NCT03623139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2022

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

3.9 years

First QC Date

July 18, 2018

Last Update Submit

April 25, 2023

Conditions

Type2 DiabetesDiabetes Mellitus, Type 2Glucose Metabolism Disorders

Keywords

carbohydratesbasic carbohydrate countingdiettype 2 diabetes

Outcome Measures

Primary Outcomes (2)

  • Change in HbA1c

    mmol/mol

    Baseline, 6 months

  • Change in mean amplitude of glycaemic excursions (MAGE)

    mmol/l

    Baseline, 6 months

Secondary Outcomes (31)

  • Change in HbA1c

    12 months

  • Change in body weight

    Baseline, 6 months, 12 months

  • Change in low-density lipoprotein cholesterol (LDL-C)

    Baseline, 6 months, 12 months

  • Change in high-density cholesterol (HDL-C)

    Baseline, 6 months, 12 months

  • Change in total cholesterol (TC)

    Baseline, 6 months, 12 months

  • +26 more secondary outcomes

Other Outcomes (2)

  • Change in physical activity level

    Baseline, 6 months, 12 months

  • Change in urinary biomarkers of carbohydrate intake

    Baseline, 6 months

Study Arms (2)

Standard nutritional education

ACTIVE COMPARATOR

Control group

Behavioral: Standard nutritional education

BCC

EXPERIMENTAL

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

Behavioral: Basic carbohydrate counting

Interventions

Standard nutritional educationBEHAVIORAL

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.

Also known as: Routine dietary care in type 2 diabetes
Standard nutritional education
Basic carbohydrate countingBEHAVIORAL

The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.

Also known as: Education in BCC in addition to standard dietary care
BCC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, DK-2730, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 31753900DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose Metabolism Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Bettina Ewers, MSc

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of nutrition, MSc

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 9, 2018

Study Start

September 28, 2018

Primary Completion

August 16, 2022

Study Completion

August 16, 2022

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)