NCT07359196

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

January 1, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 10, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 1, 2026

Last Update Submit

January 13, 2026

Conditions

Type 1 Diabetes Mellitus

Keywords

HA1cGlycemic controlNutrition educationPedCarbQuizCarbohydrate counting

Outcome Measures

Primary Outcomes (1)

  • change in HbA1c

    3 months

Secondary Outcomes (1)

  • Change in Carbohydrate counting knowledge

    base line and 3 months

Study Arms (1)

Educational intervention ( knowledge)

EXPERIMENTAL

Participants receiving carbohydrate counting education.

Behavioral: Carbohydrate Counting Education

Interventions

Carbohydrate Counting EducationBEHAVIORAL

educational session on carbohydrate counting and insulin dose adjustment.

Educational intervention ( knowledge)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Family Medicine

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 22, 2026

Study Start

January 10, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01