search
Back to results

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

Primary Purpose

Type1diabetes, Type1 Diabetes Mellitus, Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
BCC intervention
ABC-ACC intervention
Standard dietary education
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type1diabetes focused on measuring Carbohydrate counting, Basic carbohydrate counting, Advanced carbohydrate counting, Carbohydrates, Diet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Steno Diabetes Center Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

BCC intervention

ABC-ACC intervention

Standard dietary education

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in HbA1c
mmol/mol
Change in mean amplitude of glycaemic excursions (MAGE)
mmol/l

Secondary Outcome Measures

Change in HbA1c
mmol/mol
Change in body weight
kg
Change in low-density lipoprotein cholesterol (LDL-C)
mmol/l
Change in high-density cholesterol (HDL-C)
mmol/l
Change in total cholesterol (TC)
mmol/l
Change in free fatty acids (FFA)
mmol/l
Change in triglycerides (TG)
mmol/l
Change in systolic blood pressure
mm Hg
Change in diastolic blood pressure
mm Hg
Change in waist circumference
cm
Change in hip circumference
cm
Change in total fat free mass
gram
Change in total fat mass
gram
Change in time in range (3.9-10.0 mmol/l)
Percent (%)
Changes in % time spent in hypoglycaemia (<3.9 mmol/l)
Percent (%)
Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l)
Percent (%)
Change in standard deviation of mean plasma glucose
mmol/l
Change in mathematical literacy
Total score or percent (%)
Change in carbohydrate estimation accuracy
Total score or percent (%)
Change in diet-related quality of life
Total score or percent (%)
Change in perceived competences in diabetes
Total score or percent (%)
Change in degree of autonomy-supportive dietitian
Total score or percent (%)
Change in total energy intake
kJ/day
Change in dietary intake of carbohydrates
gram/day or percent of total energy (E%)
Change in dietary intake of total fat
gram/day or percent of total energy (E%)
Change in dietary intake of saturated fatty acids (SFA)
gram/day or percent of total energy (E%)
Change in dietary intake of monounsaturated fatty acids (MUFA)
gram/day or percent of total energy (E%)
Change in dietary intake of polyunsaturated fatty acids (PUFA)
gram/day or percent of total energy (E%)
Change in dietary intake of protein
gram/day or percent of total energy (E%)
Change in dietary intake of added sugar
gram/day or percent of total energy (E%)
Change in intake of dietary fibre
gram/day or g/MJ

Full Information

First Posted
July 19, 2018
Last Updated
January 16, 2023
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT03623113
Brief Title
The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention) 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes, Type1 Diabetes Mellitus, Glucose Metabolism Disorders
Keywords
Carbohydrate counting, Basic carbohydrate counting, Advanced carbohydrate counting, Carbohydrates, Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCC intervention
Arm Type
Experimental
Arm Description
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
Arm Title
ABC-ACC intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Standard dietary education
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
BCC intervention
Other Intervention Name(s)
Basic carbohydrate counting
Intervention Description
Structured training and education i basic carbohydrate counting principles
Intervention Type
Behavioral
Intervention Name(s)
ABC-ACC intervention
Other Intervention Name(s)
Advanced carbohydrate counting with a bolus calculator
Intervention Description
Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate
Intervention Type
Behavioral
Intervention Name(s)
Standard dietary education
Other Intervention Name(s)
Routine dietary care
Intervention Description
Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
mmol/mol
Time Frame
Baseline, 6 months
Title
Change in mean amplitude of glycaemic excursions (MAGE)
Description
mmol/l
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in HbA1c
Description
mmol/mol
Time Frame
12 months
Title
Change in body weight
Description
kg
Time Frame
Baseline, 6 months, 12 months
Title
Change in low-density lipoprotein cholesterol (LDL-C)
Description
mmol/l
Time Frame
Baseline, 6 months, 12 months
Title
Change in high-density cholesterol (HDL-C)
Description
mmol/l
Time Frame
Baseline, 6 months, 12 months
Title
Change in total cholesterol (TC)
Description
mmol/l
Time Frame
Baseline, 6 months, 12 months
Title
Change in free fatty acids (FFA)
Description
mmol/l
Time Frame
Baseline, 6 months, 12 months
Title
Change in triglycerides (TG)
Description
mmol/l
Time Frame
Baseline, 6 months, 12 months
Title
Change in systolic blood pressure
Description
mm Hg
Time Frame
Baseline, 6 months, 12 months
Title
Change in diastolic blood pressure
Description
mm Hg
Time Frame
Baseline, 6 months, 12 months
Title
Change in waist circumference
Description
cm
Time Frame
Baseline, 6 months, 12 months
Title
Change in hip circumference
Description
cm
Time Frame
Baseline, 6 months, 12 months
Title
Change in total fat free mass
Description
gram
Time Frame
Baseline, 6 months
Title
Change in total fat mass
Description
gram
Time Frame
Baseline, 6 months
Title
Change in time in range (3.9-10.0 mmol/l)
Description
Percent (%)
Time Frame
Baseline, 6 months
Title
Changes in % time spent in hypoglycaemia (<3.9 mmol/l)
Description
Percent (%)
Time Frame
Baseline, 6 months
Title
Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l)
Description
Percent (%)
Time Frame
Baseline, 6 months
Title
Change in standard deviation of mean plasma glucose
Description
mmol/l
Time Frame
Baseline, 6 months
Title
Change in mathematical literacy
Description
Total score or percent (%)
Time Frame
Baseline, 6 months, 12 months
Title
Change in carbohydrate estimation accuracy
Description
Total score or percent (%)
Time Frame
Baseline, 6 months, 12 months
Title
Change in diet-related quality of life
Description
Total score or percent (%)
Time Frame
Baseline, 6 months, 12 months
Title
Change in perceived competences in diabetes
Description
Total score or percent (%)
Time Frame
Baseline, 6 months, 12 months
Title
Change in degree of autonomy-supportive dietitian
Description
Total score or percent (%)
Time Frame
Baseline, 6 months, 12 months
Title
Change in total energy intake
Description
kJ/day
Time Frame
Baseline, 6 months
Title
Change in dietary intake of carbohydrates
Description
gram/day or percent of total energy (E%)
Time Frame
Baseline, 6 months
Title
Change in dietary intake of total fat
Description
gram/day or percent of total energy (E%)
Time Frame
Baseline, 6 months
Title
Change in dietary intake of saturated fatty acids (SFA)
Description
gram/day or percent of total energy (E%)
Time Frame
Baseline, 6 months
Title
Change in dietary intake of monounsaturated fatty acids (MUFA)
Description
gram/day or percent of total energy (E%)
Time Frame
Baseline, 6 months
Title
Change in dietary intake of polyunsaturated fatty acids (PUFA)
Description
gram/day or percent of total energy (E%)
Time Frame
Baseline, 6 months
Title
Change in dietary intake of protein
Description
gram/day or percent of total energy (E%)
Time Frame
Baseline, 6 months
Title
Change in dietary intake of added sugar
Description
gram/day or percent of total energy (E%)
Time Frame
Baseline, 6 months
Title
Change in intake of dietary fibre
Description
gram/day or g/MJ
Time Frame
Baseline, 6 months
Other Pre-specified Outcome Measures:
Title
Change in physical activity level
Description
Total score or percent (%)
Time Frame
Baseline, 6 months, 12 months
Title
Change in urinary biomarkers of carbohydrate intake
Description
Percent (%)
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Ewers, MSc
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Gentofte
ZIP/Postal Code
DK-2820
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31481560
Citation
Ewers B, Vilsboll 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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs