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

February 16, 2024 updated by: Eva Horová, MD, Charles University, Czech Republic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

329

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 12808
        • Charles University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients age ≥ 18 years, T1D duration for at least 12 months prior to sensor initiation, and all sensor monitoring initiated at the Diabetes Centre of the General University Hospital in Prague.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group with nutrition education
Patients who experienced at least one structured education session between 24 months before sensor initiation and 6 months after sensor initiation were allocated to the group with education.
Behavioral: structured nutrition intervention
Structured nutrition education on carbohydrate counting and flexible insulin dosing by qualified nutritionist.
Group without nutrition education
Patients who received standard care, which may have included short education during routine visits or self-education through online resources or educational materials, were assigned into the group without education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in HbA1c
Time Frame: at month 12
the difference in HbA1c between the groups with and without education
at month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at month 12
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
at month 12
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
at month 12
differences in coefficient of variation
Time Frame: at month 12
differences in coefficient of variation between groups with and without education
at month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

General University Hospital, Prague

Investigators

  • Principal Investigator: Eva Horová, 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIP-22-NL-06-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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