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

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)

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.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Type2 Diabetes
• Intervention / Treatment: Behavioral: Standard nutritional education; Behavioral: Basic carbohydrate counting

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).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bettina Ewers, MSc; Phone Number: +45 30912997; Email: bettina.ewers@regionh.dk
• Study Contact Backup: Name: Tina Vilsboell, DMSc; Email: tina.vilsboell.lauritsen.01@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, DK-2730
    • Steno Diabetes Center Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard nutritional education; Control group	Behavioral: Standard nutritional education; 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.; Other Names: Routine dietary care in type 2 diabetes
Experimental: BCC; Education and training i basic carbohydrate counting (BCC) plus standard nutritional education	Behavioral: Basic carbohydrate counting; The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.; Other Names: Education in BCC in addition to standard dietary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	mmol/mol	Baseline, 6 months
Change in mean amplitude of glycaemic excursions (MAGE)	mmol/l	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	mmol/mol	12 months
Change in body weight	kg	Baseline, 6 months, 12 months
Change in low-density lipoprotein cholesterol (LDL-C)	mmol/l	Baseline, 6 months, 12 months
Change in high-density cholesterol (HDL-C)	mmol/l	Baseline, 6 months, 12 months
Change in total cholesterol (TC)	mmol/l	Baseline, 6 months, 12 months
Change in free fatty acids (FFA)	mmol/l	Baseline, 6 months, 12 months
Change in triglycerides (TG)	mmol/l	Baseline, 6 months, 12 months
Change in diastolic blood pressure	mm Hg	Baseline, 6 months, 12 months
Change in systolic blood pressure	mm Hg	Baseline, 6 months, 12 months
Change in waist circumference	cm	Baseline, 6 months, 12 months
Change in hip circumference	cm	Baseline, 6 months, 12 months
Change in total fat free mass	gram	Baseline, 6 months
Change in total fat mass	gram	Baseline, 6 months
Change in time in range (3.9-10.0 mmol/l)	percent (%)	Baseline, 6 months
Changes in time spent in hypoglycaemia (<3.9 mmol/l)	percent (%)	Baseline, 6 months
Change time spent in hyperglycaemia (e.g. >11.1 mmol/l)	percent (%)	Baseline, 6 months
Change in standard deviation of mean plasma glucose	mmol/l	Baseline, 6 months
Change in mathematical literacy	total score or percent (%)	Baseline, 6 months, 12 months
Change in carbohydrate estimation accuracy	total score or %	Baseline, 6 months, 12 months
Change in diet-related quality of life	total score or percent (%)	Baseline, 6 months, 12 months
Change in perceived competences in diabetes	total score or percent (%)	Baseline, 6 months, 12 months
Change in degree of autonomy-supportive dietitian	total score or percent (%)	Baseline, 6 months, 12 months
Change in total energy intake	kJ/day	Baseline, 6 months
Change in dietary intake of carbohydrates	gram/day or percent of total energy (E%)	Baseline, 6 months
Change in dietary intake of total fat	gram/day or percent of total energy (E%)	Baseline, 6 months
Change in dietary intake of saturated fatty acids (SFA)	gram/day or percent of total energy (E%)	Baseline, 6 months
Change in dietary intake of monounsaturated fatty acids (MUFA)	gram/day or percent of total energy (E%)	Baseline, 6 months
Change in dietary intake of polyunsaturated fatty acids (PUFA)	gram/day or percent of total energy (E%)	Baseline, 6 months
Change in dietary intake of protein	gram/day or percent of total energy (E%)	Baseline, 6 months
Change in dietary intake of added sugar	gram/day , % of total energy or %	Baseline, 6 months
Change in intake of dietary fibre	gram/day or g/MJ	Baseline, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity level	total score or percent (%)	Baseline, 6 months, 12 months
Change in urinary biomarkers of carbohydrate intake	percent (%)	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Bettina Ewers, MSc, Steno Diabetes Center Copenhagen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 16, 2022

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: type 2 diabetes; diet; carbohydrates; basic carbohydrate counting
• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: H-18014918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No