Assessment of Carbohydrate Counting Accuracy and Glycemic Control Among Sohag University Students With Type 1 Diabetes

January 13, 2026 updated by: Elzahraa Abdellatif Mohamed, Sohag University

Assessment of Carbohydrate Content Estimation Among Sohag University Students With Type 1 Diabetes Mellitus and Their Glycemic Control

This study assesses carbohydrate counting knowledge and its impact on glycemic control among Sohag University students with type 1 diabetes mellitus. A structured educational intervention will be delivered, followed by reassessment after three months.

Study Overview

Status

Not yet recruiting

Detailed Description

This interventional study targets undergraduate students diagnosed with type 1 diabetes mellitus at Sohag University. Baseline data will include demographic characteristics, diabetes-related history, carbohydrate counting knowledge assessed using the PedCarbQuiz, and glycemic control parameters including HbA1c.

Participants will receive a structured educational session focusing on carbohydrate counting principles and insulin dose adjustment. Educational booklets will be provided. After three months, carbohydrate counting knowledge and glycemic control will be reassessed to evaluate the effectiveness of the intervention.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

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

Description

Inclusion Criteria:

  1. Confirmed diagnosis of T1DM for at least 1 year.
  2. Age ≥18 years.
  3. Currently enrolled at Sohag University.
  4. Willing to participate and provide informed consent.

Exclusion Criteria:

  1. University students who refuse to participate in the study
  2. Students with other types of diabetes (T2DM, MODY, etc.)
  3. Presence of other chronic illnesses that affect diet or glycemic control (e.g., celiac disease, chronic kidney disease).
  4. Students with communication barriers e.g cognitive impairment or psychiatric illness interfering with questionnaire completion.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational intervention ( knowledge)
Participants receiving carbohydrate counting education.
educational session on carbohydrate counting and insulin dose adjustment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in HbA1c
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Carbohydrate counting knowledge
Time Frame: base line and 3 months
Using PedCarbQuiz
base line and 3 months

Collaborators and Investigators

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

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 (Estimated)

January 10, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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