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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

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

Intervention / Treatment
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* Behavioral: Standard nutritional education
* Behavioral: Basic carbohydrate counting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbohydrates, basic carbohydrate counting, diet, type 2 diabetes