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Completed

NCT Number: NCT06264271

The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes

The study aims to elucidate whether patients with T1D initiating sensor monitoring experience greater improvement in glycemic control (HbA1c) when provided with structured nutrition education compared to those initiating sensor monitoring without such education.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charles University

Prague, 12808, Czechia

About this study

Education on carbohydrate counting and flexible insulin dosing improves glycemic control, which is also enhanced by glucose sensor usage. However, the combined effect of structured education and the initiation of sensor monitoring remains unclear.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥ 18 years
  • type 1 diabetes duration for at least 12 months prior to sensor initiation
  • glucose sensor monitoring initiated at the Diabetes Centre of the General University Hospital in Prague

Exclusion criteria

  • uncertain diabetes type
  • pregnancy
  • change or suspension of glucose sensor monitoring during the study period
  • unavailability of sensor data
  • automated insulin delivery treatment

Treatment and study plan

structured nutrition intervention

Behavioral

Structured nutrition education on carbohydrate counting and flexible insulin dosing by qualified nutritionist.

Primary outcomes

  1. difference in HbA1c

    Time frame: at month 12

    the difference in HbA1c between the groups with and without education

Secondary outcomes

  1. differences in time in range

    Time frame: at month 12

    differences in time in range (percentages) (70-180 mg/dL [3.9-10.0 mmol/L]) between groups with and without education

  2. differences in time below range

    Time frame: at month 12

    differences in time below range (percentages) in level 1 hypoglycemia (54-69 mg/dL [3.0-3.8 mmol/L]), level 2 hypoglycemia (<54 mg/dL [<3.0 mmol/L]) between groups with and without education

  3. differences in time above range

    Time frame: at month 12

    differences in time above range (percentages) (>181 mg/dL [>10.1 mmol/L]) between groups with and without education

  4. differences in coefficient of variation

    Time frame: at month 12

    differences in coefficient of variation between groups with and without education

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • General University Hospital, Prague

Registry information

Official study title

The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes Initiating the Use of Glucose Sensors

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 16, 2024
Registry last updated
Feb 20, 2024

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.

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