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

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

Sponsors

Lead Sponsor: Steno Diabetes Center Copenhagen

Collaborator: University of Copenhagen

Source Steno Diabetes Center Copenhagen
Brief 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.

Detailed 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).

Overall Status Recruiting
Start Date September 28, 2018
Completion Date October 31, 2021
Primary Completion Date October 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in HbA1c Baseline, 6 months
Change in mean amplitude of glycaemic excursions (MAGE) Baseline, 6 months
Secondary Outcome
Measure Time Frame
Change in HbA1c 12 months
Change in body weight Baseline, 6 months, 12 months
Change in low-density lipoprotein cholesterol (LDL-C) Baseline, 6 months, 12 months
Change in high-density cholesterol (HDL-C) Baseline, 6 months, 12 months
Change in total cholesterol (TC) Baseline, 6 months, 12 months
Change in free fatty acids (FFA) Baseline, 6 months, 12 months
Change in triglycerides (TG) Baseline, 6 months, 12 months
Change in systolic blood pressure Baseline, 6 months, 12 months
Change in diastolic blood pressure Baseline, 6 months, 12 months
Change in waist circumference Baseline, 6 months, 12 months
Change in hip circumference Baseline, 6 months, 12 months
Change in total fat free mass Baseline, 6 months
Change in total fat mass Baseline, 6 months
Change in time in range (3.9-10.0 mmol/l) Baseline, 6 months
Changes in % time spent in hypoglycaemia (<3.9 mmol/l) Baseline, 6 months
Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l) Baseline, 6 months
Change in standard deviation of mean plasma glucose Baseline, 6 months
Change in mathematical literacy Baseline, 6 months, 12 months
Change in carbohydrate estimation accuracy Baseline, 6 months, 12 months
Change in diet-related quality of life Baseline, 6 months, 12 months
Change in perceived competences in diabetes Baseline, 6 months, 12 months
Change in degree of autonomy-supportive dietitian Baseline, 6 months, 12 months
Change in total energy intake Baseline, 6 months
Change in dietary intake of carbohydrates Baseline, 6 months
Change in dietary intake of total fat Baseline, 6 months
Change in dietary intake of saturated fatty acids (SFA) Baseline, 6 months
Change in dietary intake of monounsaturated fatty acids (MUFA) Baseline, 6 months
Change in dietary intake of polyunsaturated fatty acids (PUFA) Baseline, 6 months
Change in dietary intake of protein Baseline, 6 months
Change in dietary intake of added sugar Baseline, 6 months
Change in intake of dietary fibre Baseline, 6 months
Enrollment 231
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: BCC intervention

Description: Structured training and education i basic carbohydrate counting principles

Arm Group Label: BCC intervention

Other Name: Basic carbohydrate counting

Intervention Type: Behavioral

Intervention Name: ABC-ACC intervention

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

Arm Group Label: ABC-ACC intervention

Other Name: Advanced carbohydrate counting with a bolus calculator

Intervention Type: Behavioral

Intervention Name: Standard dietary education

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

Arm Group Label: Standard dietary education

Other Name: Routine dietary care

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bettina Ewers, MSc Principal Investigator Steno Diabetes Center Copenhagen
Overall Contact

Last Name: Bettina Ewers, MSc

Phone: +45 30912997

Email: [email protected]

Location
Facility: Status: Contact: Steno Diabetes Center Copenhagen Bettina Ewers, MSc 0045 30912997 [email protected]
Location Countries

Denmark

Verification Date

September 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Steno Diabetes Center Copenhagen

Investigator Full Name: Bettina Ewers

Investigator Title: Head of Nutrition

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: BCC intervention

Type: Experimental

Description: The BCC program consists of three group sessions and is delivered by two trained dietitians. In addition to the BCC program, the participants receive regular medical care in the diabetes clinic

Label: ABC-ACC intervention

Type: Experimental

Description: The ABC-ACC program consists of one group session and two individual follow-up sessions and is delivered by trained dietitians with supervision by a medical doctor. In addition to the ABC-ACC program, the participants receive regular medical care in the diabetes clinic

Label: Standard dietary education

Type: Active Comparator

Description: The routine outpatient dietary care consists of three individual consultations delivered by a trained dietitian. The individual guidance is based on the overall treatment goal(s), the defined personal dietary goals for behavioral change which will be in accordance with the patient's needs and preferences. In addition to the dietary counselling, the participants receive regular medical care in the diabetes clinic

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov