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

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ClinicalTrials.gov Identifier: NCT03623113
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Bettina Ewers, Steno Diabetes Center Copenhagen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type1diabetes Type1 Diabetes Mellitus Glucose Metabolism Disorders Behavioral: BCC intervention Behavioral: ABC-ACC intervention Behavioral: Standard dietary education Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: BCC intervention
The BCC program consists of three group sessions and is delivered by two trained dietitians. In addition to the BCC program, the participants receive regular medical care in the diabetes clinic
Behavioral: BCC intervention
Structured training and education i basic carbohydrate counting principles
Other Name: Basic carbohydrate counting

Experimental: ABC-ACC intervention
The ABC-ACC program consists of one group session and two individual follow-up sessions and is delivered by trained dietitians with supervision by a medical doctor. In addition to the ABC-ACC program, the participants receive regular medical care in the diabetes clinic
Behavioral: ABC-ACC intervention
Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate
Other Name: Advanced carbohydrate counting with a bolus calculator

Active Comparator: Standard dietary education
The routine outpatient dietary care consists of three individual consultations delivered by a trained dietitian. The individual guidance is based on the overall treatment goal(s), the defined personal dietary goals for behavioral change which will be in accordance with the patient's needs and preferences. In addition to the dietary counselling, the participants receive regular medical care in the diabetes clinic
Behavioral: Standard dietary education
Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences
Other Name: Routine dietary care




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 (%)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623113


Contacts
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Contact: Bettina Ewers, MSc +45 30912997 bettina.ewers@regionh.dk
Contact: Henrik U Andersen, MD DMSc +45 30912850 henrik.ullits.andersen@regionh.dk

Locations
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Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, DK-2820
Contact: Bettina Ewers, MSc    0045 30912997    bettina.ewers@regionh.dk   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
University of Copenhagen
Investigators
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Principal Investigator: Bettina Ewers, MSc Steno Diabetes Center Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bettina Ewers, Head of Nutrition, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT03623113     History of Changes
Other Study ID Numbers: H-18014897
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bettina Ewers, Steno Diabetes Center Copenhagen:
Carbohydrate counting
Basic carbohydrate counting
Advanced carbohydrate counting
Carbohydrates
Diet
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases