Study Summary
This trial is testing an individualized eating strategy to improve glycemic management in youth with type 1 diabetes. Participants will be assessed for acceptability and adherence to the plan, and changes in glycemic levels will be compared to baseline. The goal is to inform the design of a future randomized clinical trial.
Eligible Conditions
- Type 1 Diabetes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary Β· 7 Secondary Β· Reporting Duration: Week 26
Week 26
Change in hemoglobin A1c percentage
Change in percent time in range
Week 26
Guardian composite acceptability score
Mean adherence to each of the personalized eating behavior goals
Mean adherence to personalized eating behavior pattern
Mean number of personalized eating behavior goals adhered to by participants
Percentage of time participant adhered to each personalized eating behavior goal
Youth composite acceptability score
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
"MyPlan" - Individualized Structured Eating Plan
1 of 2
"MyPlan" - Individualized Eating Pattern
1 of 2
Experimental Treatment
50 Total Participants Β· 2 Treatment Groups
Primary Treatment: "MyPlan" - Individualized Eating Pattern Β· No Placebo Group Β· N/A
"MyPlan" - Individualized Structured Eating Plan
Behavioral
Experimental Group Β· 1 Intervention: "MyPlan" - Individualized Structured Eating Plan Β· Intervention Types: Behavioral"MyPlan" - Individualized Eating Pattern
Behavioral
Experimental Group Β· 1 Intervention: "MyPlan" - Individualized Eating Pattern Β· Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 26
Who is running the clinical trial?
University of CincinnatiOTHER
389 Previous Clinical Trials
635,689 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,371 Previous Clinical Trials
3,930,634 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,149 Previous Clinical Trials
4,074,759 Total Patients Enrolled
Elizabeth J Mayer-Davis, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Sarah Couch, PhDPrincipal InvestigatorUniversity of Cincinnati
Eligibility Criteria
Age 12 - 17 Β· All Participants Β· 5 Total Inclusion Criteria
Mark βYesβ if the following statements are true for you:You have a history of type 1 diabetes for at least one year.
Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of North Carolina at Chapel Hill | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
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- Miller, Kellee M., Nicole C. Foster, Roy W. Beck, Richard M. Bergenstal, Stephanie N. DuBose, Linda A. DiMeglio, David M. Maahs, and William V. Tamborlane. 2015. βCurrent State of Type 1 Diabetes Treatment in the U.S.: Updated Data from the T1D Exchange Clinic Registryβ. Diabetes Care. American Diabetes Association. doi:10.2337/dc15-0078.
- Γverby, Nina C, Hanna D Margeirsdottir, Cathrine Brunborg, Sigmund A Anderssen, Lene F Andersen, Knut Dahl-JΓΈrgensen, and Norwegian Study Group for Childhood Diabetes. 2009. βPhysical Activity and Overweight in Children and Adolescents Using Intensified Insulin Treatmentβ. Pediatric Diabetes. Wiley. doi:10.1111/j.1399-5448.2008.00454.x.
- Smart, Carmel E, Francesca Annan, Luciana PC Bruno, Laurie A Higgins, and Carlo L Acerini. 2014. βNutritional Management in Children and Adolescents with Diabetesβ. Pediatric Diabetes. Wiley. doi:10.1111/pedi.12175.
- Beaton, G H, J Milner, P Corey, V McGuire, M Cousins, E Stewart, M de Ramos, et al.. 1979. βSources of Variance in 24-hour Dietary Recall Data: Implications for Nutrition Study Design and Interpretationβ. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/32.12.2546.
- Kichler, Jessica C., Michael Seid, Jamie Crandell, David M. Maahs, Franziska K. Bishop, Kimberly A. Driscoll, Debra Standiford, Christine M. Hunter, and Elizabeth Mayer-Davis. 2018. βThe Flexible Lifestyle Empowering Change (FLEX) Intervention for Self-management in Adolescents with Type 1 Diabetes: Trial Design and Baseline Characteristicsβ. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2017.12.006.
- Wolever, Thomas M.S., Safa Hamad, Jean-Louis Chiasson, Robert G. Josse, Lawrence A. Leiter, N. Wilson Rodger, Stuart A. Ross, and Edmond A. Ryan. 1999. βDay-to-day Consistency in Amount and Source of Carbohydrate Intake Associated with Improved Blood Glucose Control in Type 1 Diabetesβ. Journal of the American College of Nutrition. Informa UK Limited. doi:10.1080/07315724.1999.10718858.
- Maahs, David M., Elizabeth Mayer-Davis, Franziska K. Bishop, Lily Wang, Meg Mangan, and Robert G. McMurray. 2012. βOutpatient Assessment of Determinants of Glucose Excursions in Adolescents with Type 1 Diabetes: Proof of Conceptβ. Diabetes Technology & Therapeutics. Mary Ann Liebert Inc. doi:10.1089/dia.2012.0053.
- Weissberg-Benchell, Jill, Allen M Glasgow, W Douglas Tynan, Philip Wirtz, Jane Turek, and Joseph Ward. 1995. βAdolescent Diabetes Management and Mismanagementβ. Diabetes Care. American Diabetes Association. doi:10.2337/diacare.18.1.77.
- Couch, Sarah C., Brian E. Saelens, Linda Levin, Katie Dart, Grace Falciglia, and Stephen R. Daniels. 2008. βThe Efficacy of a Clinic-based Behavioral Nutrition Intervention Emphasizing a Dash-type Diet for Adolescents with Elevated Blood Pressureβ. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2007.09.022.
- Mayer-Davis, Elizabeth J, David M Maahs, Michael Seid, Jamie Crandell, Franziska K Bishop, Kimberly A Driscoll, Christine M Hunter, et al.. 2018. βEfficacy of the Flexible Lifestyles Empowering Change Intervention on Metabolic and Psychosocial Outcomes in Adolescents with Type 1 Diabetes (FLEX): A Randomised Controlled Trialβ. The Lancet Child & Adolescent Health. Elsevier BV. doi:10.1016/s2352-4642(18)30208-6.
- Orchard, Trevor J., David M. Nathan, Bernard Zinman, Patricia Cleary, David Brillon, Jye-Yu C. Backlund, and John M. Lachin. 2015. βAssociation Between 7 Years of Intensive Treatment of Type 1 Diabetes and Long-term Mortalityβ. Jama. American Medical Association (AMA). doi:10.1001/jama.2014.16107.
- Γverby, N. C., H. D. Margeirsdottir, C. Brunborg, L. F. Andersen, and K. Dahl-JΓΈrgensen. 2007. βThe Influence of Dietary Intake and Meal Pattern on Blood Glucose Control in Children and Adolescents Using Intensive Insulin Treatmentβ. Diabetologia. Springer Science and Business Media LLC. doi:10.1007/s00125-007-0775-0.
- Godwin, Sandria L., Edgar Chambers IV, and Linda Cleveland. 2004. βAccuracy of Reporting Dietary Intake Using Various Portion-size Aids In-person and via Telephoneβ. Journal of the American Dietetic Association. Elsevier BV. doi:10.1016/j.jada.2004.01.006.
- βIntensive Diabetes Treatment and Cardiovascular Disease in Patients with Type 1 Diabetesβ. 2005. βIntensive Diabetes Treatment and Cardiovascular Disease in Patients with Type 1 Diabetesβ. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa052187.
- Li, Chao, Ralph B D'Agostino Jr, Dana Dabelea, Angela D Liese, Elizabeth J Mayer-Davis, Russell Pate, and Anwar T Merchant. 2018. βLongitudinal Association Between Eating Frequency and Hemoglobin A1c and Serum Lipids in Diabetes in the SEARCH for Diabetes in Youth Studyβ. Pediatric Diabetes. Wiley. doi:10.1111/pedi.12690.
- International Hypoglycaemia Study Group. 2016. βGlucose Concentrations of Less Than 3.0 Mmol/l (54 Mg/dl) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetesβ. Diabetes Care. American Diabetes Association. doi:10.2337/dc16-2215.
- Markowitz, Jessica T., Deborah A. Butler, Lisa K. Volkening, Jeanne E. Antisdel, Barbara J. Anderson, and Lori M.B. Laffel. 2009. βBrief Screening Tool for Disordered Eating in Diabetesβ. Diabetes Care. American Diabetes Association. doi:10.2337/dc09-1890.
- Clark, Bronwyn K., Toby G. Pavey, Rui F. Lim, Sjaan R. Gomersall, and Wendy J. Brown. 2016. βPast-day Recall of Sedentary Time: Validity of a Self-reported Measure of Sedentary Time in a University Populationβ. Journal of Science and Medicine in Sport. Elsevier BV. doi:10.1016/j.jsams.2015.02.001.
- Keadle, Sarah, Kate Lyden, Amanda Hickey, Evan L Ray, Jay H Fowke, Patty S Freedson, and Charles E Matthews. 2014. βValidation of a Previous Day Recall for Measuring the Location and Purpose of Active and Sedentary Behaviors Compared to Direct Observationβ. International Journal of Behavioral Nutrition and Physical Activity. Springer Science and Business Media LLC. doi:10.1186/1479-5868-11-12.
- Beaton GH, Milner J, Corey P, McGuire V, Cousins M, Stewart E, de Ramos M, Hewitt D, Grambsch PV, Kassim N, Little JA. Sources of variance in 24-hour dietary recall data: implications for nutrition study design and interpretation. Am J Clin Nutr. 1979 Dec;32(12):2546-59. doi: 10.1093/ajcn/32.12.2546. No abstract available.
- Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.
- Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.
- Overby NC, Margeirsdottir HD, Brunborg C, Andersen LF, Dahl-Jorgensen K. The influence of dietary intake and meal pattern on blood glucose control in children and adolescents using intensive insulin treatment. Diabetologia. 2007 Oct;50(10):2044-51. doi: 10.1007/s00125-007-0775-0. Epub 2007 Aug 9.
- Wolever TM, Hamad S, Chiasson JL, Josse RG, Leiter LA, Rodger NW, Ross SA, Ryan EA. Day-to-day consistency in amount and source of carbohydrate intake associated with improved blood glucose control in type 1 diabetes. J Am Coll Nutr. 1999 Jun;18(3):242-7. doi: 10.1080/07315724.1999.10718858.
- International Hypoglycaemia Study Group. Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2017 Jan;40(1):155-157. doi: 10.2337/dc16-2215. Epub 2016 Nov 21. No abstract available.
- Weissberg-Benchell J, Glasgow AM, Tynan WD, Wirtz P, Turek J, Ward J. Adolescent diabetes management and mismanagement. Diabetes Care. 1995 Jan;18(1):77-82. doi: 10.2337/diacare.18.1.77.
- Posner BM, Smigelski C, Duggal A, Morgan JL, Cobb J, Cupples LA. Validation of two-dimensional models for estimation of portion size in nutrition research. J Am Diet Assoc. 1992 Jun;92(6):738-41. No abstract available.
- Li C, D'Agostino RB Jr, Dabelea D, Liese AD, Mayer-Davis EJ, Pate R, Merchant AT. Longitudinal association between eating frequency and hemoglobin A1c and serum lipids in diabetes in the SEARCH for Diabetes in Youth study. Pediatr Diabetes. 2018 Apr 30:10.1111/pedi.12690. doi: 10.1111/pedi.12690. Online ahead of print.
- Overby NC, Margeirsdottir HD, Brunborg C, Anderssen SA, Andersen LF, Dahl-Jorgensen K; Norwegian Study Group for Childhood Diabetes. Physical activity and overweight in children and adolescents using intensified insulin treatment. Pediatr Diabetes. 2009 Apr;10(2):135-41. doi: 10.1111/j.1399-5448.2008.00454.x. Epub 2008 Aug 20.
- Smart CE, Annan F, Bruno LP, Higgins LA, Acerini CL; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Nutritional management in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:135-53. doi: 10.1111/pedi.12175. No abstract available.
- Writing Group for the DCCT/EDIC Research Group; Orchard TJ, Nathan DM, Zinman B, Cleary P, Brillon D, Backlund JY, Lachin JM. Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA. 2015 Jan 6;313(1):45-53. doi: 10.1001/jama.2014.16107.
- 2021. ""MyPlan" - Individualized Eating Patterns for Adolescents With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05147324.
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