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Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes

Primary Purpose

Type2 Diabetes, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Standard nutritional education
Basic carbohydrate counting
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring carbohydrates, basic carbohydrate counting, diet, type 2 diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • Type 2 diabetes
  • Diabetes duration; from >12 months
  • HbA1c between 53 and 97 mmol/mol
  • Diet or any glucose-lowering medication
  • 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
  • Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
  • Use of open CGM
  • Use of a Free Libre device
  • Use of an automated bolus calculator for carbohydrate counting, as judged by the investigator
  • Gastroparesis
  • Pregnancy or breastfeeding, or plans of pregnancy within the study period
  • Uncontrolled medical issues, as judged by the investigator
  • 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 Type

Active Comparator

Experimental

Arm Label

Standard nutritional education

BCC

Arm Description

Control group

Education and training i basic carbohydrate counting (BCC) plus standard nutritional education

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 diastolic blood pressure
mm Hg
Change in systolic 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 %
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 , % of total energy or %
Change in intake of dietary fibre
gram/day or g/MJ

Full Information

First Posted
July 18, 2018
Last Updated
April 25, 2023
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03623139
Brief Title
Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes
Official Title
Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education: A Randomized Controlled Trial Focusing on HbA1c and Glucose Variability in Patients With Type 2 Diabetes (The BCC Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
August 16, 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 aim of the study is to examine the health benefits of adding a concept in basic carbohydrate counting (BCC) to the routine outpatient nutritional education for adult patients with type 2 diabetes. The study hypothesis is that training and education in the BCC concept will improve glycaemic control either by reducing HbA1c or the average plasma glucose variability more than offering the routine dietary care as a stand-alone dietary treatment.
Detailed Description
The trial has a parallel-group design with a study duration of 48 weeks for each participant (a 6-month intervention period and a 6-month follow-up period). A total of 226 patients will be enrolled in the trial. Participants will be randomized to one of two arms: 1) Standard medical and dietary care (control group) or 2) Structured training and education in the BCC concept in addition to standard medical and dietary care. The primary objective is to evaluate the six months effect of structured training and education in the BCC 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
Type2 Diabetes, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
Keywords
carbohydrates, basic carbohydrate counting, diet, type 2 diabetes

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Standard nutritional education
Arm Type
Active Comparator
Arm Description
Control group
Arm Title
BCC
Arm Type
Experimental
Arm Description
Education and training i basic carbohydrate counting (BCC) plus standard nutritional education
Intervention Type
Behavioral
Intervention Name(s)
Standard nutritional education
Other Intervention Name(s)
Routine dietary care in type 2 diabetes
Intervention Description
Routine dietary care consists of three individual consultations with a trained dietitian. The individual guidance will be in accordance with the dietary guidelines in type 2 diabetes.
Intervention Type
Behavioral
Intervention Name(s)
Basic carbohydrate counting
Other Intervention Name(s)
Education in BCC in addition to standard dietary care
Intervention Description
The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.
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 diastolic blood pressure
Description
mm Hg
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 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 %
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 , % of total energy or %
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 2 diabetes Diabetes duration; from >12 months HbA1c between 53 and 97 mmol/mol Diet or any glucose-lowering medication 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 Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator Use of open CGM Use of a Free Libre device Use of an automated bolus calculator for carbohydrate counting, as judged by the investigator Gastroparesis Pregnancy or breastfeeding, or plans of pregnancy within the study period Uncontrolled medical issues, as judged by the investigator 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
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31753900
Citation
Ewers B, Bruun JM, Vilsboll T. Effects of basic carbohydrate counting versus standard outpatient nutritional education (The BCC Study): study protocol for a randomised, parallel open-label, intervention study focusing on HbA1c and glucose variability in patients with type 2 diabetes. BMJ Open. 2019 Nov 21;9(11):e032893. doi: 10.1136/bmjopen-2019-032893.
Results Reference
derived

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Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes

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