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

NCT03623113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-01-05

No results posted yet for this study

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.

Conditions

  • Type1diabetes
  • Type1 Diabetes Mellitus
  • Glucose Metabolism Disorders

Interventions

BEHAVIORAL

BCC intervention

Structured training and education i basic carbohydrate counting principles

BEHAVIORAL

ABC-ACC intervention

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

BEHAVIORAL

Standard dietary education

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

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Bettina Ewers, MSc · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2022-08-17
Completion
2022-08-17

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623113 on ClinicalTrials.gov