The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes
NCT ID: NCT03623113
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
63 participants
INTERVENTIONAL
2018-09-28
2022-08-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes
NCT03623139
Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic
NCT05163002
An Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 Diabetes
NCT02462785
DM1, Effects of Carbo-Counting on Glycemic Control
NCT03554590
Eating Disorder Prevention Program for Women With T1D
NCT05264376
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BCC intervention
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
BCC intervention
Structured training and education i basic carbohydrate counting principles
ABC-ACC intervention
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
ABC-ACC intervention
Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate
Standard dietary education
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
Standard dietary education
Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diabetes duration; \>12 months
* HbA1c of 53-97 mmol/mol
* Multiple daily insulin injection therapy
* Provided voluntary written informed consent
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Copenhagen
OTHER
Steno Diabetes Center Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bettina Ewers
Head of Nutrition
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bettina Ewers, MSc
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Steno Diabetes Center Copenhagen
Gentofte Municipality, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-18014897
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.