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

Steno Diabetes Centers

Status: Completed

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

Treatments: Behavioral: Basic carbohydrate counting; Behavioral: Standard nutritional education

Study type: Interventional

Funder types: Other

Identifiers

NCT03623139

H-18014918

Details and patient eligibility

About

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.

Full 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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Standard nutritional education

Active Comparator group

Description:

Control group

Treatment:

Behavioral: Standard nutritional education

BCC

Experimental group

Description:

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

Treatment:

Behavioral: Basic carbohydrate counting