Type II DiabetesDMNCT04843592
SOKARY Mobile Application With Type II Diabetes
An observational study of Type II Diabetes, run by Magda Bayoumi at 1 site in Egypt.
Trial summary
Android mobile application named (SOKARY) Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- SOKARY Mobile
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2019to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patient with type II DM
Who may be able to join
- Be familiar with the use of mobile health applications.
- Own a smartphone with an android operating system.
- Able to use the internet either through Wi-Fi network and\or mobile data.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Using SOKARY Mobile Application on Compliance of Patient With Type II Diabetes: A Quasi- Experimental Study
Android mobile application named (SOKARY)
Read the detailed description
Android mobile application named (SOKARY) which means diabetes was selected as an example of mobile health application as it has the advantage of Arabic interface, free use it allows users to record his/their blood glucose level, nutrition and physical activity, then provide the user with statistics for those readings. The application also sends notifications to the users such as medication reminders and healthy lifestyle advice.
- Conditions
- Type II Diabetes
- Being tested
- SOKARY Mobile
- Keywords
- Mobile phone application, DM type II, EGYPT, Compliance
- Medical subject headings
- Diabetes Mellitus, Type 2, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOKARY MobileDevice
Effectiveness of using SOKARY Mobile Application on compliance of patient with Type II diabetes
| Study group | Role | What they receive |
|---|---|---|
| Type II diabetes | using mobile app Receives: Device: SOKARY Mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
the patient's compliance after using SOKARY mobile app
Increase level of Patients' compliance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start30 Aug 2019
- Primary completion15 Dec 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magda Bayoumi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Magda Bayoumi, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843592
- Sponsor's protocol ID
- EC10082019
- Acronym
- DM
- Status last verified
- Aug 2019
- First submitted
- 9 Apr 2021
- Last updated
- 13 Apr 2021
- 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 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using SOKARY Mobile Application on Compliance of Patient With Type II Diabetes: A Quasi- Experimental Study
- ClinicalTrials.gov ID
- NCT04843592
- Acronym / sponsor ID
- DM / EC10082019
- Conditions
- Type II Diabetes
- Keywords
- Mobile phone application, DM type II, EGYPT, Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Magda BayoumiUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 13 Apr 2021 (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.
Android mobile application named (SOKARY)
Detailed description
Android mobile application named (SOKARY) which means diabetes was selected as an example of mobile health application as it has the advantage of Arabic interface, free use it allows users to record his/their blood glucose level, nutrition and physical activity, then provide the user with statistics for those readings. The application also sends notifications to the users such as medication reminders and healthy lifestyle advice.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type II diabetes | – | Device: SOKARY Mobileusing mobile app |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patient with type II DM
Key inclusion criteria (3 listed)
- Be familiar with the use of mobile health applications.
- Own a smartphone with an android operating system.
- Able to use the internet either through Wi-Fi network and\or mobile data.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SOKARY MobileEffectiveness of using SOKARY Mobile Application on compliance of patient with Type II diabetes | Device | Type II diabetes |
Primary outcome
the patient's compliance after using SOKARY mobile app
Time frame: 3 months
Increase level of Patients' compliance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Type II Diabetes, run by Magda Bayoumi 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 3 inclusion and 1 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 13 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the patient's compliance after using SOKARY mobile app (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 13 Apr 2021.