Clinical trial NCT03196895 - References

Diabetes Mellitus, Type 2 — Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification

Citation(s)

•   Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT
  Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
•   Allen NA, Fain JA, Braun B, Chipkin SR
  Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial. Diabetes Res Clin Pract. 2008 Jun;80(3):371-9. doi: 10.1016/j.diabres.2008.01.006. Epub 2008 Mar 4.
•   Allen NA, Jacelon CS, Chipkin SR
  Feasibility and acceptability of continuous glucose monitoring and accelerometer technology in exercising individuals with type 2 diabetes. J Clin Nurs. 2009 Feb;18(3):373-83. doi: 10.1111/j.1365-2702.2008.02533.x.
•   American Diabetes Association
  Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.
•   Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG
  The Diabetes Empowerment Scale: a measure of psychosocial self-efficacy. Diabetes Care. 2000 Jun;23(6):739-43.
•   Augustin LS, Kendall CW, Jenkins DJ, Willett WC, Astrup A, Barclay AW, Björck I, Brand-Miller JC, Brighenti F, Buyken AE, Ceriello A, La Vecchia C, Livesey G, Liu S, Riccardi G, Rizkalla SW, Sievenpiper JL, Trichopoulou A, Wolever TM, Baer-Sinnott S, Poli A
  Glycemic index, glycemic load and glycemic response: An International Scientific Consensus Summit from the International Carbohydrate Quality Consortium (ICQC). Nutr Metab Cardiovasc Dis. 2015 Sep;25(9):795-815. doi: 10.1016/j.numecd.2015.05.005. Epub 2015 May 16.
•   Bailey TS, Chang A, Christiansen M
  Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol. 2015 Mar;9(2):209-14. doi: 10.1177/1932296814559746. Epub 2014 Nov 3.
•   Bosi E, Scavini M, Ceriello A, Cucinotta D, Tiengo A, Marino R, Bonizzoni E, Giorgino F; PRISMA Study Group
  Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: the PRISMA randomized trial. Diabetes Care. 2013 Oct;36(10):2887-94. doi: 10.2337/dc13-0092. Epub 2013 Jun 4.
•   Brunk DR, Taylor AG, Clark ML, Williams IC, Cox DJ
  A Culturally Appropriate Self-Management Program for Hispanic Adults With Type 2 Diabetes and Low Health Literacy Skills. J Transcult Nurs. 2017 Mar;28(2):187-194. doi: 10.1177/1043659615613418. Epub 2016 Jul 9.
•   Camarri B, Eastwood PR, Cecins NM, Thompson PJ, Jenkins S
  Six minute walk distance in healthy subjects aged 55-75 years. Respir Med. 2006 Apr;100(4):658-65. Epub 2005 Oct 17.
•   Ceriello A, Davidson J, Hanefeld M, Leiter L, Monnier L, Owens D, Tajima N, Tuomilehto J; International Prandial Glucose Regulation Study Group
  Postprandial hyperglycaemia and cardiovascular complications of diabetes: an update. Nutr Metab Cardiovasc Dis. 2006 Oct;16(7):453-6. Epub 2006 Aug 24.
•   Colberg SR, Grieco CR, Somma CT
  Exercise effects on postprandial glycemia, mood, and sympathovagal balance in type 2 diabetes. J Am Med Dir Assoc. 2014 Apr;15(4):261-6. doi: 10.1016/j.jamda.2013.11.026. Epub 2014 Feb 6.
•   Cox D, Gonder-Frederick L, McCall A, Kovatchev B, Clarke W
  The effects of glucose fluctuation on cognitive function and QOL: the functional costs of hypoglycaemia and hyperglycaemia among adults with type 1 or type 2 diabetes. Int J Clin Pract Suppl. 2002 Jul;(129):20-6. Review.
•   Cox D, Ritterband L, Magee J, Clarke W, Gonder-Frederick L
  Blood glucose awareness training delivered over the internet. Diabetes Care. 2008 Aug;31(8):1527-8. doi: 10.2337/dc07-1956. Epub 2008 May 13.
•   Cox DJ, Gill Taylor A, Dunning ES, Winston MC, Luk Van IL, McCall A, Singh H, Yancy WS Jr
  Impact of behavioral interventions in the management of adults with type 2 diabetes mellitus. Curr Diab Rep. 2013 Dec;13(6):860-8. doi: 10.1007/s11892-013-0423-7. Review.
•   Cox DJ, Gonder-Frederick L, Polonsky W, Schlundt D, Kovatchev B, Clarke W
  Blood glucose awareness training (BGAT-2): long-term benefits. Diabetes Care. 2001 Apr;24(4):637-42.
•   Cox DJ, Taylor AG, Moncrief M, Diamond A, Yancy WS Jr, Hegde S, McCall AL
  Continuous Glucose Monitoring in the Self-management of Type 2 Diabetes: A Paradigm Shift. Diabetes Care. 2016 May;39(5):e71-3. doi: 10.2337/dc15-2836. Epub 2016 Mar 17.
•   Cox DJ, Taylor AG, Nowacek G, Holley-Wilcox P, Pohl SL, Guthrow E
  The relationship between psychological stress and insulin-dependent diabetic blood glucose control: preliminary investigations. Health Psychol. 1984;3(1):63-75.
•   Cox DJ, Taylor AG, Singh H, Moncrief M, Diamond A, Yancy WS Jr, Hegde S, McCall AL
  Glycemic load, exercise, and monitoring blood glucose (GEM): A paradigm shift in the treatment of type 2 diabetes mellitus. Diabetes Res Clin Pract. 2016 Jan;111:28-35. doi: 10.1016/j.diabres.2015.10.021. Epub 2015 Oct 21.
•   Cox DJ, Tisdelle DA, Culbert JP
  Increasing adherence to behavioral homework assignments. J Behav Med. 1988 Oct;11(5):519-22.
•   Diabetes Prevention Program Research Group, Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM
  10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29. Erratum in: Lancet. 2009 Dec 19;374(9707):2054.
•   DiPietro L, Gribok A, Stevens MS, Hamm LF, Rumpler W
  Three 15-min bouts of moderate postmeal walking significantly improves 24-h glycemic control in older people at risk for impaired glucose tolerance. Diabetes Care. 2013 Oct;36(10):3262-8. doi: 10.2337/dc13-0084. Epub 2013 Jun 11.
•   Ekong G, Kavookjian J
  Motivational interviewing and outcomes in adults with type 2 diabetes: A systematic review. Patient Educ Couns. 2016 Jun;99(6):944-52. doi: 10.1016/j.pec.2015.11.022. Epub 2015 Dec 4. Review.
•   Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr; American Diabetes Association
  Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2013 Nov;36(11):3821-42. doi: 10.2337/dc13-2042. Epub 2013 Oct 9.
•   Farmer AJ, Perera R, Ward A, Heneghan C, Oke J, Barnett AH, Davidson MB, Guerci B, Coates V, Schwedes U, O'Malley S
  Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin treated type 2 diabetes. BMJ. 2012 Feb 27;344:e486. doi: 10.1136/bmj.e486.
•   Fonda SJ, Salkind SJ, Walker MS, Chellappa M, Ehrhardt N, Vigersky RA
  Heterogeneity of responses to real-time continuous glucose monitoring (RT-CGM) in patients with type 2 diabetes and its implications for application. Diabetes Care. 2013 Apr;36(4):786-92. doi: 10.2337/dc12-1225. Epub 2012 Nov 19.
•   Foster-Powell K, Holt SH, Brand-Miller JC
  International table of glycemic index and glycemic load values: 2002. Am J Clin Nutr. 2002 Jul;76(1):5-56.
•   Greaves CJ, Sheppard KE, Abraham C, Hardeman W, Roden M, Evans PH, Schwarz P; IMAGE Study Group
  Systematic review of reviews of intervention components associated with increased effectiveness in dietary and physical activity interventions. BMC Public Health. 2011 Feb 18;11:119. doi: 10.1186/1471-2458-11-119. Review.
•   Heinemann L
  (Analytical) accuracy of blood glucose meters and patients: how do they come together? J Diabetes Sci Technol. 2013 Jan 1;7(1):1-3.
•   Hill JO, Galloway JM, Goley A, Marrero DG, Minners R, Montgomery B, Peterson GE, Ratner RE, Sanchez E, Aroda VR
  Scientific statement: Socioecological determinants of prediabetes and type 2 diabetes. Diabetes Care. 2013 Aug;36(8):2430-9. doi: 10.2337/dc13-1161. Epub 2013 Jun 20. Review.
•   Hinderliter AL, Sherwood A, Craighead LW, Lin PH, Watkins L, Babyak MA, Blumenthal JA
  The long-term effects of lifestyle change on blood pressure: One-year follow-up of the ENCORE study. Am J Hypertens. 2014 May;27(5):734-41. doi: 10.1093/ajh/hpt183. Epub 2013 Oct 1.
•   Høstmark AT, Ekeland GS, Beckstrøm AC, Meen HD
  Postprandial light physical activity blunts the blood glucose increase. Prev Med. 2006 May;42(5):369-71. Epub 2006 Mar 20.
•   Ingersoll KS, Banton T, Gorlin E, Vajda K, Singh H, Peterson N, Gonder-Frederick L, Cox DJ
  Motivational Interviewing Support for a Behavioral Health Internet Intervention for Drivers with Type 1 Diabetes. Internet Interv. 2015 May 1;2(2):103-109.
•   Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD)
  Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. Review. Erratum in: Diabetes Care. 2013 Feb;36(2):490.
•   Jelleyman C, Yates T, O'Donovan G, Gray LJ, King JA, Khunti K, Davies MJ
  The effects of high-intensity interval training on glucose regulation and insulin resistance: a meta-analysis. Obes Rev. 2015 Nov;16(11):942-61. doi: 10.1111/obr.12317. Review.
•   Jilcott S, Ammerman A, Sommers J, Glasgow RE
  Applying the RE-AIM framework to assess the public health impact of policy change. Ann Behav Med. 2007 Oct;34(2):105-14.
•   Kovatchev BP, Patek SD, Ortiz EA, Breton MD
  Assessing sensor accuracy for non-adjunct use of continuous glucose monitoring. Diabetes Technol Ther. 2015 Mar;17(3):177-86. doi: 10.1089/dia.2014.0272. Epub 2014 Dec 1.
•   Kroenke K, Spitzer RL, Williams JB
  The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.
•   Liu AG, Most MM, Brashear MM, Johnson WD, Cefalu WT, Greenway FL
  Reducing the glycemic index or carbohydrate content of mixed meals reduces postprandial glycemia and insulinemia over the entire day but does not affect satiety. Diabetes Care. 2012 Aug;35(8):1633-7. doi: 10.2337/dc12-0329. Epub 2012 Jun 11.
•   Look AHEAD Research Group, Pi-Sunyer X, Blackburn G, Brancati FL, Bray GA, Bright R, Clark JM, Curtis JM, Espeland MA, Foreyt JP, Graves K, Haffner SM, Harrison B, Hill JO, Horton ES, Jakicic J, Jeffery RW, Johnson KC, Kahn S, Kelley DE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montgomery B, Nathan DM, Patricio J, Peters A, Redmon JB, Reeves RS, Ryan DH, Safford M, Van Dorsten B, Wadden TA, Wagenknecht L, Wesche-Thobaben J, Wing RR, Yanovski SZ
  Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007 Jun;30(6):1374-83. Epub 2007 Mar 15.
•   Look AHEAD Research Group, Wing RR
  Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334.
•   Mayer SB, Jeffreys AS, Olsen MK, McDuffie JR, Feinglos MN, Yancy WS Jr
  Two diets with different haemoglobin A1c and antiglycaemic medication effects despite similar weight loss in type 2 diabetes. Diabetes Obes Metab. 2014 Jan;16(1):90-3. doi: 10.1111/dom.12191. Epub 2013 Aug 29.
•   Mayer-Davis EJ, D'Agostino R Jr, Karter AJ, Haffner SM, Rewers MJ, Saad M, Bergman RN
  Intensity and amount of physical activity in relation to insulin sensitivity: the Insulin Resistance Atherosclerosis Study. JAMA. 1998 Mar 4;279(9):669-74.
•   McGuire BE, Morrison TG, Hermanns N, Skovlund S, Eldrup E, Gagliardino J, Kokoszka A, Matthews D, Pibernik-Okanovic M, Rodríguez-Saldaña J, de Wit M, Snoek FJ
  Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1. Diabetologia. 2010 Jan;53(1):66-9. doi: 10.1007/s00125-009-1559-5. Epub 2009 Oct 20.
•   Miller CK, Kristeller JL, Headings A, Nagaraja H
  Comparison of a mindful eating intervention to a diabetes self-management intervention among adults with type 2 diabetes: a randomized controlled trial. Health Educ Behav. 2014 Apr;41(2):145-54. doi: 10.1177/1090198113493092. Epub 2013 Jul 12.
•   Oldroyd J, Banerjee M, Heald A, Cruickshank K
  Diabetes and ethnic minorities. Postgrad Med J. 2005 Aug;81(958):486-90. Review.
•   Parkin CG, Buskirk A, Hinnen DA, Axel-Schweitzer M
  Results that matter: structured vs. unstructured self-monitoring of blood glucose in type 2 diabetes. Diabetes Res Clin Pract. 2012 Jul;97(1):6-15. doi: 10.1016/j.diabres.2012.03.002. Epub 2012 Mar 30. Review.
•   Polonsky WH, Fisher L
  Self-monitoring of blood glucose in noninsulin-using type 2 diabetic patients: right answer, but wrong question: self-monitoring of blood glucose can be clinically valuable for noninsulin users. Diabetes Care. 2013 Jan;36(1):179-82. doi: 10.2337/dc12-0731.
•   Robertson RP, Harmon J, Tran PO, Tanaka Y, Takahashi H
  Glucose toxicity in beta-cells: type 2 diabetes, good radicals gone bad, and the glutathione connection. Diabetes. 2003 Mar;52(3):581-7. Review.
•   Runchey SS, Pollak MN, Valsta LM, Coronado GD, Schwarz Y, Breymeyer KL, Wang C, Wang CY, Lampe JW, Neuhouser ML
  Glycemic load effect on fasting and post-prandial serum glucose, insulin, IGF-1 and IGFBP-3 in a randomized, controlled feeding study. Eur J Clin Nutr. 2012 Oct;66(10):1146-52. doi: 10.1038/ejcn.2012.107. Epub 2012 Aug 15.
•   Rynders CA, Weltman JY, Jiang B, Breton M, Patrie J, Barrett EJ, Weltman A
  Effects of exercise intensity on postprandial improvement in glucose disposal and insulin sensitivity in prediabetic adults. J Clin Endocrinol Metab. 2014 Jan;99(1):220-8. doi: 10.1210/jc.2013-2687. Epub 2013 Dec 20.
•   Stone NJ, Robinson JG, Lichtenstein AH, Goff DC Jr, Lloyd-Jones DM, Smith SC Jr, Blum C, Schwartz JS; 2013 ACC/AHA Cholesterol Guideline Panel
  Treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: synopsis of the 2013 American College of Cardiology/American Heart Association cholesterol guideline. Ann Intern Med. 2014 Mar 4;160(5):339-43. doi: 10.7326/M14-0126.
•   Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N
  The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15.
•   Taylor WJ, Myers J, Simpson RT, McPherson KM, Weatherall M
  Quality of life of people with rheumatoid arthritis as measured by the World Health Organization Quality of Life Instrument, short form (WHOQOL-BREF): score distributions and psychometric properties. Arthritis Rheum. 2004 Jun 15;51(3):350-7.
•   Tsalatsanis A, Gil-Herrera E, Yalcin A, Djulbegovic B, Barnes L
  Designing patient-centric applications for chronic disease management. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:3146-9. doi: 10.1109/IEMBS.2011.6090858.
•   Turcotte LP, Fisher JS
  Skeletal muscle insulin resistance: roles of fatty acid metabolism and exercise. Phys Ther. 2008 Nov;88(11):1279-96. doi: 10.2522/ptj.20080018. Epub 2008 Sep 18. Review.
•   Turner RC, Cull CA, Frighi V, Holman RR
  Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999 Jun 2;281(21):2005-12.
•   Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM
  Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. doi: 10.2337/dc11-1438. Epub 2011 Nov 18.
•   Whiting DR, Guariguata L, Weil C, Shaw J
  IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12.
•   Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalová L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E
  Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.

Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification

Details for clinical trial NCT03196895