The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

Steno Diabetes Center Copenhagen63 enrolled

Overview

The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes: 1. The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention) 2. The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention) The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.

The current study is a randomized controlled trial with a parallel-group design. A total of 231 patients will be enrolled in the trial. Participants will be randomized to one of three arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an automated bolus calculator (ABC-ACC), or 3) Standard dietary care. The primary objective is to evaluate the six months effects of education in the BCC concept and the ABC-ACC 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

Type1diabetes

Interventions

BCC interventionBEHAVIORAL

Structured training and education i basic carbohydrate counting principles

ABC-ACC interventionBEHAVIORAL

Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate

Standard dietary educationBEHAVIORAL

Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes * Diabetes duration; \>12 months * HbA1c of 53-97 mmol/mol * Multiple daily insulin injection therapy * 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 * Use of insulin pump, or plans of having an insulin pump within the study period * Fixed dose of rapid acting insulin therapy for meals * Split-mixed insulin therapy * Use of open CGM * Use of Freestyle Libre * Use of an automated bolus calculator * Gastroparesis * Pregnancy or breastfeeding, or plans of pregnancy within the study period * Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator * Uncontrolled medical issues, as judged by the investigator or a medical expert * Concomitant participation in other clinical studies * Unable to understand the informed consent and the study procedures

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 systolic blood pressure

mm Hg

Time frame: Baseline, 6 months, 12 months

Change in diastolic 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 percent (%)

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 or percent of total energy (E%)

Time frame: Baseline, 6 months

Change in intake of dietary fibre

gram/day or g/MJ

Time frame: Baseline, 6 months

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes