Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes
NCT ID: NCT03623139
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2018-09-28
2022-08-16
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard nutritional education
Control group
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.
BCC
Education and training i basic carbohydrate counting (BCC) plus standard nutritional education
Basic carbohydrate counting
The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.
Interventions
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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.
Basic carbohydrate counting
The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Bettina Ewers
Head of nutrition, MSc
Principal Investigators
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Bettina Ewers, MSc
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center Copenhagen
Herlev, , Denmark
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H-18014918
Identifier Type: -
Identifier Source: org_study_id
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