Using Delphi method to preliminarily perfect the comprehensive evaluation index system of food for special medical purposes designed for type 2 diabetes mellitus patients_Chinese Journal of Evidence-Based Medicine

Authors：

SHI Lei ¹ , MU Dongyu ¹ , GONG Jie ¹ , RAO Zhiyong ¹ , LIU Yuan ¹ , YU Jiajie ² ,  HU Wen ¹ , LI Youping ²

1. Department of Clinical Nutrition, West China Hospital of Sichuan University, Chengdu 610041, P.R.China;
2. Center of Chinese Evidence-Based Medicine, West China Hospital of Sichuan University, Chengdu 610041, P.R.China;

Corresponding?author：

HU Wen, Email: 983156803@qq.com

Keywords：

Delphi method; Expert consultation method; food for special medical purposes (FSMP); Index system; Clinical trial

DOI：

10.7507/1672-2531.201905114

Video：

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Objectives To use the Delphi method to preliminarily perfect the comprehensive evaluation index system which had been initially constructed by systematic review processes of diabetes food for special medical purposes (FSMP).Methods Three rounds of expert consultation by Delphi method were compared to define indices held in the evidence-based comprehensive evaluation index system of diabetes FSMP and ways to distinguish effects.Results The preliminary perfect index system after 3 rounds of expert consultation contained 4 primary directory indicators, 15 secondary directory indicators, and 20 tertiary indicators. Among them, the end index which could directly be used for evaluation contained a total of 27 indicators.Conclusions The index system is categorized into 4 segments of parameters, which are medical, nutritional, safety and other indices, which has addressed the problem posed by CFDA documents on how to scientifically validate the medical effect and safety of FSMP. It provides great significance to assess and supervise FSMP prior to and after it goes to public, assess characteristics and advantages of MNT, and improves nutrition economy and its social benefits.

Citation： SHI Lei, MU Dongyu, GONG Jie, RAO Zhiyong, LIU Yuan, YU Jiajie, HU Wen, LI Youping. Using Delphi method to preliminarily perfect the comprehensive evaluation index system of food for special medical purposes designed for type 2 diabetes mellitus patients. Chinese Journal of Evidence-Based Medicine, 2020, 20(9): 1012-1019. doi: 10.7507/1672-2531.201905114 Copy

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2.	Hofman Z, Lansink M, Rouws C, et al. Diabetes specific tube feed results in improved glycaemic and triglyceridaemic control during 6h continuous feeding in diabetes patients. Eur J Clin Nutr, 2007, 2(2): 44-50.
3.	Pohl M, Mayr P, Mertl-Roetzer M, et al. Glycaemic control in type II diabetic tube-fed patients with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids: a randomised controlled trial. Eur J Clin Nutr, 2005, 59(11): 1221-1232.
4.	León-Sanz M, García-Luna PP, Sanz-París A, et al. Glycemic and lipid control in hospitalized type 2 diabetic patients: evaluation of 2 enteral nutrition formulas (low carbohydrate-high monounsaturated fat vs. high carbohydrate). JPEN J Parenter Enteral Nutr, 2005, 29(1): 21-29.
5.	Pohl M, Mayr P, Mertl-Roetzer M, et al. Glycemic control in patients with type 2 diabetes mellitus with a disease-specific enteral formula: stage II of a randomized, controlled multicenter trial. JPEN J Parenter Enteral Nutr, 2009, 33(1): 37-49.
6.	Vaisman N, Lansink M, Rouws CH, et al. Tube feeding with a diabetes-specific feed for 12 weeks improves glycaemic control in type 2 diabetes patients. Clin Nutr, 2009, 28(5): 549-555.
7.	Craig LD, Nicholson S, SilVerstone FA, et al. Use of a reduced-carbohydrate, modified-fat enteral formula for improving metabolic control and clinical outcomes in long-term care residents with type 2 diabetes: results of a pilot trial. Nutrition, 1998, 14(6): 529-534.
8.	蘇怡靜, 鄭均源, 陳巧明, 等. 白甘薯 TNG-10 特醫食品的開發與降血糖效益之研究. 浙江溫州: 中國營養學會第十次特殊營養學術會議, 2017.
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13.	陳秋菊, 唐梅, 易昌華, 等. 老年 2 型糖尿病患者腸內營養支持 28 例. 中國老年學雜志, 2012, 32(13): 2865-2866.
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21.	McCargar LJ, Innis SM, Bowron E, et al. Effect of enteral nutritional products differing in carbohydrate and fat on indices of carbohydrate and lipid metabolism in patients with NIDDM. Mol Cell Biochem, 1998, 188(1-2): 81-89.
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27.	Sanz-París A, Calvo L, Guallard A, et al. High-fat versus high-carbohydrate enteral formulae: effect on blood glucose, C-peptide, and ketones in patients with type 2 diabetes treated with insulin or sulfonylurea. Nutrition, 1998, 14(11-12): 840-845.
28.	Mottalib A, Mohd-Yusof BN, Shehabeldin M, et al. Impact of diabetes-specific nutritional formulas versus oatmeal on postprandial glucose, insulin, GLP-1 and postprandial lipidemia. Nutrients, 2016, 8(7): E443.
29.	Magnoni D, Rouws CH, Lansink M, et al. Long-term use of a diabetes-specific oral nutritional supplement results in a low-postprandial glucose response in diabetes patients. Diabetes Res Clin Pract, 2008, 80(1): 75-82.
30.	Lansink M, van Laere KM, Vendrig L, et al. Lower postprandial glucose responses at baseline and after 4 weeks use of a diabetes-specific formula in diabetes type 2 patients. Diabetes Res Clin Pract, 2011, 93(3): 421-429.
31.	Printz H, Recke B, Fehmann HC, et al. No apparent benefit of liquid formula diet in NIDDM. Exp Clin Endocrinol Diabetes, 1997, 105(3): 134-139.
32.	Lean ME, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet, 2018, 391(10120): 541-551.
33.	Vanschoonbeek K, Lansink M, van Laere KM, et al. Slowly digestible carbohydrate sources can be used to attenuate the postprandial glycemic response to the ingestion of diabetes-specific enteral formulas. Diabetes Educ, 2009, 35(4): 631-640.
34.	Buranapin S, Siangruangsang S, Chantapanich V, et al. The comparative study of diabetic specific formula and standard formula on postprandial plasma glucose control in type 2 DM patients. J Med Assoc Thai, 2014, 97(6): 582-588.
35.	Hofman Z, van Drunen JD, de Later C, et al. The effect of different nutritional feeds on the postprandial glucose response in healthy volunteers and patients with type II diabetes. Eur J Clin Nutr, 2004, 58(11): 1553-1556.
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37.	孫玲, 帥水云, 胡香英, 等. 低血糖指數醫用食品用于 2 型糖尿病營養治療的效果. 中國當代醫藥, 2017, 24(23): 49-51.
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1. Ceriello A, Lansink M, Rouws CH, et al. Administration of a new diabetes-specific enteral formula results in an improved 24h glucose profile in type 2 diabetic patients. Diabetes Res Clin Pract, 2009, 84(3): 259-266.
2. Hofman Z, Lansink M, Rouws C, et al. Diabetes specific tube feed results in improved glycaemic and triglyceridaemic control during 6h continuous feeding in diabetes patients. Eur J Clin Nutr, 2007, 2(2): 44-50.
3. Pohl M, Mayr P, Mertl-Roetzer M, et al. Glycaemic control in type II diabetic tube-fed patients with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids: a randomised controlled trial. Eur J Clin Nutr, 2005, 59(11): 1221-1232.
4. León-Sanz M, García-Luna PP, Sanz-París A, et al. Glycemic and lipid control in hospitalized type 2 diabetic patients: evaluation of 2 enteral nutrition formulas (low carbohydrate-high monounsaturated fat vs. high carbohydrate). JPEN J Parenter Enteral Nutr, 2005, 29(1): 21-29.
5. Pohl M, Mayr P, Mertl-Roetzer M, et al. Glycemic control in patients with type 2 diabetes mellitus with a disease-specific enteral formula: stage II of a randomized, controlled multicenter trial. JPEN J Parenter Enteral Nutr, 2009, 33(1): 37-49.
6. Vaisman N, Lansink M, Rouws CH, et al. Tube feeding with a diabetes-specific feed for 12 weeks improves glycaemic control in type 2 diabetes patients. Clin Nutr, 2009, 28(5): 549-555.
7. Craig LD, Nicholson S, SilVerstone FA, et al. Use of a reduced-carbohydrate, modified-fat enteral formula for improving metabolic control and clinical outcomes in long-term care residents with type 2 diabetes: results of a pilot trial. Nutrition, 1998, 14(6): 529-534.
8. 蘇怡靜, 鄭均源, 陳巧明, 等. 白甘薯 TNG-10 特醫食品的開發與降血糖效益之研究. 浙江溫州: 中國營養學會第十次特殊營養學術會議, 2017.
9. 張媛媛, 張紅, 關健, 等. 比較低 GI 型腸內營養制劑和普通均衡型腸內營養制劑對鼻飼患者血糖控制的影響. 中國實用醫藥, 2016, 11(26): 141-142.
10. 石瑩, 蔡頌文, 盛春君, 等. 低還原糖當量值玉米麥芽糊精用于管飼膳食對 2 型糖尿病血糖及胰島素的影響. 中國臨床營養雜志, 2006, 14(3): 167-170.
11. 李碩, 黃茂濤, 胡利蘋, 等. 低血糖指數型腸內營養制劑對血糖控制的影響. 西南國防醫藥, 2013, 23(6): 635-636.
12. 施萬英, 徐甲芬, 藺淑賢, 等. 高單不飽和脂肪酸型腸內營養劑用于 2 型糖尿病. 中國臨床營養雜志, 2004, 12(1): 39-42.
13. 陳秋菊, 唐梅, 易昌華, 等. 老年 2 型糖尿病患者腸內營養支持 28 例. 中國老年學雜志, 2012, 32(13): 2865-2866.
14. 孫玲, 何友花. 探究低血糖指數腸內營養制劑對鼻飼糖尿病患者血糖的影響. 當代醫學, 2018, 24(9): 48-50.
15. Alish CJ, Garvey WT, Maki KC, et al. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther, 2010, 12(6): 419-425.
16. Mayr P, Kuhn KS, Klein P, et al. A diabetes-specific oral nutritional supplement improves glycaemic control in type 2 diabetes patients. Exp Clin Endocrinol Diabetes, 2016, 124(7): 401-409.
17. de Luis DA, Izaola O, de la Fuente B, et al. A randomized clinical trial with two doses of an enteral diabetes-specific suplements in elderly patients with diabetes mellitus type 2. Eur Rev Med Pharmacol Sci, 2013, 17(12): 1626-1630.
18. Sun J, Wang Y, Chen X, et al. An integrated intervention program to control diabetes in overweight Chinese women and men with type 2 diabetes. Asia Pac J Clin Nutr, 2008, 17(3): 514-524.
19. Li YX, Zeng JB, Yu K, et al. Beneficial effects of a diabetes specific formula on insulin sensitivity and free fatty acid in patients with type 2 diabetes mellitus. Chin Med J (Engl), 2008, 121(8): 691-695.
20. Stenvers DJ, Schouten LJ, Jurgens J, et al. Breakfast replacement with a low-glycaemic response liquid formula in patients with type 2 diabetes: a randomised clinical trial. Br J Nutr, 2014, 112(4): 504-512.
21. McCargar LJ, Innis SM, Bowron E, et al. Effect of enteral nutritional products differing in carbohydrate and fat on indices of carbohydrate and lipid metabolism in patients with NIDDM. Mol Cell Biochem, 1998, 188(1-2): 81-89.
22. Voss AC, Maki KC, Garvey WT, et al. Effect of two carbohydrate-modified tube-feeding formulas on metabolic responses in patients with type 2 diabetes. Nutrition, 2008, 24(10): 990-997.
23. Yokoyama J, Someya Y, Yoshihara R, et al. Effects of high-monounsaturated fatty acid enteral formula versus high-carbohydrate enteral formula on plasma glucose concentration and insulin secretion in healthy individuals and diabetic patients. J Int Med Res, 2008, 36(1): 137-146.
24. Gulati S, Misra A, Nanda K, et al. Efficacy and tolerance of a diabetes specific formula in patients with type 2 diabetes mellitus: An open label, randomized, crossover study. Diabetes Metab Syndr, 2015, 9(4): 252-257.
25. Stürmer W, Kramer E, Kasper H, et al. Favourable glycaemic effects of a new balanced liquid diet for enteral nutrition – results of a short-term study in 30 type II diabetic patients. Clin Nutr, 1994, 13(4): 221-227.
26. Laksir H, Lansink M, Regueme SC, et al. Glycaemic response after intake of a high energy, high protein, diabetes-specific formula in older malnourished or at risk of malnutrition type 2 diabetes patients. Clin Nutr, 2018, 37(6 Pt A): 2084-2090.
27. Sanz-París A, Calvo L, Guallard A, et al. High-fat versus high-carbohydrate enteral formulae: effect on blood glucose, C-peptide, and ketones in patients with type 2 diabetes treated with insulin or sulfonylurea. Nutrition, 1998, 14(11-12): 840-845.
28. Mottalib A, Mohd-Yusof BN, Shehabeldin M, et al. Impact of diabetes-specific nutritional formulas versus oatmeal on postprandial glucose, insulin, GLP-1 and postprandial lipidemia. Nutrients, 2016, 8(7): E443.
29. Magnoni D, Rouws CH, Lansink M, et al. Long-term use of a diabetes-specific oral nutritional supplement results in a low-postprandial glucose response in diabetes patients. Diabetes Res Clin Pract, 2008, 80(1): 75-82.
30. Lansink M, van Laere KM, Vendrig L, et al. Lower postprandial glucose responses at baseline and after 4 weeks use of a diabetes-specific formula in diabetes type 2 patients. Diabetes Res Clin Pract, 2011, 93(3): 421-429.
31. Printz H, Recke B, Fehmann HC, et al. No apparent benefit of liquid formula diet in NIDDM. Exp Clin Endocrinol Diabetes, 1997, 105(3): 134-139.
32. Lean ME, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet, 2018, 391(10120): 541-551.
33. Vanschoonbeek K, Lansink M, van Laere KM, et al. Slowly digestible carbohydrate sources can be used to attenuate the postprandial glycemic response to the ingestion of diabetes-specific enteral formulas. Diabetes Educ, 2009, 35(4): 631-640.
34. Buranapin S, Siangruangsang S, Chantapanich V, et al. The comparative study of diabetic specific formula and standard formula on postprandial plasma glucose control in type 2 DM patients. J Med Assoc Thai, 2014, 97(6): 582-588.
35. Hofman Z, van Drunen JD, de Later C, et al. The effect of different nutritional feeds on the postprandial glucose response in healthy volunteers and patients with type II diabetes. Eur J Clin Nutr, 2004, 58(11): 1553-1556.
36. 李玉秀, 潘詩海, 曾靜波, 等. 腸內營養混懸液 (TPF-DM) 對 2 型糖尿病患者血糖、胰島素和血脂的影響. 中華內科雜志, 2007, 46(3): 193-196.
37. 孫玲, 帥水云, 胡香英, 等. 低血糖指數醫用食品用于 2 型糖尿病營養治療的效果. 中國當代醫藥, 2017, 24(23): 49-51.
38. 姜桂花, 王家譜, 萬怡, 等. 分析腸內營養混懸液對 2 型糖尿病患者血糖、胰島素和血脂的影響. 中國醫學創新, 2013, (12): 113-114.
39. 周瑩霞, 陳欽達, 王琴琴, 等. 富含緩釋淀粉的腸內營養乳劑對 2 型糖尿病血糖及胰島素的影響. 上海醫學, 2004, 27(2): 116-118.
40. 吳文俊, 項松英, 沈飛霞, 等. 富含緩釋淀粉高單不飽和脂肪酸型腸內營養制劑對糖耐量異常患者糖脂代謝的影響. 溫州醫科大學學報, 2015, 45(1): 6-9.
41. 胡志庚, 劉宏, 孫靜. 含緩釋淀粉的腸內營養劑對 T2DM 餐后血糖的影響. 中國現代醫生, 2007, 45(17): 16-17, 19.
42. 王姮, 蔣朱明, 袁申元, 等. 含緩釋淀粉的整蛋白型腸內營養劑對臟器功能、血胰島素/血糖曲線下面積及血糖的影響 (120 例隨機, 對照, 多中心臨床研究). 中國臨床營養雜志, 2002, 10(2): 75-78.
43. 陳永春, 陳小梅, 許楨, 等. 含緩釋碳水化合物高單不飽和脂肪酸配方腸內營養制劑對 2 型糖尿病的影響研究. 中國全科醫學, 2012, 15(23): 2643-2645.
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Chinese Journal of Evidence-Based Medicine

Using Delphi method to preliminarily perfect the comprehensive evaluation index system of food for special medical purposes designed for type 2 diabetes mellitus patients

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