The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes

Bettina Ewers, Tina Vilsbøll, Henrik Ullits Andersen, Jens Meldgaard Bruun, Bettina Ewers, Tina Vilsbøll, Henrik Ullits Andersen, Jens Meldgaard Bruun

Abstract

Introduction: Clinical guidelines recommend that patients with type 1 diabetes (T1D) learn carbohydrate counting or similar methods to improve glycaemic control. Although systematic educating in carbohydrate counting is still not offered as standard-of-care for all patients on multiple daily injections (MDI) insulin therapy in outpatient diabetes clinics in Denmark. This may be due to the lack of evidence as to which educational methods are the most effective for training patients in carbohydrate counting. The objective of this study is to compare the effect of two different educational programmes in carbohydrate counting with the usual dietary care on glycaemic control in patients with T1D.

Methods and analysis: The study is designed as a randomised controlled trial with a parallel-group design. The total study duration is 12 months with data collection at baseline, 6 and 12 months. We plan to include 231 Danish adult patients with T1D. Participants will be randomised to one of three dietician-led interventions: (1) a programme in basic carbohydrate counting, (2) a programme in advanced carbohydrate counting including an automated bolus calculator or (3) usual dietary care. The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline to end of the intervention period (week 24) between and within each of the three study groups. Other outcome measures include changes in other parameters of plasma glucose variability (eg, time in range), body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in dietary management of diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers.

Ethics and dissemination: The protocol has been approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.

Trial registration number: ClinicalTrials.gov Registry (NCT03623113).

Keywords: advanced carbohydrate counting; basic carbohydrate counting; carbohydrate counting; nutritional education; randomised controlled trial; type 1 diabetes.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study design. ABC-ACC, advanced carbohydrate counting with an automated bolus calculator; BCC, basic carbohydratecounting.
Figure 2
Figure 2
Schematic diagram of the intervention. ABC-ACC, advanced carbohydrate counting with an automated bolus calculator; BCC, basic carbohydrate counting; BP, blood pressure; BW, body weight; CGM, continuous glucose monitoring; DXA, dual-energy-X-ray absorptiometry; V, visit; WHC, waist-hip circumference.
Figure 3
Figure 3
Study flow diagram. The planned flow of participants through the stages of the study. ABC-ACC, advanced carbohydrate counting with an automated bolus calculator; BCC, basic carbohydrate counting.

References

    1. Kliniske retningslinjer for behandling af voksne med Type 1 diabetes Sundhedsstyrelsen (Danish Health & Medicines Authority. Copenhagen, 2010.
    1. Rammeplan for diætbehandling AF type 1 diabetes Foreningen AF kliniske diætister (the association of clinical dietitians) 2011.
    1. Mann JI, De Leeuw I, Hermansen K, et al. . Evidence-Based nutritional approaches to the treatment and prevention of diabetes mellitus. Nutr Metab Cardiovasc Dis 2004;14:373–94. 10.1016/S0939-4753(04)80028-0
    1. Sheard NF, Clark NG, Brand-Miller JC, et al. . Dietary carbohydrate (amount and type) in the prevention and management of diabetes: a statement by the American diabetes association. Diabetes Care 2004;27:2266–71. 10.2337/diacare.27.9.2266
    1. Gillespie SJ, Kulkarni KD, Daly AE. Using carbohydrate counting in diabetes clinical practice. J Am Diet Assoc 1998;98:897–905. 10.1016/S0002-8223(98)00206-5
    1. Kulkarni KD. Carbohydrate counting: a practical Meal-Planning option for people with diabetes. Clinical Diabetes 2005;23:120–2. 10.2337/diaclin.23.3.120
    1. Bell KJ, Barclay AW, Petocz P, et al. . Efficacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis. The Lancet Diabetes & Endocrinology 2014;2:133–40. 10.1016/S2213-8587(13)70144-X
    1. Fu S, Li L, Deng S, et al. . Effectiveness of advanced carbohydrate counting in type 1 diabetes mellitus: a systematic review and meta-analysis. Sci Rep 2016;6:37067 10.1038/srep37067
    1. Schmidt S, Schelde B, Nørgaard K. Effects of advanced carbohydrate counting in patients with Type 1 diabetes: a systematic review. Diabet. Med. 2014;31:886–96. 10.1111/dme.12446
    1. Bowen ME, Cavanaugh KL, Wolff K, et al. . Numeracy and dietary intake in patients with type 2 diabetes. Diabetes Educ 2013;39:240–7. 10.1177/0145721713475841
    1. Cavanaugh K, Huizinga MM, Wallston KA, et al. . Association of Numeracy and diabetes control. Ann Intern Med 2008;148:737–46. 10.7326/0003-4819-148-10-200805200-00006
    1. Huizinga MM, Beech BM, Cavanaugh KL, et al. . Low numeracy skills are associated with higher BMI. Obesity 2008;16:1966–8. 10.1038/oby.2008.294
    1. Huizinga MM, Carlisle AJ, Cavanaugh KL, et al. . Literacy, Numeracy, and Portion-Size estimation skills. Am J Prev Med 2009;36:324–8. 10.1016/j.amepre.2008.11.012
    1. Marden S, Thomas PW, Sheppard ZA, et al. . Poor numeracy skills are associated with glycaemic control in Type 1 diabetes. Diabet Med 2012;29:662–9. 10.1111/j.1464-5491.2011.03466.x
    1. Rothman RL, et al. Influence of patient literacy on the effectiveness of a primary Care–Based diabetes disease management program. JAMA 2004;292:1711–6. 10.1001/jama.292.14.1711
    1. Rothman RL, Housam R, Weiss H, et al. . Patient understanding of food labels: the role of literacy and numeracy. Am J Prev Med 2006;31:391–8.
    1. Bishop FK, Maahs DM, Spiegel G, et al. . The carbohydrate counting in adolescents with type 1 diabetes (CCAT) study. Diabetes Spectrum 2009;22:56–62. 10.2337/diaspect.22.1.56
    1. Mehta SN, Quinn N, Volkening LK, et al. . Impact of carbohydrate counting on glycemic control in children with type 1 diabetes. Diabetes Care 2009;32:1014–6. 10.2337/dc08-2068
    1. Smart CE, Ross K, Edge JA, et al. . Can children with type 1 diabetes and their caregivers estimate the carbohydrate content of meals and snacks? Diabet Med 2010;27:348–53. 10.1111/j.1464-5491.2010.02945.x
    1. Brazeau AS, Mircescu H, Desjardins K, et al. . Carbohydrate counting accuracy and blood glucose variability in adults with type 1 diabetes. Diabetes Res Clin Pract 2013;99:19–23. 10.1016/j.diabres.2012.10.024
    1. Hommel E, Schmidt S, Vistisen D, et al. . Effects of advanced carbohydrate counting guided by an automated bolus calculator in type 1 diabetes mellitus (StenoABC): a 12-month, randomized clinical trial. Diabet. Med. 2017;34:708–15. 10.1111/dme.13275
    1. Schmidt S, Meldgaard M, Serifovski N, et al. . Use of an automated bolus calculator in MDI-Treated type 1 diabetes: the BolusCal study, a randomized controlled pilot study. Diabetes Care 2012;35:984–90. 10.2337/dc11-2044
    1. Ziegler R, Cavan DA, Cranston I, et al. . Use of an insulin bolus advisor improves glycemic control in multiple daily insulin injection (MDI) therapy patients with suboptimal glycemic control: first results from the ABACUS trial. Diabetes Care 2013;36:3613–9. 10.2337/dc13-0251
    1. Schmidt S, Vistisen D, Almdal T, et al. . Exploring factors influencing HbA1c and psychosocial outcomes in people with type 1 diabetes after training in advanced carbohydrate counting. Diabetes Res Clin Pract 2017;130:61–6. 10.1016/j.diabres.2017.05.021
    1. Kawamura T, Takamura C, Hirose M, et al. . The factors affecting on estimation of carbohydrate content of meals in carbohydrate counting. Clin Pediatr Endocrinol 2015;24:153–65. 10.1297/cpe.24.153
    1. Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care 1998;21:1644–51. 10.2337/diacare.21.10.1644
    1. Toft U, Kristoffersen L, Ladelund S, et al. . The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial. Int J Behav Nutr Phys Act 2008;5 10.1186/1479-5868-5-59
    1. Meldgaard M, Damm-Frydenberg C, Vesth U, et al. . Use of advanced carbohydrate counting and an automated bolus calculator in clinical practice: the BolusCal ® training concept. International Diabetes Nursing 2015;12:8–13. 10.1179/2057331615Z.0000000002
    1. Sato E, Suzukamo Y, Miyashita M, et al. . Development of a diabetes diet-related quality-of-life scale. Diabetes Care 2004;27:1271–5. 10.2337/diacare.27.6.1271
    1. Huizinga MM, Elasy TA, Wallston KA, et al. . Development and validation of the diabetes Numeracy test (DNT). BMC Health Serv Res 2008;8:96 10.1186/1472-6963-8-96
    1. Lee PH, Macfarlane DJ, Lam TH, et al. . Validity of the International physical activity questionnaire short form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act 2011;8 10.1186/1479-5868-8-115
    1. Bell KJ, Gray R, Munns D, et al. . Clinical application of the food insulin index for mealtime insulin dosing in adults with type 1 diabetes: a randomized controlled trial. Diabetes Technol Ther 2016;18:218–25. 10.1089/dia.2015.0254
    1. Tay J, Luscombe-Marsh ND, Thompson CH, et al. . Comparison of low- and high-carbohydrate diets for type 2 diabetes management: a randomized trial. Am J Clin Nutr 2015;102:780–90. 10.3945/ajcn.115.112581
    1. Moher D, Hopewell S, Schulz KF, et al. . Consort 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869 10.1136/bmj.c869

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe