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NCT Number: NCT03623113

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes:

1. The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention) 2. The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention)

The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.

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Key information

Conditions

Type1diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type1 Diabetes Mellitus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Gentofte Municipality, DK-2820, Denmark

About this study

The current study is a randomized controlled trial with a parallel-group design. A total of 231 patients will be enrolled in the trial. Participants will be randomized to one of three arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an automated bolus calculator (ABC-ACC), or 3) Standard dietary care.

The primary objective is to evaluate the six months effects of education in the BCC concept and the ABC-ACC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes
  • Diabetes duration; >12 months
  • HbA1c of 53-97 mmol/mol
  • Multiple daily insulin injection therapy
  • Provided voluntary written informed consent

Exclusion criteria

  • Practicing carbohydrate counting, as judged by the investigator
  • Participated in a BCC group program within the last two years
  • Use of insulin pump, or plans of having an insulin pump within the study period
  • Fixed dose of rapid acting insulin therapy for meals
  • Split-mixed insulin therapy
  • Use of open CGM
  • Use of Freestyle Libre
  • Use of an automated bolus calculator
  • Gastroparesis
  • Pregnancy or breastfeeding, or plans of pregnancy within the study period
  • Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
  • Uncontrolled medical issues, as judged by the investigator or a medical expert
  • Concomitant participation in other clinical studies
  • Unable to understand the informed consent and the study procedures

Treatment and study plan

BCC intervention

Behavioral

Structured training and education i basic carbohydrate counting principles

Other names: Basic carbohydrate counting

ABC-ACC intervention

Behavioral

Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate

Other names: Advanced carbohydrate counting with a bolus calculator

Standard dietary education

Behavioral

Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences

Other names: Routine dietary care

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline, 6 months

    mmol/mol

  2. Change in mean amplitude of glycaemic excursions (MAGE)

    Time frame: Baseline, 6 months

    mmol/l

Secondary outcomes

  1. Change in HbA1c

    Time frame: 12 months

    mmol/mol

  2. Change in body weight

    Time frame: Baseline, 6 months, 12 months

    kg

  3. Change in low-density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  4. Change in high-density cholesterol (HDL-C)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  5. Change in total cholesterol (TC)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  6. Change in free fatty acids (FFA)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  7. Change in triglycerides (TG)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  8. Change in systolic blood pressure

    Time frame: Baseline, 6 months, 12 months

    mm Hg

  9. Change in diastolic blood pressure

    Time frame: Baseline, 6 months, 12 months

    mm Hg

  10. Change in waist circumference

    Time frame: Baseline, 6 months, 12 months

    cm

  11. Change in hip circumference

    Time frame: Baseline, 6 months, 12 months

    cm

  12. Change in total fat free mass

    Time frame: Baseline, 6 months

    gram

  13. Change in total fat mass

    Time frame: Baseline, 6 months

    gram

  14. Change in time in range (3.9-10.0 mmol/l)

    Time frame: Baseline, 6 months

    Percent (%)

  15. Changes in % time spent in hypoglycaemia (<3.9 mmol/l)

    Time frame: Baseline, 6 months

    Percent (%)

  16. Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l)

    Time frame: Baseline, 6 months

    Percent (%)

  17. Change in standard deviation of mean plasma glucose

    Time frame: Baseline, 6 months

    mmol/l

  18. Change in mathematical literacy

    Time frame: Baseline, 6 months, 12 months

    Total score or percent (%)

  19. Change in carbohydrate estimation accuracy

    Time frame: Baseline, 6 months, 12 months

    Total score or percent (%)

  20. Change in diet-related quality of life

    Time frame: Baseline, 6 months, 12 months

    Total score or percent (%)

  21. Change in perceived competences in diabetes

    Time frame: Baseline, 6 months, 12 months

    Total score or percent (%)

  22. Change in degree of autonomy-supportive dietitian

    Time frame: Baseline, 6 months, 12 months

    Total score or percent (%)

  23. Change in total energy intake

    Time frame: Baseline, 6 months

    kJ/day

  24. Change in dietary intake of carbohydrates

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  25. Change in dietary intake of total fat

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  26. Change in dietary intake of saturated fatty acids (SFA)

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  27. Change in dietary intake of monounsaturated fatty acids (MUFA)

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  28. Change in dietary intake of polyunsaturated fatty acids (PUFA)

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  29. Change in dietary intake of protein

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  30. Change in dietary intake of added sugar

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  31. Change in intake of dietary fibre

    Time frame: Baseline, 6 months

    gram/day or g/MJ

Other outcomes

  1. Change in physical activity level

    Time frame: Baseline, 6 months, 12 months

    Total score or percent (%)

  2. Change in urinary biomarkers of carbohydrate intake

    Time frame: Baseline, 6 months

    Percent (%)

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study): A Randomized, Parallel, Open-label, Intervention Study Comparing Different Approaches to Dietary Self-management in Patients With Type 1 Diabetes

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2018
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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