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

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.	苏怡静, 郑均源, 陈巧明, 等. 白甘薯 TNG-10 特医食品的开发与降血糖效益之研究. 浙江温州: 中国营养学会第十次特殊营养学术会议, 2017.
9.	张媛媛, 张红, 关健, 等. 比较低 GI 型肠内营养制剂和普通均衡型肠内营养制剂对鼻饲患者血糖控制的影响. 中国实用医药, 2016, 11(26): 141-142.
10.	石莹, 蔡颂文, 盛春君, 等. 低还原糖当量值玉米麦芽糊精用于管饲膳食对 2 型糖尿病血糖及胰岛素的影响. 中国临床营养杂志, 2006, 14(3): 167-170.
11.	李硕, 黄茂涛, 胡利苹, 等. 低血糖指数型肠内营养制剂对血糖控制的影响. 西南国防医药, 2013, 23(6): 635-636.
12.	施万英, 徐甲芬, 蔺淑贤, 等. 高单不饱和脂肪酸型肠内营养剂用于 2 型糖尿病. 中国临床营养杂志, 2004, 12(1): 39-42.
13.	陈秋菊, 唐梅, 易昌华, 等. 老年 2 型糖尿病患者肠内营养支持 28 例. 中国老年学杂志, 2012, 32(13): 2865-2866.
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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.
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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, 潘诗海, 曾静波, 等. 肠内营养混悬液 (TPF-DM) 对 2 型糖尿病患者血糖、胰岛素和血脂的影响. 中华内科杂志, 2007, 46(3): 193-196.
37.	孙玲, 帅水云, 胡香英, 等. 低血糖指数医用食品用于 2 型糖尿病营养治疗的效果. 中国当代医药, 2017, 24(23): 49-51.
38.	姜桂花, 王家谱, 万怡, 等. 分析肠内营养混悬液对 2 型糖尿病患者血糖、胰岛素和血脂的影响. 中国医学创新, 2013, (12): 113-114.
39.	周莹霞, 陈钦达, 王琴琴, 等. 富含缓释淀粉的肠内营养乳剂对 2 型糖尿病血糖及胰岛素的影响. 上海医学, 2004, 27(2): 116-118.
40.	吴文俊, 项松英, 沈飞霞, 等. 富含缓释淀粉高单不饱和脂肪酸型肠内营养制剂对糖耐量异常患者糖脂代谢的影响. 温州医科大学学报, 2015, 45(1): 6-9.
41.	胡志庚, 刘宏, 孙静. 含缓释淀粉的肠内营养剂对 T2DM 餐后血糖的影响. 中国现代医生, 2007, 45(17): 16-17, 19.
42.	王姮, 蒋朱明, 袁申元, 等. 含缓释淀粉的整蛋白型肠内营养剂对脏器功能、血胰岛素/血糖曲线下面积及血糖的影响 (120 例随机, 对照, 多中心临床研究). 中国临床营养杂志, 2002, 10(2): 75-78.
43.	陈永春, 陈小梅, 许桢, 等. 含缓释碳水化合物高单不饱和脂肪酸配方肠内营养制剂对 2 型糖尿病的影响研究. 中国全科医学, 2012, 15(23): 2643-2645.
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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. 苏怡静, 郑均源, 陈巧明, 等. 白甘薯 TNG-10 特医食品的开发与降血糖效益之研究. 浙江温州: 中国营养学会第十次特殊营养学术会议, 2017.
9. 张媛媛, 张红, 关健, 等. 比较低 GI 型肠内营养制剂和普通均衡型肠内营养制剂对鼻饲患者血糖控制的影响. 中国实用医药, 2016, 11(26): 141-142.
10. 石莹, 蔡颂文, 盛春君, 等. 低还原糖当量值玉米麦芽糊精用于管饲膳食对 2 型糖尿病血糖及胰岛素的影响. 中国临床营养杂志, 2006, 14(3): 167-170.
11. 李硕, 黄茂涛, 胡利苹, 等. 低血糖指数型肠内营养制剂对血糖控制的影响. 西南国防医药, 2013, 23(6): 635-636.
12. 施万英, 徐甲芬, 蔺淑贤, 等. 高单不饱和脂肪酸型肠内营养剂用于 2 型糖尿病. 中国临床营养杂志, 2004, 12(1): 39-42.
13. 陈秋菊, 唐梅, 易昌华, 等. 老年 2 型糖尿病患者肠内营养支持 28 例. 中国老年学杂志, 2012, 32(13): 2865-2866.
14. 孙玲, 何友花. 探究低血糖指数肠内营养制剂对鼻饲糖尿病患者血糖的影响. 当代医学, 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, 潘诗海, 曾静波, 等. 肠内营养混悬液 (TPF-DM) 对 2 型糖尿病患者血糖、胰岛素和血脂的影响. 中华内科杂志, 2007, 46(3): 193-196.
37. 孙玲, 帅水云, 胡香英, 等. 低血糖指数医用食品用于 2 型糖尿病营养治疗的效果. 中国当代医药, 2017, 24(23): 49-51.
38. 姜桂花, 王家谱, 万怡, 等. 分析肠内营养混悬液对 2 型糖尿病患者血糖、胰岛素和血脂的影响. 中国医学创新, 2013, (12): 113-114.
39. 周莹霞, 陈钦达, 王琴琴, 等. 富含缓释淀粉的肠内营养乳剂对 2 型糖尿病血糖及胰岛素的影响. 上海医学, 2004, 27(2): 116-118.
40. 吴文俊, 项松英, 沈飞霞, 等. 富含缓释淀粉高单不饱和脂肪酸型肠内营养制剂对糖耐量异常患者糖脂代谢的影响. 温州医科大学学报, 2015, 45(1): 6-9.
41. 胡志庚, 刘宏, 孙静. 含缓释淀粉的肠内营养剂对 T2DM 餐后血糖的影响. 中国现代医生, 2007, 45(17): 16-17, 19.
42. 王姮, 蒋朱明, 袁申元, 等. 含缓释淀粉的整蛋白型肠内营养剂对脏器功能、血胰岛素/血糖曲线下面积及血糖的影响 (120 例随机, 对照, 多中心临床研究). 中国临床营养杂志, 2002, 10(2): 75-78.
43. 陈永春, 陈小梅, 许桢, 等. 含缓释碳水化合物高单不饱和脂肪酸配方肠内营养制剂对 2 型糖尿病的影响研究. 中国全科医学, 2012, 15(23): 2643-2645.
44. 邵颖, 凌轶群, 顾鸣宇. 糖尿病专用营养配方粉对糖尿病患者餐后血糖的影响. 中华中西医杂志, 2009, 7(5): 45.
45. 徐璐, 胡竹芳. 雅培益力佳 SR 在老年肥胖 2 型糖尿病患者饮食管理中的应用. 实用临床医学, 2014, (9): 32-33, 40.
46. 李帮兰, 张哲, 朱德亮, 等. 匀浆膳应用于老年Ⅱ型糖尿病患者饮食治疗的效果研究. 微量元素与健康研究, 2006, 23(3): 6-7, 16.
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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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