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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

Tracking Information
First Submitted Date  ICMJE July 19, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date October 1, 2018
Actual Study Start Date  ICMJE September 28, 2018
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Change in HbA1c [ Time Frame: Baseline, 6 months ]
    mmol/mol
  • Change in mean amplitude of glycaemic excursions (MAGE) [ Time Frame: Baseline, 6 months ]
    mmol/l
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03623113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • Change in HbA1c [ Time Frame: 12 months ]
    mmol/mol
  • Change in body weight [ Time Frame: Baseline, 6 months, 12 months ]
    kg
  • Change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in high-density cholesterol (HDL-C) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in total cholesterol (TC) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in free fatty acids (FFA) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in triglycerides (TG) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in systolic blood pressure [ Time Frame: Baseline, 6 months, 12 months ]
    mm Hg
  • Change in diastolic blood pressure [ Time Frame: Baseline, 6 months, 12 months ]
    mm Hg
  • Change in waist circumference [ Time Frame: Baseline, 6 months, 12 months ]
    cm
  • Change in hip circumference [ Time Frame: Baseline, 6 months, 12 months ]
    cm
  • Change in total fat free mass [ Time Frame: Baseline, 6 months ]
    gram
  • Change in total fat mass [ Time Frame: Baseline, 6 months ]
    gram
  • Change in time in range (3.9-10.0 mmol/l) [ Time Frame: Baseline, 6 months ]
    Percent (%)
  • Changes in % time spent in hypoglycaemia (<3.9 mmol/l) [ Time Frame: Baseline, 6 months ]
    Percent (%)
  • Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l) [ Time Frame: Baseline, 6 months ]
    Percent (%)
  • Change in standard deviation of mean plasma glucose [ Time Frame: Baseline, 6 months ]
    mmol/l
  • Change in mathematical literacy [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in carbohydrate estimation accuracy [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in diet-related quality of life [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in perceived competences in diabetes [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in degree of autonomy-supportive dietitian [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in total energy intake [ Time Frame: Baseline, 6 months ]
    kJ/day
  • Change in dietary intake of carbohydrates [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of total fat [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of saturated fatty acids (SFA) [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of monounsaturated fatty acids (MUFA) [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of polyunsaturated fatty acids (PUFA) [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of protein [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of added sugar [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in intake of dietary fibre [ Time Frame: Baseline, 6 months ]
    gram/day or g/MJ
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Change in HbA1c [ Time Frame: 12 months ]
    mmol/mol
  • Change in body weight [ Time Frame: Baseline, 6 months, 12 months ]
    kg
  • Change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in high-density cholesterol (HDL-C) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in total cholesterol (TC) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in free fatty acids (FFA) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in triglycerides (TG) [ Time Frame: Baseline, 6 months, 12 months ]
    mmol/l
  • Change in systolic blood pressure [ Time Frame: Baseline, 6 months, 12 months ]
    mm Hg
  • Change in diastolic blood pressure [ Time Frame: Baseline, 6 months, 12 months ]
    mm Hg
  • Change in waist circumference [ Time Frame: Baseline, 6 months, 12 months ]
    cm
  • Change in hip circumference [ Time Frame: Baseline, 6 months, 12 months ]
    cm
  • Change in total fat free mass [ Time Frame: Baseline, 6 months ]
    gram
  • Change in total fat mass [ Time Frame: Baseline, 6 months ]
    gram
  • Change in time in range (3.9-10.0 mmol/l) [ Time Frame: Baseline, 6 months ]
    Percent (%)
  • Changes in % time spent in hypoglycaemia (<3.9 mmol/l) [ Time Frame: Baseline, 6 months ]
    Percent (%)
  • Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l) [ Time Frame: Baseline, 6 months ]
    Percent (%)
  • Change in standard deviation of mean plasma glucose [ Time Frame: Baseline, 6 months ]
    mmol/l
  • Change in mathematical literacy [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in carbohydrate estimation accuracy [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in diet-related quality of life [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in perceived competences in diabetes [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in degree of autonomy-supportive dietitian [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in total energy intake [ Time Frame: Baseline, 6 months ]
    kJ/day
  • Change in dietary intake of carbohydrates [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of total fat [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of saturated fatty acids (SFA) [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of monounsaturated fatty acids (MUFA) [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of polyunsaturated fatty acids (PUFA) [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of protein [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in dietary intake of added sugar [ Time Frame: Baseline, 6 months ]
    gram/day or percent of total energy (E%)
  • Change in intake of dietary fibre [ Time Frame: Baseline, 6 months ]
    gram/day or g/MJ
  • Change in urinary biomarker of carbohydrate intake [ Time Frame: Baseline, 6 months ]
    Percent (%)
Current Other Pre-specified Outcome Measures
 (submitted: August 9, 2018)
  • Change in physical activity level [ Time Frame: Baseline, 6 months, 12 months ]
    Total score or percent (%)
  • Change in urinary biomarkers of carbohydrate intake [ Time Frame: Baseline, 6 months ]
    Percent (%)
Original Other Pre-specified Outcome Measures
 (submitted: August 7, 2018)
Change in physical activity level [ Time Frame: Baseline, 6 months, 12 months ]
Total score or percent (%)
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type1diabetes
  • Type1 Diabetes Mellitus
  • Glucose Metabolism Disorders
Intervention  ICMJE
  • Behavioral: BCC intervention
    Structured training and education i basic carbohydrate counting principles
    Other Name: Basic carbohydrate counting
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: BCC intervention
  • 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
    Intervention: Behavioral: ABC-ACC intervention
  • 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
    Intervention: Behavioral: Standard dietary education
Publications * Ewers B, Vilsbøll T, Andersen HU, Bruun JM. 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. BMJ Open. 2019 Sep 3;9(9):e029859. doi: 10.1136/bmjopen-2019-029859.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
231
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bettina Ewers, MSc +45 30912997 bettina.ewers@regionh.dk
Contact: Henrik U Andersen, MD DMSc +45 30912850 henrik.ullits.andersen@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623113
Other Study ID Numbers  ICMJE H-18014897
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bettina Ewers, Steno Diabetes Center Copenhagen
Study Sponsor  ICMJE Steno Diabetes Center Copenhagen
Collaborators  ICMJE University of Copenhagen
Investigators  ICMJE
Principal Investigator: Bettina Ewers, MSc Steno Diabetes Center Copenhagen
PRS Account Steno Diabetes Center Copenhagen
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP