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

Steno Diabetes Center Copenhagen48 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type2 Diabetes Diabetes Mellitus, Type 2

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.

Basic carbohydrate countingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Steno Diabetes Center Copenhagen

Herlev, Denmark

Outcomes

Primary Outcomes

Change in HbA1c

mmol/mol

Time frame: Baseline, 6 months

Change in mean amplitude of glycaemic excursions (MAGE)

mmol/l

Time frame: Baseline, 6 months

Secondary Outcomes

Change in HbA1c

mmol/mol

Time frame: 12 months

Change in body weight

Time frame: Baseline, 6 months, 12 months

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

mmol/l

Time frame: Baseline, 6 months, 12 months

Change in high-density cholesterol (HDL-C)

mmol/l

Time frame: Baseline, 6 months, 12 months

Change in total cholesterol (TC)

mmol/l

Time frame: Baseline, 6 months, 12 months

Change in free fatty acids (FFA)

mmol/l

Time frame: Baseline, 6 months, 12 months

Change in triglycerides (TG)

mmol/l

Time frame: Baseline, 6 months, 12 months

Change in diastolic blood pressure

mm Hg

Time frame: Baseline, 6 months, 12 months

Change in systolic blood pressure

mm Hg

Time frame: Baseline, 6 months, 12 months

Change in waist circumference

Time frame: Baseline, 6 months, 12 months

Change in hip circumference

Time frame: Baseline, 6 months, 12 months

Change in total fat free mass

gram

Time frame: Baseline, 6 months

Change in total fat mass

gram

Time frame: Baseline, 6 months

Change in time in range (3.9-10.0 mmol/l)

percent (%)

Time frame: Baseline, 6 months

Changes in time spent in hypoglycaemia (<3.9 mmol/l)

percent (%)

Time frame: Baseline, 6 months

Change time spent in hyperglycaemia (e.g. >11.1 mmol/l)

percent (%)

Time frame: Baseline, 6 months

Change in standard deviation of mean plasma glucose

mmol/l

Time frame: Baseline, 6 months

Change in mathematical literacy

total score or percent (%)

Time frame: Baseline, 6 months, 12 months

Change in carbohydrate estimation accuracy

total score or %

Time frame: Baseline, 6 months, 12 months

Change in diet-related quality of life

total score or percent (%)

Time frame: Baseline, 6 months, 12 months

Change in perceived competences in diabetes

total score or percent (%)

Time frame: Baseline, 6 months, 12 months

Change in degree of autonomy-supportive dietitian

total score or percent (%)

Time frame: Baseline, 6 months, 12 months

Change in total energy intake

kJ/day

Time frame: Baseline, 6 months

Change in dietary intake of carbohydrates

gram/day or percent of total energy (E%)

Time frame: Baseline, 6 months

Change in dietary intake of total fat

gram/day or percent of total energy (E%)

Time frame: Baseline, 6 months

Change in dietary intake of saturated fatty acids (SFA)

gram/day or percent of total energy (E%)

Time frame: Baseline, 6 months

Change in dietary intake of monounsaturated fatty acids (MUFA)

gram/day or percent of total energy (E%)

Time frame: Baseline, 6 months

Change in dietary intake of polyunsaturated fatty acids (PUFA)

gram/day or percent of total energy (E%)

Time frame: Baseline, 6 months

Change in dietary intake of protein

gram/day or percent of total energy (E%)

Time frame: Baseline, 6 months

Change in dietary intake of added sugar

gram/day , % of total energy or %

Time frame: Baseline, 6 months

Change in intake of dietary fibre

gram/day or g/MJ

Time frame: Baseline, 6 months

Data from ClinicalTrials.gov

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