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

NCT03623113 | Completed

• 1 other identifier: H-18014897
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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. 1.The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention)
2. 2.The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention)

Conditions

Type1diabetes; Type1 Diabetes Mellitus; Glucose Metabolism Disorders

Keywords

Carbohydrate counting; Basic carbohydrate counting; Advanced carbohydrate counting; Carbohydrates; Diet

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c

  mmol/mol

  Baseline, 6 months

• Change in mean amplitude of glycaemic excursions (MAGE)

  mmol/l

  Baseline, 6 months

Secondary Outcomes (31)

• 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

Other Outcomes (2)

• Change in physical activity level

  Baseline, 6 months, 12 months

• Change in urinary biomarkers of carbohydrate intake

  Baseline, 6 months

Study Arms (3)

BCC intervention

EXPERIMENTAL

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

Behavioral: BCC intervention

ABC-ACC intervention

EXPERIMENTAL

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

Behavioral: ABC-ACC intervention

Standard dietary education

ACTIVE COMPARATOR

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

Behavioral: Standard dietary education

Interventions

BCC intervention BEHAVIORAL

Structured training and education i basic carbohydrate counting principles

Also known as: Basic carbohydrate counting

BCC intervention

ABC-ACC intervention BEHAVIORAL

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

Also known as: Advanced carbohydrate counting with a bolus calculator

ABC-ACC intervention

Standard dietary education BEHAVIORAL

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

Also known as: Routine dietary care

Standard dietary education

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes
• Diabetes duration; \>12 months
• HbA1c of 53-97 mmol/mol
• Multiple daily insulin injection therapy
• Provided voluntary written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• University of Copenhagen: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, DK-2820, Denmark

Location

Related Publications (1)

• Ewers B, Vilsboll T, Andersen HU, Bruun JM. The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes. BMJ Open. 2019 Sep 3;9(9):e029859. doi: 10.1136/bmjopen-2019-029859.

  PMID: 31481560 DERIVED

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bettina Ewers, MSc

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nutrition

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 9, 2018
• Study Start: September 28, 2018
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)