HbA1c 和血糖在此後一個月的清除期內可以得到穩定的維持和調節。
長期糖尿病患者在服用 DF-201 產品三個月後，餐前血糖往往會下降得更多。
無論受試者的病史如何，DF-201 調節 HbA1c 的能力都不會受到影響。
Summary
Without affecting the patient's initial treatment and medication, taking DF-201 continuously for three months can effectively regulate the HbA1c and blood sugar of diabetic patients.
After taking DF-201 for three months, the HbA1c and blood sugar of diabetic patients can get maintained and regulated stably during the clearance period of one month after that.
Subjects with more prolonged diabetes tend to decrease their blood sugar more before meals after taking DF-201 products for three months.
Regardless of the subject's medical history, DF-201's ability to regulate HbA1c will not get affected.
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