- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359196
Assessment of Carbohydrate Counting Accuracy and Glycemic Control Among Sohag University Students With Type 1 Diabetes
Assessment of Carbohydrate Content Estimation Among Sohag University Students With Type 1 Diabetes Mellitus and Their Glycemic Control
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed diagnosis of T1DM for at least 1 year.
- Age ≥18 years.
- Currently enrolled at Sohag University.
- Willing to participate and provide informed consent.
Exclusion Criteria:
- University students who refuse to participate in the study
- Students with other types of diabetes (T2DM, MODY, etc.)
- Presence of other chronic illnesses that affect diet or glycemic control (e.g., celiac disease, chronic kidney disease).
- Students with communication barriers e.g cognitive impairment or psychiatric illness interfering with questionnaire completion.
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med--25-12-10MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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