Type 1 Diabetes MellitusNCT07359196
Assessment of Carbohydrate Counting Accuracy and Glycemic Control Among Sohag University Students With Type 1 Diabetes
A study testing Carbohydrate Counting Education in people with Type 1 Diabetes Mellitus, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Carbohydrate Counting Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of T1DM for at least 1 year.
- Age ≥18 years.
- Currently enrolled at Sohag University.
- Willing to participate and provide informed consent.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Carbohydrate Counting Education
- Keywords
- HA1c, Glycemic control, Nutrition education, PedCarbQuiz, Carbohydrate counting
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Counting EducationBehavioural
educational session on carbohydrate counting and insulin dose adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention ( knowledge) | Experimental | Participants receiving carbohydrate counting education. Receives: Behavioral: Carbohydrate Counting Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c
Measured: 3 months
Secondary outcomes (1)
Change in Carbohydrate counting knowledge
Using PedCarbQuiz
Measured: base line and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzahraa Abdellatif Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359196
- Sponsor's protocol ID
- Soh-Med--25-12-10MD
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Carbohydrate Content Estimation Among Sohag University Students With Type 1 Diabetes Mellitus and Their Glycemic Control
- ClinicalTrials.gov ID
- NCT07359196
- Acronym / sponsor ID
- Soh-Med--25-12-10MD
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- HA1c, Glycemic control, Nutrition education, PedCarbQuiz, Carbohydrate counting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational intervention ( knowledge) | Experimental | Behavioral: Carbohydrate Counting EducationParticipants receiving carbohydrate counting education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of T1DM for at least 1 year.
- Age ≥18 years.
- Currently enrolled at Sohag University.
- Willing to participate and provide informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate Counting Educationeducational session on carbohydrate counting and insulin dose adjustment. | Behavioural | Educational intervention ( knowledge) |
Primary outcome
change in HbA1c
Time frame: 3 months
1 secondary outcome
Change in Carbohydrate counting knowledge
Time frame: base line and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Counting Education in people with Type 1 Diabetes Mellitus, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.