Skip to main content
OpenTrials
Completed

NCT Number: NCT07834801

Structured Carbohydrate-Counting Education in Adults With Type 1 Diabetes

This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed at baseline and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turkish Diabetes Foundation Küçükyalı Internal Medicine Center

Istanbul, Turkey (Türkiye)

About this study

This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed before and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 19-65 years Diagnosis of type 1 diabetes for at least 1 year Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion HbA1c ≤10% Body mass index (BMI) 19-30 kg/m² C-peptide <0.8 ng/mL Use of a continuous glucose monitoring system No communication difficulties No previous knowledge of carbohydrate counting and willingness to receive carbohydrate-counting education -

Exclusion criteria

Gastroparesis Diabetic nephropathy Pregnancy Celiac disease Eating disorder Food allergy Gastrointestinal disease or malabsorption Inability to adhere to the study protocol Withdrawal of consent Discontinuation of continuous glucose monitoring during follow-up

-

Treatment and study plan

Carbohydrate Counting Education

Behavioral

Personalized carbohydrate counting training based on the individual's meals, carbohydrate intake, and insulin-to-carbohydrate ratio.

Primary outcomes

  1. Glycemic control/CGM metrics

    Time frame: 12 week

    Time in range (TIR) was assessed using continuous glucose monitoring (CGM) data and defined as the percentage of time that sensor glucose values remained within the target range of 70-180 mg/dL. The change in TIR was evaluated from baseline to the end of the 12-week intervention.

  2. Glycemic control/CGM metrics

    Time frame: 12 weeks

  3. Change in Time in Range (70-180 mg/dL)

    Time frame: Baseline and 12 weeks

    Time in range (TIR) was assessed using continuous glucose monitoring (CGM) data and defined as the percentage of time that sensor glucose values were within the target range of 70-180 mg/dL. Change in TIR was evaluated from baseline to the end of the 12-week intervention.

Secondary outcomes

  1. Change in Glycemic Variability

    Time frame: Baseline and 12 weeks

    Glycemic variability was assessed using the coefficient of variation (CV) derived from continuous glucose monitoring (CGM) data. Change in CV was evaluated from baseline to the end of the 12-week intervention.

  2. Change in Laboratory-Measured HbA1c

    Time frame: Baseline and 12 weeks

    HbA1c was measured using laboratory analysis. Change in HbA1c was evaluated from baseline to the end of the 12-week intervention.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

The Evaluation of the Effects of Structured Carbohydrate-Counting Education on Glycemic Control, Insulin Requirements, Anthropometric Measurements, and Dietary Intake in Adults With Type 1 Diabetes.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.