Non-compliance on Treatment Among Diabetic Students at Sohag University

An observational study of Diabetes Mellitus, Type 1, run by Sohag University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A cross-sectional study on diabetic students in Sohag University will be conducted to collect data about factors affecting compliance and adherence to diabetes treatment and its impact on development of complications. Read more about this study

Who is it for?: Ages 17 to 25 years
Conditions the study is for: Diabetes Mellitus, Type 1
How many people: 153 participants
Where: 1 siteEgypt
Study dates: 15 Mar 2022to 30 Nov 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 to 25 years
All sexes
No healthy volunteers
Child, Adult

Study population: all the diabetic students in sohag university from different faculties

Who may be able to join

Diabetic students at Sohag University age from 17 to 25

Who cannot join

Healthy students
Students in other universities

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of medicine Sohag University
Sohag, 82524

Other trials in Egypt

About this study

Read the detailed description

Personal interviews with diabetic students through a questionnaire :

To determine factors affecting non compliance on treatment among diabetic students.
To detect relation between non compliance on treatment and development of complications.

Conditions: Diabetes Mellitus, Type 1
Medical subject headings: Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

Distribution of Participants Responses as Regards DSMQ Glucose Management Domain
through a standardized questionnaire DSMQ (Diabetes self management questionnaire)
Measured: 2 months
Distribution of Participants Responses as Regards DSMQ Dietary Control Domain
non compliance on treatment among diabetic students
Measured: 2 months
Distribution of Participants Responses as Regards DSMQ Physical Activity Domain
mesurment of non compliance among diabetic students at sohag university
Measured: 2 months
Distribution of Participants Responses as Regards DSMQ Health Care Use Domain
measurment of non compliance among diabetic students at sohag university
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202230 Nov 2022

First posted18 Mar 2022
Study start15 Mar 2022
Primary completion30 Nov 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 1Studies 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: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05286450
Sponsor's protocol ID: Soh-Med-22-03-14
Status last verified: Dec 2022
First submitted: 9 Mar 2022
Last updated: 10 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-compliance on Treatment Among Diabetic Students at Sohag University
ClinicalTrials.gov ID: NCT05286450
Acronym / sponsor ID: Soh-Med-22-03-14
Conditions: Diabetes Mellitus, Type 1
Study type: Observational
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Sohag UniversityUniversity, hospital or other
Study start: 15 Mar 2022 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 18 Mar 2022 (actual)
Results: Posted 10 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Personal interviews with diabetic students through a questionnaire :

To determine factors affecting non compliance on treatment among diabetic students.
To detect relation between non compliance on treatment and development of complications.

Study design

Observational model: Other
Time perspective: Cross-sectional

Who may qualify

Ages: 17 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: all the diabetic students in sohag university from different faculties

Key inclusion criteria (1 listed)

Diabetic students at Sohag University age from 17 to 25

Key exclusion criteria (2 listed)

Healthy students
Students in other universities

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Distribution of Participants Responses as Regards DSMQ Glucose Management Domain
Time frame: 2 months
through a standardized questionnaire DSMQ (Diabetes self management questionnaire)
Distribution of Participants Responses as Regards DSMQ Dietary Control Domain
Time frame: 2 months
non compliance on treatment among diabetic students
Distribution of Participants Responses as Regards DSMQ Physical Activity Domain
Time frame: 2 months
mesurment of non compliance among diabetic students at sohag university
Distribution of Participants Responses as Regards DSMQ Health Care Use Domain
Time frame: 2 months
measurment of non compliance among diabetic students at sohag university

Results and safety

Results posted to the registry on 10 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetic Students at Sohag University	153	153

Primary outcome: Distribution of Participants Responses as Regards DSMQ Glucose Management Domain

Time frame: 2 months. Count of participants. Unit: Participants

Measure	Diabetic Students at Sohag University n = 153
I check my blood sugar levels with care and attention.: Does not apply to me	13
I check my blood sugar levels with care and attention.: Applies to me to some degree	56
I check my blood sugar levels with care and attention.: Applies to me to a consider-able degree	39
I check my blood sugar levels with care and attention.: Applies to me very much	45
I take my diabetes medication (e. g. insulin, tablets) as prescribed: Does not apply to me	1
I take my diabetes medication (e. g. insulin, tablets) as prescribed: Applies to me to some degree	12
I take my diabetes medication (e. g. insulin, tablets) as prescribed: Applies to me to a consider-able degree	32
I take my diabetes medication (e. g. insulin, tablets) as prescribed: Applies to me very much	108

Primary outcome: Distribution of Participants Responses as Regards DSMQ Dietary Control Domain

Time frame: 2 months. Count of participants. Unit: Participants

Measure	Diabetic Students at Sohag University n = 153
The food I choose to eat makes it easy to achieve optimal blood sugar levels.: Does not apply to me	12
The food I choose to eat makes it easy to achieve optimal blood sugar levels.: Applies to me to some degree	71
The food I choose to eat makes it easy to achieve optimal blood sugar levels.: Applies to me to a consider-able degree	43
The food I choose to eat makes it easy to achieve optimal blood sugar levels.: Applies to me very much	27
Occasionally I eat lots of sweets or other foods rich in carbohydrates: Does not apply to me	33
Occasionally I eat lots of sweets or other foods rich in carbohydrates: Applies to me to some degree	52
Occasionally I eat lots of sweets or other foods rich in carbohydrates: Applies to me to a consider-able degree	50
Occasionally I eat lots of sweets or other foods rich in carbohydrates: Applies to me very much	18

Primary outcome: Distribution of Participants Responses as Regards DSMQ Physical Activity Domain

Time frame: 2 months. Count of participants. Unit: Participants

Measure	Diabetic Students at Sohag University n = 153
I do regular physical activity to achieve optimal blood sugar levels.: Does not apply to me	90
I do regular physical activity to achieve optimal blood sugar levels.: Applies to me to some degree	31
I do regular physical activity to achieve optimal blood sugar levels.: Applies to me to a consider-able degree	18
I do regular physical activity to achieve optimal blood sugar levels.: Applies to me very much	14
I avoid physical activity, although it would improve my diabetes.: Does not apply to me	42
I avoid physical activity, although it would improve my diabetes.: Applies to me to some degree	45
I avoid physical activity, although it would improve my diabetes.: Applies to me to a consider-able degree	14
I avoid physical activity, although it would improve my diabetes.: Applies to me very much	52

Primary outcome: Distribution of Participants Responses as Regards DSMQ Health Care Use Domain

Time frame: 2 months. Count of participants. Unit: Participants

Measure	Diabetic Students at Sohag University n = 153
I keep all doctors' appointments recommended for my diabetes treatment: Does not apply to me	40
I keep all doctors' appointments recommended for my diabetes treatment: Applies to me to some degree	60
I keep all doctors' appointments recommended for my diabetes treatment: Applies to me to a consider-able degree	26
I keep all doctors' appointments recommended for my diabetes treatment: Applies to me very much	27
I tend to avoid diabetes-related doctors' appointments: Does not apply to me	72
I tend to avoid diabetes-related doctors' appointments: Applies to me to some degree	46
I tend to avoid diabetes-related doctors' appointments: Applies to me to a consider-able degree	23
I tend to avoid diabetes-related doctors' appointments: Applies to me very much	12

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetic Students at Sohag University	0 of 153 (0%)	0 of 153 (0%)	0 of 153

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus, Type 1

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

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. This study is not recruiting at the moment.

Samah W. Elkhayat, demonstrator principal investigator

Faculty of Medicine Sohag University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Sohag University at 1 site in Egypt.

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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Distribution of Participants Responses as Regards DSMQ Glucose Management Domain (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05286450.

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 10 Oct 2023.