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

Type1diabetes Clinical Trial

Official title:

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study): A Randomized, Parallel, Open-label, Intervention Study Comparing Different Approaches to Dietary Self-management in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623113
• Other study ID #: H-18014897
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: August 17, 2022

Study information

• Verified date: January 2024
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Glucose Metabolism Disorders
• Metabolic Diseases
• Type1 Diabetes Mellitus
• Type1diabetes

Intervention

Behavioral:
• BCC intervention
Structured training and education i basic carbohydrate counting principles
• ABC-ACC intervention
Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate
• Standard dietary education
Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical activity level	Total score or percent (%)	Baseline, 6 months, 12 months
Other	Change in urinary biomarkers of carbohydrate intake	Percent (%)	Baseline, 6 months
Primary	Change in HbA1c	mmol/mol	Baseline, 6 months
Primary	Change in mean amplitude of glycaemic excursions (MAGE)	mmol/l	Baseline, 6 months
Secondary	Change in HbA1c	mmol/mol	12 months
Secondary	Change in body weight	kg	Baseline, 6 months, 12 months
Secondary	Change in low-density lipoprotein cholesterol (LDL-C)	mmol/l	Baseline, 6 months, 12 months
Secondary	Change in high-density cholesterol (HDL-C)	mmol/l	Baseline, 6 months, 12 months
Secondary	Change in total cholesterol (TC)	mmol/l	Baseline, 6 months, 12 months
Secondary	Change in free fatty acids (FFA)	mmol/l	Baseline, 6 months, 12 months
Secondary	Change in triglycerides (TG)	mmol/l	Baseline, 6 months, 12 months
Secondary	Change in systolic blood pressure	mm Hg	Baseline, 6 months, 12 months
Secondary	Change in diastolic blood pressure	mm Hg	Baseline, 6 months, 12 months
Secondary	Change in waist circumference	cm	Baseline, 6 months, 12 months
Secondary	Change in hip circumference	cm	Baseline, 6 months, 12 months
Secondary	Change in total fat free mass	gram	Baseline, 6 months
Secondary	Change in total fat mass	gram	Baseline, 6 months
Secondary	Change in time in range (3.9-10.0 mmol/l)	Percent (%)	Baseline, 6 months
Secondary	Changes in % time spent in hypoglycaemia (<3.9 mmol/l)	Percent (%)	Baseline, 6 months
Secondary	Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l)	Percent (%)	Baseline, 6 months
Secondary	Change in standard deviation of mean plasma glucose	mmol/l	Baseline, 6 months
Secondary	Change in mathematical literacy	Total score or percent (%)	Baseline, 6 months, 12 months
Secondary	Change in carbohydrate estimation accuracy	Total score or percent (%)	Baseline, 6 months, 12 months
Secondary	Change in diet-related quality of life	Total score or percent (%)	Baseline, 6 months, 12 months
Secondary	Change in perceived competences in diabetes	Total score or percent (%)	Baseline, 6 months, 12 months
Secondary	Change in degree of autonomy-supportive dietitian	Total score or percent (%)	Baseline, 6 months, 12 months
Secondary	Change in total energy intake	kJ/day	Baseline, 6 months
Secondary	Change in dietary intake of carbohydrates	gram/day or percent of total energy (E%)	Baseline, 6 months
Secondary	Change in dietary intake of total fat	gram/day or percent of total energy (E%)	Baseline, 6 months
Secondary	Change in dietary intake of saturated fatty acids (SFA)	gram/day or percent of total energy (E%)	Baseline, 6 months
Secondary	Change in dietary intake of monounsaturated fatty acids (MUFA)	gram/day or percent of total energy (E%)	Baseline, 6 months
Secondary	Change in dietary intake of polyunsaturated fatty acids (PUFA)	gram/day or percent of total energy (E%)	Baseline, 6 months
Secondary	Change in dietary intake of protein	gram/day or percent of total energy (E%)	Baseline, 6 months
Secondary	Change in dietary intake of added sugar	gram/day or percent of total energy (E%)	Baseline, 6 months
Secondary	Change in intake of dietary fibre	gram/day or g/MJ	Baseline, 6 months