Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2Glucose Metabolism DisordersType2 Diabetes
- Interventions
- Behavioral: Standard nutritional educationBehavioral: Basic carbohydrate counting
- Registration Number
- NCT03623139
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard nutritional education Standard nutritional education Control group BCC Basic carbohydrate counting Education and training i basic carbohydrate counting (BCC) plus standard nutritional education
- Primary Outcome Measures
Name Time Method Change in mean amplitude of glycaemic excursions (MAGE) Baseline, 6 months mmol/l
Change in HbA1c Baseline, 6 months mmol/mol
- Secondary Outcome Measures
Name Time Method Change in mathematical literacy Baseline, 6 months, 12 months total score or percent (%)
Change in intake of dietary fibre Baseline, 6 months gram/day or g/MJ
Change in body weight Baseline, 6 months, 12 months kg
Change in low-density lipoprotein cholesterol (LDL-C) Baseline, 6 months, 12 months mmol/l
Change in total cholesterol (TC) Baseline, 6 months, 12 months mmol/l
Change in diastolic blood pressure Baseline, 6 months, 12 months mm Hg
Change in systolic blood pressure Baseline, 6 months, 12 months mm Hg
Change in waist circumference Baseline, 6 months, 12 months cm
Change in HbA1c 12 months mmol/mol
Changes in time spent in hypoglycaemia (<3.9 mmol/l) Baseline, 6 months percent (%)
Change in dietary intake of carbohydrates Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of monounsaturated fatty acids (MUFA) Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of polyunsaturated fatty acids (PUFA) Baseline, 6 months gram/day or percent of total energy (E%)
Change in triglycerides (TG) Baseline, 6 months, 12 months mmol/l
Change in standard deviation of mean plasma glucose Baseline, 6 months mmol/l
Change in carbohydrate estimation accuracy Baseline, 6 months, 12 months total score or %
Change in degree of autonomy-supportive dietitian Baseline, 6 months, 12 months total score or percent (%)
Change in total energy intake Baseline, 6 months kJ/day
Change in high-density cholesterol (HDL-C) Baseline, 6 months, 12 months mmol/l
Change in free fatty acids (FFA) Baseline, 6 months, 12 months mmol/l
Change in hip circumference Baseline, 6 months, 12 months cm
Change in total fat mass Baseline, 6 months gram
Change in time in range (3.9-10.0 mmol/l) Baseline, 6 months percent (%)
Change time spent in hyperglycaemia (e.g. >11.1 mmol/l) Baseline, 6 months percent (%)
Change in perceived competences in diabetes Baseline, 6 months, 12 months total score or percent (%)
Change in dietary intake of saturated fatty acids (SFA) Baseline, 6 months gram/day or percent of total energy (E%)
Change in total fat free mass Baseline, 6 months gram
Change in diet-related quality of life Baseline, 6 months, 12 months total score or percent (%)
Change in dietary intake of total fat Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of protein Baseline, 6 months gram/day or percent of total energy (E%)
Change in dietary intake of added sugar Baseline, 6 months gram/day , % of total energy or %
Trial Locations
- Locations (1)
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Denmark